Systems, devices and related methods for fastening tissue

Abstract

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

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to tissue fastening, including visualizing, containing and fastening tissue. More specifically, at least certain embodiments of the present invention relate to, among other things, systems, devices and associated methods for stapling tissue. [Background technology]

[0002] Technological advances have enabled users of medical systems, devices, and methods to perform increasingly complex procedures on surgical subjects. For example, joining tissue in the digestive tract of a surgical subject is a type of procedure that can present challenges. Surgical devices are known that grasp or clamp tissue between opposing jaw structures and then join the tissue with surgical fasteners. The fasteners include surgical staples. In some procedures, a cutting instrument is provided to cut the tissue joined by the fasteners. However, problems arise when stapling and cutting tissue to remove tumor tissue from a patient's body.

[0003] One such difficulty is associated with removing the lesion from the tissue. To remove the lesion, a user may staple the tissue around the outer edge of the lesion. If the lesion is highly infectious, it is important to cut the tissue in an area that does not contain the lesion to avoid spreading the infectious tissue. There is a need for a stapler instrument that includes both stapling and cutting characteristics that addresses this difficulty.

[0004] Surgical staplers often include a staple cartridge for housing a plurality of staples. The anvil defines a surface for forming staple legs as the staples are driven from the staple cartridge. The stapling operation may be effected by an actuator that acts on the staples and often involves pushing the actuator in a distal direction to drive the staples from the cartridge. In such configurations, problems arise when pushing the actuator due to a curve in the portion of the stapler that connects its proximal and distal ends, and a user may find it difficult to actuate the stapler if the stapler is rotated or angled from a longitudinally straight position.

[0005] Another difficulty is associated with removing a lesion from tissue by stapling the periphery of the lesion and excising the lesion from the tissue. To remove the lesion, a user may staple tissue around the lesion. When stapling, the user may need to clearly see the outer edge of the lesion; however, the user's view may be obstructed by the stapler if the distal end of the stapler is longitudinally rigid or fixed, preventing the instrument from curving out of the user's view. For example, during endoscopic surgery, the optics of the endoscope are often positioned directly adjacent to tissue, resulting in reduced awareness of the endoscope's position relative to the remainder of the body lumen or larger tumor. Summary of the Invention

[0006] Aspects of the present invention relate, among other things, to systems, devices and methods for fastening tissue. Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0007] According to one aspect, the tissue fastening device may include a handle assembly including at least two actuators. The tissue fastening device may also include a first body extending distally from the handle assembly and defining a longitudinal axis. The tissue fastening device may also include a fastener coupled to a distal end of the first body. The fastener may include a longitudinal body including a channel, a cartridge configured to include a plurality of fasteners, a longitudinal channel configured to receive an apparatus for cutting tissue, an anvil rotatable relative to the cartridge, and a fastener actuator. The fastener actuator may be coupled to one of the at least two actuators and configured to move proximally relative to the cartridge to deploy the plurality of fasteners from the cartridge.

[0008] In other aspects of the invention, the tissue fastening device may include one or more of the following features: The tissue fastening device may include a protrusion extending from a side of the fastening device and defining a lumen configured to receive a tissue harvesting tool. The fastening device may include a device for cutting tissue. The fastener actuator may be coupled to an actuation wire extending from the fastener actuator through the elongate body to the handle assembly, the actuation wire may be coupled to a first actuator of the at least two actuators. The fastener actuator may be configured to move proximally relative to the cartridge and the anvil when the first actuator is actuated. The distal portion of the first body may include a rigid curved portion such that a longitudinal axis of the fastening device is transverse to a longitudinal axis of the proximal portion of the first body. The anvil may include a first recess and the longitudinal body may include a second recess opposite the first recess, the first and second recesses may be configured to receive a tissue harvesting tool. The fastener actuator and the device for cutting tissue may be coupled to an actuation wire extending from the fastening device through the first body to a first actuator of the handle assembly, the first actuator being configured to move both the fastener actuator and the device for cutting tissue proximally. The fastening device may be rotatably coupled to the first body. The fastener actuator may include a ramp, the surface of the ramp that contacts the plurality of fasteners may have an angle of 30 degrees or less relative to a longitudinal axis of the longitudinal body. The fastening device may be fixedly coupled to the first body, the longitudinal axis of the fastening device may be transverse to the longitudinal axis of the first body.

[0009] In other aspects, the tissue fastening device may include a handle assembly including at least two actuators. The tissue fastening device may also include a first body extending distally from the handle assembly and defining a longitudinal axis. The tissue fastening device may further include a fastener coupled to a distal end of the first body. The fastener may include a longitudinal body including a channel. The fastening device may also include a cartridge including a plurality of fasteners. The fastening device may further include an anvil mounted adjacent to the cartridge. The tissue fastening device may also include a second body including a lumen. The first body may be disposed in the lumen, may be movable within the lumen, and extends from the lumen. The tissue fastening device may also include a coupler coupling a distal end of the second body to the fastening device. The fastener may be pivotable about the coupler when the first body is moved proximally or distally.

[0010] In other aspects of the invention, the tissue fastening device may further include one or more of the following features: The second body may define an opening in a sidewall of the second body through which the first body extends. The second body may include a recess configured to receive a portion of the first body when a longitudinal axis of the fastening device is parallel to a longitudinal axis of the second body. The handle assembly may include a first actuator configured to move longitudinally in the proximal and distal directions and a second actuator configured to rock relative to the body of the handle assembly.

[0011] In another aspect of the invention, a system may include a tissue fastener and a tissue harvesting tool movably coupled to the tissue fastener. The system may also include an oversheath including a distal end opening and at least two distal portions. The oversheath may be disposed about the tissue fastener and the tissue harvesting tool. The oversheath may be configured to move proximally and the at least two distal portions may be configured to move radially outward to expose the tissue fastener and the tissue harvesting tool.

[0012] In other aspects, the system may further include one or more of the following features: A longitudinal body including a channel and a guide projection. The guide projection may include a lumen configured to receive a tissue harvesting tool. The tissue fastening device may further include a cartridge including a plurality of fasteners and an anvil mounted adjacent to the cartridge. The tissue harvesting tool may be disposed within the lumen of the guide projection. The proximal portion of the oversheath may be disposed about the endoscope, which may include an image sensor and at least two working channels. The at least two distal portions may be biased radially inward and configured to partially surround the fastening device and the tissue harvesting tool.

