Systems, devices and related methods for fastening tissue

Abstract

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

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 812,538, filed on March 1, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Various aspects of the present disclosure generally relate to tissue fastening, including visualization, retraction, and joining of tissues. More specifically, at least some embodiments of the present disclosure relate to systems, devices, and related methods for suturing tissues, among other things. Background Art

[0004] Technological developments have enabled users of medical systems, devices, and methods to perform increasingly complex procedures on subjects. For example, tissue joining in the gastrointestinal tract of a subject is a procedure that can present difficulties. Surgical devices that grasp or clamp tissue between opposing jaw structures and then join the tissue with surgical fasteners are known. Fasteners include surgical staples. In some procedures, cutting instruments are provided to cut tissue that has been joined by fasteners. However, problems can arise when suturing and cutting tissue to remove tumor tissue from a patient.

[0005] One such difficulty involves removing lesions from tissue. To remove lesions, the user may suture the tissue around the outer edge of the lesion. When the lesion is highly contagious, it is important to cut the tissue in an area that does not include the lesion to avoid spreading the infectious tissue. A stapler tool that includes both suturing and cutting features is needed to address this difficulty.

[0006] Surgical staplers usually include a staple barrel to accommodate a plurality of staples. An anvil defines a surface for forming the legs of the staples when the staples in the staple barrel are driven. The suturing operation can be achieved by an actuator acting on the staples, which usually involves pushing the actuator in a distal direction to drive the staples in the staple barrel. For this configuration, problems may arise when the actuator is pushed due to the bending of some portions of the staples connecting the proximal and distal ends, so the user may find it difficult to actuate the staples when the staples are rotated or angled from a longitudinal straight position.

[0007] Another difficulty relates to removing a lesion from tissue by suturing the periphery of the lesion and cutting the lesion from the tissue. To remove the lesion, the user may first suturing the tissue surrounding the lesion. While suturing, the user may need to clearly see the outer edge of the lesion, but if the distal end of the staples is longitudinally rigid or fixed, thereby preventing the instrument from bending and moving out of the user's field of view, the user's field of view may be obscured by the staples. For example, during endoscopic surgery, the optics of the endoscope are often positioned in close proximity to the tissue, making it difficult to identify the position of the endoscope relative to the rest of the body cavity or a larger tumor. Summary of the invention

[0008] Some aspects of the present disclosure relate to systems, devices, and methods for fastening tissue, etc. Aspects disclosed herein may include one or more features described in conjunction with any other disclosed aspect.

[0009] According to one aspect, the tissue fastening device may include a handle assembly with at least two actuators. The tissue fastening device may also include a first body extending distally from the handle assembly and defining a longitudinal axis. The tissue fastening device may also include a fastening device connected to the distal end of the first body. The fastening device may include a longitudinal body with a passage, a barrel configured to have a plurality of fasteners, a longitudinal passage configured to receive a device for cutting tissue, an anvil rotatable relative to the barrel, and a fastener actuator. The fastener actuator may be connected to an actuator in the at least two actuators and configured to move proximally relative to the barrel to deploy a plurality of fasteners in the barrel.

[0010] In other aspects of the present disclosure, 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 surface of the fastening device, which defines a cavity configured to receive a tissue acquisition tool. The fastening device may include a device for cutting tissue. The fastener actuator may be connected to an actuation line extending from the fastener actuator through the elongated body to the handle assembly, and the actuation line may be connected to a first actuator of at least two actuators. The fastener actuator may be configured to move proximally relative to the barrel and the anvil when the first actuator is actuated. The distal portion of the first body may include a rigid curved portion so that the longitudinal axis of the fastening device is transverse to the longitudinal axis of the proximal portion of the first body. The anvil may include a first recess, the longitudinal body may include a second recess opposite to the first recess, and the first recess and the second recess may be configured to receive a tissue acquisition tool. The fastener actuator and the device for cutting tissue can be connected to an actuation line of the first actuator extending from the fastening device through the first body to the handle assembly, and the first actuator can be configured to move both the fastener actuator and the device for cutting tissue proximally. The fastening device can be rotatably connected to the first body. The fastener actuator can include a ramp, and the surface of the ramp contacting the plurality of fasteners can have an angle of 30 degrees or less relative to the longitudinal axis of the longitudinal body. The fastening device can be fixedly connected to the first body, and the longitudinal axis of the fastening device can be transverse to the longitudinal axis of the first body.

[0011] In other aspects, the tissue fastening device may include a handle assembly having at least two actuators. The tissue fastening device may also include a first body extending distally from the handle assembly and defining a longitudinal axis. The tissue fastening device may also include a fastening device connected to the distal end of the first body. The fastening device may include a longitudinal body having a passage. The fastening device may also include a cylinder having a plurality of fasteners. The fastening device may also include an anvil installed adjacent to the cylinder. The tissue fastening device may also include a second body having a cavity. The first body may be positioned in the cavity, may move within the cavity and extend from the cavity. The tissue fastening device may also include a connector connecting the distal end of the second body to the fastening device. When the first body moves proximally and / or distally, the fastening device may pivot around the connector.

[0012] In other aspects of the present disclosure, the tissue fastening device may also include one or more of the following features. The second body may define an opening in a side wall 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 the longitudinal axis of the fastening device is parallel to the longitudinal axis of the second body. The handle assembly may include a first actuator configured to move longitudinally in a proximal and distal direction and a second actuator configured to pivot relative to the body of the handle assembly.

[0013] In other aspects of the present disclosure, a system may include a tissue fastening device and a tissue acquisition tool movably connected to the tissue fastening device. The system may also include an outer sheath including a distal opening and at least two distal portions. The outer sheath may be positioned around the tissue fastening device and the tissue acquisition tool. The outer sheath may be configured to move proximally and the at least two distal portions may be configured to move radially outward to expose the tissue fastening device and the tissue acquisition tool.

