Patent Publication Number: US-2022233059-A1

Title: Device tip

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This patent application claims the benefit under 35 U.S.C. § 119 to U.S. Provisional Application No. 62/466,657, filed on Mar. 3, 2017, the entirety of which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     Various aspects of the present disclosure relate generally to tips for devices. More specifically, the present disclosure relates to endoscope tips for positioning endoscopic instruments. 
     BACKGROUND 
     Endoscopic retrograde cholangiopancreatography (ERCP) is a technique to treat patients with pancreatico-biliary disorders. In some instances, ERCP is performed using a side viewing endoscope. A tip of the side viewing endoscope may include side viewing optics, an optics lens wash, a side viewing light source, a side exit working channel, and an elevator assembly for elevating an instrument extending out of the side exit working channel. These features may aid a user in cannulating a subject&#39;s papilla, and accessing a target site in the subject&#39;s pancreas, with instruments for diagnostic and/or therapeutic procedures. However, elevator assemblies may have complex designs with a multitude of components, making them expensive to manufacture and maintain (e.g., clean and/or repair). Reducing the complexity of an elevator assembly may reduce overall costs associated with using an endoscope. Moreover, when overall costs fall to a certain threshold, it may be practical for the endoscope to be used as a single-use endoscope. By using the endoscope only once before discarding it, cost and time burdens associated with maintaining the endoscope may be eliminated, and the risk of exposing a subject to infection through inadequate cleaning of the endoscope also may be eliminated, leading to improved outcomes. 
     SUMMARY 
     Aspects of the present disclosure relate to, among other things, tips for devices. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects. 
     In one aspect of the present disclosure, a device may include a shaft having a distal end, and a tip at the distal end of the shaft. The tip may include an opening defined by a surface of the tip. An instrument inserted through the shaft may extend distally out of the opening. The device also may include an elevator for engaging the instrument. The elevator may include a proximal end fixed relative to the surface of the tip, a proximal portion extending distally from the proximal end, and a distal portion extending distally from the proximal portion. A force exerted on the elevator bends the proximal portion to deflect the distal portion without bending of the distal portion. 
     According to another aspect of the present disclosure, the device may include one or more of the features below. The distal portion may have a greater cross-sectional area than the proximal portion. The distal portion may be thicker than the proximal portion along an anterior-posterior direction, the anterior-posterior direction being perpendicular to a proximal-distal direction. The tip may be comprised of a single material. The elevator may be comprised of a single material. An outer surface of the elevator and the surface of the tip may be portions of a continuous surface. An outer surface of the distal portion of the elevator may be continuous with the outer surface of the proximal portion of the elevator. The proximal portion may have a substantially straight rest configuration and a bent configuration. The proximal portion may move the distal portion through an arcuate path in an anterior direction and a proximal direction as the proximal portion moves from the rest configuration to the bent configuration. 
     In another aspect of the present disclosure, a device may include a shaft having a distal end. The device also may include a tip at the distal end of the shaft. The tip may include an instrument opening. An instrument inserted through the shaft may extend distally out of the instrument opening. The tip also may include an elevator for engaging the instrument as the instrument extends distally out of the instrument opening. The elevator may include a passage extending therethrough. The device also may include a control wire coupled to the elevator. A proximal pulling force exerted on the control wire may deflect the elevator. The device also may include a first control wire opening and a second control wire opening. A first portion of the control wire may extend from the first control wire opening to the passage. A second portion of the control wire may extend from the second control wire opening to the passage. A third portion of the control wire may extend through the passage to link the first portion of the control wire to the second portion of the control wire. 
     According to another aspect of the present disclosure, the device may include one or more of the features below. A handle at a proximal end of the shaft. The handle may include an actuation mechanism for exerting the proximal pulling force on the control wire. The actuation mechanism may be operatively coupled to the first portion of the control wire and the second portion of the control wire to exert the proximal pulling force simultaneously on the first portion of the control wire and the second portion of the control wire. The elevator may include opposing side surfaces. At least one of the side surfaces may include a channel for receiving at least a portion of the control wire. An opening into the passage may be in the channel. The tip may include sidewalls on opposing sides of the elevator. At least one of the sidewalls may include a channel for receiving at least a portion of the control wire. The tip may be a one-piece, monolithic, polymer component. 
