Patent Publication Number: US-8968267-B2

Title: Methods and systems for handling or delivering materials for natural orifice surgery

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to Provisional Application No. 61/371,361, filed Aug. 6, 2010, which is herein incorporated by reference in its entirety. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     This invention was made with government support under Grant No. 2611120123004 awarded by the Department of Defense Telemedicine and Advanced Technology Research Center (TATRC). Accordingly, the government may have certain rights in the invention. 
    
    
     TECHNICAL FIELD 
     The present invention relates to various material handling and/or delivery systems and related components, including material handling and/or delivery systems for performing surgical procedures through a natural orifice or a single incision. Certain embodiments include various material handling and/or systems for performing surgical procedures in the peritoneal cavity of a patient. 
     BACKGROUND 
     Endoscopic medical procedures have been in use for nearly a century, and are used for a number of procedures such as foreign object removal, ultrasonic imaging, injection therapy, and perhaps most recently for surgical procedures. Endoluminal endoscopic surgery traditionally uses flexible instruments introduced through canals (working channels) in an endoscope to perform a number of procedures, mainly in the peritoneal cavity. 
     Natural orifice translumenal endoscopic surgery (NOTES) is a surgical procedure done endoscopically through an incision in tissue (e.g., stomach, colon, vagina, or bladder) accessible via a natural orifice (e.g., mouth, anus, urethra, or vagina) and can be done without external incisions, reducing the risk of infection and speeding recovery. The natural orifice access point, while having many patient benefits, presents challenges for introducing instrumentation through a restrictive lumen size, and when using multiple tools, as typical in many laparoscopic procedures for example, tool triangulation can be difficult. 
     An alternative to traditional endoscope based techniques is using in vivo robots via a natural orifice approach. These in vivo robots can be fully introduced into the peritoneal cavity. Once inserted, these robots have much more freedom and flexibility, as space constraints and tool triangulation issues are greatly reduced in the insufflated abdominal cavity. 
     Fully inserting in vivo robots into the body introduces a limitation as they are physically isolated from the medical professionals performing the procedure. Without external incisions, there is also a need for additional functional features, such as workspace lighting, a method of irrigating and evacuating fluids produced during procedures, and any other functionalities commonly associated with traditional endoscopic procedures. 
     There is a need for an improved material handling system for use with surgical procedures. 
     SUMMARY 
     One embodiment disclosed herein relates to a system for handling and/or delivering materials during endoscopic surgery, the system including a compliant overtube, a material capture device, and a drive member. 
     In one embodiment, a system provided herein is configured to transport a material between the outside of an endoscopic surgery patient and the inside of the endoscopic surgery patient, the system comprising a compliant overtube having a primary lumen and a proximal end and a distal end; a material capture device including a retaining mechanism disposed within the primary lumen; and a drive member configured to shuttle the material capture device between the proximal end and the distal end. The drive member can be a helical drive member disposed within the primary lumen. The capture device can further include a tab that can be disposed between adjoining coils of the helical drive member and the slot further can be disposed into a slot defined in the wall of the primary lumen. The slot can constrain the orientation of the material capture device within the primary lumen. 
     In another embodiment, the system can have a drive member that is a hydraulic or pneumatic system. 
     In some embodiments, the retaining mechanism comprises a passive spring-type grasper, which, in some embodiments, can comprise a shape memory alloy. A passive spring-type grasper retaining mechanism can be shaped into a plateau-like profile. 
     In some embodiments, the system can include a motor that drives the drive member housed within an electronic housing. Motor controls can be disposed on or within the electronic housing, or the motor can be controlled using components remote from the electronic housing. 
     In some embodiments, the system is configured for use in transgastric endoscopic surgery. 
     In some embodiments, the system includes a compliant overtube comprising silicone. 
     In one embodiment, a method for transporting a material between the outside of an endoscopic surgery patient and the inside of the endoscopic surgery patient is provided. The method comprises inserting through an incision in the endoscopic surgery patient a distal end of a compliant overtube having: a primary lumen; a material capture device comprising a retaining mechanism disposed within the primary lumen; and a drive member configured to shuttle the material capture device between the proximal end and the distal end. The method further comprises retaining the material in the retaining mechanism of the material capture device and actuating the drive member to advance the material capture device and the retained material from the inside of the patient to the outside of the patient or from the outside of the patient to the inside of the patient. The drive member can be a helical drive member disposed within the primary lumen, or the drive member can be a hydraulic or pneumatic system. 