[0013] 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. 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, serve to explain the principles of the invention. [Brief description of the drawings]

[0014] [Figure 1] 1 is a perspective view of an exemplary medical device according to an aspect of the present invention. [Diagram 2] 1 is a perspective view of an exemplary surgical system according to an aspect of the present invention. [Figure 3A] 1 is a perspective view of an exemplary medical device according to an aspect of the present invention, including components being inserted into the device by a user. [Figure 3B] 1 is a perspective view of a portion of an exemplary medical device according to an aspect of the present invention, with the part being inserted into the device by a user. [Figure 4A] 1 is a cross-sectional view of a portion of an exemplary medical device according to an aspect of the present invention. [Figure 4B] FIG. 2 is a side view of an exemplary actuation sled in accordance with an aspect of the present invention. [Figure 5A] 1 is a perspective view of an exemplary medical device according to an aspect of the present invention. [Figure 5B] 1 is a perspective view of an exemplary medical device according to an aspect of the present invention. [Figure 6A] 1 is a perspective view of an exemplary medical device according to an aspect of the present invention. [Figure 6B] 1 is a perspective view of an exemplary medical device according to an aspect of the present invention. [Figure 7A] 1 is a perspective view of an exemplary field of view of an exemplary endoscopic system in accordance with an aspect of the present invention. [Figure 7B] 1 is a perspective view of an exemplary field of view of an exemplary endoscopic system in accordance with an aspect of the present invention. [Figure 8] 1 is a perspective view of an exemplary surgical stapler system according to an aspect of the present invention. [Figure 9] 1 is a perspective view of an exemplary surgical stapler system according to an aspect of the present invention. [Figure 10A] 1 is a front view of an exemplary endoscopic oversheath in accordance with an aspect of the present invention. [Figure 10B] 1 is a side perspective view of an exemplary endoscopic oversheath in accordance with an aspect of the present invention; [Figure 11] 1 is a front view of an endoscopic system including an endoscope oversheath in accordance with an aspect of the present invention. [Figure 12] 1 is a front view of an endoscopic system including an endoscope oversheath in accordance with an aspect of the present invention. [Figure 13] 1 is a side perspective view of an exemplary endoscopic oversheath in accordance with an aspect of the present invention; [Figure 14] FIG. 2 is another side perspective view of an exemplary endoscope oversheath in accordance with an aspect of the present invention. [Figure 15] 1 is a side perspective view of an exemplary endoscopic system including an oversheath shown in cross section, in accordance with an aspect of the present invention. [Figure 16] 16 is a front view of the oversheath shown in FIG. 15 in accordance with an embodiment of the present invention. [Figure 17] 1 is a perspective view of a surgical system including an endoscope and an exemplary medical device, in accordance with an aspect of the present invention. [Figure 18] 18 is a perspective view of the medical device shown in FIG. 17, according to an embodiment of the present invention. [Figure 19] 18 is a side view of the medical device shown in FIG. 17, according to an embodiment of the present invention. [Figure 20]18 is a top view of the medical device shown in FIG. 17, according to an embodiment of the present invention. [Figure 21] 18 is a top view of the medical device shown in FIG. 17, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The present invention provides systems, devices and methods for joining, cutting and resecting tissue, among other aspects. Reference will now be made in detail to aspects of the invention, examples of which are illustrated in the accompanying drawings. Whenever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part of the device that is furthest from the user when the device is introduced into the patient. In contrast, the term "proximal" refers to the part of the device that is closest to the user when the device is placed within the patient. The term "joining tissue together" may refer, for example, to stapling, securing, attaching, fastening or otherwise joining two parts of tissue together. The term "fastener" may include staples, clips, rubber bands, sutures or any other fastener known in the art. As used herein, the terms "comprising / consisting of," "comprising / consisting of," or any other variation thereof, are intended to cover a non-exclusive inclusion such that a process, method, article or device that includes a list of elements does not necessarily include only those elements, but may also include other elements not expressly listed or inherent to such process, method, article or device. The term "exemplary" is used in the sense of "example" rather than "ideal."

[0016] Embodiments of the present invention may be used to visualize, cut, resect, and / or join together target tissue in an endo-luminal space, or facilitate the process. In particular, some embodiments combine a tissue resection device with a tissue stapling device. The tissue stapling device may include a cutting or cutting mechanism (e.g., an integrated knife) and a stapling mechanism (stapler). The stapling device may be delivered to the target tissue through an endoscope working channel to a target tissue site. The entire system may include a retraction mechanism, such as a tissue clip, to pull the tissue toward the tissue stapling device. All or a portion of the tissue stapling device and retraction mechanism may be metal, plastic, or may include shape memory metals (e.g., nitinol), shape memory polymers, polymers, or any combination of materials.

[0017] 1 illustrates a surgical device 100 according to an embodiment of the present invention. Device 100 is a surgical stapling device configured to engage body tissue, apply a plurality of surgical fasteners thereto, and form incisions in the fastened body tissue during a minimally invasive surgical procedure, such as a laparoscopic or endoscopic procedure. Although device 100 may be used to apply surgical clips or other fasteners, it will be discussed primarily in connection with applying staples from a staple cartridge disposed in the body of the device, e.g., as part of a loading unit.

[0018] As shown in FIG. 1, the device 100 includes a distal session 101 and a proximal session 102. The surgical device 100 also includes a handle assembly 103, an elongated body 104, and a stapler device 105. The elongated body 104 may extend to any length suitable for endoscopic or laparoscopic surgery and may be configured to be placed in a working channel of an endoscope. The elongated body 104 may be detachable from the handle assembly 103 to facilitate insertion of the elongated body 104 into a working channel of an endoscope or a channel of another device, for example, by backloading the body 104 into the working channel. In some examples, the elongated body may be flexible and / or rotatable about its axis. The elongated body 104 may include a lumen for placing an actuation wire therein for actuating the stapler device 105 via the handle assembly 103 or any other part of the device 100 that is actuated. The elongated body 104 can be configured to receive multiple actuation wires or a single actuation wire, such as actuation wire 118. In some instances, the elongated body 104 can be fixedly coupled to the stapler apparatus 105, and in other instances, the elongated body 104 can be removably or releasably coupled to the stapler apparatus 105.