[0014] In other aspects, the system may also include one or more of the following features. The longitudinal body includes a channel and a guide protrusion. The guide protrusion may include a cavity configured to receive a tissue acquisition tool. The tissue fastening device may also include a barrel having a plurality of fasteners, and an anvil mounted adjacent to the barrel. The tissue acquisition tool may be positioned within the cavity of the guide protrusion. The proximal portion of the outer sheath may be positioned around the endoscope, and the endoscope may include an image sensor and at least two working channels. At least two distal portions may be radially biased inwardly and configured to partially surround the fastening device and the tissue acquisition tool.

[0015] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0017] Figure 1 is a perspective view of an exemplary medical device according to some aspects of the present disclosure.

[0018] Figure 2 is a perspective view of an exemplary surgical system according to some aspects of the present disclosure.

[0019] Figure 3A is a perspective view of an exemplary medical device according to some aspects of the present disclosure, including components inserted into the device by a user.

[0020] Figure 3B is a perspective view of a portion of an exemplary medical device according to some aspects of the present disclosure, with components inserted into the device by a user.

[0021] Figure 4A is a cross-sectional view of a portion of an exemplary medical device according to some aspects of the present disclosure.

[0022] Figure 4B is a side view of an exemplary actuation sled according to some aspects of the present disclosure.

[0023] Figure 5A and 5B is a perspective view of an exemplary medical device according to some aspects of the present disclosure.

[0024] Fig. 6A and 6B is a perspective view of an exemplary medical device according to some aspects of the present disclosure.

[0025] Fig. 7A and 7B is a perspective view of an exemplary field of view of an exemplary endoscope system according to some aspects of the present disclosure.

[0026] Figure 8 is a perspective view of an exemplary surgical stapler system according to some aspects of the present disclosure.

[0027] Fig. 9 is a perspective view of an exemplary surgical stapler system according to some aspects of the present disclosure.

[0028] Fig. 10A is a front view of an exemplary endoscope outer sheath according to some aspects of the present disclosure.

[0029] Fig. 10B is a perspective side view of an exemplary endoscope outer sheath according to some aspects of the present disclosure.

[0030] Fig.11 is a front view of an endoscope system including an endoscope outer sheath according to some aspects of the present disclosure.

[0031] Fig.12is a front view of an endoscope system including an endoscope outer sheath according to some aspects of the present disclosure.

[0032] Fig.13 is a perspective side view of an exemplary endoscope outer sheath according to some aspects of the present disclosure.

[0033] Fig.14 is another perspective side view of an exemplary endoscope outer sheath according to aspects of the present disclosure.

[0034] Fig.15 is a perspective side view of an exemplary endoscope system including an outer sheath shown in cross-section according to aspects of the present disclosure.

[0035] Fig.16 According to some aspects of the present disclosure, Fig.15 Front view of the outer sheath shown in .

[0036] Fig.17 is a perspective view of a surgical system including an endoscope and an exemplary medical device according to some aspects of the present disclosure.

[0037] Fig.18 According to some aspects of the present disclosure, Fig.17 A perspective view of the medical device shown in FIG.

[0038] Fig.19 According to some aspects of the present disclosure, Fig.17 Side view of the medical device shown in .

[0039] Fig. 20 and 21 According to some aspects of the present disclosure, Fig.17 A top view of the medical device shown in FIG. DETAILED DESCRIPTION

[0040] The present disclosure relates to systems, devices and methods for joining, cutting and removing tissues, etc. Reference will now be made in detail to some aspects of the present disclosure, examples of which are shown in the accompanying drawings. Where possible, the same or similar reference numerals will be used throughout the accompanying drawings to refer to the same or similar parts. The term "distal" refers to the part farthest from the user when the device is introduced into the patient's body. In contrast, the term "proximal" refers to the part closest to the user when the device is placed in the patient's body. The term "joining tissues together" may refer to, for example, suturing, fixing, attaching, fastening or otherwise combining two parts of the tissue together. The term "fastener" may include staples, clips, elastic bands, sutures or any other fasteners known in the art. As used herein, the term "comprising", "including" or any other variation thereof is intended to cover non-exclusive contents, so that the process, method, article or device including a series of elements does not necessarily include only those elements, but may include other elements that are not explicitly listed or inherent to such processes, methods, articles or devices. The term "example" is used in the sense of "example", not "ideal".

[0041] Embodiments of the present disclosure can be used for visualization, cutting, excision and / or linking together of target tissue in the intracavitary space, or promote the process thereof. In particular, some embodiments combine a tissue excision device with a tissue suturing device. The tissue suturing device may include an excision or cutting mechanism (e.g., an integrated knife) and a suturing mechanism (suturing device). The suturing device can be delivered to the target tissue through an endoscopic working channel to the target tissue site. The entire system may include a retraction mechanism, such as a tissue clamp, to pull the tissue toward the tissue suturing device. All or some parts of the tissue suturing device and the retraction mechanism may be metal, plastic, or include any combination of shape memory metals (e.g., nitinol), shape memory polymers, polymers, or materials.

[0042] Figure 1 A surgical device 100 is shown in accordance with an embodiment of the present disclosure. Device 100 is a surgical stapling device configured to engage body tissue, apply a plurality of surgical fasteners thereto, and form an incision in the fastened body tissue during minimally invasive surgery (e.g., laparoscopic or endoscopic surgery). Device 100 can be used to apply surgical clips or other fasteners, but is primarily discussed in the context of applying staples from a staple cartridge positioned in a portion of the device body (e.g., a loading unit).

[0043] like Figure 1As shown, the device 100 includes a distal portion 101 and a proximal portion 102. The surgical device 100 also includes a handle assembly 103, an elongated body 104, and a stapler device 105. The elongated body 104 can extend any length suitable for endoscopic or laparoscopic surgery, and can be configured to be positioned in the working channel of the endoscope. The elongated body 104 can be separated from the handle assembly 103 so that the elongated body 104 is inserted into the working channel of the endoscope or the channel of another device, for example, by reversely mounting the elongated body 104 in the working channel. In some examples, the elongated body can be flexible and / or rotatable around its axis. The elongated body 104 can include a cavity for positioning an actuation line therein to actuate the stapler device 105 or any other part of the device 100 via the handle assembly 103. The elongated body 104 can be configured to receive multiple actuation lines or a single actuation line (e.g., actuation line 118). In some examples, elongate body 104 may be fixedly coupled to stapler device 105 , while in other examples, elongate body 104 may be removably or releasably coupled to stapler device 105 .

