System, device, and related method for fastening tissue

Abstract

To provide a system, a device, and a method for fastening a tissue of a flexible endoscope platform or the like having a stapling function, for example.SOLUTION: A medical device includes: a first shaft; a second shaft arranged inside a lumen of the first shaft; a first stapling head and a second stapling head arranged in a distal portion of the second shaft; and an extrusion element extending so as to penetrate the lumen, the extrusion element being configured to deploy one or more staples in a direction substantially orthogonal to a longitudinal axis of the second shaft by movement in a distal direction of the extrusion element along the longitudinal axis.SELECTED DRAWING: Figure 9

Description

Technical Field

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

Background Art

[0002] Tissue fastening (such as stapling) is used in many laparoscopic surgeries. These surgeries often involve excising a portion or section of tissue and subsequently closing it using staples. An example of a common surgery is colorectal anastomosis. In hybrid surgeries where a physician uses a laparoscopic platform and an endoscopic platform to perform the surgery, a rigid stapler is often used. A linear stapler includes a long, rigid member that cannot navigate through a serpentine biological structure without causing trauma to the tissue. Physicians are also transitioning to endoscopic outpatient surgeries that require endoscopic stapling.

[0003] With the above in mind, improvements to the present invention are useful.

Summary of the Invention

[0004] Aspects of the present invention relate to systems, devices, and methods for fastening tissue, such as a flexible endoscopic platform with a stapling function. Each aspect disclosed herein may include one or more elements described in relation to 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 including a lumen extending from the proximal end to the distal end, a first stapling head provided at the distal end, and a first stapling head configured to include one or more staples, the first stapling head having a block disposed therein and movable relative to the first stapling head, a second stapling head provided at the distal end, and an extrusion element extending through the lumen and movable from a first position to a second position, movement of the extrusion element from the first position to the second position causing the block to move toward the second stapling head to deploy one or more staples.

[0006] The extrusion element also includes a third posture and a fourth posture. Before the extrusion element moves from the first posture to the second posture, the movement of the extrusion element from the third posture to the fourth posture causes the first staple head to move towards the second staple head. The shaft extends along the longitudinal axis, and the block and the first staple head are each movable towards the second staple head along a trajectory substantially perpendicular to the longitudinal axis. The second staple head includes a flat bearing surface extending in a plane substantially orthogonal to the trajectory, and the flat bearing surface is an anvil configured to bend one or more staples into the tissue when in contact with the one or more staples. The medical device includes a first extension extending proximally from the first staple head, the first extension having a first inclined portion at the proximal end, and the distal end of the extrusion element includes a second inclined portion configured to slide relative to the first inclined portion when the extrusion element is moved from the third posture to the fourth posture. The first inclined portion extends radially inward in the proximal direction, and the second inclined portion extends radially outward in the distal direction. The outer surface of the extrusion element includes a protrusion configured to contact the block directly. The block includes a third inclined portion, and the distal end of the protrusion includes a fourth inclined portion configured to slide relative to the third inclined portion when the extrusion element is moved from the first posture to the second posture. The third inclined portion extends radially inward in the proximal direction, and the fourth inclined portion extends radially outward in the distal direction. The medical device further includes a first extension extending proximally from the first staple head, the first extension including a first recess extending in the longitudinal direction, and the movement of the extrusion element from the fourth posture to the first posture causes the protrusion to slide through the first recess. While the extrusion element moves from the fourth posture to the first posture, the block is maintained stationary relative to the first staple head. The first staple head includes a second recess coaxial with the first recess, and the movement of the extrusion element from the first posture to the second posture causes the distal end of the protrusion to extend through the second recess and contact the block. The block is attached to the inner surface of the first staple head by one or more elastic members.The medical device further includes a second shaft movable from a first configuration to a second configuration. When the second shaft is in the first configuration, the first staple head and the second staple head are spaced apart from each other by a first distance. When the second shaft is in the second configuration, the second shaft is distal to the first configuration and the first staple head and the second staple head are spaced apart from each other by a second distance, and the second distance is shorter than the first distance. The medical device further includes a first extension extending proximally from the first staple head and a second extension extending proximally from the second staple head. The first extension and the second extension are coupled to each other at a junction. The first and second extensions are movable between a first configuration in which the first staple head and the second staple head are spaced apart from each other by a first distance and a second configuration in which the first staple head and the second staple head are spaced apart from each other by a second distance, and the second distance is smaller than the first distance.

