Patent Description:
Technological developments have given users of medical systems, devices, and methods, the ability to conduct increasingly complex procedures on subjects. The coupling of tissue in, for example, a subject's gastrointestinal tract, is a type of procedure in which difficulties may arise. Surgical devices that grasp or clamp tissue between opposing jaw structures and then join the tissue by surgical fasteners are known. The fasteners include surgical staples. In some procedures, a cutting instrument is provided to cut the tissue which has been joined by the fasteners. However, problems arise when stapling and cutting tissue in order to remove tumorous tissue from a patient's body.

One such difficulty involves removing a lesion from tissue. In order to remove a lesion, the user may staple tissue around the outer edge of the lesion. When a lesion is highly contagious, it is important to cut the tissue at a region that does not include the lesion to avoid spreading the contagious tissue. There is a need for stapler instruments that include both stapling and cutting features that address this difficulty.

Often surgical staplers include a staple cartridge to house a plurality of staples. An anvil defines a surface for forming the staple legs as the staples are driven from the staple cartridge. The stapling operation may be effected by an actuator acting upon a staple, which often involves pushing the actuator in a distal direction to drive the staples from the cartridge. With such a configuration, problems arise when pushing the actuator due to curves in portions of the stapler connecting its proximal and distal ends, and a user may find it difficult to actuate the stapler when the stapler is rotated or angled from a longitudinally straight position.

Another difficulty involves removing a lesion from tissue by stapling its outer perimeter and cutting the lesion from the tissue. In order to remove the lesion, the user may first staple tissue around the lesion. When stapling, the user may need to clearly observe the outer edge of the lesion, however the user's field of view may be obstructed by the stapler if the distal end of the stapler is longitudinal rigid or fixed, preventing the instrument from bending and moving out of the field of view of the user. For example, during an endoscopic procedure, the optics of the endoscope often are positioned immediately adjacent the tissue, resulting in poor recognition of the endoscope location relative to the rest of the body lumen or larger tumors. <CIT> discloses an endoscopic surgical stapler.

Certain optional features of the invention are defined in the dependent claims. Aspects of the disclosure relate to, among other things, systems and devices for fastening tissue. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

According to one aspect, a tissue fastening device may include a handle assembly including at least two actuators. The tissue fastening device may also include a first body extending distally from the handle assembly and defining a longitudinal axis. The tissue fastening device may also include a fastening device coupled to a distal end of the first body. The fastening device may include a longitudinal body including a channel, a cartridge configured to include a plurality of fasteners, a longitudinal channel configured to receive a device for cutting tissue, an anvil rotatable relative to the cartridge, and a fastener actuator. The fastener actuator may be coupled to one actuator of the at least two actuators and configured to move proximally relative to the cartridge to deploy the plurality of fasteners from the cartridge.

In other aspects of the disclosure, the tissue fastening device may include one or more of the features below. The tissue fastening device may include a protrusion extending from a side surface of the fastening device and defining a lumen configured to receive a tissue acquisition tool. The fastening device may include a device for cutting tissue. The fastener actuator may be coupled to an actuation wire that extends from the fastener actuator through the elongated body to the handle assembly, and the actuation wire may be coupled to a first actuator of the at least two actuators. The fastener actuator may be configured to move proximally relative to the cartridge and the anvil when the first actuator is actuated. A distal portion of the first body may include a rigid curved portion such that a longitudinal axis of the fastening device is transverse to a longitudinal axis of a proximal portion of the first body. The anvil may include a first recess, the longitudinal body may include a second recess opposing the first recess, and the first and second recesses may be configured to receive a tissue acquisition tool. The fastener actuator and the device for cutting tissue may be coupled to an actuation wire that extends from the fastening device through the first body to a first actuator of the handle assembly, and the first actuator may be configured to move both the fastener actuator and the device for cutting tissue proximally. The fastening device may be rotatably coupled to the first body. The fastener actuator may include a ramp, and a surface of the ramp that contacts the plurality of fasteners may have an angle of <NUM> degrees or less relative to a longitudinal axis of the longitudinal body. The fastening device may be fixedly coupled to the first body, and a longitudinal axis of the fastening device may be transverse to a longitudinal axis of the first body.

In other aspects, a tissue fastening device may include a handle assembly including at least two actuators. The tissue fastening device may also include a first body extending distally from the handle assembly and defining a longitudinal axis. The tissue fastening device may further include a fastening device coupled to a distal end of the first body. The fastening device may include a longitudinal body including a channel. The fastening device may also include a cartridge that includes a plurality of fasteners. The fastening device may further include an anvil mounted adjacent the cartridge. The tissue fastening device may also include a second body including a lumen. The first body may be positioned in, movable within, and extends from the lumen. The tissue fastening device may also include a coupler coupling a distal end of the second body to the fastening device. The fastening device may be pivotable about the coupler when the first body is moved proximally and/or distally.

In other aspects of this disclosure, the tissue fastening device may further include one or more of the features below. The second body may define an opening in a side wall of the second body and through which the first body extends. The second body may include a recess configured to receive a portion of the first body when the longitudinal axis of the fastening device is parallel to the longitudinal axis of the second body. The handle assembly may include a first actuator configured to move longitudinally in proximal and distal directions and a second actuator configured to pivot relative to a body of the handle assembly.

In other aspects of this disclosure, a system may include a tissue fastening device and a tissue acquisition tool moveably coupled to the tissue fastening device. The system may also include an oversheath including a distal end opening and at least two distal end portions. The oversheath may be positioned around the tissue fastening device and the tissue acquisition tool. The oversheath may be configured to move proximally and the at least two distal end portions may be configured to move radially outward, to expose the tissue fastening device and tissue acquisition tool.

