Patent Description:
Tissue fastening (e.g., stapling) is used in many laparoscopic procedures. These procedures often involve resecting portions or sections of tissue, followed by closing using staples. An example of a common procedure would be colorectal anastomosis. In hybrid surgeries where physicians use laparoscopic and endoscopic platforms to conduct a procedure, a rigid stapler is often used. Linear staplers include long rigid members which are incapable of being navigated through tortuous anatomy without causing trauma to the tissue. Physicians also are moving towards endoscopic, outpatient procedures, which would require endoscopic stapling.

<CIT> discloses a surgical stapling device that includes an outer tube, a tool assembly and a drive member. The outer tube has a proximal body portion and a distal channel portion. A distal end of the proximal body portion defines cutouts and the channel portion has an outer surface. The tool assembly has an anvil assembly including an anvil body defining a longitudinal axis and having an outer surface, a tissue contact surface and a pair of pivot members positioned proximally of the tissue contact surface. The pivot members are pivotally received within the cutouts of the proximal body portion of the outer tube. The cartridge assembly includes a staple cartridge and a plurality of staples. The staple cartridge defines a longitudinal axis, a tissue contact surface, and a plurality of staple retention pockets. Each of the staple retention pockets supports one of the plurality of staples. The staple cartridge is supported within the distal channel portion of the outer tube. The anvil body is pivotally supported on the outer tube in relation to the staple cartridge such that the tool assembly is movable between a closed position in which longitudinal axes of the anvil body and the staple cartridge are parallel and an open position in which the longitudinal axes of the anvil body and the staple cartridge define an acute angle. The drive member is supported within the staple cartridge and is translatable through the staple cartridge to eject the plurality of staples from the staple cartridge. The cutouts are dimensioned to allow movement of the pivot members within the cutouts such that when the tool assembly is in the closed position, the anvil body can be positioned in relation to the staple cartridge in a "parked position" in which the contact surfaces of the anvil body and the staple cartridge are in juxtaposed engagement to a "clamped position" in which the contact surfaces of the anvil body and the staple cartridge are spaced to define a tissue gap.

<CIT> discloses a surgical stapler that has a body, a shaft assembly extending distally from the body, and an end effector coupled with a distal end of the shaft assembly. The end effector has a stapling head assembly, an anvil, and a vacuum port. The vacuum port is operable to draw tissue between the stapling head assembly and the anvil. The anvil is operable to move toward and away from the stapling head assembly to thereby capture the tissue drawn between the stapling head assembly and the anvil. The stapling head assembly comprises a plurality of wheel assemblies and staple cartridges. At least one wheel assembly is operable to rotate to thereby move the anvil toward and away from the body. The remaining wheel assemblies are operable to rotate to thereby drive staples through the captured tissue. The body includes user input features operable to drive the wheel assemblies.

It is with the above considerations in mind that the improvements of the present disclosure may be useful.

Aspects of the present disclosure relate to, among other things, systems, devices, and methods for fastening tissue, e.g., a flexible endoscope platform with stapling capability. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

The claimed invention as defined by the appended independent claim <NUM> concerns a medical device comprising a shaft extending from a proximal end toward a distal end, the shaft extending along a longitudinal axis and including a lumen extending from the proximal end toward the distal end; a first stapling head at the distal end, the first stapling head configured to contain one or more staples, and the first stapling head having a block disposed within, and movable relative to, the first stapling head; a second stapling head at the distal end; and a pushing element extending through the lumen, the pushing element being movable from a first position to a second position, wherein transition of the pushing element from the first position to the second position urges the block to move toward second stapling head along a radially-inward directed path that is substantially perpendicular to the longitudinal axis of the shaft to deploy the one or more staples. The second stapling head includes a planar face extending substantially perpendicular to the longitudinal axis, and the planar face is an anvil configured to bend the one or more staples into tissue upon contact with the one or more staples.