     In another aspect of the present disclosure, a device may include a shaft having a distal end. The device also may include a tip at the distal end of the shaft. The tip may include an elevator. An instrument inserted through the shaft may extend distally to engage the elevator. The device also may include an actuator to deflect the elevator. The elevator may include a proximal portion having a proximal end fixed relative to the shaft. The elevator also may include a distal portion extending distally from the proximal portion. The proximal portion may have a smaller cross-sectional area than the distal portion, such that a force exerted on the elevator may bend the proximal portion to deflect the distal portion. The elevator may be made of a single, continuous piece of material. 
     According to another aspect of the present disclosure, the device may include one or more of the features below. The single, continuous piece of material may be a single, continuous piece of injection-molded polymer. The proximal portion may include one or more indentations, such that the proximal portion may have one or more thin regions and one or more thick regions, to facilitate bending of the proximal portion along the one or more thin regions. The tip may further include at least one portion coupled to the single, continuous piece of material. The at least one portion may be made of a more rigid material than the single, continuous piece of material. The actuator may include a control wire coupled to the elevator. 
     It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of any claimed inventions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure. 
         FIG. 1  shows an endoscope, in accordance with aspects of the present disclosure. 
         FIG. 2  shows a perspective view of a tip of the endoscope of  FIG. 1 , in accordance with aspects of the present disclosure. 
         FIG. 3  shows a front view of the tip of the endoscope of  FIG. 1 , in accordance with aspects of the present disclosure. 
         FIG. 4  shows a side view of the tip of the endoscope of  FIG. 1  in a first configuration, in accordance with aspects of the present disclosure. 
         FIG. 5  shows a side view of the tip of the endoscope of  FIG. 1  in a second configuration, in accordance with aspects of the present disclosure. 
         FIG. 6  shows a front view of an alternative endoscope tip, in accordance with aspects of the present disclosure. 
         FIGS. 7A and 7B  show top and side views of a living hinge of an endoscope tip, in accordance with aspects of the present disclosure. 
         FIGS. 8A and 8B  show top and front views of an elevator, in accordance with aspects of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure is drawn generally to tips for devices, and more specifically to endoscope tips for positioning endoscopic instruments. Reference now will be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing an instrument into a subject. By contrast, the term “proximal” refers to a portion closest to the user when placing the instrument into the subject. The terms “anterior” and “posterior” refer to directions and/or regions extending perpendicular to proximal and distal directions. Though the following description refers to “endoscope” or “endoscopy,” the principles/aspects described herein may be used with any suitable introduction sheath or device, even if such sheath or device fails to include one or more features typically associated with “endoscopes.” It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features claimed. Further, as used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.” 
       FIG. 1  shows a device  100  for positioning an instrument  102 . Device  100  may be any type of endoscope, such as a duodenoscope. Instrument  102  may include, for example, a guidewire, cutting or grasping forceps, a biopsy device, a snare loop, an injection needle, a cutting blade, scissors, a retractable basket, a retrieval device, an ablation and/or electrophysiology catheter, a stent placement device, a surgical stapling device, a balloon catheter, a laser-emitting device, and/or any other suitable instrument. In one example, device  100  may to facilitate cannulation of a subject&#39;s papilla, and placement of instrument  102  therein, during an ERCP procedure. 
     Device  100  may include a shaft  104 . Shaft  104  may include a tube  106  that may be sufficiently flexible so as to have the ability to bend, rotate, and/or twist while being inserted into and/or through a subject&#39;s tortuous anatomy to a target site in the subject&#39;s body. Shaft  104  may have one or more lumens (not shown) extending therethrough. The lumens may include, for example, control wire lumens for receiving one or more control wires, a working lumen for receiving instrument  102 , a fluid lumen for delivering a fluid, an illumination lumen for receiving at least a portion of an illumination assembly (not shown), and/or an imaging lumen for receiving at least a portion of an imaging assembly (not shown). 