[0019] The handle assembly 103 may include a handle 106 and a body 115. The handle 106 may include a fixed portion 107 and an actuator portion 108. The fixed portion 107 of the handle 106 may be fixedly coupled to the body 115 and the fixed portion 107 may include a circular or oval portion or a ring for placement of a user's finger therein, which may assist a user in holding the handle assembly 103. In some examples, the actuator portion 108 of the handle 106 may be an actuator that may be pivotally coupled to the body 115 and move relative to the fixed portion 107 of the handle 106. The actuator portion 108 may include a circular or oval portion for placement of a user's finger therein, which may assist in actuating the surgical device 100. In some examples, actuator portion 108 of handle 106 can be coupled to a proximal portion of an actuation wire, such as actuation wire 118, via adjustment coupler 116 and can be configured to actuate the anvil of stapler apparatus 105 via actuation wire 118 extending between stapler apparatus 105 and handle assembly 103. In other examples, actuator portion 108 of handle 106 can be configured to control any other mechanism of apparatus 100, such as actuation to deploy staples from stapler apparatus 105.

[0020] In some examples, the handle assembly 103 may include a movable cover 112 that is pivotally coupled to the housing 115 at a pivot point 112a. In FIG. 1, the cover 112 is shown in an open position, exposing an interior portion of the housing 115. The cover 112 may be coupled to a proximal portion of the housing 115 and may cover the interior components of the handle assembly 103 when positioned longitudinally parallel to the housing 115 with a distal-most end 112b of the cover 112 facing a surface 115b of the housing 115. The cover 112 may be temporarily and fixedly coupled in position over the interior components of the housing 115 via a coupling mechanism, such as a snap-lock mechanism, on a distal portion of the cover 112 and a distal portion of the handle assembly 103 to hold the cover 112 in place and prevent movement of the cover 112 relative to the housing 115. When held in place, the cover 112 may form a pair of slots in the housing 115 (not shown). Once the distal portion of cover 112 is uncoupled from the distal portion of the housing, a user may pivot (or swing) cover 112 about pivot point 112 a to access the internal components of handle assembly 103 .

[0021] The handle assembly 103 may further include a rotatable elongate connector 114 that may connect the elongate body 104 to the handle assembly 103. In some examples, the rotatable elongate connector 114 may rotate relative to the housing 115, either to clamp the elongate body 104 onto the handle assembly 103 to fixedly couple the elongate body 104 to the handle assembly 103, or to rotate the elongate body 104 off the handle assembly 103. Within the body 115, one or more adjustment couplers 116, 119 may be disposed in longitudinal alignment with or longitudinally parallel to the rotatable elongate connector 114 and may be configured to receive an actuation wire, such as a portion of the actuation wire 118. Any of the adjustment couplers 116, 119 may be movable to clamp the actuation wire and may be a vice that fixedly couples the actuation wire to the adjustment coupler 116, 119. In some examples, the adjustment couplers 116,119 may be movable via a screw to adjust the couplers 116,119 and couple or uncouple the actuation wires to the couplers 116,119.

[0022] The adjustment coupler 119 may be coupled to the longitudinal actuator 110 and may be longitudinally movable by the longitudinal actuator 110 moving within the housing 115. The longitudinal actuator 110 may be partially disposed within the housing 115 and longitudinally slidable within two slots formed when the cover 112 is disposed over the internal components of the handle assembly 103. The longitudinal actuator 110 may include a pair of opposing circular or elliptical portions or rings, each circular portion defining an aperture for a user to place their finger therein. In some examples, the longitudinal actuator 110 may be coupled to an actuation wire (not shown), for example, via the adjustment coupler 119 or via a different coupler within the housing 115, and may be configured to control the deployment of staples from the stapler device 105. In other examples, the longitudinal actuator 110 may be configured to control the actuation of any other mechanism of the device 100, for example, the anvil of the stapler device 105.

[0023] The distal section 101 of the device 100 includes a stapler device 105 coupled to a distal portion of an elongated body 104. A connector 125 of the stapler device 105 can couple the elongated body 104 to the stapler device 105. In some examples, the connector 125 can be offset from a longitudinal axis of a body 121 of the stapler device 105. The body 121 of the stapler device 105 can include a cartridge 122 disposed within a channel of the body 121. The cartridge 122 can be fixedly coupled to the body 121 or can be removable from the body 121. In some examples, the cartridge 122 can be integrally formed with the body 121. At a proximal portion of the body 121, an anvil 120 can be rotatably or pivotally coupled to the body 121 by a pivot 120a and can extend distally toward a distal end of the stapler device 105. In some examples, the anvil 120 can be rotatable and biased in an open configuration, i.e., the anvil 120 can be biased away from the body 121 and cartridge 122 to create a space between a distal portion of the anvil 120 and a distal portion of the body 121 and cartridge 122. The anvil 120 can be rotatable about axis 120a to contact the body 121 or can clamp tissue between the anvil 120 and body 121 to provide a surface against which the staples can be driven as they are removed from the cartridge 122.

[0024] In some examples, the body 121 may include a channel that supports the cartridge 122. The cartridge 122 may include a plurality of surgical fasteners, such as staples. The fasteners may be deployed from the cartridge 122 when under the influence of a driving force applied by an actuation sled, such as actuation sled 341 shown in FIG. 3A. A plurality of spaced apart longitudinal slots 123 in the cartridge 122 allow the staples to pass through the cartridge 122 and perforate tissue. In some examples, the actuation sled, when actuated, moves longitudinally proximally from a distal end of the cartridge 122 and / or body 121 and contacts the fasteners in the cartridge 122 and pushes the fasteners through the longitudinal slots 123 to attach the fasteners to the tissue. In some examples, a single fastener may extend through each slot 123. Each fastener may be partially within the slot 123 prior to deployment to aid in alignment of the fasteners with the slots 123. In some instances, two actuation sleds 341, 380 may be required to actuate two different longitudinal rows of fasteners in the cartridge 122 (shown in FIG. 3A).