The pushing element also includes a third position and a fourth position, before the pushing element is moved from the first position to the second position, wherein movement of the pushing element from the third position to the fourth position causes the first stapling head to move toward the second stapling head. The first stapling head also moves toward the second stapling head along the radially-inward directed path that is substantially perpendicular to the longitudinal axis of the shaft, and the planar face of the second stapling head may extend in a plane substantially perpendicular to the radially-inward directed path. The medical device may further include a first extension extending proximally from the first stapling head, the first extension having a first ramp at a proximal end; and a distal end of the pushing element may include a second ramp configured to slide against the first ramp when the pushing element is moved from the third position to the fourth position. The first ramp may extend radially inwardly in a proximal direction; and the second ramp may extend radially outwardly in a distal direction. An outer surface of the pushing element may include a protrusion, wherein the protrusion is configured to directly contact the block. The block may include a third ramp, and a distal end of the protrusion may include a fourth ramp configured to slide against the third ramp when the pushing element is moved from the first position to the second position. The third ramp may extend radially inwardly in a proximal direction, and the fourth ramp may extend radially outwardly in a distal direction. The medical device may further include a first extension extending proximally from the first stapling head, the first extension including a longitudinally extending first recess; and movement of the pushing element from the fourth position to the first position may cause the protrusion to slide through the first recess. While the pushing element moves from the fourth position to the first position, the block may remain stationary relative to the first stapling head. The first stapling head may include a second recess coaxial with the first recess; and movement of the pushing element from the first position to the second position may cause a distal end of the protrusion to extend through the second recess and into contact with the block. The block may be coupled to an inner surface of the first stapling head by one or more resilient members. The medical device may further include a second shaft movable from a first configuration to a second configuration, wherein: when the second shaft is in the first configuration, the first stapling head and the second stapling head are spaced apart from one another by a first distance; and in the second configuration, the second shaft is distal relative to the first configuration, and positions the first stapling head and the second stapling head at a second distance from one another; the second distance being less than the first distance. The medical device may further include a first extension extending proximally from the first stapling head, and a second extension extending proximally from the second stapling head, wherein the first extension and the second extension are coupled to one another at a joint, wherein the first and second extensions are movable between: a first configuration where the first stapling head and the second stapling head are spaced apart from one another by a first distance; and a second configuration where the first stapling head and the second stapling head are spaced apart from one another by a second distance, wherein the second distance is less than the first distance.

Also disclosed herein is a medical device comprising a shaft extending from a proximal end toward a distal end along a longitudinal axis, the shaft including: a first conduit extending from the proximal end toward the distal end; an expandable chamber coupled to the first conduit; and one or more staples coupled to the expandable chamber, wherein, delivery of fluid to the expandable chamber via the first conduit is configured to move the one or more staples toward a surface to deploy the one or more staples by contacting the one or more staples with the surface.

The shaft may further include a recess at least partially defined by the surface, and expansion of the expandable member moves the one or more staples into the recess. The medical device may further include a second conduit extending from the proximal end toward the distal end, wherein the distal end of the shaft is configured to articulate relative to the longitudinal axis when the second conduit is filled with a fluid. The medical device may further include an electroactive polymer extending along a portion of the shaft, wherein the distal end of the shaft is configured to articulate relative to the longitudinal axis when current is applied to the electroactive polymer.

Further disclosed yet is a medical device comprising a shaft extending from a proximal end toward a distal end along a longitudinal axis, the shaft including a lumen extending from the proximal end toward the distal end; a pushing element extending through the lumen, wherein distal movement of the pushing element along the longitudinal axis is configured to deploy one or more staples in a direction substantially perpendicular to the longitudinal axis of the shaft.

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 invention, which is defined by the appended set of claims.

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, devices, and methods 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 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 a device into a subject. By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject. The term "tissue fastening" 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.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features of the claimed invention, which is defined by the appended set of claims. As used herein, the terms "comprises," "comprising," "having," "including," or other variations 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 include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example," rather than "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of the stated value unless otherwise stated.