In other aspects, the system may further include one or more of the features below. A longitudinal body including a channel and a guide protrusion. The guide protrusion may include a lumen configured to receive the tissue acquisition tool. The tissue fastening device may further include a cartridge including a plurality of fasteners; and an anvil mounted adjacent the cartridge. The tissue acquisition tool may be positioned within the lumen of the guide protrusion. A proximal portion of the oversheath may be positioned around an endoscope, and the endoscope may include an image sensor and at least two working channels. The at least two distal end portions may be biased radially inward and configured to partially enclose fastening device and tissue acquisition tool.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure.

The present disclosure is drawn to systems and devices for coupling, cutting, and resecting tissue, among other aspects. Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a patient. By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the patient. The term "coupling tissue together" may refer, for example, to stapling, fixing, attaching, fastening, or otherwise joining two portions of tissue together. The term "fastener" may include staples, clips, elastic bands, suture, or any other fastener known in the art. 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.

Embodiments of the present disclosure may be used to visualize, cut, resect, and/or couple together target tissue in an endo-luminal space, or facilitate the process thereof. In particular, some embodiments combine a tissue resecting device with a tissue stapling device. The tissue stapling apparatus may include a resection or cutting mechanism (e.g., an integrated knife) and a stapling mechanism (stapler). The stapling apparatus may be delivered to target tissue through an endoscope working channel to the target tissue site. The overall system may include a retraction mechanism, such as a tissue clip, to pull tissue towards the tissue stapling device. All or parts of the tissue stapling device and the retraction mechanism could be metallic, plastic, or include a shape memory metal (such as nitinol), a shape memory polymer, a polymer, or any combination of materials.

<FIG> shows a surgical apparatus <NUM> in accordance with an embodiment of this disclosure. Apparatus <NUM> is a surgical stapling apparatus configured to engage body tissue, apply a plurality of surgical fasteners thereto, and form an incision in the fastened body tissue during minimally invasive surgical procedures, such as laparoscopic or endoscopic procedures. Apparatus <NUM> may be used to apply surgical clips or other fasteners, but will be primarily discussed in the context of applying staples from a staple cartridge positioned in a portion of the device's body, such as a loading unit.

As illustrated in <FIG>, apparatus <NUM> includes a distal section <NUM> and a proximal section <NUM>. Surgical apparatus <NUM> also includes a handle assembly <NUM>, an elongate body <NUM>, and a stapler device <NUM>. The elongate body <NUM> may extend any length suitable for endoscopic or laparoscopic procedures, and may be configured to be positioned within a working channel of an endoscope. The elongate body <NUM> may be detachable from the handle assembly <NUM> to facilitate insertion of the elongate body <NUM> into a working channel of an endoscope or a channel of another device, for example by backloading body <NUM> into the working channel. In some examples, the elongate body may be flexible and/or may be rotatable about its axis. The elongate body <NUM> may include a lumen for positioning actuation wires within for actuating the stapler device <NUM> via the handle assembly <NUM> or actuating any other portion of the apparatus <NUM>. The elongate body <NUM> may be configured to receive a plurality of actuation wires or a single actuation wire (for example, actuation wire <NUM>). In some examples, the elongate body <NUM> may be fixedly coupled to the stapler device <NUM>, and in other examples the elongate body <NUM> may be removably or releasably coupled to the stapler device <NUM>.

The handle assembly <NUM> may include a handle <NUM> and a body <NUM>. The handle <NUM> may include a fixed portion <NUM> and an actuator portion <NUM>. Fixed portion <NUM> of handle <NUM> may be fixedly coupled to body <NUM>, and fixed portion <NUM> may include a circular or oval portion or ring for positioning a user's fingers within, which may assist a user in holding the handle assembly <NUM>. In some examples, moveable portion <NUM> of handle <NUM> may be an actuator which may be pivotally coupled to body <NUM> and movable relative to the fixed portion <NUM> of handle <NUM>. Movable portion <NUM> may include a circular or oval portion for positioning a user's fingers within, which may assist in actuating surgical apparatus <NUM>. In some examples, movable portion <NUM> of handle <NUM> may be coupled to a proximal portion of an actuation wire, such as actuation wire <NUM>, via an adjustable coupler <NUM> and may be configured to actuate an anvil of stapler device <NUM> via actuation wire <NUM> extending between stapler device <NUM> and handle assembly <NUM>. In other examples, movable portion <NUM> of handle <NUM> may be configured to control any other mechanism of apparatus <NUM>, such as actuation of deploying staples from stapler device <NUM>.

In some examples, handle assembly <NUM> may include a moveable cover <NUM> pivotably coupled to housing <NUM> at pivot point 112a. In <FIG>, cover <NUM> is shown in an open position, exposing the internal portions of housing <NUM>. Cover <NUM> may be coupled to a proximal portion of housing <NUM> and may cover the internal components of handle assembly <NUM> when positioned longitudinally parallel to housing <NUM>, such that distalmost end 112b of cover <NUM> faces surface 115b of housing <NUM>. Cover <NUM> may be temporarily fixedly coupled to a position covering the internal components of housing <NUM> via a coupling mechanism at a distal portion of cover <NUM> and a distal portion of handle assembly <NUM>, such as a snap locking mechanism, in order to hold cover <NUM> in place and prevent movement of cover <NUM> relative to housing <NUM>. When held in place, cover <NUM> may form a pair of slots in housing <NUM> (not shown). When the distal portion of cover <NUM> is uncoupled from the distal portion of housing, a user may rotate (or pivot) cover <NUM> at pivot point 112a in order to have access to the internal components of handle assembly <NUM>.