     Device  100  also may include a tip  108  at a distal end of shaft  104 . Tip  108  may be attached to the distal end of shaft  104 . For example, tip  108  may be a cap configured to receive the distal end of shaft  104 . Tip  108  may include one or more openings that communication with the lumens of shaft  104 . For example, tip  108  may include control wire openings  110  and  112  through which one or more control wires may exit from the control wire lumens of shaft  104 , a working opening  114  through which instrument  102  may exit from the working lumen of shaft  104 , a fluid opening or nozzle  116  through which fluid may be emitted from the fluid lumen of shaft  104 , an illumination opening or window  118  through which light may be emitted, and/or an imaging opening or window  120  for receiving light used by the imaging device to generate an image. While not depicted in  FIG. 1 , it should be understood that illumination opening  118  may include a light emitter (e.g., a light-emitting diode, or the like) coupled to a cable or wire running through the illumination lumen of shaft  104 , and/or imaging opening  120  may include an imager (e.g., a charge-coupled device image sensor, a complementary metal-oxide image semiconductor, or the like) coupled to a cable or wire running through the imaging lumen of shaft  104 . 
     Control wire openings  110  and  112  may be on a distal-facing surface  124  of tip  108 . Working opening  114  may be on a distal-facing surface  126  of tip  108 . Distal-facing surface  126  may be recessed from distal-facing surface  124  in a proximal direction. Illumination opening  118  and imaging opening  120  may be on an anterior-facing surface  128 . Fluid opening  116  may be on distal-facing surface  124 , and may open toward illumination opening  118  and imaging opening  120  to, for example, direct a stream of rinsing fluid across illumination opening  118  and/or imaging opening  120  to wash off bodily fluids or debris. 
     Working opening  114  may open into a cavity  130  of tip  108 . Cavity  130  may be defined by distal-facing surface  126 , lateral-facing sidewalls  132  and  134 , a posterior-facing surface  136 , and an anterior-facing surface  138  of an elevator  140 . Instrument  102  may extend distally out of working opening  114  and into cavity  130 , where instrument  102  may be positioned for engagement with anterior-facing surface  138  of elevator  140 . Anterior-facing surface  138  of elevator  140  may include, for example, an indentation  168  (e.g., a slot, groove, cavity, or the like) formed therein. Indentation  168  may receive at least a portion of instrument  102  to exert a holding or gripping force on instrument  102 . 
     Elevator  140  may be cantilevered, having a fixed proximal end  142  at distal-facing surface  126 , and a free distal end  144 . Elevator  140  may include a proximal portion  146  and a distal portion  148 . Proximal portion  146  may be thinner than distal portion  148  to facilitate bending of proximal portion  146 . This is because distal portion  148 , due to its thickness, may be more rigid than proximal portion  146 . In some examples, proximal portion  146  may bend while distal portion  148  may remain unbent. 
     Proximal portion  146  may have a rectangular cross-sectional shape to facilitate bending along the anterior-posterior direction. Additionally or alternatively, a length of proximal portion  146  (along the proximal-distal direction) may be greater than a width of proximal portion  146  (along a lateral direction perpendicular to the proximal-distal direction), and the width of proximal portion  146  may be greater than a height/thickness of proximal portion  146  (along the anterior-posterior direction). Additionally or alternatively, proximal portion  146  may have a substantially constant thickness all the way from distal-facing surface  126  to a proximal end of distal portion  148 , where elevator  140  may undergo an abrupt increase in thickness. Anterior-facing surface  138  may be angled (e.g., inclined) relative to proximal portion  146  to facilitate engagement between anterior-facing surface  138  and instrument  102 . Additionally or alternatively, one or more of a posterior-facing surface of proximal portion  146  and an anterior-facing surface of proximal portion  146  may be substantially planar and/or substantially perpendicular to one or more of lateral-facing sidewalls  132  and  134 . 
