Patent Publication Number: US-2023137851-A1

Title: Endoscopic Retraction Assist Devices and Related Systems and Methods

Description:
BACKGROUND 
     Endoscopic submucosal dissection (ESD) is an evolving technique in the field of advanced endoscopy. Endoscopic Intramural Surgery (EIS) is one of the newest branches of gastrointestinal endoscopy and has a bright future. In this technique, a small opening is made in the inner layer of the gastrointestinal wall followed by the passage of the endoscope through that small opening either into the wall or sometimes outside the wall to preform dissections/removal of tissue. Upon completion of the procedure, the small opening is closed completely. Thus, it is a true minimally invasive surgery. Different procedures that fall under the category of EIS are endoscopic submucosal dissection (ESD), per oral endoscopic myotomy (POEM), and others. 
     EIS has been gradually growing in popularity all over the world due to its many advantages including lower risk of complications, decreased costs, faster recovery, and at the same time providing equivalent efficacy compared with open surgery or laparoscopic/robotic surgery. Despite its many advantages, the acceptance of EIS amongst gastrointestinal endoscopists is slow due to lack of proper devices to facilitate the process. 
     SUMMARY 
     Some embodiments of the present invention are directed to an endoscopic retraction assist device including: a body including opposite proximal and distal end portions and a central portion between the proximal and distal end portions; and a device channel defined in the body. At the central portion of the body, the device channel may transition from a circular portion having a circular cross section or perimeter to an arcuate portion having an elongated arcuate cross section or perimeter. 
     In some embodiments, the arcuate portion of the device channel is closer to the distal end portion of the body than is the circular portion of the device channel. The distal end portion of the body may include a ledge extending between the arcuate portion of the device channel and a distal end of the body. The ledge may be arcuate and may optionally widen from the arcuate portion of the device channel to the distal end of the body. 
     In some embodiments, the device channel defines a longitudinal axis, the body includes a top wall, a bottom wall, and first and second opposite side walls, and the bottom wall extends further in a first direction along or parallel to the longitudinal axis from the central portion toward a distal end of the body than do the top wall and the first and second side walls. The distal end portion of the body may widen from the central portion of the body toward the distal end of the body. 
     In some embodiments, the arcuate portion of the device channel has a maximum width that is 2-5 times a width or diameter of the circular portion of the device channel. 
     In some embodiments, the body is formed of a flexible and resilient material. 
     In some embodiments, the device and/or the body include a clip including first and second spaced apart arms extending downwardly from the proximal end portion of the body. The clip may be configured to releasably and slidably hold an endoscope therein. 
     In some embodiments, the proximal end portion of the body is configured to receive a tube through which a retraction device can be received. 
     In some embodiments, the body is monolithic. 
     Some other embodiments of the present invention are directed to an endoscope system including a tip. The tip includes: a body including opposite proximal and distal end portions and a central portion between the proximal and distal end portions; a clip including first and second spaced apart arms extending downwardly from the proximal end portion of the body; and a device channel defined in the body. The system includes an endoscope received in the clip and a retraction device received in the device channel. At the central portion of the body, the device channel may transition from a circular portion having a circular cross section or perimeter to an arcuate portion having an elongated arcuate cross section or perimeter. 
     In some embodiments, the endoscope has a lengthwise instrument channel defined therein, and the system may further include a dissection device received in the instrument channel. 
     Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a perspective view of an endoscope system according to some embodiments of the present invention. 
         FIG.  2    is a perspective view of a tip of the system of  FIG.  1   . 
         FIG.  3    is a side view of the tip of  FIG.  2   . 
         FIG.  4    is another perspective view of the tip of  FIG.  2   . 
         FIG.  5    is a top sectional view of the tip of  FIG.  2   . 
         FIG.  6    is a front end view of the tip of  FIG.  2   . 
     
    
    