<FIG> illustrate an exemplary medical device <NUM> that may be used to staple tissue <NUM>. In some embodiments, medical device <NUM> may be a surgical stapling apparatus configured to engage body tissue <NUM>, apply one or a plurality of surgical fasteners thereto, and optionally form an incision in the fastened body tissue during minimally invasive surgical procedures, such as endoscopic procedures. Medical device <NUM> may be used to apply surgical clips or other fasteners, but will be primarily discussed in the context of applying staples.

Medical device <NUM> may include an elongate member or shaft <NUM> that extends from a proximal end (not shown) toward a distal end <NUM>. A stapling assembly <NUM> may be disposed at distal end <NUM>. For clarity, medical device is shown in <FIG> without stapling assembly <NUM> attached. In some embodiments, stapling assembly <NUM> may be movable from a first position, such as a transporting position shown in <FIG>, to a second position, such as an operating position shown in <FIG>. In some examples, stapling assembly <NUM> may include one or more struts <NUM> coupled to distal end <NUM>, or that are movable through lumens <NUM> of medical device <NUM>. Stapling assembly <NUM> may not be operable in the transporting position shown in <FIG>, and may be configured to deliver staples to tissue only when in the operating position shown in <FIG>. Stated another way, medical device <NUM> may not be able to deploy staples or other tissue fastening elements when in a transporting position even in response to an action (e.g., pressing a button on an actuator) from an operator that would deploy the staples or tissue fastening elements when the medical device <NUM> is in the operating position.

Shaft <NUM> may be any suitable endoscopic member configured to bend and articulate so as to traverse tortuous anatomy in a body. Shaft <NUM> may be formed from one or more biocompatible materials, such as, e.g., HDPE, silicone, polyurethane, ETFE, SIBS, PIB-PUR, or any other suitable medical grade polymers, and may be flexible and configured to extend through tortuous anatomy. Shaft <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. Or, shaft <NUM> may be positioned in the body without an endoscope. Shaft <NUM> may include illumination/optics assembly <NUM> and one or more lumens <NUM>. Although endoscopes are referenced herein, reference to endoscopes or endoscopy should not be construed as limiting the possible applications of the disclosed aspects. For example, the disclosed aspects may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices.

Assembly <NUM> may include an illumination device and an optics device. For example, the illumination device may include one or more of a fiber optic device (e.g., a light cable) or a light-emitting diode (LED) so as to provide illumination light to a location within a body of a subject distal of distal end <NUM>. The optics device may include any appropriate device configured to provide a visual image of an internal location of the body of the subject. For example, the optics device may include one or more optical elements (e.g., lens, cameras, etc.).

The one or more lumens <NUM> may be arranged at any appropriate location about the distal end face of shaft <NUM>. In some arrangements, the one or more lumens <NUM> may be arranged to provide irrigation and/or aspiration fluid. In such cases, the one or more lumens <NUM> may be fluidly coupled to one or more ports (not shown) of a handle (not shown). Such ports may be, in turn, fluidly coupled to one or more sources of irrigation and/or aspiration fluid for delivery via the one or more lumens <NUM>. Further, the one or more lumens <NUM> may be arranged to receive one or more articulation wires (not shown) or the like for imparting selective articulation to at least distal end <NUM> of shaft <NUM>. In one embodiment, a tool <NUM> may extend through lumen <NUM>. Tool <NUM> may be configured to grasp tissue <NUM>, and position tissue <NUM> within or adjacent to stapling assembly <NUM>. For example, tool <NUM> may include a grasper, forceps, a snare, a clamp, a tissue loop, a helix coil, or a clip applier, or any other tool for performing a medical procedure.

In <FIG>, tool <NUM> is shown being extended toward tissue <NUM>. In <FIG>, tool <NUM> is shown positioning tissue <NUM> between adjacent stapling heads of stapling assembly <NUM>. In <FIG>, a first tissue portion <NUM> is shown with a first row of staples <NUM> deployed therein, while a second tissue portion <NUM> is shown with a second row of staples <NUM> deployed therethrough. The separate stapling heads of stapling assembly <NUM> may be moved together by actuation of a push button or other mechanism, which ejects a staple from one stapling head toward the other stapling head. Medical device <NUM> also may include one or more tools for separating stapled tissue portions, such as, e.g., a knife.