[0025] The cartridge 122 may also include an elongated longitudinal slot 124. The elongated longitudinal slot 124 may be configured to receive and / or support a resection tool, such as a knife blade (not shown). The elongated longitudinal slot 124 may be disposed on a side of the cartridge 122 and may extend longitudinally from a proximal end to a distal end of the cartridge 122. In some examples, each of the spaced longitudinal slots 123 may be disposed on one side of the elongated longitudinal slot 124. The anvil 120 may include a longitudinally disposed groove (not shown). The groove may be longitudinally disposed to align with the elongated longitudinal slot 124 when the anvil 120 is in a closed position (i.e., the anvil 120 is rotated such that a distal portion of the anvil 120 contacts the body 121 and / or the cartridge 122, or tissue is sandwiched between the anvil 120 and the body 121). Such a groove may be configured to receive a resection tool, such as a knife or other sharp cutting tool, within the elongated longitudinal slot 124. The cutting tool may be driven from the actuation wire that moved the actuation sled via an additional separate actuation wire, or may be driven via the same actuation wire as the actuation sled to move both the actuation sled and the cutting tool simultaneously.

[0026] A user may use the device 100 to fasten one or more fasteners to tissue by first placing tissue within the working area of ​​the stapler device 105, i.e., between the body 121 and the anvil 120. Once the tissue is placed within the working area of ​​the stapler device 105, the user may actuate the actuator portion 108 of the handle 106. The actuation wire may then be moved proximally and the anvil 120 may be caused to close onto the tissue placed within the working area of ​​the stapler device. While the user holds the actuator portion 108 in an engaged position, thus maintaining the staples of the stapler device on the tissue, the user may pull (or actuate) the longitudinal actuator 110 proximally to move the actuation wire coupled to the actuation sled in the stapler device. As the actuation sled is moved proximally via the actuation wire coupled to the longitudinal actuator 110, a ramp of the actuation sled may engage the fasteners in the cartridge 122 and push the fasteners through the longitudinal slots 123 to pierce the tissue. As the fasteners are deployed by the actuation sled, the fasteners may subsequently engage the anvil 120 and join the layers of tissue together. In some examples, the longitudinal actuator 110 may actuate an actuation wire coupled to both the actuation sled and the cutting tool to simultaneously move both the actuation sled and the cutting tool to pierce and fasten the tissue with one or more fasteners and cut the tissue.

[0027] In some examples, a user may backload the elongated body 104 through the distal end of the working channel of the endoscope, through the body of the endoscope, and out the proximal end of the endoscope before coupling the elongated body 104 to the handle assembly 103. Once the elongated body 104 is positioned within the working channel of the endoscope with the stapler device 105 at the distal end of the endoscope, a user may couple the handle assembly 103 to the elongated body 104 by inserting the proximal end of the elongated body 104 into the rotatable elongated connector 114 and then rotating the rotatable elongated connector 114 to secure the elongated body 104 to the handle assembly 103. A user may then couple the proximal ends of the actuation wires (e.g., actuation wire 118) disposed within the elongated body to the adjustment couplers 116, 119. Once elongate body 104 is coupled to handle assembly 103 and actuation wires (e.g., actuation wire 118) are coupled to adjustment couplers 116, 119, a user may close movable cover 112 such that distal-most end 112b of cover 112 faces surface 115b of housing 115. To hold cover 112 in place during use of device 100, cover 112 may be temporarily fixedly coupled in position over internal components of housing 115 via a coupling mechanism on a distal portion of cover 112 and a distal portion of handle assembly 103, e.g., a snap-lock mechanism.

[0028] 2 illustrates a distal section of an endoscope 250 according to an embodiment of the present invention, a tissue harvesting tool 252 disposed within a working channel 256 of the endoscope 250, and a surgical device 200 disposed within another working channel 257 of the endoscope 250. The surgical device 200 is generally similar to the surgical device 100 and includes a stapler device 201 with a longitudinal slot 223 for fastener placement, an elongated longitudinal slot 224 for receiving a knife, and an anvil 220. A cartridge 225 is integrally formed in a body 222 of the stapler device 201. A user may use the tissue harvesting tool 252 in combination with a stapler device, such as the stapler device 201, to facilitate grasping and placing tissue between an actuator portion of the stapler device 201, i.e., the body 222 and the anvil 220 for stapling. The tissue harvesting tool 252 may include an elongate body 253 extending longitudinally at a distal portion 254. In some examples, the distal portion 254 of the tissue harvesting tool 252 may include a pair of rotatable jaws 256, 257 movable between a closed configuration and an open configuration. A user may actuate the jaws 256, 257 using an actuator (not shown) present at a proximal portion of the tissue harvesting tool 252 to open and close the jaws 256, 257 to facilitate grasping and releasing tissue. A user may place the tissue harvesting tool 252 in a working channel 256, shown in FIG. 2, separate from the working channel 257 in which the surgical device 200 is disposed. In other examples, a user may place the tissue harvesting tool 252 in the same working channel as the surgical device 200 (not shown) to facilitate disposition of tissue between the anvil 220 and the body 222.

[0029] 3A illustrates a distal portion of an embodiment of a surgical device 300 including a stapler device 301 configured to receive a removable cartridge 323. When the removable cartridge 323 is removed from the body 321, the actuation sled 341 and knife 342 may become visible (as shown in FIG. 3A). In some examples, when the cartridge 323 is disposed within a channel 327 of the body 321, the actuation sled 341 and knife 342 may be received within the cartridge 323 and may not be visible. In other examples, the actuation sled 341 and knife 342 may be received within the cartridge 323 and may become visible when the cartridge 323 is disposed within the body 321, for example, by extending out of a channel in the cartridge 323. The actuation sled 341 and knife 342 may be coupled to a single actuation wire that extends to a proximal portion of the surgical device 300 such that when actuated, the actuation sled 341 and knife 342 move proximally in unison. In other examples, the actuation sled 341 and knife 342 may be coupled to separate actuation wires that extend from a proximal portion of either the actuation sled 341 or knife 342 to a proximal portion of the surgical device 300, such as the handle assembly 103, such that either the actuation sled 341 or knife 342 may be independently actuated. The actuation sled 341 may be configured to be moved proximally to push fasteners, such as staples in the cartridge 323, out of slots 345 in the cartridge to secure tissue together. The actuation sled 341 and knife 342 may be pushed into a pocket at the distal end of the cartridge 323 by a user when the cartridge 323 is first positioned within the body 321.

