Abstract:
The present disclosure provides an actuation device that comprises: (a) a device body that comprises a first fixation mechanism configured to affix a proximal end of a first elongate member of an accessory device to the device body, (b) an actuator that comprises an operable mechanism and a second fixation mechanism configured to affix a proximal end of a second elongate member of the accessory device to the actuator, wherein the operable mechanism is configured to move the second elongate member relative to the first elongate member, and (c) a fastener configured to attach the device body to an endoscope. The present disclosure further provides endoscopic systems comprising an actuation device of this type in an assembly with an endoscope and an accessory device, and also provides kits that comprise an actuation device of this type and one or more accessory devices.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 62/258,107, filed Nov. 20, 2015; which is herein incorporated by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure generally relates to actuation devices suitable for use in operating accessory devices during an endoscopic procedure. 
       BACKGROUND 
       [0003]    Currently, operators typically often perform endoscopic procedures with the help of assistants to actuate the accessory devices. Ideally, an operator would be able to operate an endoscope while at the same time actuating an accessory device. 
       SUMMARY 
       [0004]    In various aspects, the present disclosure pertains to actuation devices suitable for use in operating accessory devices during an endoscopic procedure. The actuation devices comprise: (a) a device body that comprises a first fixation mechanism configured to affix a proximal end of a first elongate member of an accessory device to the device body, (b) an actuator comprising an operable mechanism and a second fixation mechanism configured to affix a proximal end of a second elongate member of an accessory device to the actuator, wherein the operable mechanism is configured to move the second elongate member relative to the first elongate member, and (c) a fastener configured to attach the device body to an endoscope. 
         [0005]    In some embodiments, the device body comprises an opening that allows access to a working channel of the endoscope. 
         [0006]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the device body may comprise a protrusion that is configured for insertion into a working channel of the endoscope when the device body is attached to the endoscope. In certain of these embodiments, the protrusion may comprise a lumen through which the first and second elongate members of the accessory device can be threaded into the working channel of the endoscope. 
         [0007]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the first mechanism may comprise a set screw or clamp and a through hole, the second mechanism may comprise a set screw or clamp and a through hole or a blind hole, or a combination of both. 
         [0008]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the second fixation mechanism may comprise an electrical connector that is configured to electrically connect the second elongate member to an electrical generator. 
         [0009]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the fastener may comprise an attachment component that spreads and snaps onto the endoscope. 
         [0010]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the device body may be connected to the fastener in a hinged arrangement. 
         [0011]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the actuator may be pivotally mounted relative to the device body and the actuator may comprise a lever that can move the actuator around a pivot, such that movement of the lever in a first direction results in retraction of the second elongate member relative to the first elongate member and such that movement of the lever in a second direction opposite the first direction results in advancement of the second elongate member relative to the first elongate member. In certain of these embodiments, (a) the actuator may comprise a projection and the device body may comprise a curved slot within which the projection travels upon rotation of the actuator about the pivot, or (b) the actuator may comprise a first arm that comprises the lever and a second arm that comprises the second fixation mechanism, or (c) the actuation device may further comprise a spring that is configured to bring the actuator to a default position when the lever is released, or (d) a combination of any two or all three of (a), (b) and (c). 
         [0012]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the actuator can be set to a plurality of fixed positions within the device body. For instance, the actuator and device body may comprise interlocking stepped ridges, or one of the actuator and the device body may comprise a plurality of depressions and the other of the actuator and the device body may comprise a spring-driven ball that engages the depressions, among other possibilities. 
         [0013]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the device body may comprise a port that is configured to allow access for a guidewire. 
         [0014]    Other aspects of the present disclosure pertain to endoscopic systems that comprise (a) an endoscope having endoscope controls and a working channel, (b) an actuation device in accordance with any of the above aspects and embodiments, attached to the endoscope through the fastener, and (c) an accessory device that comprises first and second elongate members, the first elongate member being attached to the device body through the first fixation mechanism and the second elongate member being attached to the actuator through the second fixation mechanism. The actuation device may be configured such that, when attached to the endoscope, a single hand of a user can operate both the endoscope controls and operable mechanism of the actuation device. 
         [0015]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the first elongate member may be an outer elongate member having a lumen (e.g., in the form of a tube) and the second elongate member may be an inner elongate member (e.g., in the form of a wire or a tube) that is disposed at least partially within the lumen of the outer elongate member. 
         [0016]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the accessory device may be fed through the working channel of the endoscope. 
         [0017]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the accessory device may be fed alongside the endoscope. 
