Patent Publication Number: US-2022211385-A1

Title: Systems and methods for endoscopic submucosal dissection

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims benefit of and priority to U.S. Provisional Application No. 62/848,668, filed May 16, 2019, which is incorporated herein by reference in its entireties. 
    
    
     FIELD 
     The present technology is related generally to surgical clips used in endoscopic submucosal dissection. 
     BACKGROUND 
     Endoscopic resection has been accepted as a first choice for the treatment of early stage GI carcinomas because of reduced invasiveness and lower cost relative to other treatment options. Endoscopic submucosal resection (ESD) allows for an en bloc resection and accurate histopathological diagnosis regardless of the size, an existence of severe fibrosis at the submucosal layer, and the location of a lesion. One of the benefits of ESD is lower recurrence rates compared to endoscopic mucosal resection. During some ESD procedures, jaw members of a surgical clip are engaged to tissue. After performing the dissection, the jaw members are disengaged from the tissue. 
     SUMMARY 
     In one aspect, the present disclosure provides a surgical clip including an inner body, first and second jaw members coupled to the inner body, and a release lever. The first and second jaw members are configured to move between an open configuration and a closed configuration to grasp tissue therebetween. The release lever is movably coupled to the inner body and disposed adjacent a proximal end portion of the first jaw member. The release lever is engagable with the proximal end portion of the first jaw member to move a distal end portion of the first jaw member away from a distal end portion of the second jaw member. 
     In aspects, the release lever may include a proximal end portion accessible via a slot defined in the inner body. 
     In aspects, the release lever may have a distal end portion pivotably coupled to the inner body, and the proximal end portion of the release lever may be configured to pivot about the distal end portion thereof. 
     In aspects, the surgical clip may further include an outer body disposed about the inner body. The outer body may have a portion that defines a slot that overlaps the slot of the inner body. At least the portion of the outer body may have an oval transverse cross-sectional shape. 
     In aspects, the release lever may have a T-shaped configuration, and the inner body may define a T-shaped slot in which the release lever is received. 
     In aspects, the proximal end portion of the first jaw member is movably received in a longitudinally-extending channel defined in the inner body 
     In aspects, the channel may have an enlarged proximal end portion in which the proximal end portion of the first jaw member is received when the first and second jaw members are in the closed configuration. 
     In aspects, the release lever may have a tab received in the proximal end portion of the channel. 
     In aspects, the channel may have a distal end portion. The distal end portion of the first jaw member may move toward the distal end portion of the second jaw members as the proximal end portion of the first jaw member moves proximally through the distal end portion of the channel. 
     In aspects, the first and second jaw members may be configured to move through the channel between a proximal position, in which the first and second jaw members are selectively fixed in the closed configuration, and a distal position, in which the first and second jaw members are in the open configuration. 
     In aspects, the proximal end portion of the first jaw member may extend laterally from the first jaw member and be at least partially received in the channel. 
     In aspects, the surgical clip may further include a pivot member axially restrained with the first and second jaw members and axially slidable within the inner body, such that retraction of the pivot member approximates the first and second jaw members and advancement of the pivot member moves the first and second jaw members away from each other. 
     In aspects, the second jaw member may remain in a fixed position relative to the inner body when the release lever is actuated. 
     In accordance with another aspect of the disclosure, a surgical system for performing an endoscopic submucosal dissection is provided. The system includes a snare and a surgical clip. The surgical clip includes an inner body, first and second jaw members, and a release lever. The inner body defines a slot, and the first and second jaw members are at least partially received in the inner body. The first and second jaw members are configured to move between an open configuration and a closed configuration to grasp tissue therebetween. The release lever is movably coupled to the inner body and configured to be actuated by the snare via the slot in the inner body. The first jaw member has a distal end portion configured to move away from a distal end portion of the second jaw member in response to the snare actuating the release lever. 
     In aspects, the first jaw member may include a proximal end portion movably received within a channel defined in the inner body. 
     In aspects, the channel may have an enlarged proximal end portion in which the proximal end portion of the first jaw member is received when the first and second jaw members are in the closed configuration. 
     In aspects, the first and second jaw members may be configured to move through the channel between a proximal position, in which the first and second jaw members are releasably fixed in the closed configuration, and a distal position, in which the first and second jaw members are in the open configuration. 
     In aspects, the proximal end portion of the first jaw member may extend laterally from the first jaw member and be at least partially received in the channel. 
