Systems, devices, and related methods for fastening tissue

Abstract

The medical device includes a shaft extending from a proximal end to a distal end, the shaft including a lumen extending from the proximal end to the distal end; a first stapling head disposed at the distal end, the first stapling head configured to contain one or more staples and having a block disposed within the first stapling head and movable relative to the first stapling head; a second stapling head disposed at the distal end; and a pusher element extending through the lumen and movable from a first position to a second position, wherein movement of the pusher element from the first position to the second position moves the block toward the second stapling head to deploy the one or more staples.

Description

[Technical Field]

[0001] Various aspects of the present invention relate to tissue fastening, including tissue visualization, tissue retraction, and tissue joining. More particularly, embodiments of the present invention relate to systems, devices, and associated methods for stapling tissue. [Background technology]

[0002] Tissue fastening (e.g., stapling) is used in many laparoscopic surgeries. These surgeries often involve the removal of a portion or section of tissue followed by closure using staples. An example of a common procedure is colorectal anastomosis. In hybrid surgeries, where physicians use laparoscopic and endoscopic platforms to perform the procedure, rigid staplers are often used. Linear staplers contain long, rigid members that cannot be navigated through tortuous anatomy without causing trauma to the tissue. Physicians are also transitioning to endoscopic outpatient surgeries, which require endoscopic stapling.

[0003] With the above in mind, improvements of the present invention are useful. Summary of the Invention

[0004] Aspects of the present invention relate to systems, devices, and methods for fastening tissue, e.g., a flexible endoscopic platform with stapling capabilities. Each aspect disclosed herein may include one or more elements described in connection with any of the other disclosed aspects.

[0005] In one aspect, the present invention relates to a medical device including a shaft extending from a proximal end to a distal end, the shaft having a lumen extending from the proximal end to the distal end, a first stapling head disposed at the distal end, the first stapling head configured to contain one or more staples, the first stapling head having a block disposed within the first stapling head and movable relative to the first stapling head, a second stapling head disposed at the distal end, and a pusher element extending through the lumen and movable from a first position to a second position, wherein movement of the pusher element from the first position to the second position moves the block toward the second stapling head to deploy the one or more staples.

[0006] The pusher element also includes a third position and a fourth position, and before the pusher element moves from the first position to the second position, movement of the pusher element from the third position to the fourth position moves the first stapling head toward the second stapling head. The shaft extends along a longitudinal axis, and the block and first stapling head are each movable toward the second stapling head along a trajectory generally perpendicular to the longitudinal axis. The second stapling head includes a flat surface extending in a plane generally perpendicular to the trajectory, the flat surface being an anvil configured to bend one or more staples into tissue upon contact with the one or more staples. The medical device includes a first extension extending proximally from the first stapling head, the first extension having a first sloped portion at a proximal end, and a pusher element having a distal end including a second sloped portion configured to slide against the first sloped portion when the pusher element is moved from the third position to the fourth position. The first sloped portion extends radially inward in the proximal direction, and the second sloped portion extends radially outward in the distal direction. The outer surface of the pusher element includes a protrusion configured to directly contact the block. The block includes a third sloped portion, and the distal end of the protrusion includes a fourth sloped portion configured to slide against the third sloped portion when the pusher element is moved from the first position to the second position. The third sloped portion extends radially inward in the proximal direction, and the fourth sloped portion extends radially outward in the distal direction. The medical device further includes a first extension extending proximally from the first stapling head, the first extension including a longitudinally extending first recess, and movement of the pusher element from the fourth position to the first position causes the protrusion to slide through the first recess. The block is maintained stationary relative to the first stapling head while the pusher element moves from the fourth position to the first position. The first stapling head includes a second recess coaxial with the first recess, and movement of the pusher element from the first position to the second position causes the distal end of the protrusion to extend through the second recess into contact with the block. The block is attached to an inner surface of the first stapling head by one or more resilient members.The medical device further includes 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 a first distance, and when the second shaft is in the second configuration, the second shaft is distal to the first configuration and spaces the first stapling head and the second stapling head apart a second distance, the second distance being less than the first distance. The medical device further includes a first extension extending proximally from the first stapling head and a second extension extending proximally from the second stapling head, the first extension and the second extension being coupled to one another at a joint, the first and second extensions being movable between a first configuration in which the first stapling head and the second stapling head are spaced apart by a first distance and a second configuration in which the first stapling head and the second stapling head are spaced apart by a second distance, the second distance being less than the first distance.