[0044] Handle assembly 103 may include handle 106 and body 115. Handle 106 may include fixed portion 107 and actuator portion 108. Fixed portion 107 of handle 106 may be fixedly coupled to body 115, and fixed portion 107 may include a circular or oval portion or ring for positioning a user's fingers therein, which may help the user hold handle assembly 103. In some examples, movable portion 108 of handle 106 may be an actuator that is pivotally coupled to body 115 and movable relative to fixed portion 107 of handle 106. Movable portion 108 may include a circular or oval portion for positioning a user's fingers therein, which may help actuate surgical device 100. In some examples, the movable portion 108 of the handle 106 can be coupled to a proximal portion of an actuation line (e.g., actuation line 118) via an adjustable coupling 116 and can be configured to actuate an anvil of the stapler device 105 via the actuation line 118 extending between the stapler device 105 and the handle assembly 103. In other examples, the movable portion 108 of the handle 106 can be configured to control any other mechanism of the device 100, such as actuation of deploying staples from the stapler device 105.

[0045] In some examples, the handle assembly 103 may include a removable cover 112 pivotally coupled to the housing 115 at a pivot point 112a. Figure 11, the cover 112 is shown in an open position, exposing the interior portion of the housing 115. The cover 112 can be coupled to the proximal portion of the housing 115 and can cover the internal components of the handle assembly 103 when positioned longitudinally parallel to the housing 115, so that the distal-most end 112b of the cover 112 faces the surface 115b of the housing 115. The cover 112 can be temporarily fixedly coupled to the position covering the internal components of the housing 115 via a coupling mechanism (e.g., a snap-lock mechanism) at the distal portion of the cover 112 and the distal portion of the handle assembly 103 to hold the cover 112 in place and prevent the cover 112 from moving relative to the housing 115. When held in place, the cover 112 can form a pair of slots (not shown) in the housing 115. When the distal portion of the cover 112 is separated from the distal portion of the housing, the user can rotate (or pivot) the cover 112 at the pivot point 112a to access the internal components of the handle assembly 103.

[0046] The handle assembly 103 may also include a rotatable elongated connector 114 that can connect the elongated body 104 to the handle assembly 103. In some examples, the rotatable elongated connector 114 can be rotated relative to the housing 115 to fasten to the elongated body 104 to fixedly couple the elongated body 104 to the handle assembly 103, or rotated to release the elongated body 104 from the handle assembly 103. Within the body 115, one or more adjustable connectors 116, 119 can be positioned longitudinally aligned or longitudinally parallel to the rotatable elongated connector 114 and can be configured to receive a portion of an actuation line (e.g., an actuation line 118). Any of the adjustable connectors 116, 119 can be a movable vise to clamp the actuation line and fixedly couple the actuation line to the adjustable connectors 116, 119. In some examples, the adjustable connectors 116 , 119 may be moved via screws to adjust the connectors 116 , 119 and to connect or disconnect the actuation wires to or from the connectors 116 , 119 .

[0047] The adjustable connector 119 can be connected to the longitudinal actuator 110 and can be moved longitudinally in the housing 115 via the translation longitudinal actuator 110. The longitudinal actuator 110 can be partially positioned in the housing 115 and can slide longitudinally in two narrow slots formed when the cover 112 is positioned on the internal components of the handle assembly 103. The longitudinal actuator 110 may include a pair of opposite circular or oval portions or rings, wherein each circular portion defines a hole for the user to position their fingers therein. In some examples, the longitudinal actuator 110 can be connected to an actuation line (not shown), such as via the adjustable connector 119 or via different connectors in the housing 115, and can be configured to control the deployment of staples from the stapler device 105. In other examples, the longitudinal actuator 110 can be configured to control any other mechanism of the device 100, such as the actuation of the anvil of the stapler device 105.

[0048] The distal portion 101 of the device 100 includes a stapler device 105 connected to the distal portion of the elongated body 104. The connector 125 of the stapler device 105 can connect the elongated body 104 to the stapler device 105. In some examples, the connector 125 can deviate from the longitudinal axis of the main body 121 of the stapler device 105. The main body 121 of the stapler device 105 may include a barrel 122 positioned in a channel of the main body 121. The barrel 122 can be fixedly connected to the main body 121 or can be removed from the main body 121. In some examples, the barrel 122 can be integrally formed in the main body 121. At the proximal portion of the main body 121, the anvil 120 can be rotatably or pivotally connected to the main body 121 at the pivot 120a and can extend distally toward the distal end of the stapler device 105. In some examples, the anvil 120 is rotatably biased and can be biased to an open configuration, i.e., biased away from the body 121 and the barrel 122, thereby creating a space between the distal portion of the anvil 120 and the distal portions of the body 121 and the barrel 122. The anvil 120 can be rotated about the axis 120a to contact the body 121, or to clamp tissue between the anvil 120 and the body 121, and to provide a surface that can be used to drive the staples when the staples are ejected from the barrel 122.

[0049] In some examples, the body 121 may include a channel that supports the cartridge 122. The cartridge 122 may contain a plurality of surgical fasteners, such as staples, and the fasteners may be actuated by a sled (e.g., Figure 3A The actuation sled 341 shown in the figure can be deployed from the barrel 122 under the influence of a driving force applied by the actuation sled 341 shown in the figure. A plurality of spaced longitudinal slots 123 in the barrel 122 allow the staples to pass through the barrel 122 and pierce the tissue. In some examples, the actuation sled moves proximally in the longitudinal direction from the distal end of the barrel 122 and / or the body 121 when actuated, contacts the fasteners in the barrel 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 located in the slot 123 before deployment to help align the fastener with the slot 123. In some examples, two actuation sleds 341, 380 may be needed to align two different longitudinal rows of fasteners ( Figure 3A ) actuation.