Handle assembly <NUM> may further include a rotatable elongate connector <NUM> which may connect the elongate body <NUM> to handle assembly <NUM>. In some examples, rotatable elongate connector <NUM> may rotate relative to housing <NUM> to either tighten onto elongate body <NUM> in order to fixedly couple elongate body <NUM> to handle assembly <NUM>, or rotated to release elongate body <NUM> from handle assembly <NUM>. Within body <NUM>, one or more adjustable couplers <NUM>, <NUM> may be positioned in longitudinal alignment with, or longitudinally parallel with, rotatable elongate connector <NUM> and may be configured to receive a portion of an actuation wire, such as actuation wire <NUM>. Any of adjustable couplers <NUM>, <NUM> may be a vice which is moveable in order to clamp down onto an actuation wire and fixedly couple actuation wire to the adjustable coupler <NUM>, <NUM>. In some examples, adjustable coupler <NUM>, <NUM> may be moveable via a screw to adjust the coupler <NUM>, <NUM> and couple or uncouple an actuation wire from coupler <NUM>, <NUM>.

Adjustable coupler <NUM> may be coupled to longitudinal actuator <NUM> and moveable longitudinally via translating longitudinal actuator <NUM> within housing <NUM>. Longitudinal actuator <NUM> may be partially positioned within housing <NUM> and may be slidable longitudinally within two slots formed when cover <NUM> is positioned over the internal components of handle assembly <NUM>. Longitudinal actuator <NUM> may include a pair of opposing circular or oval portions or rings, with each circular portion defining an aperture for a user to position their fingers within. In some examples, longitudinal actuator <NUM> may be coupled to an actuation wire (not shown), such as via adjustable coupler <NUM> or via a different coupler within housing <NUM>, and may be configured to control staple deployment from stapler device <NUM>. In other examples, longitudinal actuator <NUM> may be configured to control any other mechanism of apparatus <NUM>, such as actuation of an anvil of stapler device <NUM>.

Distal section <NUM> of apparatus <NUM> includes a stapler device <NUM> coupled to a distal portion of elongate body <NUM>. A connector <NUM> of stapler device <NUM> may couple elongated body <NUM> to stapler device <NUM>. In some examples, connector <NUM> may be offset from a longitudinal axis of the body <NUM> of stapler device <NUM>. Body <NUM> of stapler device <NUM> may include a cartridge <NUM> positioned within a channel of body <NUM>. Cartridge <NUM> may be fixedly coupled to body <NUM> or may be removable from body <NUM>. In some examples, cartridge <NUM> may be integrally formed in body <NUM>. At a proximal portion of body <NUM>, an anvil <NUM> may be rotatably or pivotably coupled to body <NUM> at pivot axis 120a, and may extend distally towards a distal end of stapler device <NUM>. In some examples, anvil <NUM> may be rotatably biased and may be biased to an open configuration, i.e. biased away from body <NUM> and cartridge <NUM> creating a space between the distal portion of anvil <NUM> and the distal portion of body <NUM> and cartridge <NUM>. Anvil <NUM> may be rotatable about axis 120a to contact body <NUM>, or pinch tissue between anvil <NUM> and body <NUM>, and provide a surface for which staples may be driven when ejected from cartridge <NUM>.

In some examples, body <NUM> may include a channel that supports cartridge <NUM>. Cartridge <NUM> may contain a plurality of surgical fasteners, such as staples, and the fasteners may be deployed from cartridge <NUM> when under the influence of a driving force exerted by an actuation sled, such as actuation sled <NUM> shown in <FIG>. A plurality of spaced apart longitudinal slots <NUM> in cartridge <NUM> allow staples to pass through cartridge <NUM> and pierce tissue. According to the invention, an actuation sled moves proximally in the longitudinal direction from a distal end of cartridge <NUM> and/or body <NUM> when actuated, contacting fasteners within cartridge <NUM> and pushing fasteners through longitudinal slots <NUM> in order to couple fasteners to tissue. In some examples, a single fastener may extend through each slot <NUM>. Each fastener may be partially within a slot <NUM> prior to deployment to assist with alignment of the fastener with the slot <NUM>. In some examples, two actuation sleds <NUM>, <NUM> may be required to actuate two different longitudinal rows of fasteners in cartridge <NUM> (shown in <FIG>).

Cartridge <NUM> may also include an elongate longitudinal slot <NUM>. The elongate longitudinal slot <NUM> may be configured to receive and/or support a resecting tool, such as a knife blade (not shown). The elongate longitudinal slot <NUM> may be positioned on a side of cartridge <NUM> and may run longitudinally from the proximal end to the distal end of cartridge <NUM>. In some examples, each of the spaced apart longitudinal slots <NUM> may be positioned on one side of the elongate longitudinal slot <NUM>. Anvil <NUM> may include a groove (not shown) positioned longitudinally that may align with elongated longitudinal slot <NUM> when anvil <NUM> is in the closed position (i.e. anvil <NUM> is rotated such that a distal portion of anvil <NUM> comes into contact with body <NUM> and/or cartridge <NUM>, or pinches tissue between anvil <NUM> and body <NUM>) and such groove may be configured to receive a resecting tool such as a knife or other sharp cutting tool within the elongate longitudinal slot <NUM>. The cutting tool may be actuated via an additional, separate actuation wire from the actuation wire that translated the actuation sled, or may be actuated via the same actuation wire as the actuation sled to translate both the actuation sled and the cutting tool at the same time.

A user may use apparatus <NUM> to couple one or more fasteners to tissue by first positioning tissue within the active region of stapler device <NUM>, or between body <NUM> and anvil <NUM>. Once tissue is positioned in the active region of stapler device <NUM>, a user may actuate the actuator portion <NUM> of handle <NUM>, which may then translate an actuation wire proximally and cause anvil <NUM> to close onto the tissue positioned within the stapler device's active region. While the user holds actuation portion <NUM> in an engaged position, thus maintaining the stapler device's clasp on the tissue, the user may pull proximally (or actuate) longitudinal actuator <NUM> to translate an actuation wire coupled to an actuation sled in the stapler device. When the actuation sled is translated proximally via the actuation wire coupled to the longitudinal actuator <NUM>, a ramp of the actuation sled may engage a fastener in cartridge <NUM> and push the fastener through a longitudinal slot <NUM> to pierce the tissue. When the fastener is deployed by the actuation sled, the fastener may subsequently engage anvil <NUM> and couple layers of tissue together. In some examples, the longitudinal actuator <NUM> may actuate an actuation wire coupled to both an actuation sled and a cutting tool, and may translate both the actuation sled and the cutting tool simultaneously to both pierce and fasten tissue with one or more fasteners and cut tissue.