[0007] In 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 includes 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. Delivery of fluid to the expandable chamber via the first conduit is configured to deploy the one or more staples by moving the one or more staples toward the surface and contacting the one or more staples with the surface.

[0008] The shaft further includes depressions formed at least partially by the surface, and the expansion of the expandable member moves one or more staples into the depressions. The medical device further includes a second conduit extending from the proximal end towards the distal end, and the distal end of the shaft is configured to flex with respect to the longitudinal axis when the second conduit is filled with fluid. The medical device further includes an electroactive polymer extending along a portion of the shaft, and the distal end of the shaft is configured to flex with respect 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 towards a distal end along a longitudinal axis, the shaft including a lumen extending from the proximal end to the distal end and an extrusion element extending through the lumen, and the distal movement of the extrusion 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.

[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 aspects of the invention and, together with the description, explain the principles of the invention.

Brief Description of the Drawings

[0012]

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Embodiments for Carrying Out the Invention

[0013] The present invention relates to systems, devices, and methods for binding, cutting, and excising tissue. Embodiments of the present invention will be described in detail below, and examples thereof are shown in the accompanying drawings. Identical or similar reference numerals are used throughout the drawings to refer to the same or similar parts whenever possible. The term "distal" refers to the part that is farthest from the user when the device is introduced into the patient's body. In contrast, the term "proximal" refers to the part that is closest to the user when the device is placed in the patient's body. The term "tissue fastening" refers to, for example, stapling, fixing, attaching, fastening, or otherwise joining two parts of tissue together. The term "fastener" may include staples, clips, elastic bands, sutures, or any other fastener known in the art.

[0014] Both the above general description and the following detailed description are exemplary and explanatory and do not limit the elements, as set forth in the claims. As used herein, terms such as "comprises," "comprising," "having," "including," or other variations thereof are intended to include non-exclusive inclusion, so that a process, method, article, or device comprising a list of elements does not include only these elements but may include other elements not expressly listed or other elements specific to such process, method, article, or device. Further, the term "exemplary" as used herein means "an example" rather than "ideal" in this specification. As used herein, the terms "about," "substantially," and "nearly" indicate a range of values within + / - 5% of the recited value, unless otherwise specified.

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

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

[0017] The shaft 102 is any suitable endoscope member configured to curve across a serpentine biological structure within the body and to flex. The shaft 102 can be formed of one or more biocompatible materials such as, for example, HDPE, silicone, polyurethane, ETFE, SIBS, PIB-PUR, or any other suitable medical grade polymer, and is configured to be flexible and extend through the serpentine biological structure. The shaft 102 extends over any length suitable for endoscopic or laparoscopic surgery and is configured to be disposed within the working channel of an endoscope. Alternatively, the shaft 102 can be disposed within the body without an endoscope. The shaft 102 can include a lighting / optical assembly 106 and one or more lumens 108. Although an endoscope is referenced herein, references to an endoscope or endoscopy should not be construed as limiting the possible uses of the disclosed embodiments. For example, the disclosed embodiments can be used in a duodenoscope, bronchoscope, ureteroscope, colonoscope, catheter, diagnostic or therapeutic instrument or device, or other types of medical devices.

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

[0019] One or more lumens 108 can be disposed at any suitable location around the distal end face of the shaft 102. In some configurations, one or more lumens 108 are arranged to provide irrigation fluid and / or suction fluid. In such cases, one or more lumens 108 communicate with one or more ports (not shown) of a handle (not shown). Next, such ports are then communicated with a source of one or more irrigation fluids and / or suction fluids for delivery through one or more lumens 108. Further, one or more lumens 108 are configured to receive one or more flexion and extension wires (not shown), etc. to impart selective flexion and extension movement to at least the distal end 104 of the shaft 102. In one embodiment, the instrument 114 extends through the lumen 108. The instrument 114 is configured to grasp the tissue 20 and place the tissue 20 within or adjacent to the stapling assembly 110. For example, the instrument 114 can include a grasper, forceps, snare, clamp, tissue loop, helical coil, or clip applicator, or any other instrument for performing a medical procedure.