A medical device <NUM> according to the claimed invention is shown in <FIG>. Medical device <NUM> includes a shaft <NUM> as set forth in <FIG>. Medical device <NUM> also includes one or more staples <NUM> (<FIG>) configured to be deployed along a trajectory that is substantially perpendicular to the longitudinal axis of shaft <NUM>. Medical device <NUM> may include a navigation state (<FIG>), where staples <NUM> may be positioned proximally to articulating portions of shaft <NUM>. In the navigation state, the stapling heads of stapling assembly <NUM> are positioned close to the distal face of elongate member <NUM>. The stapler is intended to be close to the face of elongate member <NUM>, to make traversing through anatomy easier when not using the stapling function. The stapling heads of stapling assembly may rest in an open position (both in the navigation state and in the operating position) to maintain visualization. The stapling head may be pushed forward using a mechanical driving mechanism (e.g., driving wires, sheath, etc.) which may be connected to the struts. The driving mechanism may extend through the scope to the proximal end to be actuated in the handle by a medical profession. Once medical device <NUM> is moved to a desired location, a tissue acquisition feature, e.g., tool <NUM> described with reference to <FIG>, located internal or external to shaft <NUM> can be used to acquire and position tissue for stapling.

The medical device <NUM> includes a stapling assembly <NUM> disposed at distal end <NUM>. Stapling assembly <NUM> includes a first stapling head <NUM> that may be fixed to distal end <NUM>, and a second stapling head <NUM> that may be movable relative to distal end <NUM>. In other embodiments, first stapling head <NUM> and second stapling head <NUM> may be movable between a transporting configuration, and an operable configuration, in a similar manner as described above with reference to <FIG>. First stapling head <NUM> includes a flat face <NUM> that extends substantially perpendicular to a longitudinal axis of shaft <NUM>. Flat face <NUM> may include one or more depressions <NUM>, and acts as an anvil for the legs of staples <NUM>. First stapling head <NUM> may be coupled to shaft <NUM> by a support <NUM>. It is contemplated that support <NUM> may extend through one or more lumens of shaft <NUM> (i.e., a through-the-scope attachment), may be coupled to an exterior of shaft <NUM> (i.e., an over-the-scope attachment), or may include a combination of such attachments. First stapling head <NUM> also may include a curved radially outward facing surface opposite of flat face <NUM>, and may generally have a half-moon shape, although other suitable shapes also are contemplated.

Second stapling head <NUM> may be disposed within a housing <NUM> that is coupled to distal end <NUM>. In some embodiments, housing <NUM> may be fixed to distal end <NUM> by a through-the-scope attachment, an over-the-scope attachment, or by a combination of attachment types. An extension <NUM> may extend proximally from second stapling head <NUM>. The proximal end of extension <NUM> may include a ramped surface <NUM>, which extends radially inward in the proximal direction. Extension <NUM> also may include a recess 222a formed in its outer surface (<FIG>). A pushing element <NUM> extends through lumen <NUM> of shaft <NUM>. The distal end of pushing element <NUM> may include a ramped surface <NUM> that extends radially outward in the distal direction. Ramped surface <NUM> may be configured in any manner to engage with corresponding ramped surface <NUM> of the extension <NUM>. Pushing element <NUM> also may include a protrusion <NUM> extending from its outer surface. The distal end of protrusion <NUM> may include a ramped surface <NUM> that extends radially outward in the distal direction (like ramped surface <NUM>). Ramped surface <NUM> may be continuous with ramped surface <NUM> (i.e., may be coaxial or collinear), and may be proximal to an entirety of ramped surface <NUM>). Recess 222a may be configured to receive protrusion <NUM>, and may have a radial dimension b that is slightly longer or substantially equal to a dimension c that protrusion <NUM> extends from the outer surface of pushing element <NUM> (referring to <FIG>).