[0050] The barrel 122 may also include an elongated longitudinal slot 124. The elongated longitudinal slot 124 may be configured to receive and / or support a cutting tool, such as a blade (not shown). The elongated longitudinal slot 124 may be positioned on one side of the barrel 122 and may extend longitudinally from the proximal end of the barrel 122 to the distal end. In some examples, each of the spaced longitudinal slots 123 may be positioned on one side of the elongated longitudinal slot 124. The anvil 120 may include a longitudinally positioned recess (not shown) that may be aligned with the elongated longitudinal slot 124 when the anvil 120 is in a closed position (i.e., the anvil 120 rotates so that the distal portion of the anvil 120 is in contact with the body 121 and / or the barrel 122, or the tissue is clamped between the anvil 120 and the body 121), and the recess may be configured to receive a cutting tool such as a knife or other sharp cutting tool in the elongated longitudinal slot 124. The cutting tool may be actuated via an additional, separate actuation wire that is different from the actuation wire that translates the actuation sled, or may be actuated via the same actuation wire as the actuation sled to simultaneously translate both the actuation sled and the cutting tool.

[0051] By first positioning tissue in the action zone of stapler device 105 or between main body 121 and anvil 120, the user can use device 100 to link one or more fasteners to tissue.Once tissue is positioned in the action zone of stapler device 105, the user can actuate the actuator portion 108 of handle 106, and then this can cause anvil 120 to be closed to the tissue positioned in the action zone of stapler device to translate the actuation line to the proximal side.When the user is held in the engagement position by actuator portion 108, thus keeping the stapler device fastened on tissue, the user can pull (or actuate) longitudinal actuator 110 to the proximal side to translate the actuation line linked with the actuation slide in the stapler device.When the actuation slide is translated to the proximal side via the actuation line linked to the longitudinal actuator 110, the inclined surface of the actuation slide can engage the fastener in the barrel 122 and push the fastener through the longitudinal slot 123 to pierce tissue. When the fasteners are deployed by the actuation sled, the fasteners can then engage the anvil 120 and join the multiple layers of tissue together. In some examples, the longitudinal actuator 110 can actuate an actuation wire that is connected to both the actuation sled and the cutting tool, and can simultaneously translate both the actuation sled and the cutting tool, thereby not only piercing and fastening the tissue with one or more fasteners, but also cutting the tissue.

[0052] In some examples, the user may reverse the elongated body 104 through the distal end of the endoscope's working channel, 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 endoscope's working channel with the stapler device 105 at the distal end of the endoscope, the 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. The user may then couple the proximal end of an actuation wire (e.g., actuation wire 118) located within the elongated body to the adjustable connectors 116, 119. Once the elongated body 104 is coupled to the handle assembly 103 and the actuation wire (e.g., actuation wire 118) is coupled to the adjustable connectors 116, 119, the user can close the movable cover 112 so that the distal-most end 112b of the cover 112 faces the surface 115b of the housing 115. The cover 112 can be temporarily fixedly coupled to the position of the internal components covering the housing 115 via a coupling mechanism (e.g., a snap-lock mechanism) at the distal portion of the cover 112 and the distal portion of the handle assembly 103 to maintain the cover 112 in place during use of the device 100.

[0053] Figure 2 The distal portion of an endoscope 250 according to an embodiment of the present disclosure is shown, a tissue acquisition tool 252 is positioned in a working channel 256 of the endoscope 250, and a surgical device 200 is positioned in another working channel 257 of the endoscope 250. The surgical device 200 is substantially similar to the surgical device 100 and includes a stapler device 201 having a longitudinal slot 223 for fastener deployment, an elongated longitudinal slot 224 for receiving a knife, and an anvil 220. The barrel 225 is integrally formed in the body 222 of the stapler device 201. The user can use the tissue acquisition tool 252 in conjunction with the stapler device (e.g., the stapler device 201) to grasp tissue and position the tissue in the active portion of the stapler device 201 (i.e., between the body 222 and the anvil 220) for suturing. The tissue acquisition tool 252 may include an elongated body 253 extending longitudinally to a distal portion 254. In some examples, the distal portion 254 of the tissue acquisition tool 252 may include a pair of rotatable jaws 256, 257 that can be moved between a closed configuration and an open configuration. The user can use an actuator present at the proximal portion of the tissue acquisition tool 252 (not shown) to actuate the jaws 256, 257 to open and close the jaws 256, 257 to facilitate grasping and releasing tissue. The user can position the tissue acquisition tool 252 in a working channel 256 separate from the working channel 257 in which the surgical device 200 is located, such as Figure 2In other examples, a user may position tissue harvesting tool 252 in the same working channel as surgical device 200 (not shown) in order to position tissue between anvil 220 and body 222 .

[0054] Figure 3A The distal portion of one embodiment of a surgical device 300 including a stapler device 301 is shown, and the stapler device 301 is configured to receive a removable cartridge 323. When the removable cartridge 323 is removed from the body 321, the actuation slide 341 and the knife 342 are visible (eg, Figure 3A 327 of the body 321). In some examples, the actuation sled 341 and the knife 342 can be received in the barrel 323 and not visible when the barrel 323 is positioned in the channel 327 of the body 321. In other examples, the actuation sled 341 and the knife 342 can be housed in the barrel 323 and can be visible when the barrel 323 is positioned in the body 321, such as by extending from the channel of the barrel 323. The actuation sled 341 and the knife 342 can be connected to a single actuation line extending to the proximal portion of the surgical device 300, so that when actuated, the actuation sled 341 and the knife 342 move proximally in unison. In other examples, the actuation sled 341 and the knife 342 can be connected to separate actuation lines extending from the proximal portion of the actuation sled 341 or the knife 342 to the proximal portion of the surgical device 300 (e.g., to the handle assembly 103), so that the actuation sled 341 or the knife 342 can be independently actuated. The actuation sled 341 can be configured to translate proximally to push fasteners such as staples in the barrel 323 out of the barrel's slots 345 to fasten tissues together. When the barrel 323 is first positioned in the body 321, the actuation sled 341 and the knife 342 can be pressed into the distal pocket of the barrel 323 by the user.