[0007] In another aspect, the present invention relates to a medical device that includes a shaft extending from a proximal end to a distal end along a longitudinal axis, the shaft including a first conduit extending from the proximal end to 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 and deploy the one or more staples by contacting the one or more staples with the surface.

[0008] The shaft further includes a depression formed at least in part by the surface, and expansion of the expandable member drives one or more staples into the depression. The medical device further includes a second conduit extending from the proximal end toward the distal end, the distal end of the shaft configured to flex relative to the longitudinal axis when the second conduit is filled with a fluid. The medical device further includes an electroactive polymer extending along a portion of the shaft, the distal end of the shaft configured to flex relative to the longitudinal axis when an electric current is applied to the electroactive polymer.

[0009] In yet another aspect, the present invention relates to a medical device including a shaft extending from a proximal end to a distal end along a longitudinal axis, the shaft including a lumen extending from the proximal end to the distal end and a pusher element extending through the lumen, wherein distal movement of the pusher element along the longitudinal axis is configured to deploy one or more staples in a direction generally perpendicular to the longitudinal axis of the shaft.

[0010] It is to 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, as claimed.

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and, together with the description, serve to explain the principles of the invention. [Brief explanation of the drawings]

[0012] [Figure 1] 10A-10C illustrate an exemplary stapling method in accordance with aspects of the present invention. [Figure 2] 10A-10C illustrate an exemplary stapling method in accordance with aspects of the present invention. [Figure 3] 10A-10C illustrate an exemplary stapling method in accordance with aspects of the present invention. [Figure 4] 10A-10C illustrate an exemplary stapling method in accordance with aspects of the present invention. [Figure 5]10A-10C illustrate an exemplary stapling method in accordance with aspects of the present invention. [Figure 6] 10A-10C illustrate an exemplary stapling method in accordance with aspects of the present invention. [Figure 7] 1 is a perspective view of a medical device according to an embodiment of the present invention; [Figure 8] 8A-8C are side views illustrating a stapling procedure using the medical device of FIG. 7. [Figure 9] 8A-8C are side views illustrating a stapling procedure using the medical device of FIG. 7. [Figure 10] 8A-8C are side views illustrating a stapling procedure using the medical device of FIG. 7. [Figure 11] 8A-8C are side views illustrating a stapling procedure using the medical device of FIG. 7. [Figure 12] 8A-8C are side views illustrating a stapling procedure using the medical device of FIG. 7. [Figure 13] 7-13 is a cross-sectional view of the housing and block of the medical device of FIGS. [Figure 14] FIG. 13 is a cross-sectional view of a pusher element of the medical device of FIGS. 7-12. [Figure 15] 7-13 is a cross-sectional view of an extension of the medical device of FIGS. 7-12. FIG. [Figure 16] 14 illustrates movement of the block of FIG. 13 to deploy one or more staples. [Figure 17] 14 illustrates movement of the block of FIG. 13 to deploy one or more staples. [Figure 18] 1 illustrates a medical device according to an alternative embodiment of the present invention. [Figure 19] 1 illustrates a medical device according to an alternative embodiment of the present invention. [Figure 20] FIG. 10 illustrates a medical device according to yet another alternative embodiment of the present invention. [Figure 21] FIG. 10 illustrates a medical device according to yet another alternative embodiment of the present invention. [Figure 22] FIG. 10 illustrates a medical device according to yet another alternative embodiment of the present invention. [Figure 23] FIG. 10 illustrates a medical device according to yet another alternative embodiment of the present invention. [Figure 24] FIG. 10 illustrates a medical device according to yet another alternative embodiment of the present invention. [Figure 25] FIG. 10 illustrates a medical device according to yet another alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention relates to systems, devices, and methods for joining, cutting, and resecting tissue. Aspects of the invention are described in detail below, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion of the device that is furthest from the user when introduced into a patient's body. In contrast, the term "proximal" refers to the portion of the device that is closest to the user when positioned within a patient's body. The term "tissue fastening" refers to, for example, stapling, securing, attaching, fastening, or otherwise joining two portions of tissue together. The term "fastener" may include staples, clips, elastic bands, sutures, or any other fastener known in the art.