Referring to <FIG>, second stapling head <NUM> may include a recess 206a that may be substantially coaxial with recess 222a. Second stapling head <NUM> also may include an opening 206b, which may be positioned adjacent to flat face <NUM> of first stapling head <NUM> during a stapling procedure. A block <NUM> is disposed within second stapling head <NUM>, and is movable within second stapling head <NUM> and at least partially through opening 206b. Staples may be positioned beneath block <NUM> (e.g., in a cartridge), and when block <NUM> is pushed downward, the staples are forced into anvils on the opposing staple head. Recess 206a may have a length/width dimension a that is less than dimension c of protrusion <NUM>, so that protrusion <NUM> may extend through recess 206a to contact block <NUM>. Block <NUM> may be biased toward a first configuration shown in <FIG>, for example, by one or more resilient members or springs <NUM> attached to block <NUM> and to an inner surface of second stapling head <NUM>. Two springs <NUM> are shown in <FIG> that are compressed in a resting state, although more or fewer springs also are contemplated. The springs <NUM> may be extended when protrusion <NUM> of pushing element <NUM> contacts and urges block <NUM> toward flat face <NUM> to deploy staples <NUM>. Block <NUM> also may include a ramped surface <NUM> at its proximal end that extends radially inward in the proximal direction. Ramped surfaces <NUM> and <NUM> may cooperate with one another in a substantially similar manner to the manner in which ramped surfaces <NUM> and <NUM> cooperate with one another.

The various steps of operating medical device <NUM> will now be described. Ramped surfaces <NUM> and <NUM> may cooperate with one another such that when pushing element <NUM> is pushed distally along or parallel to a longitudinal axis of shaft <NUM>, ramped surface <NUM> urges second stapling head <NUM> along a radially-inward directed path that is substantially perpendicular to the longitudinal axis of shaft <NUM> (see <FIG>). After second stapling head <NUM> reaches the end of its travel path and has travelled a predetermined first distance (toward first stapling head <NUM> in a direction perpendicular to the longitudinal axis of shaft <NUM>), further distal movement of pushing element <NUM> may cause protrusion <NUM> to extend through recess 222a of extension <NUM> (e.g., <FIG>). For at least a second predetermined distance, additional distal movement of pushing element <NUM> may cause protrusion <NUM> to slide, translate, or move relative to and/or through recess 222a without causing any movement of block <NUM> relative to second stapling head <NUM> (<FIG>). In some embodiments, the second predetermined distance may correspond to or may be substantially equal to a length of recess 222a. However, after pushing element <NUM> has travelled the second predetermined distance, further distal movement of pushing element <NUM> may deploy block <NUM> containing one or more staples <NUM> (<FIG>). In particular, the further distal travel of pushing element <NUM> causes protrusion <NUM> to move through recess 206a and into contact with block <NUM>. In particular, ramped surface <NUM> may slide against ramped surface <NUM> to urge block <NUM> toward first stapling head <NUM> (particularly toward flat face <NUM>). Springs <NUM> may extend from the resting states during this movement of block <NUM>. Block <NUM> may travel along a substantially similar trajectory that second stapling head <NUM> originally travelled (i.e., in a direction perpendicular to the longitudinal axis of shaft <NUM> and toward first stapling head <NUM>).

Urging block <NUM> toward flat face <NUM> causes the legs of staples <NUM> to contact flat face <NUM> (see <FIG>), deploying staples <NUM> into tissue disposed between first stapling head <NUM> and second stapling head <NUM> (<FIG>). After the staple deployment is complete, a distally-directed force acting on pushing element <NUM> may be released (or reversed), causing springs <NUM> to move back to their resting, compressed configurations, and retracting block <NUM> into housing <NUM>. Furthermore, the release (or reversal) of the distally directed force on pushing element <NUM> may cause the entirety of second stapling head <NUM> to move radially outward, along the path perpendicular to the longitudinal axis of shaft <NUM>, to its original position.