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

[0021] In FIGS. 7-12, a medical device 200 is shown. 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, 12) configured to be deployed along a trajectory that is substantially orthogonal to the longitudinal axis of the shaft 102. The medical device 200 includes a navigation state (FIG. 2), and the staple 244 is disposed proximal to the flexion-extension portion of the shaft 102. In the navigation state, the staple head of the stapling assembly 110 is disposed close to the distal surface of the elongate member 102. The stapler is in the vicinity of the surface of the elongate member 102 to facilitate crossing of the biological structure when the stapling function is not used. The staple head of the stapling assembly can be stationary in an open position (both the navigation state and the operating state) to maintain visualization. The staple head is pushed forward using a mechanical drive mechanism (e.g., a drive wire, a sheath, etc.) connected to the strut. The drive mechanism extends through the scope to the proximal end to be actuated by a handle by a physician. When the medical device 200 is moved to a desired site, tissue can be acquired and placed for stapling using a tissue acquisition element disposed inside or outside the shaft 102, such as the instrument 114 described with reference to FIGS. 1-6.

[0022] In some embodiments, the medical device 200 includes a stapling assembly 202 disposed at the distal end 104. The stapling assembly 202 includes a first stapling head 204 fixed to the distal end 104 and a second stapling head 206 movable relative to the distal end 104. In other embodiments, the first stapling head 204 and the second stapling head 206 are movable between a delivery posture and an operative posture in a manner similar to that described above with reference to FIGS. 1-6. The first stapling head 204 includes a flat surface 214 that extends generally perpendicular to the longitudinal axis of the shaft 102. The flat surface 214 includes one or more depressions 212 that can function as an anvil for the legs of the staple 244. The first stapling head 204 is coupled to the shaft 102 by a support 210. The support 210 can extend through one or more lumens of the shaft 102 (i.e., an in-scope attachment), be coupled to the exterior of the shaft 102 (i.e., an on-scope attachment), or include a combination of such attachments. Although other suitable configurations are contemplated, the first stapling head 204 generally has a semi-circular shape and also includes a surface that curves radially outwardly on the side opposite the flat surface 214.

[0023] The second staple 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 in-scope attachment, an on-scope attachment, or a combination of multiple types of attachments. An extension 222 extends proximally from the second staple head 206. The proximal end of the extension 222 includes an inclined surface 224 that extends radially inwardly in the proximal direction. The extension 222 includes a recess 222a formed in its outer surface (FIG. 15). An extrusion element 226 extends through the lumen 108 of the shaft 102. The distal end of the extrusion element 226 includes an inclined surface 228 that extends radially outwardly in the distal direction. The inclined surface 228 can be configured in any manner that engages the corresponding inclined surface 224 of the extension 222. The extrusion element 226 also includes a protrusion 230 extending from its outer surface. The distal end of the protrusion 230 includes an inclined surface 232 that extends radially outwardly in the distal direction (like the inclined surface 228). The inclined surface 232 may be continuous with the inclined surface 228 (i.e., coaxial or in a straight line), or may be proximate to the entire inclined surface 228. The recess 222a is configured to receive the protrusion 230 and has a radial dimension b that is slightly longer or approximately equal to the dimension c by which the protrusion 230 extends from the outer surface of the extrusion element 226 (see FIGS. 14, 15).

[0024] Referring to FIG. 13, the second staple head 206 includes a recess 206a that is substantially coaxial with the recess 222a. The second staple head 206 also includes an opening 206b that is disposed adjacent to the flat surface 214 of the first staple head 204 during the stapling procedure. The block 240 is disposed within the second staple head 206 and is movable within the second staple head 206 and at least partially through the opening 206b. The staples are disposed under the block 240 (e.g., within a cartridge), and when the block 240 is pressed downward, the staples are pushed into the anvil of the opposing staple head. Since the recess 206a has a length / width dimension a that is less than the dimension c of the protrusion 230, the protrusion 230 extends through the recess 206a and contacts the block 240. The block 240 is biased to the first position shown in FIG. 13, for example, by one or more elastic members, i.e., springs 213, attached to the inner surfaces of the block 240 and the second staple head 206. Although two springs 213 compressed in the stationary state are shown in FIG. 13, more or fewer springs are contemplated. The springs 213 are extended when the protrusion 230 of the extrusion element 226 contacts the block 240 and biases the block 240 toward the flat surface 214 to deploy the staple 244. The block 240 also includes an inclined surface 242 that extends radially inward in the proximal direction at the proximal end of the block 240. The inclined surfaces 232, 242 can cooperate with each other in substantially the same manner as the inclined surfaces 224, 228 cooperate with each other.