[0014] Both the general description above and the detailed description below are exemplary and explanatory and are not limiting of the elements, as recited in the claims. As used herein, terms such as "comprises," "comprising," "having," "including," or other variations thereof, are intended to include a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may include other elements not expressly listed or inherent in such process, method, article, or apparatus. Furthermore, the term "exemplary" is used herein to mean "example" rather than "ideal." As used herein, the terms "about," "substantially," and "nearly" indicate a range of values within + / - 5% of the stated value, unless otherwise specified.

[0015] 1-6 illustrate an exemplary medical device 100 used to staple tissue 20. In some embodiments, medical device 100 is a surgical stapling device configured to engage body tissue 20 and apply one or more surgical fasteners to the body tissue, and optionally create an incision in the fastened body tissue during a minimally invasive surgical procedure, such as an endoscopic procedure. Medical device 100 can be used to apply surgical clips or other fasteners, but is described primarily in the context of applying staples.

[0016] The medical device 100 includes an elongate member or shaft 102 extending from a proximal end (not shown) to a distal end 104. A staple fastening assembly 110 is disposed at the distal end 104. For clarity, the medical device is shown in FIG. 1 without the staple fastening assembly 110 attached. In some embodiments, the staple fastening assembly 110 is movable from a first position, such as the delivery position shown in FIG. 2, to a second position, such as the operating position shown in FIG. 3. In some examples, the staple fastening assembly 110 includes one or more struts 112 coupled to the distal end 104 or movable through a lumen 108 of the medical device 100. The staple fastening assembly 110 is not operable in the delivery position shown in FIG. 2 and is configured to deliver staples to tissue only when in the operating position shown in FIG. 3. In other words, when the medical device 100 is in the delivery position, it cannot deploy staples or other tissue fastening elements, even in response to an action from an operator (e.g., pressing an actuator button) that would deploy a staple or tissue fastening element when the medical device 100 is in the operating position.

[0017] The shaft 102 is any suitable endoscopic member configured to curve and flex to traverse tortuous anatomy within the body. The shaft 102 can be formed of one or more biocompatible materials, such as HDPE, silicone, polyurethane, ETFE, SIBS, PIB-PUR, or any other suitable medical-grade polymer, and is flexible and configured to extend through tortuous anatomy. The shaft 102 can extend any length suitable for endoscopic or laparoscopic surgery and be configured to be positioned within the working channel of an endoscope. Alternatively, the shaft 102 can be positioned within the body without an endoscope. The shaft 102 can include an illumination / optical assembly 106 and one or more lumens 108. While an endoscope is referenced herein, reference to an endoscope or endoscopy should not be construed as limiting the possible applications of the disclosed embodiments. For example, the disclosed embodiments can be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic instruments or devices, or other types of medical devices.

[0018] The assembly 106 may include an illumination device and an optical device. For example, the illumination device may include one or more of a fiber optic device (e.g., an optical cable) or light emitting diodes (LEDs) to provide illumination light to a site within the patient's body distal to the distal end 104. The optical device may include any suitable device configured to form a visual image of a site within the patient's body. For example, the optical device may include one or more optical elements (e.g., a lens, a camera, etc.).

[0019] The one or more lumens 108 can be disposed at any suitable location about the distal end face of the shaft 102. In some configurations, the one or more lumens 108 are disposed to provide irrigation and / or aspiration fluid. In such cases, the one or more lumens 108 are connected to one or more ports (not shown) in the handle (not shown). Such ports are then connected to one or more sources of irrigation and / or aspiration fluid for delivery via the one or more lumens 108. Additionally, the one or more lumens 108 are configured to receive one or more articulation wires (not shown) or the like to impart selective articulation to at least the distal end 104 of the shaft 102. In one embodiment, an instrument 114 extends through the lumen 108. The instrument 114 is configured to grasp tissue 20 and position the tissue 20 within or adjacent to the stapling assembly 110. For example, the instrument 114 may include a grasper, forceps, snare, clamp, tissue loop, helical coil, or clip applier, or any other instrument for performing a medical procedure.