[0055] The actuation sled 341 may include a ramp 346 configured to engage staples or other fasteners from within the barrel 323 directly or indirectly through the slot 345 to deploy the fasteners to join tissue. In some examples, the ramp 346 may be 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 341 may be at a shallow angle so as to require the actuation sled 341 to translate a longer distance proximally to deploy the fasteners in the barrel 323. By providing an actuation sled 341 with a shallow angle, long ramp 341, a user may engage multiple fasteners simultaneously when pulling the actuation sled 341 proximally, thereby allowing multiple staples to be deployed and pierce tissue simultaneously in some examples. In addition, the small angle (e.g., about 30 degrees or less) bevel 346 can prevent intermittent force from being applied to the actuator in the handle assembly by continuously engaging the fasteners in the barrel 323 due to the actuation sled 341 being released from the fastener before engaging the next fastener, thereby preventing errors during the surgical procedure by providing a more continuous force to the actuator. In some examples, the bevel 346 of the actuation sled 341 can simultaneously engage two, three, four, or more fasteners in the barrel 323. Since the actuation sled 341 is pulled proximally to deploy the fasteners, pulling the flexible wire (e.g., a push mechanism) is more convenient than deploying the fasteners. Figure 1 346) when the user generates a higher load. The actuation body 343 can extend proximally from the proximal portion of the ramp 346, so that the actuation sled 341 can be pulled from the actuation body 343 to deploy the fasteners. For example, the actuation body 343 can be connected to an actuation wire extending to the proximal portion of the surgical device 300. In some examples, the device 300 can include two actuation sleds 341 and two actuation bodies 343, which are connected to the same actuation wire to engage and deploy two separate rows of fasteners in the barrel 323.

[0056] The knife 342 may have a structure similar to the actuation sled 341 and may include a hook-shaped distal portion 344 including a sharp edge for cutting tissue. The knife 342 may be configured to travel longitudinally within the elongated longitudinal slot of the barrel 323. In some examples, a portion of the knife 342 extends into a recess of the anvil 320, such as Figure 3B 370 shown in the anvil 320 and travels longitudinally within the recess from the distal end to the proximal end of the anvil 320 when the user actuates the knife 342, thereby causing the knife 342 to translate longitudinally across the barrel 323 to cut tissue.

[0057] Figure 3BThe distal portion of an alternative embodiment of a surgical device 355 is shown, which includes a stapler device 356 configured to receive a removable barrel 363. In the stapler device 356, a body 361 includes a distal end having a distal front end face 362, which encloses the barrel 363 within the body 361, exposing only the top of the barrel 363 or the portion of the barrel 363 opposite to the bottom surface of the anvil 360. The distal front end face 362 prevents the distal end of the barrel 363, or in some examples, the actuating slide and / or knife, from contacting tissue when the stapler device 356 is moved. The anvil 360 includes a recess 370 in the surface opposite to the barrel 363, which is configured to receive the knife when the anvil 360 is in the closed position.

[0058] Figure 4A An enlarged cross-sectional view of an exemplary stapler device 401 is shown, which includes a body 421 , an anvil 420 , a barrel 423 having a fastener 445 , and an actuation sled 441 having an actuation body 443 . Figure 4A The stapler device 401 in FIG. 4 is shown deploying a fastener 445 onto tissue 449. The actuation sled 441 engages a piston or spacer 451, which then engages the fastener 445 to deploy the fastener 445. Figure 4A As shown, when the actuation sled 441 moves in the proximal direction P, the actuation sled 441 engages the piston or spacer 451. Each piston or spacer 451 may be configured to translate within the barrel 423 and may be sized to engage only one fastener. In other examples, the size of each piston or spacer 451 may be designed to engage multiple fasteners, or the size of one or more pistons or spacers 451 may be designed to engage multiple fasteners, while the size of one or more other pistons or spacers 451 may be designed to engage only one fastener. The actuation sled 441 may be configured to move each piston or spacer 451 in a direction transverse to the longitudinal axis of the body 421. For example, the actuation sled 441 and the actuation body 443 may be pulled proximally via the actuation wire, which may move the ramp 442 ( Figure 4B 451) to bring it into contact with one or more pistons or spacers 451 and push one or more pistons or spacers 451 to deploy one or more fasteners 445 in the barrel 423. Each of the pistons or spacers 451 may have an upper surface that is aligned and / or flush with a portion of each corresponding fastener 445. For example, each fastener 445 may be a staple and may include three substantially flat portions, wherein the middle substantially flat portion is aligned with the top surface of each spacer 451. Each piston or spacer 451 may have sufficient rigidity to move upward in unison when the ramp 442 of the actuating sled engages the corner of the piston or spacer 451. In some examples, each piston or spacer 451 may be coupled to the barrel 423 so that it is aligned along the longitudinal axis of the barrel 423 or along the Figure 4AMovement in the proximal P or distal D directions shown in the figure is blocked, but movement in a direction perpendicular to the longitudinal axis of the barrel 423 is allowed. The piston or spacer 451 in the barrel 423 can prevent the fastener 445 (e.g., staple) from being partially deployed and can avoid improper suturing caused by the distal portion of the staple moving upward when the proximal portion of the staple has not moved. By providing a spacer 451 with a flat top surface aligned with the fastener 445, the inclined surface 442 of the actuating slide 441 can move proximally and push each fastener 445 upward in unison by engaging each spacer.

[0059] Figure 4B An exemplary actuation sled 441 is shown, including a ramp 442, a width 475, a height 477, and an actuation body 443. The ramp 442 may include a first proximal portion 444 and a second distal portion 446. In some examples, the inclination angle 473 of the first proximal portion 444 may be different from the inclination angle 471 of the second distal portion 446. For example, the first proximal portion 446 may have an inclination angle of 30 degrees, while the second distal portion may have an inclination angle of 20 degrees. By changing the slope of the ramp 442, the actuation sled 441 may push the spacer 451 at different pressure levels when moving proximally. In other examples, the first proximal portion 446 and the second distal portion 446 may have the same inclination angle 471, 473, or they may have any other angle between 0 degrees and 90 degrees. In some examples, the actuation sled 441 may have a length 475 of 0.50 inches and a height of 0.215 inches. The actuation body 443 can extend from the bottom of the ramp 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 0.008 inch diameter stainless steel wire.