[0030] The actuation sled 341 may include a ramp 346 configured to directly or indirectly engage staples or other fasteners through the slots 345 from within the cartridge 323 to deploy the fasteners to join tissue. In some instances, the ramp 346 may be angled at 45 degrees, 40 degrees, 35 degrees, 30 degrees, 25 degrees, or any other angle relative to the longitudinal axis of the body 321. The ramp 346 may be at a shallow angle to require the actuation sled 341 to move proximally a greater distance to deploy the fasteners in the cartridge 323. By providing an actuation sled 341 with a long ramp 346 at a shallow angle, a user may simultaneously engage multiple fasteners when pulling the actuation sled 341 proximally, thus allowing multiple staples to simultaneously deploy and perforate tissue, in some instances. Additionally, a shallow angled ramp 346, for example, at an angle of approximately 30 degrees or less, can prevent intermittent forces from being applied to the actuator in the handle assembly due to the actuation sled 341 successively engaging the fasteners in the cartridge 323 and disengaging from the fastener before engaging the next fastener, thus allowing a more continuous force to be applied to the actuator and preventing errors during surgery. In some examples, the ramp 346 of the actuation sled 341 can simultaneously engage two, three, four or more fasteners in the cartridge 323. Because the actuation sled 341 is pulled proximally to deploy the fastener, the user can create a higher load when pulling the flexible wire, for example, the actuation wire 118 shown in FIG. 1, compared to a pulling mechanism to deploy the fastener. The actuation body 343 can extend proximally from a proximal portion of the ramp 346, and the actuation sled 341 can be pulled from the actuation body 343 to deploy the fastener. For example, the actuation body 343 can be coupled to an actuation wire that extends to a proximal portion of the surgical device 300. In some examples, the device 300 can include two actuation sleds 341 and two actuation bodies 343 coupled to the same actuation wire to engage and deploy two separate rows of fasteners in the cartridge 323.

[0031] Knife 342 may have a similar structure to actuation sled 341 and may include a hook-like distal portion 344 that includes a sharp edge for cutting tissue. Knife 342 may be configured to move longitudinally within an elongated longitudinal slot of cartridge 323. In some examples, a portion of knife 342 extends within a groove in anvil 320, such as groove 370 shown in FIG. 3B, and moves longitudinally within the groove from the distal end to the proximal end of anvil 320 when a user actuates knife 342, thus moving knife 342 longitudinally across cartridge 323 to cut tissue.

[0032] 3B illustrates a distal portion of an alternative embodiment of a surgical device 355 including a stapler device 356 configured to receive a removable cartridge 363. In the stapler device 356, a body 361 includes a distal end with a distal front surface 362 that encloses the cartridge 363 within the body 361 and exposes only a top portion of the cartridge 363, i.e., a portion of the cartridge 363 that faces a bottom surface of the anvil 360. The distal front surface 362 prevents the distal end of the cartridge 363, or in some instances the actuation sled and / or knife, from contacting tissue when the stapler device 356 is moved. The anvil 360 includes a groove 370 in a surface that faces the cartridge 363 that is configured to receive a knife when the anvil 360 is in a closed position.

[0033] 4A illustrates an enlarged cross-sectional view of an exemplary stapler apparatus 401 including a body 421, an anvil 420, a cartridge 423 with fasteners 445, and an actuation sled 441 with an actuation body 443. The stapler apparatus 401 in FIG. 4A is shown deploying fasteners 445 on tissue 449. The actuation sled 441 engages pistons or spacers 451, which in turn engage fasteners 445 to deploy fasteners 445. As shown in FIG. 4A, the actuation sled 441 engages pistons or spacers 451 as the actuation sled 441 moves in a proximal direction P. Each piston or spacer 451 may be configured to move within the cartridge 423 and may be sized to engage only one fastener. In other examples, each piston or spacer 451 can be sized to engage multiple fasteners, or one or more pistons or spacers 451 can be sized to engage multiple fasteners while one or more other pistons or spacers 451 can be sized to engage only one fastener. The actuation sled 441 can be configured to move each piston or spacer 451 laterally relative to the longitudinal axis of the body 421. For example, the actuation sled 441 and actuation body 443 can be pulled proximally via an actuation wire, which can move the ramp 442 (shown in FIG. 4B ) into contact with one or more pistons or spacers 451 and push the one or more pistons or spacers 451 to deploy the one or more fasteners 445 from the cartridge 423. Each of the pistons or spacers 451 can have an upper surface that is aligned and / or flush with a portion of each respective fastener 445. For example, each fastener 445 can be a staple and can include three generally flat portions, with a middle generally flat portion that aligns with the top surface of each spacer 451. Each piston or spacer 451 can be sufficiently stiff to move uniformly upward when the ramped portion 442 of the actuation sled engages a corner of the piston or spacer 451.In some examples, each piston or spacer 451 can be coupled to the cartridge 423 to allow movement in a direction perpendicular to the longitudinal axis of the cartridge 423 while preventing movement along the longitudinal axis of the cartridge 423 or in the proximal P or distal D directions as shown in FIG. 4A. The piston or spacer 451 in the cartridge 423 can prevent the fasteners 445, e.g., staples, from being partially deployed and can avoid improper stapling caused by the distal portion of the staple moving upward when the proximal portion of the staple does not move. By providing a spacer 451 with a flat upper surface that aligns with the fasteners 445, the ramped portion 442 of the actuation sled 441 can move proximally by engaging the spacers and can push the fasteners 445 uniformly upward.

[0034] FIG. 4B shows an exemplary actuation sled 441 including a sloped portion 442, a width 475, a height 477, and an actuation body 443. The sloped portion 442 can include a first proximal session 444 and a second distal session 446. In some examples, the first proximal session 444 can have a slope angle 473 different from the slope angle 471 of the second distal session 446. For example, the first proximal session 446 can have a slope angle of 30 degrees, and the second distal session can have a slope angle of 20 degrees. The different slopes of the sloped portion 442 allow the actuation sled 441 to press the spacer 451 with different pressure levels when moving proximally. In other examples, the first proximal session 446 and the second distal session 446 can have the same slope angles 471, 473, or any other angle between 0 and 90 degrees. In some examples, the actuation sled 441 can have a length 475 of .50 inches and a height of .215 inches. The actuation body 443 can extend from the bottom of the ramp portion 442 and in some examples can also extend the length 475 of the actuation sled 441. In some examples, the actuation body can be a stainless steel wire with a diameter of .008 inches.