     DETAILED DESCRIPTION 
     The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which illustrative embodiments of the invention are shown. In the drawings, the relative sizes of regions or features may be exaggerated for clarity. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. 
     It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. 
     Spatially relative terms, such as “beneath”, “below”, “lower”, “above”, “upper” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90° or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. 
     As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms “includes,” “comprises,” “including” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. 
     It is noted that any one or more aspects or features described with respect to one embodiment may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below. 
     An endoscope system  10  according to some embodiments is illustrated in  FIG.  1   . The system  10  includes a tip  100  (which may also be referred to herein as an “Endoscopic Retraction Assist Device” or “ERAD”). 
     As described in more detail below, an endoscope  12  may be held by the tip  100 . The endoscope  12  includes opposite proximal and distal end portions  14 ,  16 . An instrument channel  18  (e.g., working channel) may extend lengthwise through the endoscope  12  between the proximal and distal end portions  14 ,  16 . The endoscope  12  may include one or more illumination windows  20  and an observation window  22  at the distal end portion  16  thereof. 
     A device or instrument  30  such as a retraction device may be received in a channel of the tip  100 . The retraction device  30  includes opposite proximal and distal end portions  32 ,  34 . An operator may control or manipulate the first retraction device  30  at the proximal end portion  32  as understood by those skilled in the art. 
     The device  30  may be received in and extend through an elongated tube  40 . The tube  40  includes opposite proximal and distal end portions  42 ,  44 . The distal end portion  44  of the tube  40  may connect to the tip  100  and the proximal end portion  32  of the device  30  may extend from the proximal end portion  42  of the tube  40 . A stopper  46  may be at the proximal end portion  42  of the tube  40  and the device  30  may extend through the stopper  46 . The stopper  46  is an air leak prevention device that allows the passage of instruments used for retraction. 
     A device or instrument  50  such as a dissection device may be received in the instrument channel  18  of the endoscope  12 . The dissection device  50  includes opposite proximal and distal end portions  52 ,  54 . An operator may control or manipulate the dissection device  50  at the proximal end portion  52  as understood by those skilled in the art. 
     Referring now to  FIGS.  2 - 6   , the tip  100  has a body  102 . The body  102  includes opposite proximal and distal end portions  104 ,  106 . The body  102  includes a central portion  108  between the proximal and distal end portions  104 ,  106 . 
     A device or instrument channel or passageway  110  is defined in the body  102 . The channel  110  defines a longitudinal axis A of the tip  100 . 
     The channel  110  may be considered to have several portions or sections. A proximal portion  110 P of the channel  110  at the proximal portion  104  of the body  102  may have a circular cross section or perimeter and may have a constant diameter. A transitional portion  110 T of the channel  110  at the central portion  108  of the body  102  may transition from a circular portion  110 C having a circular cross section or perimeter to an arcuate portion  110 A having an arcuate cross section or perimeter. 
     The arcuate portion  110 A of the channel  110  may increase in width in a longitudinal direction extending from the circular portion  110 C of the channel  110  to a distal end  107  of the body  102 . Referring to  FIG.  6   , the arcuate portion  110 A of the channel  110  may have a maximum width w 1  that is 2-5 times a diameter or width dl of the circular portion  110 C of the channel  110 . 
     In some embodiments, the distal end portion  106  of the body  102  includes a ledge  111  extending between the arcuate portion  110 A of the channel  110  and the distal end  107  of the body  102 . The ledge  111  may be arcuate (e.g., inverse U-shape) and may widen from the arcuate portion  110 A of the channel  110  to the distal end  107  of the body  102 . 
     The body  102  may include, and the channel  110  may be at least partially defined by, a bottom or lower surface or wall  112 , a top or upper surface or wall  114  that is opposite the bottom wall  112 , a first side surface or wall  116 , and/or a second side surface or wall  118  that is opposite the first side wall  116 . 
     The bottom wall  112  may extend further longitudinally from the central portion  108  of the body  102  toward the distal end portion  106  of the body  102  than does the top wall  114  and the side walls  116 ,  118 . In some embodiments, the distal end portion  106  of the body including the distal end  107  thereof only includes the bottom wall  112  (e.g., the ledge  111 ) and does not include the top wall  114  and the side walls  116 ,  118 . 
     A clip  122  may be at the proximal end portion  104  of the body  102 . The clip  122  may include a first arm  124  extending downwardly from the first side wall  116  of the body  102  and a second arm  126  extending downwardly from the second side wall  118  of the body  102 . The clip  122  may be configured to releasably and/or slidably hold an endoscope (e.g., the endoscope  12  in  FIG.  1   ). 
     The proximal end portion  104  of the body  102  is configured to receive an elongated member such as the tube  40  shown in  FIG.  1   . For example, the tube may be received and held in the proximal end portion  110 P of the channel  110 . A device such as the retraction device  30  shown in  FIG.  1    may be received in the tube  40 . 
     The tip  100  may be moveable or slidable relative to the endoscope  12  ex vivo but the tip  100  and the endoscope  12  may move as a single unit in vivo. 
     The tip body  102  may be formed of a flexible material such as a polymeric, plastic, and/or silastic material. The tip body  102  may be resilient. The tip body  102  may be transparent or translucent. 
     Referring to  FIG.  6   , the arcuate portion  110 A of the channel  110  has an arcuate cross section or perimeter (e.g., in a plane perpendicular to the longitudinal axis A). The arcuate portion  110 A of the channel  110  is elongated and includes opposite first and second end surfaces  110 A 1 ,  110 A 2 . Referring to  FIG.  6   , an angle α may be defined between the first and second end surfaces  110 A 1 ,  110 A 2 . The angle α may be at the center of curvature of the channel  110  and may be between 40 degrees and 80 degrees and, in some embodiments, is about 60 degrees. The configuration with the elongated arcuate channel allows the retraction device received in the channel to translate along the elongated arcuate profile of the channel between the first and second end surfaces thereof. 
     Referring to  FIG.  1   , in use, the tip  100  is attached to the endoscope  12  by receiving the endoscope  12  in the clip  122 . The endoscope  12  with the attached tip  100  is then passed inside a gastrointestinal lumen. The tip  100  is made of a flexible material that bends in narrow areas, but is resilient and springs back to its original shape when the pressure of the narrow space is reduced. Thus, passage of the tip  100  through the narrow lumen is non-traumatic, and the presence of memory shape will keep its functionality intact. 
     The tip  100  acts as an external channel for passing the tissue retractor device  30  and thus the tip  100  acts as a tissue retractor assist device. Due to the presence of arcuate and longitudinal channel features, both horizontal and vertical movements of the retractor device  30  are possible, thus moving the retracted tissue in multiple directions to assist in dissection. This provides dynamic tissue retraction thus facilitating the dissection and increasing the speed of dissection. 
     The fact that the different ends or surfaces (lower, upper, sides) end or terminate at different distances from the proximal end of the tip gives the device  30  that extends out of the channel  110  the flexibility and maneuverability during tissue retraction. 
     The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.