It is contemplated that movement of pushing element <NUM> from the position shown in <FIG>, to the position shown in <FIG> (after deployment of staple <NUM>), may be performed with a single, smooth motion. However, in some embodiments, a stop may be included such that, at any time after second stapling head <NUM> has travelled the predetermined first distance (reached the end of its travel path toward first stapling head <NUM>), a medical professional is required to perform some action to enable pushing element <NUM> to continue distally to drive block <NUM>. The stop may, for example, be incorporated into recess 222a and may block movement of protrusion <NUM>. In some embodiments, application of additional force to pushing element <NUM> may cause the stop to deform and move out of the path of pushing element <NUM>. In other embodiments, movement of the stop may be controlled by an actuator, button, or the like, on a handle of the medical device. The inclusion of the stop may enable a medical professional to clamp tissue with only stapling heads <NUM> and <NUM>, before needing to drive staples <NUM> through the tissue. This may help a medical professional readjust the clamped tissue sections when, for example, the wrong sections of tissue are grasped.

Another medical device <NUM> is shown in <FIG> and19. Medical device <NUM> includes an alternative mechanism for moving two stapling heads closer to one another, where an outer shaft slides over the stapling heads to force them toward one another. For example, medical device <NUM> may include a shaft <NUM> extending from a proximal end (not shown) toward a distal end <NUM>. A shaft <NUM> may extend within a lumen of shaft <NUM>. Two stapling heads 312a and 314a may extend from the distal end of shaft <NUM> via supports <NUM> and <NUM>, respectively. Supports <NUM> and <NUM> may extend both distally and radially outward (e.g., relative to a longitudinal axis of shaft <NUM>) from the distal end of shaft <NUM>. As shaft <NUM> is moved distally relative to shaft <NUM> (or shaft <NUM> and supports <NUM> and <NUM> are moved proximally relative to shaft <NUM>), stapling heads 312a and 314a are moved toward one another along radially inwardly directed paths (<FIG>). Once stapling heads 312a and 314a have reached the end of their travel paths such that they are substantially adjacent to one another, a second and separate staple deployment step may be carried out. It is contemplated that medical device <NUM> may include any other staple deployment mechanism disclosed herein. For example, a pusher element <NUM> may extend through support <NUM> and cause a block <NUM> (within, e.g., first stapling head 312a) to drive staples <NUM> into a surface of stapling head 314a. Alternatively, the fluid delivery mechanism described below with respect to <FIG> may be utilized. In yet another embodiment, the closure of stapling heads 312a and 314a may itself deploy the staples <NUM>.

Yet another medical device <NUM> is shown in <FIG>. Medical device <NUM> includes another alternative mechanism for closing two stapling heads, where wires are linked to a scissor joint attached to the stapling heads. For example, medical device <NUM> may include a shaft <NUM> extending from a proximal end (not shown) toward a distal end. Two stapling heads <NUM> and <NUM> may extend from the distal end of shaft <NUM> via supports <NUM> and <NUM>, respectively. Supports <NUM> and <NUM> may extend proximally from their respective stapling heads, across one another and connected to one another at a joint <NUM> (e.g., a scissor joint, pivot, etc.). Wires or other actuating members <NUM> may extend proximally from each support <NUM> and <NUM>. Actuation of the wires <NUM> may cause stapling heads <NUM> and <NUM> to move toward one another (<FIG>). More specifically, proximal and radially inward directed forces may be applied to each wire <NUM>. Because the working channel is small, pulling back on the wires may be sufficient to create the radially inward directed force necessary (so long as there is enough room for the wires to travel inward as they are pulled). The wires may be connected to a button or other actuation mechanism in the handle, so the user does not pull the wires directly. Once stapling heads <NUM> and <NUM> have reached the end of their travel paths and are adjacent to one another, a second and separate staple deployment step may be carried out. It is contemplated that medical device <NUM> may include any other staple deployment mechanism disclosed herein. For example, the fluid delivery mechanism described below with respect to <FIG> may be utilized. For example, fluid may be delivered to, e.g., stapling head <NUM>, via a conduit <NUM> to an expandable member (not shown) disposed within stapling head <NUM>. In yet another embodiment, the closure of stapling heads <NUM> and <NUM> may itself deploy the staples <NUM>.