[0035] 4B illustrates a partial cross-sectional view of an exemplary actuation sled 441, a portion of anvil 420 including a recess 450 on a surface of the anvil facing cartridge 423, a portion of cartridge 423, fastener 445, and tissue 449 disposed between cartridge 423 and anvil 420. When actuation sled 441 is actuated, such as by being pulled proximally from its proximal end 443 via an actuation mechanism, such as an actuator in handle assembly 103, ramp 442 engages fastener 445 and moves the fastener toward tissue 449 to pierce tissue 449 as actuation sled 441 moves in a proximal direction. In another example, a pin can be disposed between fastener 445 and actuation sled 441, and ramp 442 can engage the pin instead of fastener 445, which urges fastener 445 toward tissue 449. As fastener 445 is moved through tissue 449 via engagement with actuation sled 441 , portions of fastener 445 may be forced toward each other via engagement with recesses 450 and cause the fastener to latch onto tissue 449 .

[0036] FIG. 5A illustrates an exemplary stapler device 501 angled relative to and radially displaced from a longitudinal axis 560 of an endoscope 550. An elongate body 555 can include a distal end exposed from the endoscope, which can be biased in a curved orientation (as shown in FIG. 5A) such that the longitudinal axis 561 of the stapler device 501 intersects with the longitudinal axis 560 of the endoscope 550 within which a portion of the elongate body 555 is disposed. In some examples, the angle formed between the longitudinal axis 561 of the stapler device 501 and the longitudinal axis 560 of the endoscope 550 can be 15 degrees, 30 degrees, 45 degrees, 60 degrees, or any other angle. Alternatively, the distal end of the body 555 can include links or other structures that render the distal end in the rigid or generally rigid configuration illustrated in FIG. 5A. FIG. 5B illustrates an alternative view of the stapler device 501. The elongated body 555 of the stapler device 501 is rotated 90 degrees to position the stapler device 501 such that the elongated body 555 is angled such that the longitudinal axis 561 of the stapler device 501 is away from the longitudinal axis 560 of the endoscope 550. Axis 562 indicates an axis perpendicular to the longitudinal axis 560. By having the elongated body 555 rigidly curved or otherwise biased to be curved to angle the longitudinal axis 561 of the stapler device 501 relative to the longitudinal axis 560 of the endoscope 550, the user's workspace can be modified to allow for greater visualization, such as, for example, visualization through a camera located at the distal end of the endoscope 550. Other benefits of angling the stapler device 501 relative to the longitudinal axis of the endoscope 550 can include facilitating alignment with a tissue harvesting tool and aiding in placing tissue between the anvil and the body of the stapler device 501. In some examples, the elongated body 555 can be articulated to angle and radially offset the stapler apparatus 501. The body can be articulated via an articulation link that is actuated at the proximal end of the endoscope 550.

[0037] 6A and 6B show examples of a centerline 660 of the field of view of the camera at the distal end of the endoscope 650. In FIG. 6A, the longitudinal axis 661 of the stapler device 601 is parallel to the centerline 660, and thus the stapler device 601 is located to one side of the field of view. FIG. 6B shows the stapler device 601 angled relative to the centerline 660 of the camera's field of view. In FIG. 6B, by pushing the stapler device 601 distally and articulating the elongated body attached thereto, the longitudinal axis 661 intersects the centerline 660 and places the distal portion of the stapler device 601 directly within the center of the field of view of the camera of the endoscope 650.

[0038] 7A and 7B show the camera view at the distal end of the endoscope where a stapler device 701 and tissue harvesting tool 754 are used to manipulate and join tissue 770. Because stapler device 701 is angled relative to the longitudinal axis of the endoscope, the view includes a view of the space between the anvil and the body of stapler device 701, facilitating placement of tissue 770 between the anvil and body for stapling.

[0039] 8 shows an example of an alternative embodiment of a stapler device 801 including a guide protrusion 840. The guide protrusion 840 may include a lumen 842 configured to receive a tissue harvesting tool 844. The tissue harvesting tool 844 may be positioned within the lumen 842 of the guide protrusion 840 prior to inserting the endoscope 843 into the patient's body. The tool 844 and the stapler device 801 may be backloaded into one or more lumens of the endoscope 843. Pre-aligning the tissue harvesting tool 844 within the lumen 842 of the guide protrusion may facilitate positioning the tissue harvesting tool 844 within the space 846 between the anvil and body of the stapler device 801 (i.e., the working area of ​​the stapler device) and may guide the tissue harvesting tool 844 toward the stapler device 801 as it is moved. The lumen 842 may be curved or otherwise angled toward the stapler device 801 to bend the tissue harvesting tool 844 toward the stapler device 801. For example, the plane of the distal end opening of lumen 842 can be angled to face the working area of ​​the stapler apparatus. Guide protrusion 840 can extend radially away from a portion of stapler apparatus 801 that is proximal to the anvil or space 846 of stapler apparatus 801. Guide protrusion 840 can be fixed to stapler apparatus 801. In some examples, guide protrusion 840 can be rigid or semi-rigid. Guide protrusion 840 can include a lumen 842 that includes a central longitudinal axis spaced from the longitudinal axis of stapler apparatus 801.

[0040] 9 illustrates an exemplary embodiment of a stapler apparatus 901 including an anvil 920, a body 922, a recess 946 in the anvil 920, and a recess 947 in the body 922. The recesses 946, 947 may be disposed on radially inwardly facing surfaces of the anvil 920 and the body 922, respectively, opposite one another and may form a lumen between the anvil 920 and the body 922 when the anvil 920 and the body 922 are in a closed position in which the lumen transverses a longitudinal axis of the stapler apparatus 901. The tissue harvesting tool 944 may be disposed within the lumen recess 946, 947 when the stapler apparatus 901 is in the closed position such that a distal end of the tissue harvesting tool 944 is moved into the space between the anvil 920 and the body 922 when the elongated body 943 of the tissue harvesting tool 944 is moved proximally. Pre-positioning the tissue harvesting tool 944 within the space between the anvil 920 and the body 922 or within the actuator portion of the stapler device 901 may allow a user to more easily position the distal end of the tissue harvesting tool 944 and tissue within the actuator portion of the stapler device 901. The tissue harvesting tool 944 may be pre-loaded into the lumen formed by the recesses 946, 947 prior to insertion into the patient's body.