[0020] In FIG. 4, instrument 114 is extended toward tissue 20. In FIG. 5, instrument 114 positions tissue 20 between adjacent stapling heads of stapling assembly 110. In FIG. 6, a first tissue portion 22 is shown with a first row of staples 244 deployed therein, and a second tissue portion 24 is shown with a second row of staples 244 deployed therethrough. The separate stapling heads of stapling assembly 110 are moved together by actuation of a push button or other mechanism that ejects staples from one stapling head toward the other. Medical device 100 may also include one or more instruments for separating the stapled tissue portions, such as, for example, a knife.

[0021] 7-12 illustrate a medical device 200. The medical device 200 includes a shaft 102, as shown in FIGS. 1-6. The medical device 200 includes one or more staples 244 (FIGS. 11 and 12) configured to be deployed along a trajectory generally perpendicular to the longitudinal axis of the shaft 102. The medical device 200 includes a navigation state (FIG. 2), in which the staples 244 are positioned proximal to the articulated portion of the shaft 102. In the navigation state, the stapling head of the staple fastening assembly 110 is positioned near the distal surface of the elongate member 102. The stapler is near the surface of the elongate member 102 to facilitate crossing the anatomy when the stapling function is not being used. The stapling head of the stapling assembly can be stationary in an open position (both the navigation state and the operating position) to maintain visualization. The stapling head is driven forward using a mechanical drive mechanism (e.g., a drive wire, sheath, etc.) connected to the strut. A drive mechanism extends through the scope to the proximal end to be actuated by a physician with a handle. Once the medical device 200 is moved to the desired site, a tissue acquisition element disposed on or off the shaft 102, such as the instrument 114 described with reference to Figures 1-6, can be used to acquire and position tissue for stapling.

[0022] In some embodiments, medical device 200 includes a stapling assembly 202 disposed at distal end 104. Stapling assembly 202 includes a first stapling head 204 fixed to distal end 104 and a second stapling head 206 movable relative to distal end 104. In other embodiments, first stapling head 204 and second stapling head 206 are movable between a delivery position and an operable position in a manner similar to that described above with reference to FIGS. 1-6. First stapling head 204 includes a flat surface 214 extending generally perpendicular to the longitudinal axis of shaft 102. Flat surface 214 includes one or more depressions 212 and can function as anvils for the legs of staples 244. First stapling head 204 is coupled to shaft 102 by a support 210. It is contemplated that buttress material 210 may extend through one or more lumens of shaft 102 (i.e., an intra-scope through-attachment), may be coupled to the exterior of shaft 102 (i.e., an on-scope attachment), or may include a combination of such attachments. First stapling head 204 also includes a curved, radially outward-facing surface opposite flat surface 214, generally having a half-moon shape, although other suitable shapes are also contemplated.

[0023] The second stapling head 206 is disposed within a housing 220 coupled to the distal end 104. In some embodiments, the housing 220 is secured to the distal end 104 by an intra-scope attachment, an extra-scope attachment, or a combination of attachment types. An extension 222 extends proximally from the second stapling head 206. The proximal end of the extension 222 includes a beveled surface 224 extending radially inward in the proximal direction. The extension 222 includes a recess 222a formed in its outer surface (FIG. 15). A pusher element 226 extends through the lumen 108 of the shaft 102. The distal end of the pusher element 226 includes a beveled surface 228 extending radially outward in the distal direction. The beveled surface 228 can be configured in any manner to engage the corresponding beveled surface 224 of the extension 222. Pusher element 226 also includes a protrusion 230 extending from its outer surface. The distal end of protrusion 230 includes a ramp 232 extending radially outward in the distal direction (like ramp 228). Ramped surface 232 may be continuous with (i.e., coaxial or collinear with) ramp 228 or may extend adjacent to the entire ramp 228. Recess 222a is configured to receive protrusion 230 and has a radial dimension b that is slightly greater than or approximately equal to the dimension c that protrusion 230 extends from the outer surface of pusher element 226 (see FIGS. 14 and 15 ).