In some examples, a user may backload elongate body <NUM> through the distal end of a working channel of an endoscope, through the body of the endoscope, and out of a proximal end of the endoscope prior to coupling the elongate body <NUM> to the handle assembly <NUM>. Once elongate body <NUM> is positioned within a working channel of an endoscope with stapler device <NUM> at the endoscope's distal end, a user may couple handle assembly <NUM> to elongate body <NUM> by inserting the proximal end of elongate body <NUM> into rotatable elongate connector <NUM>, and then rotating rotatable elongate connector <NUM> to fix elongate body <NUM> to handle assembly <NUM>. A user may then couple the proximal ends of actuation wires (such as actuation wire <NUM>) positioned within elongate body to adjustable couplers <NUM>, <NUM>. Once elongate body <NUM> is coupled to handle assembly <NUM> and actuation wires (such as actuation wire <NUM>) are coupled to adjustable couplers <NUM>, <NUM>, the user may close moveable cover <NUM> such that distalmost end 112b of cover <NUM> faces surface 115b of housing <NUM>. Cover <NUM> may be temporarily fixedly coupled to a position covering the internal components of housing <NUM> via a coupling mechanism at a distal portion of cover <NUM>, and a distal portion of handle assembly <NUM>, such as a snap locking mechanism, in order to hold cover <NUM> in place during use of apparatus <NUM>.

<FIG> shows a distal section of an endoscope <NUM>, a tissue acquisition tool <NUM> positioned within a working channel <NUM> of the endoscope <NUM>, and a surgical apparatus <NUM> positioned within another working channel <NUM> of the endoscope <NUM>, in accordance with an embodiment of this disclosure. Surgical apparatus <NUM> is substantially similar to surgical apparatus <NUM> and includes a stapler device <NUM> with longitudinal slots <NUM> for fastener deployment, an elongated longitudinal slot <NUM> for receiving a knife, and anvil <NUM>. Cartridge <NUM> is integrally formed in body <NUM> of stapler device <NUM>. A user may use a tissue acquisition tool <NUM> in combination with a stapler device, such as stapler device <NUM>, to facilitate grabbing tissue and positioning tissue in the active portion of stapler device <NUM>, i.e. between body <NUM> and anvil <NUM> for stapling. Tissue acquisition tool <NUM> may include an elongate body <NUM> extending longitudinally to a distal end portion <NUM>. In some examples, distal end portion <NUM> of tissue acquisition tool <NUM> may include a pair of rotatable jaws <NUM>, <NUM> that are moveable between a closed configuration and an open configuration. A user may actuate jaws <NUM>, <NUM> using an actuator present at the proximal portion of tissue acquisition tool <NUM> (not shown) to open and close jaws <NUM>, <NUM> to facilitate grabbing and releasing tissue. A user may position tissue acquisition tool <NUM> within a working channel <NUM>, as shown in <FIG>, separate from the working channel <NUM> in which the surgical apparatus <NUM> is positioned. In other examples, a user may position tissue acquisition tool <NUM> in the same working channel as surgical apparatus <NUM> (not shown) to facilitate positioning tissue between anvil <NUM> and body <NUM>.

<FIG> shows a distal portion of an embodiment of surgical apparatus <NUM> according to the invention including stapler device <NUM> that is configured to receive a removable cartridge <NUM>. When removable cartridge <NUM> is removed from body <NUM>, actuation sled <NUM> and knife <NUM> may be visible (shown in <FIG>). In some examples, when cartridge <NUM> is positioned within a channel <NUM> of body <NUM>, actuation sled <NUM> and knife <NUM> may be received within cartridge <NUM> and may not be visible. In other examples, actuation sled <NUM> and knife <NUM> may be received within cartridge <NUM> and may be visible when cartridge <NUM> is positioned within body <NUM>, such as by extending out of a channel in cartridge <NUM>. Actuation sled <NUM> and knife <NUM> may be coupled to a single actuation wire extending to a proximal portion of surgical apparatus <NUM> such that, when actuated, the actuation sled <NUM> and knife <NUM> move proximally in unison. In other examples, actuation sled <NUM> and knife <NUM> may be coupled to separate actuation wires extending from a proximal portion of either actuation sled <NUM> or knife <NUM> to a proximal portion of surgical apparatus <NUM>, such as to handle assembly <NUM> such that either the actuation sled <NUM> or the knife <NUM> may be actuated independently. Actuation sled <NUM> is configured to be translated proximally to push fasteners, such as staples within cartridge <NUM>, out of slots <NUM> in cartridge to fasten tissue together. Actuation sled <NUM> and knife <NUM> may be pressed by the user into a distal pocket of cartridge <NUM> when cartridge <NUM> is first positioned within body <NUM>.