[0041] 10A and 10B show front and side perspective views of an exemplary multi-lumen oversheath 1050 including a shaft 1051, a distal portion 1053, and lumens 1052, 1054, and 1056. The oversheath 1050 may provide a user with an endoscope including a tissue harvesting tool, a stapling device, and a steerable visualization tool, such as a camera. FIG. 11 shows a front view of the oversheath 1050 with an endoscope 1140 disposed within the lumen 1052. Since the endoscope 1140 includes a single working channel 1142, the oversheath 1050 provides the user with a total of three working channels, namely lumens 1054, 1056, and working channel 1142. FIG. 12 shows another exemplary embodiment of an oversheath 1250 including two lumens 1252, 1254 with an endoscope 1240 disposed within the lumen 1252. Because the endoscope 1240 includes a working channel 1242, the oversheath 1250 provides an additional working channel (i.e., lumen 1254) for use by a user. Each of the oversheaths 1050 and 1250 may extend along the entire length of the endoscope 1140, 1240. In other examples, the oversheaths 1050, 1250 may extend along only a portion of the endoscope 1140, 1240. For example, FIGS. 13 and 14 show alternative embodiments of the oversheaths 1350, 1450 with lumens 1352, 1354, 1356, 1452, 1456. The oversheaths 1350, 1450 extend along only a portion of the distal end of the endoscope on which they are disposed, such as the distal end of the endoscope 1340 or endoscope 1440 shown in FIGS. 13 and 14. Placing either the stapler device or tissue harvesting tool within the lumen of the oversheath can move the device or tool further radially away from the center of view of the camera at the distal end of the endoscope, providing a less obstructed view of the target tissue the user is attempting to locate in the stapler's operating area.

[0042] In some instances, an oversheath may be used to protect the patient's tissue from undesired contact with devices at the distal end of the endoscope while the endoscope is moved through the patient's body. FIG. 15 shows an exemplary oversheath 1552 positioned over an endoscope 1540. Extending distally from the distal end of the endoscope 1540 are a stapler device 1501 and a tissue harvesting tool 1543, similar to the devices shown in FIG. 8, although any tool may be used with the oversheath 1552. The oversheath 1552 may be positioned over the stapler device 1501 and the tissue harvesting tool 1543 and may prevent the stapler device 1501 and the tissue harvesting tool 1543 from contacting tissue and / or moving radially outward from the longitudinal axis of the endoscope 1540 as the endoscope 1540 is moved through the patient's body. An opening 1570 at the distal end of the over-sheath 1552 may provide a user with the ability to see in front of the endoscope 1540 while the endoscope 1540 and over-sheath 1552 are moved through the patient's body. The opening 1570 may include one or more proximally extending slots 1570a (four are shown in FIG. 16 ). The distal portions 1555, 1556 of the over-sheath 1552 may be movable and flexible to expand and contract the opening 1570. An exemplary expanded state of the opening 1570 is shown as opening 1571, with dotted lines 1557, 1558 representing the distal portions 1555, 1556 after being moved radially outward. The distal portions 1555, 1556 may be moved radially outward to form an expanded state to allow a user to access a target area with the stapler device 1501 and tissue harvesting tool 1543. To aid in radially outward movement of the distal portions 1555, 1556, the oversheath 1552 can include tearable longitudinal slits 1567. For example, the tearable slits 1567 can extend proximally from each of the slots 1570a a sufficient distance to allow separation of the portions 1555, 1556 (e.g., to the distal face of the endoscope 1540).In other examples, the distal portions 1555, 1556 can be movable to allow a user to pull the over-sheath 1550 proximally and position the stapler device 1501 and the tissue harvesting tool 1543 within the target area. As shown in FIG. 16 , the over-sheath 1550 can include four distal portions 1555, 1556, 1565, 1566 that can be movable. In some examples, each of the distal portions 1555, 1556, 1565, 1566 of the over-sheath 1550 can be configured to move proximally or distally relative to the endoscope 1540 to allow a user to uncover or cover the stapler device 1501 and the tissue harvesting tool 1543. In some examples, the distal portions 1555, 1556, 1565, 1566 may move radially outward to expand the opening 1570 to allow the harvesting tool 1543 and the stapler device 1501 to pass through the opening 1570. For example, the distal portions 1555, 1556, 1565, 1566 may move radially outward upon contact of the stapler device 1501 and / or the harvesting tool 1543 as the over-sheath 1552 is moved proximally. In some examples, the over-sheath 1550 may be transparent / see-through so that a user can see through the over-sheath 1550 as the endoscope 1540 moves through the patient's body.

[0043] 17 illustrates an exemplary medical device 1700 including a stapler device 1701, an elongate body 1704, an elongate rod 1770 including a lumen 1772, and a rotatable connector 1780. The stapler device 1701 and the elongate body 1704 can include any of the properties and characteristics discussed above. The rod 1770 can be rigid and can be manufactured from polyether ether ketone (PEEK) or other suitable materials. The elongate body 1704 can be a non-compressible member, such as a Bowden cable, and can include a lumen (not shown) for receiving an actuation wire and other components of the stapler device 1701. The lumen 1772 of the rod 1770 can extend longitudinally from a proximal end to a distal end of the rod 1770. In some examples, the lumen 1772 can be configured to receive the elongate body 1704 and allow the elongate body to move proximally and distally through the lumen 1772. The body 1704 can extend out of the lumen 1772 through an opening 1779 in a sidewall of the rod 1770. The rotatable connector 1780 can couple the stapler apparatus 1701 to the rod 1770 and can be disposed between a proximal end and a distal end of the stapler apparatus 1701. In some examples, the rotatable connector 1780 allows the stapler apparatus 1701 to pivot relative to the rod 1770 such that the stapler apparatus 1701 can move between a position in which the longitudinal axis of the stapler apparatus 1701 is parallel to the longitudinal axis of the rod 1770 and a position in which the longitudinal axis of the stapler apparatus 1701 is transverse to the longitudinal axis of the rod 1770. In an embodiment, the rotatable connector 1780 can be pivoted such that the angle between the longitudinal axes is greater than zero degrees and as much as 180 degrees, and the longitudinal axis of the stapler device 1701 is parallel to the longitudinal axis of the rod 1770. Figures 18-21 show various views of the medical device 1700 with the stapler device 1701 rotated at various angles relative to the rod 1770.18 and 19, the lumen opening 1779 can be oval and elongated in the longitudinal direction of the rod 1770 to allow a smooth transition of the elongated body 1704 into and out of the rod 1770 and minimize friction between the lumen opening 1779 and the elongated body 1704 as the elongated body 1704 moves through the lumen opening 1779. A user can rock the stapler device 1701 by pulling or pushing the elongated body 1704 (to move the elongated body 1704 proximally or distally), which in turn pushes or pulls the stapler device 1701 to rotate the stapler device 1701 about the rotatable connector 1780. In some embodiments, the rotatable connector 1780 can include a pin extending through the device at the distal end of the rod 1770 and a flange extending from the stapler device 1701. The stapler device 1701 can include a pair of flanges extending from a portion of its body that includes an aperture for the pin, and the rod 1770 can include a device extending from a distal end of the rod 1770 that includes an aperture configured to align with the aperture of the pair of flanges, and the pin can be positioned with the aperture of the pair of flanges and the aperture of the device extending from the distal end of the rod 1770 to form a rotatable connector 1780.