<FIG> show another medical device <NUM>, still, that may be used to staple tissue <NUM>. Medical device <NUM> may include an elongate member or shaft <NUM> that extends from a proximal end (not shown) toward a distal end <NUM>. Medical device <NUM> may include a distally-facing surface or end face <NUM> at distal end <NUM>. Medical device <NUM> also may include a first fluid conduit <NUM> and a second fluid conduit <NUM>. Second fluid conduit <NUM> may terminate at its distal end at an expandable chamber <NUM>.

Expandable chamber <NUM> may be movable from a first configuration (shown in <FIG>) to a second configuration (shown in <FIG>). Expandable chamber <NUM> may have a first volume in the first configuration, which is smaller than a second volume in a second configuration. The second volume may be <NUM>, <NUM>, <NUM>, or more times larger than the first volume, although other suitable ratios also are contemplated. The exterior of expandable chamber may be formed by an expandable and resilient material, such as, e.g., rubber, polymers, or the like.

Medical device <NUM> also may include a recess <NUM> formed within distally-facing surface <NUM>. However, it also is contemplated that recess <NUM> may be alternatively, or additionally, formed in a circumferential side surface of shaft <NUM>. Recess <NUM> may be partially-defined by a flat surface <NUM> (which may act as an anvil during a stapling procedure). Expandable chamber <NUM> may be coupled to one or more staples <NUM>, and may be arranged within distal end <NUM> such that the expansion of expandable chamber <NUM> is in the direction of recess <NUM>. For example, solid and relatively stiff material may surround most portions of expandable chamber <NUM>, while an opening <NUM> is disposed between expandable chamber <NUM> and recess <NUM>. In this configuration, the expansion of expandable chamber <NUM> must be through opening <NUM> and into recess <NUM>. Alternatively, expandable chamber <NUM> may not expand into recess <NUM> itself, but rather may drive staples <NUM> into and/or through recess <NUM> toward flat face <NUM>. The driving of staples <NUM> into flat face <NUM> may occur along a trajectory that is substantially perpendicular to the plane of flat face <NUM>.

First and second conduits <NUM>, <NUM> may be coupled to a fluid source <NUM>, configured to drive fluid through the conduits. Fluid source <NUM> may be a pump controlled by a controller. The pump may be any suitable pump, such as, e.g., a peristaltic pump, piston pump, motorized pump, microfluidic pump, infusion pump, or the like. The pump may be powered by electrical power, mechanical power, chemical power, or another suitable mechanism. Fluid source <NUM> may include a source (e.g., a reservoir) of fluid to be circulated through conduits <NUM>, <NUM>. In some examples, fluid source <NUM> may include a plurality of reservoirs, and may deliver fluid through each conduit <NUM>, <NUM> from a dedicated reservoir. Alternatively, the same reservoir may supply both conduits <NUM>, <NUM>, and the flow may be controlled via one or more valves (not shown). The fluid circulated through conduits <NUM> and <NUM> may be any suitable biocompatible fluid, such as, e.g., sterile water or saline (in case of leaks). The controller may include a processor that is generally configured to accept information from the medical device and medical device components, and process the information according to various algorithms to produce control signals for controlling the fluid source <NUM>. For example, the processor may accept information from the system and system components, process the information according to various algorithms, and produce information signals that may be directed to visual indicators, digital displays, audio tone generators, or other indicators of, e.g., a user interface, in order to inform a user of the system status, component status, procedure status or any other information that is being monitored by the system. The processor may be a digital IC processor, analog processor or any other suitable logic or control system that carries out the control algorithms. One or more pressure sensors may be coupled to each fluid conduit <NUM> and <NUM>, and the controller may control the flow of fluid through conduits <NUM> and <NUM> by receiving and analyzing outputs from the one or more pressure sensors.