[0024] 13, second stapling head 206 includes a recess 206a that is generally coaxial with recess 222a. Second stapling head 206 also includes an opening 206b that is positioned adjacent to flat surface 214 of first stapling head 204 during a stapling procedure. Block 240 is disposed within second stapling head 206 and is movable within second stapling head 206 and at least partially through opening 206b. Staples are disposed beneath block 240 (e.g., in a cartridge) so that when block 240 is pressed downward, the staples are forced into the anvil of the opposing stapling head. Recess 206a has a length / width dimension a that is less than dimension c of protrusion 230, such that protrusion 230 extends through recess 206a and contacts block 240. Block 240 is biased to the first position shown in FIG. 13 by, for example, one or more resilient members, or springs 213, attached to the inner surfaces of block 240 and second stapling head 206. While FIG. 13 shows two springs 213 compressed in a resting state, more or fewer springs are contemplated. Springs 213 are extended when protrusion 230 of pusher element 226 contacts block 240 and urges block 240 toward flat surface 214 to deploy staples 244. Block 240 also includes an inclined surface 242 at the proximal end of block 240 that extends radially inward in the proximal direction. Inclined surfaces 232, 242 can cooperate with one another in a manner generally similar to the manner in which inclined surfaces 224, 228 cooperate with one another.

[0025] Various steps for operating medical device 200 will now be described. When pusher element 226 is pushed distally along or parallel to the longitudinal axis of shaft 102, inclined surfaces 224, 228 bias second stapling head 206 along a radially inward direction generally perpendicular to the longitudinal axis of shaft 102 (see FIGS. 8 and 9). After second stapling head 206 reaches the end of its path of travel and travels a predetermined first distance (toward first stapling head 204 in a direction perpendicular to the longitudinal axis of shaft 102), further distal movement of pusher element 226 extends protrusion 230 through recess 222a of extension 222 (e.g., FIG. 11). At least Also It was decided Second Further distal movement of the pusher element 226 can slide, translate, or move the protrusion 230 relative to and / or through the recess 222a without causing movement of the block 240 relative to the second staple head 206 (FIG. 11). , Preliminary It was decided Second The distance corresponds to or is approximately the same as the length of the recess 222a. But It was decided Second Further distal movement of pusher element 226 after moving the distance deploys block 240, which includes one or more staples 244 (FIGS. 10 and 12). In particular, further distal movement of pusher element 226 moves protrusion 230 through recess 206a and into contact with block 240. In particular, angled surface 232 can slide against angled surface 242 to bias block 240 toward first stapling head 204 (particularly toward flat surface 214). Spring 213 extends from a resting state during this movement of block 240. Block 240 can move along a trajectory generally similar to that which second stapling head 206 originally moved (i.e., toward first stapling head 204 in a direction perpendicular to the longitudinal axis of shaft 102).

[0026] When block 240 is urged toward flat surface 214, the legs of staples 244 contact flat surface 214 (see FIGS. 16 and 17 ), deploying staples 244 into tissue disposed between first stapling head 204 and second stapling head 206 ( FIGS. 10 and 12 ). After staple deployment is complete, the distal force acting on pusher element 226 can be released (or reversed) to return spring 213 to its resting, compressed configuration and retract block 240 into housing 206. Further, the release (or reversal) of the distal force acting on pusher element 226 moves the entire second stapling head 206 radially outward along a path perpendicular to the longitudinal axis of shaft 102 to its original position.

[0027] Movement of the pusher element 226 from the position shown in FIG. 8 to the position shown in FIGS. 10 and 12 (after the staples 244 have been deployed) can be performed in a single, smooth motion. In some embodiments, a stop may be included so that any time after the second stapling head 206 has moved a predetermined first distance (after reaching the end of its path of movement toward the first stapling head 204), the physician is required to perform some action to cause the pusher element 226 to continue driving the block 240 distally. The stop may be incorporated, for example, into the recess 222a to block the movement of the protrusion 230. In some embodiments, application of additional force to the pusher element 226 may deform the stop and move it out of the path of the pusher element 226. In another embodiment, movement of the stop may be controlled by an actuator, button, or the like on the handle of the medical device. Including a stop allows the physician to clamp tissue with only the stapling heads 204, 206 before it is necessary to drive the staples 244 into the tissue. This can help the physician to realign the grasped tissue portion, for example, if the wrong portion of tissue is grasped.