Actuation sled <NUM> may include a ramp <NUM> that is configured to engage, directly or indirectly, staples, or other fasteners from within cartridge <NUM> through slots <NUM>, to deploy fasteners to couple tissue. In some examples, ramp <NUM> may be angled at <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, or any other angle relative to a longitudinal axis of body <NUM>. Ramp <NUM> may be a shallow angle to require the actuation sled <NUM> to translate proximally for a longer distance in order to deploy fasteners in cartridge <NUM>. By providing actuation sled <NUM> with a shallow angle, long ramp <NUM>, a user may engage multiple fasteners at the same time when pulling actuation sled <NUM> proximally, and thus allowing, in some examples, multiple staples to deploy and pierce tissue at the same time. Furthermore, a shallow angle ramp <NUM>, e.g. an angle approximately <NUM> degrees or less, may prevent intermittent forces being applied to the actuator in the handle assembly due to the actuation sled <NUM> releasing from a fastener before engaging the next fastener, by continuously engaging fasteners in cartridge <NUM>, and thus may prevent errors during a procedure by providing a more continuous force applied to the actuator. In some examples, the ramp <NUM> of actuation sled <NUM> may engage two, three, four, or more fasteners in cartridge <NUM> at the same time. Since actuation sled <NUM> is pulled proximally to deploy fasteners, a user may generate higher loads when pulling a flexible wire, such as an actuation wire <NUM> shown in <FIG>, compared to a pushing mechanism to deploy fasteners. An actuation body <NUM> may extend proximally from a proximal portion of ramp <NUM>, and actuation sled <NUM> may be pulled from the actuation body <NUM> to deploy fasteners. For example, actuation body <NUM> may be coupled to an actuation wire that extends to a proximal portion of the surgical apparatus <NUM>. In some examples, apparatus <NUM> may include two actuation sleds <NUM> and two actuation bodies <NUM> coupled to the same actuation wire to engage and deploy two separate rows of fasteners in cartridge <NUM>.

Knife <NUM> may have a similar structure to actuation sled <NUM> and may include a hooked distal portion <NUM> that includes sharp edges for cutting tissue. Knife <NUM> may be configured to travel longitudinally within an elongated longitudinal slot of cartridge <NUM>. In some examples, a portion of knife <NUM> extends into a groove of anvil <NUM>, such as groove <NUM> shown in <FIG>, and travels within the groove longitudinally from the distal end of anvil <NUM> to the proximal end when a user actuates knife <NUM>, thus translating knife <NUM> longitudinally across cartridge <NUM> to cut tissue.

<FIG> shows a distal portion of an alternative embodiment of surgical apparatus <NUM> including stapler device <NUM> that is configured to receive a removable cartridge <NUM>. In stapler device <NUM>, body <NUM> includes a distal end with a distal front face <NUM> that encloses cartridge <NUM> within body <NUM> with only the top portion of cartridge <NUM>, or the portion of cartridge <NUM> opposing a bottom surface of anvil <NUM>, exposed. Distal front face <NUM> prevents the distal end of cartridge <NUM>, or in some examples an actuation sled and/or a knife, from contacting tissue when moving stapler device <NUM>. Anvil <NUM> includes a groove <NUM> within a surface opposing cartridge <NUM>, configured to receive a knife when anvil <NUM> is in a closed position.

<FIG> shows an enlarged, cross-sectional view of an exemplary stapler device <NUM> including body <NUM>, anvil <NUM>, cartridge <NUM> with fasteners <NUM>, and actuation sled <NUM> with actuation body <NUM>. The stapler device <NUM> in <FIG> is shown deploying fasteners <NUM> onto tissue <NUM>. Actuation sled <NUM> engages pistons or spacers <NUM>, and the pistons or spacers <NUM> then engage the fasters <NUM> to deploy the fasteners <NUM>. As shown in <FIG>, actuation sled <NUM> engages the pistons or spacers <NUM> as actuation sled <NUM> moves in the proximal direction P. Each piston or spacer <NUM> may be configured to translate within cartridge <NUM> and may be sized to engage only one fastener. In other examples, each piston or spacer <NUM> may be sized to engage multiple fasteners, or one or more pistons or spacers <NUM> may be sized to engage multiple fasteners while one or more other pistons or spacers <NUM> may be sized to engage only one fastener. Actuation sled <NUM> may be configured to move each piston or spacer <NUM> in a direction transverse to the longitudinal axis of body <NUM>. For example, actuation sled <NUM> and actuation body <NUM> may be pulled proximally via an actuation wire, which may move ramp <NUM> (shown in <FIG>) into contact with one or more pistons or spacers <NUM> and push one or more pistons or spacers <NUM> to deploy one or more fasteners <NUM> from cartridge <NUM>. Each of the pistons or spacers <NUM> may have an upper surface that aligns and/or is flush with a portion of each respective fastener <NUM>. For example, each fastener <NUM> may be a staple and may include three substantially flat sections with the middle substantially flat section aligning with the top surface of each spacer <NUM>. Each piston or spacer <NUM> may be sufficiently rigid to move uniformly upward when the ramp <NUM> of actuation sled engages a corner of the piston or spacer <NUM>. In some examples, each piston or spacer <NUM> may be coupled to cartridge <NUM> such that movement along the longitudinal axis of cartridge <NUM>, or in the proximal P or distal D directions shown in <FIG>, is prevented while allowing movement in a direction perpendicular to the longitudinal axis of cartridge <NUM>. The pistons or spacers <NUM> in cartridge <NUM> may prevent fasteners <NUM>, such as staples, from partially deploying and may avoid improper stapling caused by a distal portion of a staple moving upward when a proximal portion of the staple does not move. By providing spacers <NUM> with flat top surfaces that align with fasteners <NUM>, the ramp <NUM> of actuation sled <NUM> can move proximally and push each fastener <NUM> uniformly upward by engaging each spacer.

<FIG> shows an exemplary actuation sled <NUM> including a ramp <NUM>, a width <NUM>, a height <NUM>, and an actuation body <NUM>. Ramp <NUM> may include a first proximal section <NUM> and a second distal section <NUM>. In some examples, the first proximal section <NUM> may have a different incline angle <NUM> than the incline angle <NUM> of the second distal section <NUM>. For example, the first proximal section <NUM> may have an incline angle of <NUM> degrees and the second distal section may have an incline angle of <NUM> degrees. By varying the slope of ramp <NUM>, actuation sled <NUM> may push spacers <NUM> with varying levels of pressure as it moves proximally. In other examples, the first proximal section <NUM> and the second distal section <NUM> may have the same incline angles <NUM>, <NUM> or they may have any other angle between <NUM> and <NUM> degrees. In some examples, actuation sled <NUM> may have a length <NUM> of. <NUM> inches (<NUM>,<NUM>) and a height of. <NUM> inches (<NUM>,<NUM>). Actuation body <NUM> may extend from the bottom of ramp <NUM> and, in some examples, may also extend the length <NUM> of the actuation sled <NUM>. In some examples, actuation body may be. <NUM> inch (<NUM>,<NUM>) diameter stainless steel wire.