     In some embodiments, the distal end of the compliant overtube is inserted through an incision that is in a tissue that is accessible through a natural orifice. 
     In some embodiments, the retaining mechanism comprises a passive spring-type grasper, which, in some embodiments, can comprise a shape memory alloy. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. 
     Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an isometric view of the material handling system, according to one embodiment. 
         FIG. 2  is a cross sectional view of a distal portion of a material handling system, according to one embodiment. 
         FIG. 3  is a side view of a material capture device of a material handling system, according to one embodiment. 
         FIG. 4  is a view of a portion of a material handling system with the exterior shown transparently to reveal inner components, according to one embodiment. 
         FIG. 5A  is a cross sectional view of a material capture device orientation mechanism for a material handling system, according to one embodiment. 
         FIG. 5B  is a cross sectional view of a material capture device orientation mechanism for a material handling system, according to another embodiment. 
         FIG. 6  is a perspective view of a distal portion of the material handling system, according to one embodiment. 
         FIG. 7  is a top view of a motor assembly, a micro-control unit, and a power source for a material handling system, according to one embodiment. 
     
    
    
     It is to be understood that the figures are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated, relative to other elements, to improve the understanding of aspects and sample embodiments of the invention. 
     DETAILED DESCRIPTION 
     The various systems and devices disclosed herein relate to devices for use in medical procedures and systems. More specifically, the various embodiments relate to systems that can be used to handle and/or deliver materials in endoscopic surgery, such as natural orifice translumenal endoscopic surgery (NOTES). Various embodiments of the disclosed systems and devices can be used to handle and/or deliver or transport one or more materials between the outside of an endoscopic surgery patient and the inside of the endoscopic surgery patient. In some embodiments, the provided systems improve the ability of a medical professional to perform surgical procedures in the peritoneal cavity of a patient, executed through a natural orifice or other access point in conjunction with other surgical equipment. 
     Certain embodiments disclosed herein relate to devices for use in endoscopic surgery, including certain embodiments for use in natural orifice translumenal endoscopic surgery (NOTES).  FIG. 1  depicts one embodiment of a material handling and/or delivery system  100  having a proximal end  10  and a distal end  20 . In the material handling system  100  depicted in  FIG. 1 , the system includes an electronics housing  30  and a material handling component  50 . 
     As best shown in  FIGS. 1 and 2 , the material handling component  50  comprises a compliant overtube  200  having a proximal end  60  and a distal end  70  and including a primary lumen  210  disposed therethrough. In some embodiments, one or more additional lumens  230 ,  240  are also disposed within and along the length of overtube  200 , as best shown in  FIG. 2 . The compliant overtube  200  comprises one or more materials that impart flexibility and frictional properties that are conducive to abrasion resistance, while reducing the amount of trauma caused to a patient by the overtube  200  during a surgical procedure. In one embodiment, the overtube  200  is capable of bending to the contours of a natural orifice, such as the esophagus, as well as the peritoneal cavity. 
     Materials suitable for use in the overtube  200  include, for example, silicone, PTFE, or vinyl. The type of material selected for use in the overtube  200  may depend on the specific use. For example, silicone may be used in an overtube  200  for use in transgastric NOTES in order to provide sufficient flexibility along the length of the esophagus. In addition, in some embodiments, the properties of the material used for the overtube  200  may be modified using known techniques to provide the desired flexibility, frictional properties, and/or abrasion resistance. For example, the coefficient of friction of materials (e.g., silicone and other rubbery materials) can be decreased by the addition of wet and/or dry lubricants, or permanently bonded coatings. 
     Overtube  200  is shaped and dimensioned as appropriate for the desired use. For example, an overtube  200  for use in transgastric NOTES can have an outer surface of any shape to accommodate the primary lumen  210  and any other lumens, so long as the overall diameter allows the overtube  200  to traverse an esophagus having an average bend radius of about 7.5 cm. 