[0044] Each of the aforementioned devices and apparatus may be used to visualize, join, and / or cut tissue. In some examples, a user may load the elongate body of a stapler device into the working channel of an endoscope by backfeeding the elongate body through the distal end working channel of the endoscope to place a portion of the elongate body in the working channel. Once the elongate body is placed in the working channel, a handle assembly may be coupled to the proximal end of the elongate body. The user may then introduce the endoscope into the patient's body and move the endoscope towards the target area. The user may use the endoscope to locate a target area (e.g., a tumor or other diseased tissue) present in a body lumen of a subject by directly visualizing the target area using an image sensor. Once the user has placed the distal end of the endoscope proximate to the target area, the user may place a tissue harvesting tool into the working channel of the endoscope if such a tool is not already present. In some instances, if a user places an oversheath over the endoscope prior to insertion of the endoscope into the patient's body, the user can move the oversheath proximally to expose the stapler device to the target area and / or peel back portions of the oversheath to expose the stapler device. Once the distal end of the endoscope is positioned at the target area, the user can actuate the stapler device to an open position, creating a space between the anvil and body of the stapler. The user can then introduce a tissue harvesting tool to the target area and position the tissue harvesting tool between or near the actuator portions of the stapler device, for example, in the space between the anvil and body of the stapler device. The user can then grasp tissue with the tissue harvesting tool and move the tissue into the actuator portions of the stapler device. Once the tissue is positioned within the actuator portions of the stapler device, the user can move the anvil and body of the stapler device to a closed position and clamp the grasped tissue with the stapler device. The user can then actuate the actuator to pull the actuation wire, thus moving the actuation sled of the stapler device proximally.By moving the actuation sled proximally via the actuator, the user can place fasteners within the clamped tissue and against the anvil of the stapler apparatus. In some instances, the user can actuate a knife in the stapler apparatus to sever a portion of the target tissue either before or after fastening the tissue together via the fasteners.

[0045] By providing a stapler instrument that includes a flexible body, while still being able to effectively staple tissue, a user may be able to increase visualization of the target tissue and prevent undesirable stapling errors, such as stapling within an area of ​​infected tissue. The increased visualization from an easy-to-operate, flexible stapler may also help ensure that much or all of the target lesion is removed.

[0046] It will be apparent to those skilled in the art that various modifications and variations in the disclosed apparatus and methods can be made 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 features disclosed herein. It is intended that the specification and examples be considered as exemplary only.

Claims

1. a handle assembly including at least two actuators; a first body extending distally from the handle assembly and defining a longitudinal axis and a lumen; a fastening device coupled to a distal end of the first body, the fastening device comprising: a longitudinal body including a channel; a cartridge configured to contain a plurality of fasteners; a longitudinal channel configured to receive an instrument for cutting tissue; an anvil rotatable relative to the cartridge; a fastener actuator coupled to one of the at least two actuators and configured to move proximally relative to the cartridge to deploy the plurality of fasteners from the cartridge; Equipped with a second body, the fastening device coupled to a distal end of the second body, the second body disposed in, movable within, and extending from the lumen; 1. A tissue fastening device, wherein in a first configuration, a distal portion of the second body is at a first angle relative to the longitudinal axis of the first body, and in a second configuration, the distal portion of the second body is at a second angle relative to the longitudinal axis of the first body.

2. The device of claim 1 , wherein the fastening device includes a protrusion extending from a side of the fastening device and defining a lumen configured to receive a tissue harvesting tool.

3. The device of claim 1 or 2, wherein the fastening device comprises a device for cutting tissue.

4. 4. The device of claim 1, wherein the fastener actuator is coupled to an actuation wire extending from the fastener actuator through the second body to the handle assembly, the actuation wire being coupled to one of the at least two actuators, and the fastener actuator is configured to move proximally relative to the cartridge and the anvil when the one actuator is actuated.

5. The device of any one of claims 1 to 4, wherein a distal portion of the second body includes a curved portion such that a longitudinal axis of the fastening device is transverse to a longitudinal axis of a proximal portion of the second body.

6. The anvil includes a first recess, and the longitudinal body corresponds to the first recess.

6. The device of claim 1, further comprising a second recess facing the first recess, the first and second recesses being configured to receive a tissue harvesting tool.

7. 4. The device of claim 3, wherein the fastener actuator and the device for cutting tissue are coupled to an actuation wire that extends from the fastening device through the second body to a first actuator of the handle assembly, the first actuator configured to proximally move both the fastener actuator and the device for cutting tissue.

8. The apparatus of any one of claims 1 to 7, wherein the fastening device is rotatably coupled to the first body.

9. 9. The apparatus of claim 1, wherein the fastener actuator includes a ramp, the surface of the ramp that contacts a piston or spacer to deploy the plurality of fasteners having an angle of 30 degrees or less with respect to a longitudinal axis of the longitudinal body.

10. The device of any one of claims 1 to 9, wherein the fastening device is fixedly coupled to the second body.

11. 11. The device of claim 1, further comprising a coupler coupling a distal end of the first body to the fastening device, the fastening device being pivotable about the coupler when the second body is moved proximally or distally.

12. The device of claim 1 , wherein the first body defines an opening in a sidewall thereof through which the second body extends.

13. The device of claim 1 , wherein the first body includes a recess configured to receive a portion of the second body when the longitudinal axis of the fastening device is parallel to a longitudinal axis of the first body.

14. 14. The device of any one of claims 1 to 13, wherein the handle assembly includes a first actuator configured to move longitudinally in proximal and distal directions, and a second actuator configured to oscillate relative to a body of the handle assembly.

15. The apparatus of claim 11 , wherein the coupler is disposed proximal to the plurality of fasteners.

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