     Proximal portion  146  may act as a living hinge to allow distal portion  148  of elevator  140  to move relative to the rest of tip  108 . Proximal portion  146  may bend such that distal portion  148  may travel along an arcuate path that may cover a distance in a proximal-distal direction and an anterior-posterior direction. In some examples, elevator  140  may be integral with the rest of tip  108 . For example, tip  108 , as shown in  FIG. 2 , may be a single, monolithic, injection-molded component. Tip  108  may be made of a polymeric material, such as polyethylene, polypropylene, and/or any other suitable polymer. Tip  108  may be made by any other suitable process, and with any other suitable material, for forming tip  108  as a single piece of the same material throughout. 
     Distal portion  148  may be thicker than proximal portion  146  to provide space for a passage  150 . The thickness of distal portion  148  may ensure that distal portion  148  does not bend, and that bending of elevator  140  is limited to proximal portion  146 . Passage  150  may be a through-hole extending between opposing lateral-facing surfaces  152  and  154  of elevator  140 . Passage  150  may receive control wire  122 . For example, a first portion  156  of control wire  122  may extend distally from control wire opening  110  to lateral-facing surface  152  and passage  150  (see  FIG. 3 ). A second portion  158  of control wire  122  may extend distally from control wire opening  112  to lateral-facing surface  154  and passage  150 . A third portion (not shown) of control wire  122  may extend through passage  150 . First portion  156 , second portion  158 , and the third portion of control wire  122  may form a U-shaped extent of control wire  122 . 
     Channels  160 ,  162 ,  164 , and  166  may be provided in sidewall  132 , lateral-facing surface  152 , lateral-facing surface  154 , and sidewall  134  for receiving portions of control wire  122 . The received portions of control wire  122  may slide along channels  160  and  166  as control wire  122  is retracted into and/or extended out of control wire openings  110  and  112 . In the depicted example, passage  150  may open into channels  162  and  164 . Control wire  122  may be strung through passage  150  by deflecting elevator  140  in a posterior direction to expose passage  150  from behind sidewalls  132  and  134 , inserting control wire  122  through passage  150 , aligning control wire  122  with channels  160 ,  162 ,  164 , and  166 , inserting control wire  122  into control wire openings  110  and  112 . 
     By pulling one or both of first portion  156  and second portion  158  of control wire  122  in a proximal direction, the user may retract control wire  122  into control wire openings  110  and  112 . This retraction may cause proximal portion  146  of elevator  140  to bend as distal portion  148  of elevator  140  is drawn toward distal-facing surface  124 .  FIGS. 3 and 4  show views of tip  108  where elevator  140  is at rest, while  FIG. 5  shows a view of tip  108  where proximal portion  146  of elevator  140  is bent due to forces exerted on distal portion  148  of elevator  140  by control wire  122 . Pulling both of first portion  156  and second portion  158 , which are on opposite sides of elevator  140 , may ensure that elevator  140  may be drawn toward distal-facing surface  124  with little or no twisting or torqueing, to ensure that instrument  102  is brought into a desired position. 
     Instrument  102  may be held in indentation  168  of distal portion  148  as distal portion  148  is drawn toward distal-facing surface  124 . As distal portion  148  is deflected, distal portion  148  may deflect instrument  102 , thereby adjusting the position of instrument  102 . Instrument  102  may be extended out of, retracted into, and/or rotated (e.g., twisted) in the working lumen of shaft  104  and working opening  114  before, during, and/or after instrument  102  is deflected by distal portion  148 . Continued pulling of control wire  122  may cause distal portion  148  to pin instrument  102  against a protrusion  170  on distal-facing surface  124 . This may lock instrument  102  in place relative to tip  108 . When locked, the ability to extend, retract, and/or rotate instrument  102  may be hindered or eliminated. In one example, protrusion  170  may have a shape complementary to a shape of indentation  168  to facilitate holding or locking of instrument  102  between protrusion  170  and distal portion  148 . For example, protrusion  170  may have a wedge-like shape. When the user ceases to pull control wire  122 , and/or extends control wire  122  distally, proximal portion  146  may inherently seek to move to its unbent state, thereby moving distal portion  148  away from distal-facing surface  124  and back toward its orientation as shown in  FIGS. 2-4 . This may unlock instrument  102 . 