Articulation of medical device <NUM> may be achieved, at least in part, by filling first conduit <NUM> with fluid. Additionally, medical device <NUM> may be constructed to have a non-uniform stiffness. That is, medical device <NUM> may exhibit a tendency to bend in one or more directions, as opposed to one or more other directions. Stated another way, medical device <NUM> may be pre-disposed to articulate away from a longitudinal axis of shaft <NUM> along a particular trajectory. The tendency or predisposition to bend away from the longitudinal axis may be achieved by forming shaft <NUM> from at least two materials having different durometers or different hardness. In this embodiment, when first conduit <NUM> is filled with fluid, the portion of shaft <NUM> having a higher hardness would resist movement, and the portion of shaft <NUM> having a lower hardness would bend (e.g., as shown in <FIG>). In another embodiment, surface modifications such as, e.g., cuts, slits, recesses, or the like, may be made along only a portion of the outer circumference of shaft <NUM>. Similarly, material may be removed from certain interior portions of shaft <NUM>. When first conduit <NUM> fills with fluid in these embodiments, the portions of shaft <NUM> having surface modifications or otherwise having portions removed may bend, while portions of shaft <NUM> without such surface modifications or material removed may resist movement. Increasing the pressure within first conduit <NUM> may increase the articulation of shaft <NUM>, while maintaining any particular pressure level may maintain the particular articulation angle.

In yet another example shown in <FIG>, articulation of a shaft <NUM> may be achieved via the use of electroactive polymers <NUM>, in place of the pressurized fluid. For example, such polymers <NUM> may contain cationic materials, which are randomly dispersed and without orientation. The surface on one side of shaft <NUM> adjacent to the polymer <NUM> may include anionic material <NUM>. When an electrical current is activated in a generator <NUM> coupled to polymer <NUM>, the cations in polymer <NUM> may orient and migrate towards the anionic material <NUM>. This in turn may cause polymer <NUM> to bend. If the electrical current is flowing through polymer <NUM>, shaft <NUM> maintains its bent configuration. In other words, the articulation of shaft <NUM> may be maintained during any 'on' cycle of an electrical generator coupled to the polymer. It also is contemplated that polymer <NUM> may include anionic materials, which are randomly dispersed and without orientation, and that material <NUM> includes cationic material. In still further examples, a magnetic attraction between polymer <NUM> and material <NUM> may be utilized to achieve the articulation.

Claim 1:
A medical device (<NUM>, <NUM>), comprising:
a shaft (<NUM>) extending from a proximal end toward a distal end (<NUM>), the shaft extending along a longitudinal axis and the shaft including a lumen (<NUM>) extending from the proximal end toward the distal end;
a first stapling head (<NUM>) at the distal end, the first stapling head configured to contain one or more staples (<NUM>), and the first stapling head having a block (<NUM>) disposed within, and movable relative to, the first stapling head;
a second stapling head (<NUM>) at the distal end; and
a pushing element (<NUM>) extending through the lumen, the pushing element being movable from a first position to a second position, wherein transition of the pushing element from the first position to the second position urges the block to move toward the second stapling head along a radially-inward directed path that is substantially perpendicular to the longitudinal axis of the shaft to deploy the one or more staples;
wherein the second stapling head includes a planar face (<NUM>) extending substantially perpendicular to the longitudinal axis, wherein the planar face is an anvil configured to bend the one or more staples into tissue (<NUM>) upon contact with the one or more staples,
wherein the pushing element also includes a third position and a fourth position, before the pushing element is moved from the first position to the second position, and wherein movement of the pushing element from the third position to the fourth position causes the first stapling head to move toward the second stapling head, and
wherein the first stapling head also moves toward the second stapling head along the radially-inward directed path that is substantially perpendicular to the longitudinal axis of the shaft.