[0025] Next, various steps of operating the medical device 200 will be described. When the extrusion elements 226 are pushed distally along or parallel to the longitudinal axis of the shaft 102, the inclined surfaces 228 bias the second staple head 206 in a direction radially inwardly directed substantially orthogonal to the longitudinal axis of the shaft 102 (see FIGS. 8 and 9). After the second staple head 206 reaches the end of its travel path and moves a predetermined first distance (towards the first staple head 204 in a direction perpendicular to the longitudinal axis of the shaft 102), further distal movement of the extrusion element 226 extends the protrusion 230 through the recess 222a of the extension 222 (e.g., FIG. 11). For at least a second predetermined distance, further distal movement of the extrusion 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). In some embodiments, the second predetermined distance corresponds to or is substantially the same as the length of the recess 222a. However, further distal movement of the extrusion element 226 after it has moved the second predetermined distance disposes the block 240 including one or more staples 244 (FIGS. 10 and 12). In particular, further distal movement of the extrusion element 226 moves the protrusion 230 through the recess 206a into contact with the block 240. In particular, the inclined surface 232 can slide relative to the inclined surface 242 to bias the block 240 towards the first staple head 204 (in particular towards the flat surface 214). The spring 213 extends from a rest state during this movement of the block 240. The block 240 can move along a path substantially similar to that along which the second staple head 206 originally moved (i.e., towards the first staple head 204 in a direction perpendicular to the longitudinal axis of the shaft 102).

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

[0027] The movement of the extrusion element 226 from the posture shown in FIG. 8 to the postures shown in FIGS. 10 and 12 (after the deployment of the staple 244) can be performed in a single smooth movement. In some embodiments, at any time after the second staple retaining head 206 has moved a predetermined first distance (after reaching the end of its travel path toward the first staple retaining head 204), the physician may include a stop so that it is necessary to perform some action for the extrusion 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, applying additional force to the extrusion element 226 can deform the stop and disengage it from the path of the extrusion element 226. In another embodiment, the movement of the stop can be controlled by an actuator, button, etc. on the handle of the medical device. By including the stop, the physician can clamp the tissue with only the staple retaining heads 204, 206 before it becomes necessary to drive the staple 244 into the tissue. This helps the physician to readjust the grasped tissue portion, for example, when the wrong portion of the tissue is grasped.

[0028] Figures 18 and 19 illustrate a medical device 300. The medical device 300 includes an alternative mechanism for bringing two staple heads closer to each other, and an outer shaft slides over the staple heads to force the staple heads towards each other. For example, the medical device 300 includes a shaft 302 extending from a proximal end (not shown) towards a distal end 304. A shaft 310 extends within the lumen of the shaft 302. Two staple heads 312a, 314a extend from the distal end of the shaft 310 via supports 312, 314 respectively. The supports 312, 314 extend distally and radially outwardly (e.g., with respect to the longitudinal axis of the shaft 310) from the distal end of the shaft 310. When the shaft 302 is moved distally relative to the shaft 310 (or the shaft 310 and the supports 312, 314 are moved proximally relative to the shaft 302), the staple heads 312a, 314a move towards each other along a path directed radially inwardly (FIG. 19). The staple heads 312a, 314a can perform a second separate staple deployment step when the ends of the movement paths of the staple heads 312a, 314a are reached such that the staple heads 312a, 314a are substantially adjacent to each other. The medical device 300 may include any other staple deployment mechanism disclosed herein. For example, an extrusion element 226 extends through the support 312 and a block 240 can drive staples 244 onto the surface of the staple head 314a (e.g., within the first staple head 312a). Alternatively, a fluid delivery mechanism described below with respect to FIGS. 22-24 can be utilized. In yet another embodiment, staples 244 can be deployed simply by closing the staple heads 312a, 314a.