[0028] 18 and 19 illustrate a medical device 300. The medical device 300 includes an alternative mechanism for approximating the two stapling heads together, in which an outer shaft slides over the stapling heads to urge the stapling heads toward each other. For example, the medical device 300 includes a shaft 302 extending from a proximal end (not shown) to a distal end 304. A shaft 310 extends within a lumen of the shaft 302. Two stapling heads 312a, 314a extend from the distal end of the shaft 310 via supports 312, 314, respectively. The supports 312, 314 extend both distally and radially outward (e.g., relative to the longitudinal axis of the shaft 310) from the distal end of the shaft 310. As shaft 302 is moved distally relative to shaft 310 (or shaft 310 and buttresses 312, 314 are moved proximally relative to shaft 302), stapling heads 312a, 314a move toward each other along a radially inwardly directed path ( FIG. 19 ). When stapling heads 312a, 314a reach the end of their paths of travel such that stapling heads 312a, 314a are substantially adjacent to each other, a second, separate staple deployment step can be performed. Medical device 300 may include any other staple deployment mechanism disclosed herein. For example, pusher element 226 can extend through buttress 312, and block 240 (e.g., within first stapling head 312a) can drive staples 244 onto the surface of stapling head 314a. Alternatively, a fluid delivery mechanism can be utilized as described below with respect to Figures 22-24. In yet another embodiment, the closing of the stapling heads 312a, 314a can itself deploy the staples 244.

[0029] 20 and 21 illustrate a medical device 400. The medical device 400 includes another alternative mechanism for closing the two stapling heads, in which a wire is connected to a scissor joint attached to the stapling heads. For example, the medical device 400 includes a shaft 402 extending from a proximal end (not shown) toward a distal end. Two stapling heads 404, 406 extend from the distal end of the shaft 402 via supports 408, 410, respectively. The supports 408, 410 extend proximally from the respective stapling heads, cross each other, and are connected to each other at a joint 412 (e.g., a scissor joint, pivot, etc.). A wire or other actuating member 414 extends proximally from each support 408, 410. Actuation of the wire 414 can move the stapling heads 404, 406 toward each other (FIG. 21). More specifically, a proximal, radially inward force can be applied to each wire 414. Because the working channel is small, pulling back on the wires can be sufficient to generate the necessary radially inward force (as long as there is enough room for the wires to move inward when pulled). The wires can be connected to a button or other actuation mechanism on the handle so that the user does not pull on them directly. Once the stapling heads 404, 406 reach the end of their travel path and are adjacent to each other, a second, separate staple deployment step can be performed. The medical device 400 can include any of the alternative staple deployment mechanisms disclosed herein. For example, a fluid delivery mechanism, such as that described below with respect to FIGS. 22-24, can be utilized. For example, fluid can be delivered to the stapling head 404 via a conduit 416 to an expandable member (not shown) disposed within the stapling head 404, for example. In yet another embodiment, the closing of the stapling heads 404, 406 may itself deploy the staples 244.

[0030] 22-24 illustrate an exemplary medical device 500 that can be used to staple tissue 20. Medical device 500 includes an elongate member, or shaft 501, extending from a proximal end (not shown) to a distal end 502. Medical device 500 includes a distally facing surface, or end face 503, at distal end 502. Medical device 500 also includes a first fluid conduit 504 and a second fluid conduit 506. Second fluid conduit 506 terminates in an expandable chamber 508 at the distal end of second fluid conduit 506.

[0031] The expandable chamber 508 is movable from a first configuration (shown in FIGS. 22 and 23) to a second configuration (shown in FIG. 24). The expandable chamber 508 has a first volume in the first configuration, which is smaller than a second volume in the second configuration. The second volume may be 1.5, 2, 3, or more times larger than the first volume, although other suitable ratios are contemplated. The exterior of the expandable chamber may be formed from an expandable and resilient material, such as, for example, rubber, polymer, or the like.