     Device  100  also may include a handle  172  coupled to a proximal end of shaft  104 . Handle  172  may include one or more lumens (not shown) that communicate with the lumen(s) of shaft  104 . Handle  172  also may include one or more ports  174  that open into the one or more lumens of handle  172 . For example, instrument  102  may be inserted into port  174  on its way to the working lumen of shaft  104 . In one example, handle  172  may include a cable  176 . Cable  176  may couple one or more external systems (not shown) to device  100 . Cable  176  may, for example, couple handle  172  to a fluid supply, an illumination source, and/or an imaging processor or display. 
     Handle  172  also may include an actuation mechanism  178 . Actuation mechanism  178  may include one or more knobs, buttons, levers, switches, and/or any other suitable actuators, for controlling at least one of deflection of shaft  104 , the delivery of fluid, the emission of illumination, and/or imaging functions. In one example, actuation mechanism  178  may be operatively coupled to proximal portions (not shown) of control wire  122  that extend proximally from control wire openings  110  and  112  into handle  172 . The user may manipulate actuation mechanism  178  to selectively exert at least one of a pulling force and a pushing force on control wire  122  to control the position of elevator  140 , and thereby control the position of instrument  102 . 
       FIG. 6  shows an alternative embodiment of a tip  108 ′. Tip  108 ′ may be similar to tip  108 , except tip  108 ′ may be made of separate components coupled together at a joint  109 ′. In one example, portions of tip  108 ′ on a first side of joint  109 ′ may be a single, monolithic component, while portions of tip  108 ′ on a second side of joint  109 ′ may be another single, monolithic component. By producing the components separately and then joining them together, one material may be used for one of the components, while another material (with different properties) may be used for the other component. For example, the component to the left of joint  109 ′ may be made of a material that is more flexible than the material used to make the component to the right of joint  109 ′, to facilitate bending of the elevator. 
     In the example shown in  FIG. 6 , the component to the left of joint  109 ′ may include an elevator, a working opening, control wire openings, a distal-facing surface, a lateral-facing sidewall, and/or a posterior-facing surface, similar to those of tip  108 . The component to the right of joint  109 ′ may include a fluid opening, a lateral-facing sidewall, an anterior-facing surface, an imaging opening, and/or an illumination opening, similar to those of tip  108 . It should be understood, however, that joint  109 ′ may divide tip  108 ′ in any other suitable manner. It also is contemplated that joint  109 ′ may follow a straight line across tip  108 ′, or may include one or more bends and/or corners, as it crosses tip  108 ′. It also is contemplated that joint  109 ′ may divide tip  108 ′ into more than two components. 
       FIGS. 7A and 7B  show views of an alternative embodiment of a proximal portion  146 ′ of an elevator. Proximal portion  146 ′ may have one or more elements thereon for precisely controlling bending of proximal portion  146 ′. In one example, proximal portion  146 ′ may include cutouts or indentations  147 ′ (e.g., notches, grooves, slots, holes, and the like) to facilitate bending by creating thinner portions of proximal portion  146 ′. Additionally or alternatively, proximal portion  146 ′ may include protrusions (e.g., ridges, spines, and the like) (not shown) to limit bending by creating thicker portions of proximal portion  146 ′. The cutouts, indentations, and/or protrusions may be on a posterior-facing surface of proximal portion  146 ′, an anterior-facing surface of proximal portion  146 ′, and/or one or more lateral-facing surfaces of proximal portion  146 ′. 
       FIGS. 8A and 8B  show views of an alternative embodiment of an elevator  140 ′ including a plurality of indentations  168 ′ and  169 ′. Indentations  168 ′ and  169 ′ may have different characteristics. For example, one of indentations  168 ′ and  169 ′ may be wider, deeper, and/or longer than the other. Indentation  168 ′ may be sized to hold larger instruments, and indentation  169 ′ may be sized to hold smaller instruments. 
     It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed systems and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as exemplary only.