[0029] Figures 20 and 21 show a medical device 400. The medical device 400 includes another alternative mechanism for closing two staple heads, and the wire is connected to a scissor joint attached to the staple head. For example, the medical device 400 includes a shaft 402 that extends from a proximal end (not shown) towards a distal end. Two staple heads 404, 406 each extend from the distal end of the shaft 402 via supports 408, 410. Supports 408, 410 extend proximally from their respective staple heads, cross each other, and are connected to each other at a connection 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 staple heads 404, 406 towards each other (Figure 21). More specifically, a force acting in the proximal direction and radially inwards can be applied to each wire 414. Since the working channel is small, pulling back the wire may be sufficient to generate the required radially inwards acting force (as long as there is enough space for the wire to move inwards when the wire is pulled). Since the wire can be connected to a button on the handle or other actuating mechanism, the user does not directly pull the wire. When the staple heads 404, 406 reach the end of the movement path of the staple heads 404, 406 and are adjacent to each other, a second separate staple deployment step can be performed. The medical device 400 can include any other staple deployment mechanism disclosed herein. For example, the fluid delivery mechanism described below with respect to Figures 22 - 24 can be utilized. For example, fluid is delivered to the staple head 404 via a conduit 416 to an expandable member (not shown) disposed within the staple head 404, for example. In yet another embodiment, staples 244 can be deployed by the closing of the staple heads 404, 406 themselves.

[0030] Figures 22-24 show an exemplary medical device 500 that can be used to staple tissue 20. The medical device 500 includes an elongate member, i.e., a shaft 501, that extends from a proximal end (not shown) to a distal end 502. The medical device 500 includes a surface that faces distally at the distal end 502, i.e., an end face 503. The medical device 500 also includes a first fluid conduit 504 and a second fluid conduit 506. The second fluid conduit 506 terminates at an expandable chamber 508 that is expandable at the distal end of the second fluid conduit 506.

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

[0032] Medical device 500 also includes a recess 509 formed within the distal face 503. However, the recess 509 may alternatively or additionally be formed in the circumferential side surface of the shaft 501. The recess 509 is partially formed 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 is disposed 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 and relatively rigid material surrounds most of the expandable chamber 508 while an opening 511 is disposed between the expandable chamber 508 and the recess 509. In this configuration, expansion of the expandable chamber 508 needs to pass through the opening 511 and into the recess 509. Alternatively, the expandable chamber 508 cannot expand into the recess 509 itself, but the staple 244 can be driven into and / or through the recess 509 and towards the flat surface 510. Driving the staple 244 into the flat surface 510 occurs along a trajectory that is substantially 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 control unit. The pump can be any suitable pump such as, for example, 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 that is circulated through the conduits 504, 506. In some examples, the fluid source 507 can include multiple reservoirs and can deliver fluid through each conduit 504, 506 from a dedicated reservoir. Alternatively, the same reservoir is supplied to both conduits 504, 506 and the flow thereof is controlled via one or more valves (not shown). The fluid circulated through the conduits 504, 506 is any suitable biocompatible fluid such as, for example, sterile water or saline (in the case of a leak). The control unit can include a processor generally configured to receive 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 receives information from the system and system components, processes the information according to various algorithms, and generates information signals directed to indicators such as visual indicators, digital displays, audio tone generators, or other indicators of the user interface to notify the user of, for example, system status, component status, procedure status, or other information monitored by the system. The processor can be a digital IC processor, an analog processor, or any other logic or control system that executes control algorithms. One or more pressure sensors can be connected to each fluid conduit 504, 506, and the control unit can control the flow of fluid passing through the conduits 504, 506 by receiving and analyzing the output from the one or more pressure sensors.

[0034] The flexion and extension movement of the medical device 500 can be achieved, at least in part, by filling the first conduit 504 with fluid. Further, the medical device 500 may be configured to have non-uniform rigidity. That is, the medical device 500 tends to bend in one or more directions so as to oppose one or more other directions. In other words, the medical device 500 can be pre-positioned to flex in a direction away from the longitudinal axis of the shaft 501 along a particular trajectory. The tendency or predisposition to bend in a direction away from the longitudinal axis can be achieved by forming the shaft 501 from at least two materials having different durometers or different 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 and 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, for example, cuts, slits, depressions, etc. can be made only along a portion of the outer peripheral surface of the shaft 501. Similarly, material may be removed from a particular inner 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 the portion of the shaft 501 having the removed portion bends and the portion of the shaft 501 that does not have such a surface modification or removed material can resist movement. Increasing the pressure within the first conduit 504 can increase the flexion and extension movement of the shaft 501, while maintaining any particular pressure level can maintain a particular flexion and extension movement angle.