     In aspects, the second jaw member may remain in a fixed position relative to the inner body when the release lever is actuated by the snare. 
     In accordance with yet another aspect of the disclosure, a method of performing an endoscopic submucosal dissection is provided. The method includes deploying a surgical clip, approximating a pair of jaws of the surgical clip about tissue, and actuating a release lever of the surgical clip, whereby the release lever pivots the first jaw member away from the second jaw member to release the tissue from the first and second jaw members. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Objects and features of the presently disclosed surgical clips will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which: 
         FIG. 1  is a perspective view illustrating an exemplary embodiment of a hand-held surgical instrument including a handle assembly, a flexible shaft, and a surgical clip coupled to a distal end portion of the flexible shaft. 
         FIG. 2  is a side, perspective view illustrating the surgical clip of  FIG. 1 , with an outer body removed; 
         FIG. 3A  is a side view of an outer body and a release lever of the surgical clip of  FIG. 1 ; 
         FIG. 3B  is a side view of an inner body and the release lever of the surgical clip of  FIG. 1 ; 
         FIG. 3C  is a top view of the inner body and release lever of the surgical clip of  FIG. 1 ; 
         FIG. 4  is a perspective view illustrating a surgical system including the surgical clip of  FIG. 1  and a snare for releasing the surgical clip from tissue; and 
         FIG. 5  is a perspective view illustrating another aspect of an outer body of the surgical clip of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     The disclosure is generally directed to surgical clips including a tubular body, a pair of jaw members received in and deployable from the tubular body, and a release feature for selectively unlocking one of the jaw members. When the jaw members are closed about tissue and in a locked state, the jaw members may be released from the locked state by activating the release feature. These and other aspects of the present disclosure are described in greater detail below. 
       FIG. 1  illustrates a hand-held surgical instrument  10  for deploying a surgical clip  100 . The surgical instrument  10  generally includes a handle assembly or actuator  11 , a shaft  12  extending distally from the handle assembly  11 , and a surgical clip  100  detachably coupled to a distal end portion  14  of the shaft  12 . In some aspects, instead of the clip  100  being deployable from a hand-held instrument, the clip  100  may be deployed from a surgical robotic arm. 
     The surgical instrument  10  includes an actuation mechanism, such as, for example, a puller (not shown) axially movable within the shaft  12 . The puller may have a proximal end operably coupled to a trigger  15  of the handle assembly  11 , such that an actuation of the trigger  15  proximally translates the puller. The puller may have a distal end detachably coupled to the surgical clip  100 , such that proximal translation of the puller moves the surgical clip  100  from an open configuration to a closed configuration, as will be described. It is contemplated that the surgical instrument  10  may include any suitable actuation mechanism for deploying the surgical clip  100 , such as a drive rod or a drive tube. 
     With reference to  FIGS. 2-3C , the surgical clip  100  has a tubular outer body  102  and a tubular inner body  104  received in the outer body  102 . The outer body  102  is configured to be detachably coupled to the distal end  14  of the shaft  12 . In aspects, the shaft  12  may have a release latch (not shown) coupled to the outer body  102  and an actuation mechanism (e.g., a pull rod, not shown) for actuating the release latch to deploy the surgical clip  100  from the shaft  12 . The outer body  102  has a hollow interior and defines a slot  106  ( FIG. 3A ) providing access into the hollow interior. The inner body  104  defines first and second longitudinally-extending channels  108 ,  110  in a tubular wall  112  thereof. In some embodiments, the first and second channels  108 ,  110  may be joined, thereby forming one continuous channel, as shown in  FIG. 3B . The channels  108 ,  110  may cooperatively define a T-shaped configuration, wherein each of the channels  108 ,  110  has an enlarged proximal end portion  108   a ,  110   a , and a distal end portion  108   b ,  110   b . The tubular wall  112  of the inner body  104  has a stop surface  114  configured to resist advancement of a proximal end portion  120   a  of a first jaw member  120  when the proximal end portion  120   a  of the first jaw member  120  is received in the proximal end portion  108   a  of the first channel  108 , as will be described further below. In a distal direction, the distal end portion  108   b ,  110   b  of each of the channels  108 ,  110  may extend away from a central longitudinal axis of the inner body  104 , as shown in  FIG. 2 . 