         [0018]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, the accessory device may be selected from a knife, a sphincterotome, a snare, an injection device, and forceps. 
         [0019]    In some embodiments, which may be used in conjunction with any of the above aspects and embodiments, a cutting member may be attached to a distal end of the second elongate member, such that the cutting member may be exposed upon advancement of the second elongate member relative to the first elongate member, or such that the cutting member may be exposed upon retraction of the second elongate member relative to the first elongate member. 
         [0020]    Further aspects of the present disclosure may pertain to kits that comprise (a) an actuation device in accordance with any of the above aspects and embodiments and (b) an accessory device in accordance with any of the above aspects and embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIGS. 1A and 1B  are schematic perspective views showing an endoscope handle, a proximal portion of an accessory device, and an actuation device in accordance with the present disclosure, wherein a lever of the actuation device is placed in two positions for actuation of the accessory device. 
           [0022]      FIGS. 2A and 2B  are front and back views of actuation device in accordance with the present disclosure. 
           [0023]      FIG. 3  is a perspective view of an endoscope handle, a proximal portion of an accessory device and an actuation device, in accordance with the present disclosure. 
           [0024]      FIG. 4  is a view of a portion of an endoscope handle, a proximal portion of an accessory device and an actuation device, in accordance with the present disclosure. 
           [0025]      FIGS. 5A and 5B  are views of a distal portion of a sphincterotome that is operable using an actuation device in accordance with the present disclosure, wherein the sphincterotome is shown in non-deployed and deployed configurations, respectively. 
           [0026]      FIGS. 6A and 6B  are views of a distal portion of an endoscope and attached cutting knife that is operable using an actuation device in accordance with the present disclosure, wherein the cutting knife is shown in non-deployed and deployed configurations, respectively. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    Various particular aspects and embodiments of the disclosure will now be described. As used herein, the term “distal” refers to the end farthest away from a medical professional when introducing a device into a patient, while the term “proximal” refers to the end closest to the medical professional when introducing a device into a patient. 
         [0028]    With reference now to  FIG. 1A , an actuation device  100  is shown in a coupled state with an endoscope  200  and an accessory device  132 . The actuation device  100  shown comprises a device body  110 , which in the specific embodiment shown includes a housing portion  110   h , a bracket portion  110   b  and a linking portion  110   l , which links the housing portion  110   h  to the bracket portion  110   b . The device body  110  further comprises a first connection point  110   p  where a proximal end of a first elongate member of the accessory device  132 , specifically, a hollow outer elongate member  132   o  (e.g., a catheter) in the particular embodiment shown, is fixed to the body  110 . Connection is made via a first attachment mechanism. For example, a through-hole may be formed in the housing portion  110   h  and a fixation member (e.g., a set screw, clamp, etc.) may be used to fix the proximal end of the hollow outer elongate member  132   o  within the through-hole. 
         [0029]    The actuation device  100  further includes an operable mechanism, specifically, an actuator  122  pivotally mounted relative to the housing portion  110   h , in the embodiment shown. The actuator  122  shown comprises a lever  122   a  that can rotate the actuator  122  around a pivot  126  (e.g., via a pivot pin). The actuator  122  also comprises a second connection point  122   p  where a proximal end of a second elongate member of the accessory device  132 , specifically, an inner elongate member  132   i  in the particular embodiment shown, is attached to the actuator  122 . The inner elongate member  132   i  is slidably disposed within the outer elongate member  132   o  of the accessory device  132 . The inner elongate member  132   i  may be solid (e.g., in the form of a wire) or hollow (e.g., in the form of a tube). Connection is made via a second attachment mechanism. For example, a hole (e.g., a blind hole or a through hole) may be formed in the actuator  122  and a fixation member (e.g., a set screw, clamp, etc.) may be used to fix a proximal end of the inner elongate member  132   i  within the hole. In this way, an operable mechanism may be provided, which is configured to move one elongate member (i.e., an inner elongate member  132   i  in the embodiment shown) relative to another elongate member (i.e., an outer elongate member  132   o  in the embodiment shown). 
         [0030]    In applications where electrosurgery is required, the actuation device  100  may have an electrically active port so that it can be connected to an electrosurgical generator. In certain of these embodiments, the second attachment mechanism may provide a port for electrical connection to the inner elongate member  132   i.    
         [0031]    In some embodiments, the actuator  122  may comprise first and second arms, with the first arm corresponding to the lever  122   a  and the second arm being provided with the second connection point  122   p  where the proximal end of the inner elongate member  132   i  of the accessory device  132  is attached to the actuator  122 . 