[0060] Figure 4B A partial cross-sectional view of an exemplary actuation sled 441, a portion of anvil 420 (including a recess 450 in the surface of the anvil facing barrel 423), a portion of barrel 423, a fastener 445, and tissue 449 positioned between barrel 423 and anvil 420 is shown. When actuation sled 441 is actuated, such as by being pulled proximally from its proximal end 443 via an actuation mechanism (e.g., an actuator in handle assembly 103), ramp 442 will engage fastener 445 as actuation sled 441 moves in a proximal direction and translates the fastener toward tissue 449 to pierce tissue 449. In other examples, a pin may be positioned between fastener 445 and actuation sled 441, and ramp 442 may engage the pin instead of fastener 445, with the pin pushing fastener 445 toward tissue 449. As fastener 445 translates through tissue 449 via engagement with actuation sled 441 , portions of fastener 445 may be urged toward each other via engagement with recesses 450 , thereby causing the fastener to latch onto tissue 449 .

[0061] Figure 5A An exemplary stapler device 501 is shown at an angle relative to and radially offset from the longitudinal axis 560 of the endoscope 550. The elongated body 555 may include a distal end that emerges from the endoscope and may be biased into a curved orientation ( Figure 5A 550) such that the longitudinal axis 561 of the stapler device 501 intersects the longitudinal axis 560 of the endoscope 550, and a portion of the elongated body 555 is positioned in the endoscope 550. 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 may be fifteen degrees, thirty degrees, forty-five degrees, sixty degrees, or any other angle. Alternatively, the distal end of the body 555 may include a connecting rod or a distal end that is positioned at a Figure 5A Other structures of the rigid or substantially rigid configuration shown. Figure 5B An alternative view of the stapler device 501 is shown, wherein the elongated body 555 has been rotated ninety degrees to position the stapler device 501 so that the longitudinal axis 561 of the stapler device 501 is angled with the longitudinal axis 560 of the endoscope 550. Axis 562 shows an axis perpendicular to the longitudinal axis 560. By having an elongated body 555, which is rigidly bent or otherwise biased to bend so that the longitudinal axis 561 of the stapler device 501 is angled relative to the longitudinal axis 560 of the endoscope 550, the user's workspace can be changed to allow better visualization, such as visualization by a camera located at the distal end of the endoscope 550. Other benefits of the stapler device 501 being tilted relative to the longitudinal axis of the endoscope 550 may include facilitating alignment with a tissue acquisition tool and helping to position tissue between the anvil and the body of the stapler device 501. In some examples, the elongated body 555 may be hinged to tilt and radially offset the stapler device 501. The body may be articulated via an articulation link activated at the proximal end of the endoscope 550 .

[0062] Fig. 6A and 6B An example of a centerline 660 of the camera field of view at the distal end of an endoscope 650 is shown. Fig. 6A In the figure, the longitudinal axis 661 of the stapler device 601 is parallel to the centerline 660, so the stapler device 601 is located on one side of the field of view. Figure 6B The stapler device 601 is shown angled relative to the centerline 660 of the camera field of view. Figure 6B , by pushing the stapler device 601 distally and articulating the elongated body attached thereto, the longitudinal axis 661 intersects the centerline 660 and positions the distal portion of the stapler device 601 directly within the center of the camera field of view of the endoscope 650.

[0063] Fig. 7A and 7BThe field of view of the camera at the distal end of the endoscope is shown, where the stapler device 701 and tissue acquisition tool 754 are used to manipulate and join tissue 770. Because the stapler device 701 is angled relative to the longitudinal axis of the endoscope, the field of view includes a view of the space between the anvil and the body of the stapler device 701, which helps position the tissue 770 between the anvil and the body for suturing.

[0064] Figure 8 An example of an alternative embodiment of a stapler device 801 including a guide protrusion 840 is shown. The guide protrusion 840 may include a cavity 842 configured to receive a tissue acquisition tool 844. Before the endoscope 843 is inserted into the patient's body, the tissue acquisition tool 844 may be positioned in the cavity 842 of the guide protrusion 840. The tool 844 and the stapler device 801 may be reversed into one or more cavities of the endoscope 843. Pre-aligning the tissue acquisition tool 844 in the cavity 842 of the guide protrusion may help position the tissue acquisition tool 844 in the space 846 between the anvil and the body of the stapler device 801 (i.e., the action zone of the stapler device), and may guide the tissue acquisition tool 844 toward the stapler device 801 during translation. The cavity 842 may be curved or otherwise tilted toward the stapler device 801 to bend the tissue acquisition tool 844 toward the stapler device 801. For example, the plane of the distal opening of the cavity 842 may be tilted to face the action zone of the stapler device. The guide projection 840 may extend radially away from the stapler device 801 near a portion of the anvil or space 846 of the stapler device 801. The guide projection 840 may be fixed to the stapler device 801. In some examples, the guide projection 840 may be rigid or may be semi-rigid. The guide projection 840 may include a cavity 842 including a central longitudinal axis spaced apart from the longitudinal axis of the stapler device 801.

[0065] Fig. 9An exemplary embodiment of a stapler device 901 is shown that includes 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 can be located on radially inwardly facing surfaces of the anvil 920 and the body 922, respectively, opposite each other and can form a cavity between the anvil 920 and the body 922 when the anvil 920 and the body 922 are in a closed position, which cavity crosses the longitudinal axis of the stapler device 901. When the stapler device 901 is in the closed position, the tissue acquisition tool 944 can be positioned within the cavity recesses 946, 947 so that when the elongated body 943 of the tissue acquisition tool 944 is translated proximally, the distal end of the tissue acquisition tool 944 moves into the space between the anvil 920 and the body 922. Pre-positioning the tissue acquisition tool 944 within the space between the anvil 920 and the body 922, or within the active portion of the stapler device 901, can allow a user to more easily position the distal end of the tissue acquisition tool 944 and position tissue within the active portion of the stapler device 901. The tissue acquisition tool 944 can be pre-loaded into the cavity formed by the recesses 946, 947 prior to insertion into the patient.