[0032] The medical device 500 also includes a recess 509 formed in the distal surface 503. However, the recess 509 may alternatively or additionally be formed on a circumferential side of the shaft 501. The recess 509 is formed in part by a flat surface 510 (which may function as an anvil during the stapling procedure). The expandable chamber 508 can be coupled to one or more staples 244, and the expandable chamber 508 is positioned within the distal end 502 such that expansion of the expandable chamber 508 is in the direction of the recess 509. For example, a solid, relatively rigid material may surround a majority of the expandable chamber 508, while an opening 511 is positioned between the expandable chamber 508 and the recess 509. In this configuration, expansion of the expandable chamber 508 must pass through the opening 511 and into the recess 509. Alternatively, the expandable chamber 508 may not expand into the recess 509 itself, but may drive the staples 244 into and / or through the recess 509 toward the flat surface 510. The driving of the staples 244 into the flat surface 510 occurs along a trajectory that is approximately perpendicular to the plane of the flat surface 510.

[0033] The first and second conduits 504, 506 are connected to a fluid source 507 configured to drive fluid through the conduits. The fluid source 507 is a pump controlled by a controller. The pump may be any suitable pump, such as a peristaltic pump, a piston pump, an electric pump, a microfluidic pump, an infusion pump, etc. The pump may be powered by electricity, mechanical power, chemical power, or another suitable mechanism. The fluid source 507 may include a source (e.g., a reservoir) of fluid circulated through the conduits 504, 506. In some examples, the fluid source 507 may include multiple reservoirs and deliver fluid through each conduit 504, 506 from a dedicated reservoir. Alternatively, the same reservoir supplies both conduits 504, 506, and the flow is controlled via one or more valves (not shown). The fluid circulated through the conduits 504, 506 may be any suitable biocompatible fluid, such as sterile water or saline (in case of a leak). The controller may include a processor generally configured to accept information from the medical device and medical device components and process the information according to various algorithms to generate control signals for controlling the fluid source 507. For example, the processor may receive information from the system and system components, process the information according to various algorithms, and generate information signals directed to an indicator, such as a visual indicator, a digital display, an audio tone generator, or another indicator in a user interface, to notify a user of, for example, system status, component status, procedure status, or other information monitored by the system. The processor may be a digital IC processor, an analog processor, or any other logic or control system that executes control algorithms. One or more pressure sensors may be coupled to each fluid conduit 504, 506, and the controller may control the flow of fluid through the conduits 504, 506 by receiving and analyzing output from the one or more pressure sensors.

[0034] The bending or extension of the medical device 500 can be achieved, at least in part, by filling the first conduit 504 with a fluid. Additionally, the medical device 500 may be configured to have non-uniform stiffness. That is, the medical device 500 exhibits a tendency to bend in one or more directions as opposed to one or more other directions. Stated another way, the medical device 500 can be pre-positioned to bend away from the longitudinal axis of the shaft 501 along a particular trajectory. The tendency or predisposition to bend away from the longitudinal axis can be achieved by forming the shaft 501 from at least two materials having different durometers or hardnesses. In this embodiment, when the first conduit 504 is filled with fluid, the portion of the shaft 501 having a higher hardness resists movement, while the portion of the shaft 501 having a lower hardness bends (e.g., as shown in FIGS. 23 and 24). In another embodiment, surface modifications, such as cuts, slits, or indentations, can be formed along only a portion of the outer periphery of the shaft 501. Similarly, material may be removed from a particular interior portion of the shaft 501. In these embodiments, when the first conduit 504 is filled with fluid, the portion of the shaft 501 having the surface modification or removed portion may bend, while the portion of the shaft 501 without such surface modification or material removed may resist movement. Increasing the pressure within the first conduit 504 may increase the flexion / extension of the shaft 501, while maintaining any particular pressure level may maintain a particular flexion / extension angle.