[0035] In yet another embodiment shown in FIG. 25, the flexion and extension movement of the shaft 601 can be achieved by using an electroactive polymer 604 instead of pressurized fluid. For example, such a polymer 604 can include a randomly dispersed and unoriented cationic material. The surface of one side of the shaft 601 adjacent to the polymer 604 can include an anionic material 605. When a current is activated by a generator 607 coupled to the polymer 604, the cations of the polymer 604 can be oriented and move towards the anionic material 605. Thereby, the polymer 604 can be bent. When the current is flowing through the polymer 604, the shaft 601 maintains its bent posture. In other words, the flexion and extension movement of the shaft 601 can be maintained during any "on" cycle of the generator coupled to the polymer. It is also conceivable that the polymer 604 includes a randomly dispersed and unoriented anionic material and the material 605 includes a cationic material. In yet another example, the magnetic attraction between the polymer 604 and the material 605 can be utilized to achieve the flexion and extension movement.

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

Claims

**Claim 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 staple - fastening head provided at the distal end and configured to include one or more staples, the first staple - fastening head having a block disposed therein and movable relative to the first staple - fastening head, the first staple - fastening head, A second staple - fastening head provided at the distal end, An extrusion element extending through the lumen and movable from a first position to a second position, wherein the movement of the extrusion element from the first position to the second position moves the block toward the second staple - fastening head to deploy one or more staples, the extrusion element, A medical device comprising the above - mentioned components. **Claim 2** The extrusion element also includes a third position and a fourth position. The movement of the extrusion element from the third position to the fourth position before the extrusion element is moved from the first position to the second position moves the first staple - fastening head toward the second staple - fastening head. The medical device according to claim 1. **Claim 3** The shaft extends along a longitudinal axis, and the block and the first staple - fastening head are each movable along a path perpendicular to the longitudinal axis toward the second staple - fastening head. The medical device according to claim 2. **Claim 4** The second staple - fastening head includes a flat surface extending within a plane perpendicular to the path, and the flat surface is an anvil configured to bend the one or more staples into tissue when contacting the one or more staples. The medical device according to claim 3. **Claim 5** The medical device includes a first extension extending proximally from the first staple - fastening head. The first extension has a first inclined portion at its proximal end, and the distal end of the extrusion element includes a second inclined portion configured to slide relative to the first inclined portion when the extrusion element is moved from the third position to the fourth position. The medical device according to any one of claims 2 - 4. **Claim 6** The first inclined portion extends radially inwardly in the proximal direction, and the second inclined portion extends radially outwardly in the distal direction. The medical device according to claim 5. **Claim 7** The outer surface of the extrusion element has a protrusion that directly contacts the block, the medical device according to any one of claims 2 to 7.

8. The block includes a third inclined portion, and a distal end of the protrusion includes a fourth inclined portion configured to slide with respect to the third inclined portion when the extrusion element is moved from the first posture to the second posture, the medical device according to claim 7.

9. The third inclined portion extends radially inward in the proximal direction, and the fourth inclined portion extends radially outward in the distal direction, the medical device according to claim 7.

10. The medical device further includes a first extension extending in the proximal direction from the first staple head, the first extension includes a first depression extending in the longitudinal direction, and the movement of the extrusion element from the fourth posture to the first posture slides the protrusion through the first depression, the medical device according to claim 7.

11. While the extrusion element moves from the fourth posture to the first posture, the block is maintained stationary with respect to the first staple head, the medical device according to claim 10.

12. The first staple head includes a second depression coaxial with the first depression, and the movement of the extrusion element from the first posture to the second posture causes the distal end of the protrusion to extend through the second depression and contact the block, the medical device according to claim 11.

13. The block is attached to the inner surface of the first staple head by one or more elastic members, the medical device according to any one of claims 1 to 12.

14. Further including a second shaft movable from a first form to a second form, when the second shaft is in the first form, the first staple head and the second staple head are arranged at a first distance from each other, in the second form, the second shaft is on the distal side with respect to the first form, and the first staple head and the second staple head are arranged at a second distance from each other, the second distance being smaller than the first distance, the medical device according to claim 1.

15. The medical device according to claim 1, further comprising a first extension extending proximally from the first staple fastening head and a second extension extending proximally from the second staple fastening head, wherein the first extension and the second extension are connected to each other at a connecting portion, and the first and second extensions are movable between a first configuration in which the first staple fastening head and the second staple fastening head are spaced apart from each other by a first distance and a second configuration in which the first staple fastening head and the second staple fastening head are spaced apart from each other by a second distance, the second distance being smaller than the first distance.

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