     The surgical clip  100  includes first and second jaw members  120 ,  122  coupled to the inner body  104 . Each of the first and second jaw members  120 ,  122  has a proximal end portion  120   a ,  122   a  slidably received in the hollow interior of the inner body  104 , and a distal end portion  120   b ,  122   b  disposed distally of the inner body  102 . The distal end portion  120 ,  122   b  of the jaw members  120 ,  122  may define teeth (not shown) for assisting in grasping tissue between the jaw members  120 ,  122 . The jaw members  120 ,  122  are resiliently biased toward an open configuration due to the shape and structure of the individual jaw members  120 ,  122 . For example, each of the jaw members  120 ,  122  may be curved outwardly away from one another. In some aspects, the jaw members  120 ,  122  may be resiliently biased toward the open configuration by a biasing member (not shown). Alternately, the jaw members  120 ,  122  may be devoid of a resilient bias. 
     The jaw members  120 ,  122  are axially movable relative to the inner body  104  from a proximal position, in which the distal end portion  120   b ,  122   b  of the jaw member  120 ,  122  are approximated, and a distal position, in which the distal end portion  120   b ,  122   b  of the jaw members  120 ,  122  are spaced from one another. The proximal end portions  120   a ,  122   a  of the respective jaw members  120 ,  122  remain separated by a pivot member  128  disposed therebetween. The pivot member  128  is axially restrained with the proximal end portion  120   a ,  122   a  of the jaw members  120 ,  122  and axially slidable within the inner body  104 , such that the jaw members  120 ,  122  retract and advance with the pivot member  128 . The pivot member  128  may be detachably coupled to the distal end portion of the puller and axially movable relative to the inner body  104  by the puller. 
     The proximal end portions  120   a ,  122   a  of the respective first and second jaw members  120 ,  122  has a tab or appendage  130 ,  132  extending laterally therefrom. The tab  130 ,  132  of each of the first and second jaw members  120 ,  122  is received in a respective channel  108 ,  110  of the inner body  104 . As the proximal end portion  120   a ,  122   a  of each of the jaw members  120 ,  122  is translated within the inner body  104 , the tabs  130 ,  132  move through the respective channels  108 ,  110  between a proximal position, in which the tabs  130 ,  132  are received in the enlarged section  134 ,  136  of the proximal end portions  108   a ,  110   a  of the channels  108 ,  110 , and a distal position, in which the tabs  130 ,  132  are received in the ramped distal end portions  108   b ,  110   b  of the channels  108 ,  110 . 
     Coupled to the inner body  104  of the surgical clip  100  is a release lever  124 , which assumes a T-shaped configuration and is received in a T-shaped slot  140  defined in the tubular wall  112  of the inner body  104 . In some aspects, the release lever  124  may assume any suitable shape, such as linear. The release lever  124  has a proximal end portion  124   a  accessible through the slots  106 ,  140  of the outer body  102  and inner body  104 , respectively, and a distal end portion  124   b  pivotably coupled (e.g., via a hinge) to the tubular wall  112  of the inner body  104 . The proximal end portion  124   a  of the release lever  124  is pivotable about the distal end portion  124   b  thereof upon receiving a threshold force. The release lever  124  has a tab or appendage  142  ( FIG. 2 ) extending laterally therefrom that is received in the enlarged section  134  of the proximal end portion  108   a  of the first channel  108 . The tab  142  is configured to move out of the enlarged section  134  of the channel  108  toward a central longitudinal axis of the first channel  108  in response to an actuation of the release lever  124 . 
       FIG. 4  illustrates a surgical system  150  including the surgical clip  100  and a snare  160 . The snare  160  is configured to actuate the release lever  124  of the surgical clip  100  to release the jaw members  120 ,  122  of the surgical clip  100  from tissue. In aspects, the surgical system  150  may include any other suitable surgical device for actuating the release lever  124 . 
     In use, with the surgical clip  100  coupled to the shaft  12  and the jaw members  120 ,  122  in the open configuration, the surgical clip  100  is positioned adjacent tissue. The tissue is positioned between the jaw members  120 ,  122 , whereupon the trigger  15  is retracted to retract the puller and, in turn, the pivot member  128 . As the pivot member  128  retracts, the proximal end portions  120   a ,  122   a  of the respective jaw members  120 ,  122  are moved proximally through the inner body  104 , whereby the tubular wall  112  of the inner body  104  acts on the jaw members  120 ,  122  to move the jaw members  120 ,  122  toward the closed configuration. Further, the jaw members  120 ,  122  are also caused to approximate as the tabs  130 ,  132  of the respective first and second jaw members  120 ,  122  move proximally out of the distal end portions  108   b ,  110   b  of the respective channels  108 ,  110 . Upon the tabs  130 ,  132  of the jaw members  120 ,  122  entering the proximal end portions  108   a ,  110   a  of the channels  108 ,  110 , the tabs  130 ,  132  flex outwardly into the enlarged section  134  of the proximal end portions  108   a ,  110   a  of the channels  108 ,  110 , thereby locking the jaw members  120 ,  122  in the closed configuration about the lesion. 