<FIG> shows a partial cross-sectional view of an exemplary actuation sled <NUM>, a portion of an anvil <NUM> including a recess <NUM> in the anvil's surface that faces cartridge <NUM>, a portion of a cartridge <NUM>, a fastener <NUM>, and tissue <NUM> positioned between cartridge <NUM> and anvil <NUM>. When actuation sled <NUM> is actuated, for exampled pulled from its proximal end <NUM> proximally via an actuation mechanism such as an actuator in handle assembly <NUM>, ramp <NUM> will engage fastener <NUM> and translate fastener towards tissue <NUM> to pierce tissue <NUM> as the actuation sled <NUM> moves in the proximal direction. In other examples, a pin may be positioned between fastener <NUM> and actuation sled <NUM>, and ramp <NUM> may engage the pin instead of fastener <NUM>, the pin forcing the fastener <NUM> towards tissue <NUM>. When fastener <NUM> is translated through tissue <NUM> via engagement with actuation sled <NUM>, portions of fastener <NUM> may be pushed towards each other via engagement with recess <NUM> and may cause fastener to clasp onto tissue <NUM>.

<FIG> shows an exemplary stapler device <NUM> that is angled relative to the longitudinal axis <NUM> of endoscope <NUM> and radially displaced from the endoscope's longitudinal axis <NUM>. Elongate body <NUM> may include a distal end exposed from the endoscope, the distal end may be biased into a curved orientation (shown in <FIG>) such that the longitudinal axis <NUM> of the stapler device <NUM> intersects the longitudinal axis <NUM> of the endoscope <NUM> in which a portion of elongate body <NUM> is positioned within. In some examples, the angle formed between the longitudinal axis <NUM> of stapler device <NUM> and the longitudinal axis <NUM> of the endoscope <NUM> may be fifteen degrees, thirty degrees, forty-five degrees, sixty degrees, or any other angle. Alternatively, the distal end of body <NUM> may include links or other structure that causes the distal end to be in a rigid or substantially rigid configuration shown in <FIG> shows an alternative view of stapler device <NUM> in which elongate body <NUM> has been rotated ninety degrees to position stapler device <NUM> such that the longitudinal axis <NUM> of stapler device <NUM> is angled away from the longitudinal axis <NUM> of endoscope <NUM>. Axis <NUM> shows an axis perpendicular to longitudinal axis <NUM>. By having an elongate body <NUM> that is rigidly curved or otherwise biased curved to angle the longitudinal axis <NUM> of stapler device <NUM> relative to the longitudinal axis <NUM> of endoscope <NUM>, the user's working space may be modified to allow for greater visualization, for example visualization through a camera positioned at the distal end of endoscope <NUM>. Other benefits of angling stapler device <NUM> relative to the longitudinal axis of endoscope <NUM> may include facilitating alignment with a tissue acquisition tool and aiding in positioning tissue between the anvil and the body of stapler device <NUM>. In some examples, elongated body <NUM> may be articulable to angle and radially offset stapler device <NUM>. Body may be articulated via articulation links activated at a proximal end of endoscope <NUM>.

<FIG> show an example of a center line <NUM> of a field of view of a camera at the distal end of endoscope <NUM>. In <FIG>, the longitudinal axis <NUM> of stapler device <NUM> is parallel to the center line <NUM>, and thus stapler device <NUM> is positioned on a side of the field of view. <FIG> shows stapler device <NUM> angled relative to the center line <NUM> of a field of view of a camera. In <FIG>, by pushing stapler device <NUM> distally and articulating the elongate body attached to it, the longitudinal axis <NUM> intersects with the center line <NUM> and positions the distal end portion of stapler device <NUM> directly within the center of the field of view of the camera of endoscope <NUM>.

<FIG> show a field of view of a camera at a distal end of an endoscope in which a stapler device <NUM> and a tissue acquisition tool <NUM> are being utilized to manipulate and couple tissue <NUM>. Since stapler device <NUM> is angled relative to the longitudinal axis of the endoscope, the field of view includes a view of the space between the anvil and the body of stapler device <NUM>, facilitating the positioning of tissue <NUM> between the anvil and body for stapling.

<FIG> shows an example of an alternative embodiment of a stapler device <NUM> including a guide protrusion <NUM>. Guide protrusion <NUM> may include a lumen <NUM> configured to receive a tissue acquisition tool <NUM>. Tissue acquisition tool <NUM> may be positioned within lumen <NUM> of guide protrusion <NUM> prior to inserting endoscope <NUM> into a patient's body. Tool <NUM> and stapler device <NUM> can be backloaded into one or more lumens of endoscope <NUM>. Pre-aligning a tissue acquisition tool <NUM> within guide protrusion's lumen <NUM> may facilitate positioning tissue acquisition tool <NUM> within the space <NUM> between stapler device's <NUM> anvil and body (i.e. stapler device's active region), and may guide tissue acquisition tool <NUM> towards stapler device <NUM> when translated. Lumen <NUM> may be curved or otherwise angled towards stapler device <NUM> to bend tissue acquisition tool <NUM> towards stapler device <NUM>. For example, the plane of the distal opening of lumen <NUM> may be angled to face the stapler device's active region. Guide protrusion <NUM> may extend radially away from a portion of stapler device <NUM> that is proximal to stapler device's <NUM> anvil or space <NUM>. Guide protrusion <NUM> may be fixed to stapler device <NUM>. In some examples, guide protrusion <NUM> may be rigid or may be semi-rigid. Guide protrusion <NUM> may include a lumen <NUM> that includes a central longitudinal axis that is spaced from the longitudinal axis of stapler device <NUM>.