     As best shown in  FIGS. 2-4 , in one embodiment, a material capture device  220  is slidably housed within the primary lumen  210  of the overtube  200 . A retaining mechanism  208  is coupled with the material capture device  220  to releasably secure one or more materials (e.g., sutures, excised tissue, tool tips, waste bags, diagnostic sensors, or the like) to the material capture device  220 . As best shown in  FIG. 3 , in one embodiment, the retaining mechanism  208  is a passive spring-type grasper comprising, for example a shape memory alloy (e.g., nickel-titanium, copper-zinc-aluminum-nickel, or copper-aluminum-nickel). In this embodiment, the retaining mechanism  208  is a thin ribbon of super-elastic shape memory alloy shaped into a plateau-like profile in its resting state (shown as dark heavy lines in  FIG. 3 ). The spring-type grasper retaining mechanism  208  shown in  FIG. 3  deforms (shown in light lines  208   a ) to accommodate the insertion of a material  600 . In some embodiments, the retaining mechanism  208  can comprise a plurality of passive spring-type graspers and/or an alternative passive spring-type grasper configuration, such as a multipronged grasper (e.g., 3- or 4-pronged grasper; not shown). Alternatively, the retaining mechanism  208  can be an actively actuated grasper, such as in a hinged jaw configuration (not shown). In some embodiments, the retaining mechanism  208  is actuated using a linear, rotary, hydraulic, or pneumatic actuator (not shown). 
     Material capture device  220  and retaining mechanism  208  are configured such that, as the material capture device  220  slides between the proximal and distal ends  60 ,  70  of the compliant overtube  200 , the one or more materials are transported between the proximal and distal ends  60 ,  70  of compliant overtube  200 . The material capture device  220  is dimensioned and shaped as appropriate to accommodate a desired retaining mechanism  208  and to allow access to the retaining mechanism  208  at both the proximal  60  and distal  70  ends of the compliant overtube. In the embodiment shown in  FIG. 3 , the material capture device  220  is shaped as a hollow section of tube within which a retaining mechanism  208  can be inserted and affixed. 
     As best shown in  FIG. 4 , a rotating helical drive member  206  is disposed within the primary lumen  210  of compliant overtube  200 . In one embodiment, as best shown in  FIGS. 4 and 5A , the material capture device  220  is dimensioned to fit within drive member  206  and is operably associated with the drive member  206  via an attached tab  204   a  that can be disposed between adjoining coils of the helical drive member  206 . Slot  204   b  defined in the wall of primary lumen  210  constrains the orientation of tab  204   a , and thereby the orientation of material capture device  220 , such that rotation of drive member  206  causes translation of the material capture device  220  axially along the compliant overtube  200 . 
     Alternatively, as best shown in  FIG. 5B , the overtube  200  comprises offset tabs  500   a  disposed along the length of the interior of primary lumen  210  and material capture device  220  comprises shuttle tabs  500   b  to orient the material capture device  220  with respect to the compliant overtube  200 . 
     In a further alternative, the material capture device  220  can have any known structure for allowing the device  220  to be urged along the length of the overtube  200 . 
     As best shown in  FIGS. 1 and 6 , the drive member  206  of  FIG. 4  is retained within the compliant overtube  200  by an overtube cap  202  on the distal end  70  of compliant overtube  200  and with an overtube coupling  42  on the proximal end  60 . In one embodiment the overtube cap  202  is configured to provide an access point to interface with other surgical equipment (not shown), such as an in vivo robot, while minimizing the overall diameter of the end of the material delivery system  100  that may be inserted into a patient, thus reducing procedural trauma on surrounding tissues. In some embodiments, the overtube cap  202  is configured to retain the drive member  206  while allowing medical professionals to access the material capture device  220 . In another embodiment, the overtube coupling  42  is configured to provide access to the material capture device  220  and provide a location to couple the compliant overtube  200  to the rest of the material handling system  100 . 
     As best shown in  FIGS. 1 and 7 , drive member  206  of  FIG. 4  is coupled to motor  400  via a motor coupling  40 . The drive member  206  can be releasably coupled to the motor coupling  40 , such that the material handling component  50  is detachable from the electronic housing  30 . The motor coupling  40  can be a two-piece design, with one half rigidly attached to the motor  400 , and the other rigidly attached to the drive member  206 , allowing for detachment of the drive member  206  from the motor  400  such that a medical professional can access the material capture device  220 . To ensure proper alignment of the compliant overtube  200  and drive member  206  to the motor  400 , an overtube coupling  42  as shown in  FIG. 1  can be attached near the proximal end of the overtube  200  and coupled to the base plate  32  via an overtube mount  406  located on the base plate  32  ( FIG. 7 ). In one embodiment, the overtube mount  406  may utilize permanent magnets, embedded both in the base plate  32  and in the overtube coupling  42 , enabling positive coupling and quick removal and re-attachment of the material handling component  50  to the electronic housing  30  when a medical professional accesses the material capture device  220 . 