     With the tissue grasped between the jaw members  120 ,  122 , the puller is further retracted to detach the puller from the jaw members  120 ,  122 , thereby releasing the outer body  102  of the surgical clip  100  from the shaft  12  and leaving the surgical clip  100  at the desired location. Other mechanisms for releasing the surgical clip  100  from the shaft  12  are also contemplated. 
     When removal of the surgical clip  100  is desired, the snare  160 , or any other suitable grasping device (e.g., a forceps), may be positioned in the slot  106  of the outer body  102 . The snare  160  is cinched to pass the snare  160  through the slot  106  of the outer body  102 , into the slot  140  of the inner body  104 , and into engagement with the proximal end portion  124   a  of the release lever  124 . Further cinching of the snare  160  pivots the proximal end portion  124   a  of the release lever  124  relative to the inner body  104  to move the tab  142  of the release lever  124  in the direction indicated by arrow “A” in  FIG. 2 . The tab  142  of the release lever  124  drives the tab  130  of the first jaw member  120  off of the stop surface  114  of the inner body  104  and out of the enlarged section  134  of the proximal end portion  108   a  of the first channel  108 . Movement of the tab  130  of the first jaw member  120  out of the enlarged section  134  causes the distal end portion  120   b  of the first jaw member  120  to pivot, in the direction indicated by arrow “B” in  FIG. 2 , away from the distal end portion  122   b  of the second jaw member  122 , thereby releasing the tissue from between the jaw members  120 ,  122 . 
     Since the tab  142  of the release lever  124  is only engaged with the first jaw member  120 , actuating the release lever  124  only moves the first jaw member  120  while the second jaw member  122  remains in a fixed position relative to the inner body  104 . Since only one of the jaw members  120 ,  122  is released, removal of the surgical clip  100  from tissue is simplified. Further, the elongated configuration of the release lever  124  improves its responsiveness and serves to minimize the force required to actuate the release lever  124 . 
     With reference to  FIG. 5 , an alternate aspect of an outer body  202  for use with the inner body  102  ( FIG. 2 ) of the surgical clip  100  is illustrated. The outer body  202  is similar to the outer body  102  of  FIG. 3A  except the outer body  202  has an elliptical or oval transverse cross-sectional shape configured to rotationally align a slot  206  of the outer body  202  with a snare, such as, for example, snare  160 . 
     More specifically, the outer body  202  has first and second ends  202   a ,  202   b  and a middle portion  202   c , which defines the slot  206  therein. The middle portion  202   c  has a pair of opposed wide sides  208   a ,  208   b , one of which defining the slot  206  therein, and a pair of opposed narrow sides  210   a ,  210   b . The outer body  202  has an outer surface  212  that tapers from the first end  202   a  toward each of the wide sides  208   a ,  208   b  of the middle portion  202   c  to define opposed first and second ramped surfaces  214   a ,  214   b . The outer surface  212  also tapers from the second end  202   b  toward each of the wide sides  208   a ,  208   b  of the middle portion  202   c  to define opposed third and fourth ramped surfaces  214   c ,  214   d . The ramped surfaces  214   a ,  214   b ,  214   c ,  214   d  assist a clinician by guiding the snare toward the slot  206  in the middle portion  202   c . It is contemplated that the outer body  202  may be formed by compressing a middle portion of an oval-shaped hypotube. In aspects, the inner body  102  ( FIG. 2 ) may have an oval-shaped transverse cross-section. 
     In use, a clinician may attempt to position a snare  160  into the slot  206  of the outer body  202  to engage the release lever  124  ( FIG. 3A ). In instances where the snare  160  is improperly positioned relative to the slot  206 , such as on the narrow sides  210   a ,  210   b  of the middle portion  202   c , and therefore out of alignment with the slot  206 , the outer body  202  along with the remainder of the surgical clip  100  may be caused to rotate up to 90 degrees about the longitudinal axis of the outer body  202  to align the long portion of the snare  160  with the slot  206 . 
     It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).