         [0032]    In addition to the preceding components, the actuation device  100  may further include a fastener  112  that is configured to attach the device body  110  to the endoscope  200  at a point adjacent to a handle of the endoscope. Examples of fasteners for this purpose include, for instance, straps (e.g., elastic straps, VELCRO hook-and-loop fastener straps, etc.), snap-on clamps, and form fitting grooves, among other possibilities. 
         [0033]    With an arrangement such as that shown in  FIGS. 1A and 1B , rotation of the actuator  122  around the pivot  126  and relative to the device body  110  results in movement of the inner elongate member  132   i  (which is fixed to the actuator  122 ) relative to the outer elongate member  132   o  (which is fixed to the device body  110 ). In the particular embodiment shown, pulling the lever  122   a  toward the endoscope  200  as shown in  FIG. 1B  causes the inner elongate member  132   i  to advance distally relative to the outer elongate member  132   o , whereas pushing the lever  122   a  away from endoscope  200  as shown in  FIG. 1A  causes the inner elongate member  132   i  to retract proximally relative to the outer elongate member  132   o.    
         [0034]    As will be appreciated by those of ordinary skill in the art, the distance that the inner elongate member  132   i  moves in relation to the outer elongate member  132   o  is determined by the degree (angle) of rotation of the actuator  122  around the pivot  126  and the distance between the second connection point  122   p  and the pivot  126 . 
         [0035]    Thus, by affixing the outer elongate member  132   o  to the housing  110   h  of the device body  110  and by affixing the inner elongate member  132   i  that runs within the outer elongate member  132   o  to the pivoting actuator  122 , the rotation of the actuator  122  can actuate the desired effect. 
         [0036]    Although pulling the lever  122   a  in the embodiment shown acts to advance the inner elongate member  132   i  relative to outer elongate member  132   o  and pushing the lever  122   a  retracts the inner elongate member  132   i  relative to outer elongate member  132   o , one of ordinary skill in the art will appreciate that, in other arrangements, such as that shown in  FIG. 4 , among others, pulling the lever  122   a  will act to retract the inner elongate member  132   i  relative to outer elongate member  132   o  and pushing the lever  122   a  will act to advance the inner elongate member  132   i  relative to outer elongate member  132   o . As discussed in more detail below, advancement and retraction of this type may be used to actuate a variety of accessory devices  132  during the course of an endoscopic procedure. 
         [0037]    In some embodiments, the actuation device  100  will further comprise a spring or another mechanism that is configured to bring the actuator  122  to a default position when the lever  122   a  is released. For instance, the default position may correspond to an actuator  122  position where the inner elongate member  132   i  is retracted relative to the outer elongate member  132   o . Alternatively, the default position may correspond to an actuator  122  position where the inner elongate member  132   i  is advanced relative to the outer elongate member  132   o , or something in between. In one particular example, the default position may correspond to an actuator  122  position where an implement (knife, needle, etc.) disposed at a distal end of the inner elongate member  132   i  is retracted within the outer elongate member  132   o.    
         [0038]    In some embodiments, the actuation device  100  will further comprise a port that is configured to allow access for a guidewire. In applications where a guidewire is used in conjunction with the accessory device  132 , a separate guidewire port may be provided in the actuation device  100  to allow access for the guidewire. 
         [0039]    In some embodiments, the actuator  122  (and thus the position of the inner elongate member  132   i  relative to the outer elongate member  132   o ) may be set to any of a plurality of different positions. For example, the actuator  122  may be held at a desired position relative to the housing portion  110   h  via a releasable locking mechanism, for instance, by providing the actuator  122  and the housing portion  110   h  with interlocking stepped ridges (e.g., analogous to the complementary ridges of a hemostat). Upon release, the actuator  122  may, in some embodiments, return to a default position via a spring mechanism as discussed above. As another example, the lever actuator  122  may comprise a plurality of depressions and the housing portion  110   h  may comprise a spring-driven ball (e.g., in the form of a ball nose spring plunger, etc.) that engages the depressions, or conversely, the housing portion  110   h  may comprise a plurality of depressions while the actuator  122  may comprise a spring-driven ball that engages the depressions. 