[0035] In yet another embodiment shown in FIG. 25 , bending and extension of the shaft 601 can be achieved by using an electroactive polymer 604 instead of pressurized fluid. For example, such polymer 604 can include randomly dispersed, non-oriented cationic material. One surface of the shaft 601 adjacent to the polymer 604 can include anionic material 605. When current is activated in a generator 607 coupled to the polymer 604, the cations in the polymer 604 can orient and migrate toward the anionic material 605, thereby bending the polymer 604. As long as current is flowing through the polymer 604, the shaft 601 maintains its bent position. In other words, bending and extension of the shaft 601 can be maintained during any “on” cycle of the generator coupled to the polymer. It is also possible that the polymer 604 includes randomly dispersed, non-oriented anionic material, and the material 605 includes a cationic material. In yet another example, bending and extension can be achieved by utilizing magnetic attraction between the polymer 604 and the material 605.

[0036] Those skilled in the art will recognize that various modifications and variations can be made in the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the elements disclosed herein. It is intended that the specification and examples be considered as illustrative only.

Claims

1. a shaft extending from a proximal end to a distal end, the shaft including a lumen extending from the proximal end to the distal end; a first stapling head at the distal end configured to contain one or more staples, the first stapling head having a block disposed within and movable relative to the first stapling head; a second stapling head disposed at the distal end; and a pusher element extending through the lumen and movable along the longitudinal axis of the shaft from a first position to a second position, wherein movement of the pusher element from the first position to the second position moves the first stapling head toward the second stapling head along a radially inward trajectory perpendicular to the longitudinal axis of the shaft, and further movement of the pusher element moves the block toward the second stapling head to deploy one or more staples; and the pusher element also includes a third position and a fourth position, movement of the pusher element from the third position to the fourth position before the pusher element is moved from the first position to the second position moves the first stapling head toward the second stapling head, the track is a first track, the block is movable toward the second stapling head along a second trajectory that is perpendicular to the longitudinal axis, the second stapling head includes a flat surface extending in a plane perpendicular to the track, the flat surface being an anvil configured to bend the one or more staples into tissue upon contacting the one or more staples.

2. 2. The medical device of claim 1, wherein the medical device includes a first extension extending proximally from the first stapling head, the first extension having a first sloped portion at a proximal end, and the distal end of the pusher element includes a second sloped portion configured to slide relative to the first sloped portion when the pusher element is moved from a third position to a fourth position.

3. The medical device of claim 2 , wherein the first angled portion extends radially inward in a proximal direction and the second angled portion extends radially outward in a distal direction.

4. A shaft extending from a proximal end to a distal end, the shaft including a lumen extending from the proximal end to the distal end; a first stapling head at the distal end configured to contain one or more staples, the first stapling head having a block disposed within and movable relative to the first stapling head; a second stapling head disposed at the distal end; and a pusher element extending through the lumen and movable along the longitudinal axis of the shaft from a first position to a second position, wherein movement of the pusher element from the first position to the second position moves the first stapling head toward the second stapling head along a radially inward trajectory perpendicular to the longitudinal axis of the shaft, and further movement of the pusher element moves the block toward the second stapling head to deploy one or more staples; and the pusher element also includes a third position and a fourth position, and movement of the pusher element from the third position to the fourth position before the pusher element is moved from the first position to the second position moves the first stapling head toward the second stapling head; The medical device wherein the outer surface of the pusher element has a protrusion that directly contacts the block.

5. 5. The medical device of claim 4, wherein the block includes a third ramp portion, and the distal end of the protrusion includes a fourth ramp portion configured to slide relative to the third ramp portion when the pusher element is moved from the first position to the second position.

6. The medical device of claim 5 , wherein the third angled portion extends radially inward in a proximal direction and the fourth angled portion extends radially outward in a distal direction.

7. 5. The medical device of claim 4, further comprising a first extension extending proximally from the first stapling head, the first extension including a longitudinally extending first recess, and wherein movement of the pusher element from the fourth position to the first position causes the protrusion to slide through the first recess.

8. The medical device of claim 7 , wherein the block is maintained stationary relative to the first stapling head while the pusher element moves from the fourth position to the first position.

9. 9. The medical device of claim 8, wherein the first stapling head includes a second recess coaxial with the first recess, and wherein movement of the pusher element from the first position to the second position causes the distal end of the protrusion to extend through the second recess and contact a block.

10. The medical device of any one of claims 1 to 9, wherein the block is attached to an inner surface of the first stapling head by one or more resilient members.

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