     In another embodiment (not shown), the drive member may be a hydraulic or pneumatic system where a secondary lumen  230  or tertiary lumen  240  as shown in  FIG. 2  may be used as a hydraulic or pneumatic channel to drive the material capture device  220 . In this embodiment, the motor  400  may be substituted with a hydraulic or pneumatic apparatus. 
     Continuing with  FIGS. 1 and 7 , in some embodiments, the motor  400  is housed in an electronic housing  30  comprising a baseplate  32  and a top plate  34  that are removably attached to one another. In some embodiments, the motor  400  is attached to the baseplate  32  and/or the top plate  34 . The electronic housing  30  can house additional components such as a micro-control unit  402  and/or a power supply  404  for motor  400 . The micro-control unit  402  and/or the power supply  404  can be attached to the base plate  32  and/or top plate  34  similarly to the motor  400 . The top plate  34  and base plate  32  can be made of materials suitable for protecting electronic components from damage. In some embodiments, the base plate  32  and/or top plate  34  may be omitted from the material handling system  100 . 
     In one embodiment, as best shown in  FIG. 1 , the top plate supports operational controls  36 . Operational controls  36  can include, for example, momentary contact pushbuttons for automatic and/or manual control of the motor  400 , which would propel the drive member  206 . Alternatively, operational controls  36  can be located on a separate component (e.g., a computer) that is in electronic communication with one or more components housed in the electronic housing  30 . 
     In one embodiment, the motor  400  may operate using an open-loop logic from a micro-control unit  402 . The motor speed and the number of coils per unit length of the drive member  206  can be adjusted to control the rate of speed at which the material capture device  220  traverses the length of the overtube  200 . For example, a rotation rate of 650 rpm with a drive member  206  having 3 coils per inch will allow the material capture device  220  to traverse an overtube  200  with a length of about 1 meter in 10 seconds. The motor speed and number of coils per unit length of the drive member  206  can additionally be adjusted to control the level of friction between the material capture device  220  and the drive member  206  and/or the overtube  200 . 
     The micro-control unit  402  can include a motor position sensor (not shown) that can be used to calculate the position of the material capture device  220  within compliant overtube  200  based on the rotation count of the motor  400  and the coil configuration of the drive member  206 . In one embodiment, as best shown in  FIG. 1 , the top plate houses one or more location indicators  38  that can be used to display the position of the material capture device  220  within compliant overtube  200 . 
     The provided material handling system  100  can be used to provide the bridge between other surgical instrumentation, such as in vivo robots, and medical professionals. To facilitate this function, the compliant overtube  200  may contain a secondary lumen  230  and/or a tertiary lumen  240 , as best shown in  FIG. 2 . These lumens may provide additional functionality for a medical professional, for example a lighting port, a video port and/or a port for suction and/or irrigation. In one embodiment, the secondary lumen  230  allows for insertion of a flexible fiberscope that has integrated lighting and video capabilities, and the tertiary lumen  240  has the structural integrity to sustain pressures from a suction/irrigation pump. Further lumens may also be provided. 
     In use, the material handling system  100  may be inserted into a person by a medical professional in a number of ways. In one embodiment, the compliant overtube  200  and the components located within may be passed through a natural orifice without active steering, relying only on the compliance in the system to guide the device into the peritoneal cavity. In another embodiment, an articulated fiberscope may be inserted into a secondary lumen  230 , after which the compliant overtube  200  and the components located within may be passed through a natural orifice, as a medical professional actively steers the device with the articulated fiberscope. In yet another embodiment, the drive member  206 , material capture device  200 , and overtube coupling  42  may be removed from the compliant overtube  200 , an articulated endoscope may be inserted into the lumen  210  where the removed components were located, after which the compliant overtube  200  may be passed through a natural orifice, as a medical professional actively steers the device using the articulated endoscope. The endoscope would then be removed, and the drive member  206 , material capture device  220 , and overtube coupling  42  may be reinstalled on the compliant overtube  200 . 
     Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the above described features.