[0066] Fig. 10A and 10B Shown are front and side perspective views of an exemplary multi-lumen outer sheath 1050 including a shaft 1051, a distal portion 1053, lumens 1052, 1054, and 1056. The outer sheath 1050 can provide a user with tools for utilizing tissue harvesting tools, stapler devices, and steerable visualization tools such as an endoscope including a camera. Fig.11 A front view of outer sheath 1050 is shown with endoscope 1140 positioned within lumen 1052. Because endoscope 1140 includes a single working channel 1142, outer sheath 1050 provides a total of three working channels, namely, lumens 1054, 1056, and working channel 1142, to the user. Fig.12 Another exemplary embodiment of an outer sheath 1250 is shown including two lumens 1252, 1254, wherein an endoscope 1240 is positioned within lumen 1252. Because endoscope 1240 includes working channel 1242, outer sheath 1250 provides an additional working channel (i.e., lumen 1254) for use by the user. Each of outer sheaths 1050 and 1250 may extend along the entire length of endoscopes 1140, 1240. In other examples, outer sheaths 1050, 1250 may extend along only a portion of endoscopes 1140, 1240. For example, Fig.13 and 14 An alternative embodiment of an outer sheath 1350, 1450 is shown having lumens 1352, 1354, 1356, 1452, 1456. The outer sheaths 1350, 1450 extend along only a portion of the distal end of the endoscope over which they are positioned, e.g. Fig.13 and 14 The distal end of endoscope 1340 or endoscope 1440 is shown. Positioning the stapler device or tissue harvesting tool within the lumen of the outer sheath allows the device or tool to be moved radially further away from the center of the field of view of the camera at the distal end of the endoscope and provides the user with a less obstructed view of the target tissue as the user attempts to position the target tissue in the stapler's active zone.

[0067] In some examples, the outer sheath may be used to protect patient tissue from unwanted contact with devices at the distal end of the endoscope as the endoscope is advanced through the patient's body. Fig.15 An exemplary outer sheath 1552 is shown positioned over the endoscope 1540. Extending distally from the distal end of the endoscope 1540 is a stapler device 1501 and a tissue harvesting tool 1543, much like Figure 8 , although any tool may be used with outer sheath 1552. Outer sheath 1552 is positioned over stapler device 1501 and tissue acquisition tool 1543 and may prevent stapler device 1501 and tissue acquisition tool 1543 from contacting tissue and / or moving radially outward from the longitudinal axis of endoscope 1540 as endoscope 1540 moves through the patient's body. Opening 1570 at the distal end of outer sheath 1552 may provide the user with the ability to look ahead of endoscope 1540 as endoscope 1540 and outer sheath 1552 move through the patient's body. Opening 1570 may include one or more proximally extending slots 1570a ( Fig.16 4 are shown in the figure). The distal portions 1555, 1556 of the outer sheath 1552 can be movable and flexible to expand and contract the opening 1570. An exemplary expanded state of the opening 1570 is shown as opening 1571, wherein the dotted lines 1557, 1558 represent the distal portions 1555, 1556 after radially outward movement. The distal portions 1555, 1556 can move radially outward to form an expanded state, thereby allowing the user to access the target area by means of the stapler device 1501 and the tissue acquisition tool 1543. In order to help the distal portions 1555, 1556 move radially outward, the outer sheath 1552 may include a tearable longitudinal slit 1567. For example, the tearable slit 1567 may extend proximally from each of the slots 1570a to a distance sufficient to allow the portions 1555, 1556 to separate (e.g., to the distal side of the endoscope 1540). In other examples, distal portions 1555, 1556 may be movable to allow a user to pull outer sheath 1550 proximally and position stapler device 1501 and tissue acquisition tool 1543 within a target area. Fig.16As shown, the outer sheath 1550 may include four movable distal portions 1555, 1556, 1565, 1566. In some examples, each distal portion 1555, 1556, 1565, 1566 of the outer sheath 1550 may be configured to move proximally or distally relative to the endoscope 1540 to allow the user to uncover or cover the stapler device 1501 and the tissue acquisition tool 1543. In some examples, the distal portions 1555, 1556, 1565, 1566 may move radially outward to expand the opening 1570 to allow the acquisition tool 1543 and the stapler device 1501 to pass through the opening 1570. For example, as the outer sheath 1552 translates proximally, the distal portions 1555, 1556, 1565, 1566 may move radially outward when contacting the stapler device 1501 and / or the acquisition tool 1543. In some examples, outer sheath 1550 may be transparent / clear to allow a user to see through outer sheath 1550 as endoscope 1540 is moved through a patient's body.