<FIG> shows an exemplary embodiment of a stapler device <NUM> including anvil <NUM>, body <NUM>, recess <NUM> in anvil <NUM>, and recess <NUM> in body <NUM>. Recesses <NUM>, <NUM> may be positioned on radially inward facing surfaces of anvil <NUM> and body <NUM> respectively, opposing each other and may form a lumen between anvil <NUM> and body <NUM> when anvil <NUM> and body <NUM> are in a closed position that lumen traverses the longitudinal axis of stapler device <NUM>. A tissue acquisition tool <NUM> may be positioned within lumen recesses <NUM>, <NUM> when stapler device <NUM> is in a closed position such that when elongated body <NUM> of tissue acquisition tool <NUM> is translated proximally, the distal end of tissue acquisition tool <NUM> is moved into the space between anvil <NUM> and body <NUM>. Pre-positioning tissue acquisition tool <NUM> within the space between anvil <NUM> and body <NUM>, or within the active portion of stapler device <NUM>, may allow a user to more easily position the distal end of tissue acquisition tool <NUM> and tissue within the active portion of stapler device <NUM>. Tissue acquisition tool <NUM> may be preloaded into the lumen formed by recesses <NUM>, <NUM> prior to insertion into a patient's body.

<FIG> show front and side perspective views of an exemplary multi-lumen oversheath <NUM> including shaft <NUM>, distal end portion <NUM>, lumens <NUM>, <NUM>, and <NUM>. Oversheath <NUM> may provide a user with means for utilizing a tissue acquisition tool, a stapling device, and a steerable visualization tool, such as an endoscope that includes a camera. <FIG> shows a front view of oversheath <NUM> with an endoscope <NUM> positioned within lumen <NUM>. Since endoscope <NUM> includes a single working channel <NUM>, oversheath <NUM> provides the user with three total working channels, i.e. lumens <NUM>, <NUM> and working channel <NUM>. <FIG> shows another exemplary embodiment of an oversheath <NUM> including two lumens <NUM>, <NUM> with an endoscope <NUM> positioned within lumen <NUM>. Since endoscope <NUM> includes a working channel <NUM>, the oversheath <NUM> provides an additional working channel (i.e. lumen <NUM>) for the user to utilize. Each of oversheath <NUM> and <NUM> may extend along the entire length of the endoscope <NUM>, <NUM>. In other examples, oversheath <NUM>, <NUM> may extend along only a portion of endoscope <NUM>, <NUM>. For example, <FIG> show alternative embodiments of oversheaths <NUM>, <NUM> with lumens <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. Oversheaths <NUM>, <NUM> extend along only a portion of the distal end of an endoscope that they are positioned over, such as distal ends of endoscope <NUM> or endoscope <NUM> shown in <FIG>. Positioning either a stapler device or a tissue acquisition tool within a lumen of an oversheath may move the device or tool farther radially away from the center of the field of view of a camera at the distal end of an endoscope, and may provide a less obstructed view of target tissue the user seeks to position in the active region of the stapler.

In some examples, an oversheath may be used to protect the patient's tissue from unwanted contact with devices at the distal end of an endoscope while the endoscope travels through the patient's body. <FIG> shows an exemplary oversheath <NUM> positioned over an endoscope <NUM>. Extending distally from the distal end of endoscope <NUM> are stapler device <NUM> and tissue acquisition tool <NUM>, much like the devices shown in <FIG>, though any tools may be used with oversheath <NUM>. Oversheath <NUM> is positioned over stapler device <NUM> and tissue acquisition tool <NUM>, and may prevent stapler device <NUM> and tissue acquisition tool <NUM> from contacting tissue and/or moving radially outward from the longitudinal axis of endoscope <NUM>, as endoscope <NUM> moves through a patient's body. An opening <NUM> at the distal end of oversheath <NUM> may provide the user with the ability to view in front of the endoscope <NUM> while the endoscope <NUM> and oversheath <NUM> move through a patient's body. Opening <NUM> may include one or more proximally extending slots 1570a (<NUM> shown in <FIG>). Distal portions <NUM>, <NUM> of oversheath <NUM> may be movable and flexible to expand and contract opening <NUM>. An exemplary expanded state of opening <NUM> is shown as opening <NUM> with dotted lines <NUM>, <NUM> representing distal portions <NUM>, <NUM> after having moved radially outward. Distal portions <NUM>, <NUM> may move radially outwardly to form an expanded state in order to allow a user to access a target area with stapler device <NUM> and tissue acquisition tool <NUM>. To assist radially outward movement of distal portion <NUM>, <NUM>, oversheath <NUM> may include longitudinal slits <NUM> that can be torn. For example, a tearable slit <NUM> may extend from each of slots 1570a proximally a distance sufficient to allow separation of portions <NUM>, <NUM> (e.g. to the distal face of endoscope <NUM>). In other examples, distal portions <NUM>, <NUM> may be movable to allow the user to pull oversheath <NUM> proximally and position stapler device <NUM> and tissue acquisition tool <NUM> within a target area. As shown in <FIG>, oversheath <NUM> may include four distal portions <NUM>, <NUM>, <NUM>, <NUM> that may be moveable. In some examples, each of distal portions <NUM>, <NUM>, <NUM>, <NUM> of oversheath <NUM> may be configured to move proximally or distally relative to endoscope <NUM> to allow a user to uncover or cover stapler device <NUM> and tissue acquisition tool <NUM>. In some examples, distal portions <NUM>, <NUM>, <NUM>, <NUM> may move radially outward to expand opening <NUM> in order to allow acquisition tool <NUM> and stapler device <NUM> to pass through opening <NUM>. For example, distal portions <NUM>, <NUM>, <NUM>, <NUM> may move radially outward when contacted by the stapler device <NUM> and/or acquisition tool <NUM> as the oversheath <NUM> is translated proximally. In some examples, oversheath <NUM> may be transparent/clear to allow a user to see through oversheath <NUM> as endoscope <NUM> moves through a patient's body.