         [0040]    Further details of an actuation device  100  like that shown in  FIGS. 1A and 1B  will now be described in conjunction with  FIGS. 2A and 2B . Shown are the components of the device body  110 , specifically, the housing portion  110   h , bracket portion  110   b  and linking portion  110   l , which are secured to one another and which could readily be formed as a single piece, if desired. As seen from  FIG. 2A , the fastener  112  that is configured to attach the device body  110  to the endoscope is in the form of a piece that spreads and snaps onto the endoscope body. The fastener  112  is linked to the bracket  110   b  via a hinge in the embodiment shown, allowing the fastener  112  to hinge around the endoscope body  220 . In addition, there is also seen a protrusion  128  that is configured to be inserted into a working channel of the endoscope  200  to which the actuation device  100  is attached. In certain embodiments, an opening will be provided in the actuation device  100 , which permits the accessory device  132  access to an endoscope working channel. In the embodiment shown, a lumen extends from a proximal point  127   p  to a distal point  127   d  at a distal end of the protrusion  128 , through which the accessory device  132  may be threaded. This arrangement may be further appreciated with the assistance of  FIG. 3 , which shows the actuation device  100  attached to the endoscope body  220  via the fastener  112 . The protrusion  128  is not seen as it is inserted into a port of a working channel  210  of the endoscope, and the accessory device  132  is introduced into the working channel  210  by looping the accessory device  132  into a lumen entrance at point  128   p . In this way, the accessory device  132  may be looped around from the bottom of the actuation device  100  to the top of the actuation device  100  to enter into the working channel  210 , among other possibilities. 
         [0041]    As can be seen from  FIG. 3 , the actuation device  100  allows an endoscopist to control both the endoscope  200  and the accessory device  132  using one hand. This way, the endoscopist may maneuver and deploy the accessory device  132  without help from an assistant. In this regard, the present disclosure solves the inconvenience of the endoscopist having to depend on an assistant to work the accessory device, thereby allowing the endoscopist full control of the endoscope and accessory device. This way the endoscopist can easily switch between using the features of the endoscope (e.g., water introduction, insufflation, suction, left/right movement, up/down movement, endoscope lock, etc.) and operating the accessory device, single-handedly and comfortably. This also leaves the endoscopists other hand free to continue maneuvering the sheath of the endoscope. 
         [0042]    Although the accessory device  132  is routed through the working channel  210  of the endoscope  200  in  FIG. 3 , in other embodiments, the accessory device  132  may be run alongside the endoscope (e.g., along the length of the endoscope body  220 ), rather than within a working channel  210  of the endoscope. In these embodiments, the actuation device may be provided with a through-hole or clip for accessory device management. In various embodiments, the accessory device  132  may be longer than the endoscope body  220  to allow the physician to push the accessory device  132  beyond the distal end of the endoscope body and pull it back in as needed. 
         [0043]    With reference now to  FIG. 2B , one can see the housing portion  110   h , bracket portion  110   b  and linking portion  110   l  of the device body  110 . Further shown is the first connection point  110   p  where the proximal end of the hollow outer elongate member  132   o  is fixed to the body  110 . Also shown are portions of the actuator  122  that are pivotally mounted relative to the housing portion  110   h , specifically, the lever  122   a  which is employed to rotate the actuator  122  around the pivot  126  (which in this particular case is in the form of a pivot pin). Also shown is the second connection point  122   p  where the proximal end of the inner elongate member  132   i  (in the form of an actuation wire) is attached. In this particular embodiment, the actuation wire is attached via a 2-in-1 active cord connector  123  which is screwed into a D-block  127  until the actuation wire is fixed in place. Thus, in this embodiment, the connector acts as both a mechanical connector and an electrical connector (e.g., a monopolar electrical connector). Moreover, the connector also forms a protrusion which travels within a slot  119  that is formed in housing  110   h . The slot  119  limits the travel of the protrusion and thus the rotation of the actuator within the housing  110   h.    
         [0044]    Accessory devices which may be actuated by the actuation device of the present disclosure include those that are used in conjunction various procedures including, for example, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), polypectomy, colonoscopy, transurethral surgery, respiratory surgery, and laparoscopic surgery, among others. 