[0068] Fig.17 An exemplary medical device 1700 is shown, including a stapler device 1701, an elongated body 1704, an elongated rod 1770 having a cavity 1772, and a rotatable connector 1780. The stapler device 1701 and the elongated body 1704 may include any of the features and characteristics discussed above. Rod 1770 may be rigid and may be made of polyetheretherketone (PEEK) or other suitable materials. The elongated body 1704 may be an incompressible member, such as a Bowden cable, and may include a cavity (not shown) for receiving other components of the actuating wire and stapler device 1701. The cavity 1772 of the rod 1770 may extend longitudinally from the proximal end to the distal portion of the rod 1770. In some examples, the cavity 1772 may receive the elongated body 1704 and may be configured to allow the elongated body to move proximally and distally through the cavity 1772. The body 1704 may extend from the cavity 1772 via an opening 1779 in the side wall of the rod 1770. A rotatable connector 1780 may couple the stapler device 1701 to the rod 1770 and may be positioned between the proximal and distal ends of the stapler device 1701. In some examples, the rotatable connector 1780 allows the stapler device 1701 to pivot relative to the rod 1770 so that the stapler device 1701 may move between a position where the longitudinal axis of the stapler device 1701 is parallel to the longitudinal axis of the rod 1770 and a position where the longitudinal axis of the stapler device 1701 is transverse to the longitudinal axis of the rod 1770. In an embodiment, the rotatable connector 1780 may allow such pivoting so that the angle between the longitudinal axes is greater than 0 degrees and may be up to almost 180 degrees (wherein the longitudinal axis of the stapler device 1701 is parallel to the longitudinal axis of the rod 1770). Figure 18-21 Various views of medical device 1700 are shown with stapler device 1701 rotated at different angles relative to rod 1770. Fig.18 and 19 As shown, cavity opening 1779 may be oval and may be elongated in the longitudinal direction of rod 1770 to allow elongated body 1704 to smoothly transition in and out of rod 1770 and minimize friction between cavity opening 1779 and elongated body 1704 as elongated body 1704 moves through cavity opening 1779. A user may pivot stapler device 1701 by pushing or pulling elongated body 1704 (to move elongated body 1704 proximally or distally), which then pushes or pulls stapler device 1701 and causes stapler device 1701 to rotate about rotatable connector 1780. In some embodiments, rotatable connector 1780 may include a pin extending through the device at the distal end of rod 1770 and a flange extending from stapler device 1701. The stapler device 1701 may include a pair of flanges extending from a portion of its body, the flanges including holes for pins, and the rod 1770 may include a device extending from the distal end of the rod 1770, the device including holes configured to align with the holes of the pair of flanges, and the pin may be positioned together with the holes of the pair of flanges and the holes of the device extending from the distal end of the rod 1770 to form a rotatable connector 1780.

[0069] Each of the above-mentioned instruments and devices can be used for visualization, connection and / or cutting tissue. In some examples, the user can load the slender body of the stapler device into the working channel of the endoscope by feeding the slender body through the distal end of the endoscope working channel in reverse to position a portion of the slender body in the working channel. Once the slender body is positioned in the working channel, the handle assembly can be connected to the proximal end of the slender body. Then, the user can introduce the endoscope into the patient and move the endoscope toward the target area. The user can use the endoscope to locate the target area (such as a tumor or other diseased tissue) present in the body cavity of the object by directly visualizing the target area using an image sensor. Once the user positions the distal end of the endoscope near the target area, the user can position the tissue collection tool in the working channel of the endoscope if such a tool has not been placed in place. In some examples, if the user places the outer sheath on the endoscope before inserting the endoscope into the patient, the user can move the outer sheath proximally to expose the stapler device to the target area and / or tear off some parts of the outer sheath to expose the stapler device. When the distal end of the endoscope is positioned at the target area, the user can actuate the stapler device to the open position, thereby forming a space between the anvil and the main body of the stapler. The user can then introduce a tissue acquisition tool into the target area and position the tissue acquisition tool between or near the active part of the stapler device, such as the space between the anvil and the main body of the stapler device. The user can then grab the tissue with the tissue acquisition tool and move the tissue into the active part of the stapler device. Once the tissue is positioned in the active part of the stapler device, the user can move the anvil and the main body of the stapler device to the closed position and clamp the grasped tissue with the stapler device. The user can then actuate the actuator to pull the actuation line, thereby moving the actuation slide of the stapler device proximally. By moving the actuation slide proximally via the actuator, the user can deploy fasteners into the clamped tissue and against the anvil of the stapler device. In some examples, the user can actuate the knife in the stapler device to cut some parts of the target tissue before or after the tissue is fastened together via the fastener.

[0070] By providing a stapler instrument that includes a flexible body while still being able to effectively staple tissue, the user can increase visualization of the target tissue and can prevent unwanted suturing errors, such as suturing within portions of contagious tissue. The improved visualization provided by an easy-to-operate, flexible stapler can also help ensure that as much as possible or all of the target lesion is removed.

[0071] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed apparatus and methods without departing from the scope of the present disclosure. Other aspects of the present disclosure will be apparent to those skilled in the art by considering the description and practice of the features disclosed herein. The description and examples are intended to be considered exemplary only.

Claims

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

2. The device of claim 1, wherein the fastening device comprises a protrusion extending from a side surface of the fastening device and defining a cavity configured to receive a tissue acquisition tool.

3. A device according to claim 1 or 2, wherein the fastening means comprises the means for cutting tissue.

4. A device according to claim 1 or 2, wherein the fastener actuator is connected to an actuation line extending from the fastener actuator through the second body to the handle assembly, wherein the actuation line is connected to one of the at least two actuators, and wherein the fastener actuator is configured to move proximally relative to the barrel and the anvil when the one actuator is actuated.

5. The device according to claim 1 or 2, wherein the distal portion of the second body includes a curved portion such that the longitudinal axis of the fastening device is transverse to the longitudinal axis of the proximal portion of the second body.

6. The device of claim 1 or 2, wherein the anvil comprises a first recess, wherein the longitudinal body comprises a second recess opposite the first recess, and wherein the first recess and the second recess are configured to receive a tissue acquisition tool.

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

8. A device according to claim 1, 2 or 7, wherein the fastening means is rotatably connected to the first body.

9. The device of claim 1, 2 or 7, wherein the fastener actuator includes a ramp, and wherein a surface of the ramp that contacts a piston or spacer to deploy the plurality of fasteners has an angle of 30 degrees or less relative to the longitudinal axis of the longitudinal body.

10. The device of claim 1, 2 or 7, wherein the fastening means is fixedly attached to the second body.

11. The apparatus according to claim 1, 2 or 7, further comprising: A distal end of the second body is coupled to a connector of the fastening device, wherein the fastening device is pivotable about the connector when the second body is moved proximally and / or distally.

12. The device of claim 1, wherein the first body defines an opening in a side wall of the first body, the second body extending through the opening.

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

14. The device of claim 1, 2, 7, 12 or 13, wherein the handle assembly includes a first actuator configured to move longitudinally in a proximal and distal direction and a second actuator configured to pivot relative to a body of the handle assembly.

15. The device of claim 11, wherein the connector is positioned proximal to the fastener.

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