<FIG> shows an exemplary medical apparatus <NUM> including a stapler device <NUM>, an elongate body <NUM>, an elongate rod <NUM> including a lumen <NUM>, and a rotatable connector <NUM>. The stapler device <NUM> and elongate body <NUM> may include any of the features and characteristics discussed hereinabove. Rod <NUM> may be rigid and may be manufactured from polyether ether ketone (PEEK) or other suitable materials. Elongate body <NUM> may be a non-compressible member, such as a Bowden cable, and may include a lumen (not shown) for receiving actuation wires and other components of stapler device <NUM>. Lumen <NUM> of rod <NUM> may extend longitudinally from a proximal end to a distal portion of rod <NUM>. In some examples, lumen <NUM> may receive elongate body <NUM> and may be configured to allow elongated body to move proximally and distally through lumen <NUM>. Body <NUM> may extend out of lumen <NUM> via an opening <NUM> in a side wall of rod <NUM>. Rotatable connector <NUM> may couple stapler device <NUM> to rod <NUM> and may be positioned between the proximal and distal ends of stapler device <NUM>. In some examples, rotatable connector <NUM> permits pivoting of stapler device <NUM> relative to rod <NUM> such that stapler device <NUM> may move between a position where the longitudinal axis of stapler device <NUM> is parallel with the longitudinal axis of rod <NUM> and a position where the longitudinal axis of stapler device <NUM> is transverse to the longitudinal axis of rod <NUM>. In embodiments, rotatable connector <NUM> may permit such pivoting so that the angle between the longitudinal axes is greater than zero degrees and up to as much as <NUM> degrees, where the longitudinal axis of stapler device <NUM> is parallel with the longitudinal axis of rod <NUM>. <FIG> show various views of medical apparatus <NUM> with stapler device <NUM> rotated various degrees relative to rod <NUM>. As shown in <FIG>, lumen opening <NUM> may be oval shaped and may be elongate in the longitudinal direction of rod <NUM> to allow elongate body <NUM> to smoothly transition into and out of rod <NUM> and to minimize friction between lumen opening <NUM> and elongate body <NUM> when elongate body <NUM> moves through lumen opening <NUM>. A user may pivot stapler device <NUM> by pushing or pulling on elongate body <NUM> (to move elongated body <NUM> proximally or distally), which then pushes or pulls on stapler device <NUM> and causes stapler device <NUM> to rotate about rotatable connector <NUM>. In some embodiments, rotatable connector <NUM> may include a pin extending through a device at a distal end of rod <NUM> and a flange extending from stapler device <NUM>. Stapler device <NUM> may include a pair of flanges extending from a portion of its body that include apertures for a pin, and rod <NUM> may include a device extending from a distal end of rod <NUM> including an aperture that is configured to align with the apertures of the pair of flanges, and a pin may be positioned with the apertures of the pair of flanges and the aperture of the device extending from a distal end of rod <NUM> to form rotatable connector <NUM>.

Each of the aforementioned apparatuses and devices may be used to visualize, couple, and/or cut tissue. In some examples, a user may load an elongate body of a stapler device in a working channel of an endoscope by backfeeding the elongate body through a distal end of an endoscope working channel to position a portion of the elongate body within the working channel. Once the elongate body is positioned within a working channel, a handle assembly may be coupled to the proximal end of the elongate body. The user may then introduce the endoscope into the patient's body and move the endoscope towards a target area. The user may locate a target area (such as a tumor or other diseased tissue) present in a body lumen of a subject using the endoscope by directly visualizing the target area using an image sensor. Once the user has positioned the endoscope's distal end proximate to a target area, the user may position a tissue acquisition tool within a working channel of the endoscope, if such a tool is not already present. In some examples, if the user placed an oversheath over the endoscope prior to insertion of the endoscope into the patient's body, the user may move the oversheath proximally to expose the stapler device to the target area and/or tear away portions of the oversheath to expose the stapler device. When the distal end of the endoscope is positioned at the target area, the user may actuate the stapler device to an open position creating a space between the stapler's anvil and body. The user may then introduce the tissue acquisition tool to the target area and position the tissue acquisition tool between or close to the active portion of the stapler device, e.g. the space between the stapler device's anvil and body. The user may then grasp tissue with the tissue acquisition tool and move tissue into the stapler device's active portion. Once tissue is positioned within the stapler device's active portion, the user may move the stapler device's anvil and body to a closed position and clamp down on the grasped tissue with the stapler device. The user may then actuate an actuator in order to pull on an actuation wire, thus moving an actuation sled of the stapler device proximally. By moving the actuation sled proximally via an actuator, the user may deploy fasteners into the clamped tissue and against the stapler device's anvil. In some examples, the user may actuate a knife in the stapler device to cut portions of the target tissue either before or after fastening tissue together via fasteners.

Claim 1:
A tissue fastening device comprising:
a handle assembly (<NUM>) including at least two actuators (<NUM>,<NUM>);
a first body (<NUM>) extending distally from the handle assembly and defining a longitudinal axis;
a fastening device (<NUM>) coupled to a distal end of the first body, wherein the fastening device comprises:
a longitudinal body including a channel (<NUM>);
a cartridge (<NUM>) configured to include a plurality of fasteners
said cartridge comprising a a longitudinal channel configured to receive a device for cutting tissue (<NUM>);
an anvil rotatable relative to the cartridge; and
a fastener actuator (<NUM>) coupled to one actuator of the at least two actuators, characterized in that the fastener actuator is configured to move proximally relative to the cartridge to deploy the plurality of fasteners from the cartridge.