         [0045]    One specific example of an accessory device  132  is a sphincterotome, a distal end of which is illustrated in  FIGS. 5A-5B . The sphincterotome  132  includes an outer elongate member  132   o  (i.e., a catheter) and an inner elongate member  132   i  (i.e., a pull wire), which emerges from the outer elongate member  132   o  at a point  132   p  near its distal end. The outer elongate member  132   o  and inner elongate member  132   i  are connected to an actuation device  100  as previously described. When the lever  122   a  of the actuation device  100  is positioned such that the inner elongate member  132   i  is distally advanced relative to the outer elongate member  132   o , the sphincterotome  132  takes on an orientation like that shown in  FIG. 5A . On the other hand, when the lever  122   a  of the actuation device  100  is positioned such that the inner elongate member  132   i  is proximally retracted relative to the outer elongate member  132   o , the distal tip of the sphincterotome  132  bends as shown in  FIG. 5B , exposing the distal end of the inner elongate member  132   i , which acts as a cutting wire. Electrical current may be passed through the exposed wire during the cutting process, for example, by establishing a monopolar connection to an electrosurgical generator using an electrical connector as previously described. 
         [0046]    If desired the accessory device  132  may be configured such that the default position for the lever is one where the inner elongate member  132   i  is advanced relative to the outer elongate member  132   o , resulting in a default position for the sphincterotome  132  like that shown in  FIG. 5A . Such an accessory device  132  may be run alongside an endoscope or be routed through a working channel of the endoscope. 
         [0047]    In the preceding example of a sphincterotome, the accessory device  132  is deployed by retracting the inner elongate member  132   i  relative to the outer elongate member  132   o . In other instances, the accessory device  132  is deployed by advancing the inner elongate member  132   i  relative to the outer elongate member  132   o . In this regard, and turning to  FIGS. 6A-6B , another example of an accessory device  132  in the form of a cutting knife is shown. The accessory device  132  includes an inner elongate member  132   i  (i.e., a wire) and an outer elongate member  132   o  (i.e., a catheter) which are connected at a proximal end (not shown) to an actuation device  100  as previously described. The distal end of the accessory device  132  may be reversibly attached to a distal end  200   d  of an endoscope via a loop  135  as shown, with the accessory device  132  running outside the endoscope  200 , rather than being routed through a working channel of the endoscope, although an analogous accessory device  132  could be routed through the working channel if desired. 
         [0048]    When the lever  122   a  of the actuation device  100  is positioned such that the inner elongate member  132   i  is proximally retracted relative to the outer elongate member  132   o , the accessory device  132  takes on an orientation like that shown in  FIG. 6A . On the other hand, when the lever  122   a  of the actuation device  100  is positioned such that the inner elongate member  132   i  is distally advanced relative to the outer elongate member  132   o , a cutting knife  136  disposed at a distal end of the inner elongate member  132   i  extends from the distal end  132   od  of the outer elongate member  132   o  as shown in  FIG. 6B . Electrical current may be passed through the exposed cutting knife  136  during the cutting process, for example, by establishing a monopolar connection to an electrosurgical generator as previously described. 
         [0049]    If desired, the actuation device may be configured such that the default position for the lever  122   a  is one where the inner elongate member  132   i  is retracted relative to the outer elongate member  132   o , resulting in a default position for the accessory device  132  like that shown in  FIG. 6A . The act of engaging the lever  122   a  (e.g., squeezing the lever  122   a  or pushing the lever  122   a , depending on the configuration) will deploy the cutting knife  136  out of the distal end  132   od  of the outer elongate member  132   o , thereby exposing the cutting knife  136  for use. Releasing the lever  122   a  places the cutting knife  136  into its default retracted position for safety. 
         [0050]    In other embodiments, the actuation device  100  may be coupled to an accessory device  132  that comprises an articulating hook or grasper at the distal end. The lever  122   a  may be used to articulate the distal tool to one side, analogous to the above-described sphincterotome, with the inner elongate member  132   i  being provided in an off-center position (e.g., in an off-center lumen). In other embodiments, the actuation device  100  may be used to deploy a clip, may be used to deploy a band during EMR, or may be used to deploy a stent. In yet other embodiments, the actuation device  100  may be used to inject a solution, for example, for contrast or for elevation of a lesion, among many other possible applications. In still other embodiments, the actuation device  100  may be used to actuate a snare (including a hot snare) or to actuate hot or cold biopsy forceps. In still other embodiments, the actuation device  100  may be used to actuate a catheter (e.g., Alair™ Bronchial Thermoplasty system, Boston Scientific Corporation, Marlborough Mass.), a medical laser probe (e.g., thulium laser system) or mechanical scissors. 
         [0051]    In some embodiments, the actuation device may be manufactured to be universal, so that different accessory devices may be easily attached to it. That way when the physician is switching tools, the handle can be left in place while the accessory tool is swapped. 
         [0052]    While the devices, assemblies and methods of this disclosure have been described in terms of preferred embodiments, it may be apparent to those of skill in the art that variations can be applied without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.