Device for fastening tissue

Abstract

According to one aspect, a fastening device may include a coupling body having (1) a portion configured to couple to a distal end of a medical device, (2) a cartridge holder, and (3) an anvil pivotally coupled to the cartridge holder. The cartridge holder and the anvil may extend distally from the portion and may be configured to extend distally from a distal-most surface of the medical device when the portion is coupled to the distal end of the medical device. A flexible member may be configured to extend through a channel of the medical device. A fastener cartridge may be coupled to the distal end of the flexible member, include at least one fastener, and be configured for releasable coupling to the cartridge holder.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 878,141, filed on July 24, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to tissue closure. More particularly, at least some embodiments of the present disclosure relate to a stapling mechanism for a medical device (eg, an endoscopic stapler), and related methods utilizing the same. Background of the Invention

[0005] Staplers are used in many medical procedures, including, for example, laparoscopic surgery. These procedures typically involve removing portions or segments of tissue, which are then closed using a stapler. An exemplary procedure is colorectal stapling. Rigid staplers are commonly used in hybrid surgical procedures, where doctors utilize both laparoscopes and endoscopic platforms to perform the procedure. Linear staplers, which may include long rigid members, may not be able to navigate through tortuous anatomical structures without causing tissue trauma. Summary of the Invention

[0006] Aspects of the present disclosure relate to, among other things, 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, a fastening device may include a coupling body having (1) a portion configured to couple to a distal end of a medical device, (2) a cartridge holder, and (3) an anvil pivotally coupled to the cartridge holder. The cartridge holder and the anvil may extend distally from the portion and may be configured to extend distally from a distal-most surface of the medical device when the portion is coupled to the distal end of the medical device. A flexible member may be configured to extend through a passageway of the medical device. A fastener cartridge may be coupled to the distal end of the flexible member, include at least one fastener, and be configured for releasable coupling to the cartridge holder.

[0008] In other aspects of the present disclosure, the device may include one or more of the following features. The fastener magazine may include a protrusion, and the magazine holder may include a recess configured to receive the protrusion. The recess may be a first recess, and the protrusion may be a first protrusion, and the fastener magazine may include a second protrusion, and the magazine holder may include a second recess configured to receive the second protrusion. The device may include a knife for cutting tissue. The blade may be configured to move from a chamber within the magazine holder through a channel of the fastener magazine. When the fastener magazine is coupled to the magazine holder, the distal-most end of the fastener magazine may be distal to the chamber. The knife may be configured to move proximally from the chamber at the distal portion of the magazine holder. As the blade moves proximally, the knife may be positioned adjacent to the fastener magazine and within the channel of the magazine holder. The knife may include a first proximally facing sharp edge. The anvil may include a channel configured to receive the knife. The magazine holder may include a channel for receiving the fastener magazine; and at least one tang may extend into the channel. The fastener tray may include at least one recess configured to receive at least one tang, and when the fastener tray is coupled to the tray holder, the at least one tang may be positioned within the at least one recess. The anvil may include a distal portion and two spaced proximal portions, the proximal portions extending from the proximal end of the distal portion, and each of the two proximal portions may be pivotally coupled to the coupling body. The flexible member may be a first flexible member, and the device further includes a second flexible member and an actuation wire, the second flexible member being coupled to the coupling body and configured to extend to the proximal portion of the medical device, and the actuation wire extending through the second flexible member. The actuation wire may be configured to move the anvil toward and / or away from the tray holder. The tray holder may include a protrusion at the distal portion of the tray holder, and the protrusion may be configured to contact the anvil when the anvil moves toward the tray holder to stop the anvil from moving toward the tray holder and to drain the space between the fastener tray and the anvil. The coupling body may include a flange configured to limit the movement of the anvil relative to the tray holder. The flexible member may include at least one actuation wire configured to deploy at least one fastener from the fastener cartridge.

[0009] In other aspects, the medical device may include a flexible member configured to extend through a channel of an endoscope; and a stapler cartridge may be coupled to a distal end of the flexible member and may include a plurality of staples. The stapler cartridge may be configured to extend through the channel of the endoscope and removably coupled to a cartridge holder.

[0010] In other aspects of the present disclosure, the device may include one or more of the following features. The stapler cartridge may include a protrusion configured to be positioned within a recess of the cartridge holder when the fastener cartridge is coupled to the cartridge holder. The stapler cartridge may define a longitudinal channel configured to receive a blade.

[0011] In other aspects, a medical method may include inserting a flexible medical device into a natural orifice of the body; deploying at least one fastener from a fastener cartridge coupled to a cartridge holder at a distal end of the medical device; detaching the fastener cartridge from the cartridge holder while the flexible medical device, cartridge holder, and fastener cartridge are in the body; and removing the fastener cartridge from the body by moving the fastener cartridge proximally through a channel of the medical device.

[0012] In other aspects, the medical methods of other aspects of the present invention may include one or more of the following features: the fastener cartridge may be a first fastener cartridge; and the method may further include moving a second fastener cartridge distally through the passageway while the flexible medical device is in the body, and coupling the second fastener cartridge to the cartridge holder.

[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. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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.

[0016] Figure 1 is a perspective view of an exemplary medical device coupled to an endoscope according to aspects of the present disclosure.

[0017] Figure 2 According to aspects of the present disclosure, Figure 1 A perspective view of an exemplary portion of a medical device.

[0018] Figure 3 According to aspects of the present disclosure, Figure 1 A perspective view of an exemplary portion of a medical device.

[0019] Figures 4A to 4C is a cross-sectional view of a portion of an exemplary coupling feature of a medical device according to aspects of the present disclosure.

[0020] Figures 5A to 5C is a cross-sectional view of a portion of an exemplary coupling feature of a medical device according to aspects of the present disclosure.

[0021] Figure 6A and Figure 6B is a side view of an exemplary medical device according to aspects of the present disclosure.

[0022] Figure 7 is a side view of an exemplary medical device according to aspects of the present disclosure.

[0023] Figure 8is a perspective view of a portion of an exemplary medical device according to aspects of the present disclosure.

[0024] Figure 9 is a perspective view of a portion of an exemplary medical device according to aspects of the present disclosure.

[0025] Figure 10A and Figure 10B is a perspective view of a portion of an exemplary medical device according to aspects of the present disclosure.

[0026] Figure 11 According to aspects of the present disclosure, Figure 10B A side cross-sectional view of a portion of an exemplary medical device is shown. DETAILED DESCRIPTION

[0027] The present disclosure relates to systems, devices and methods for connecting, cutting, dissecting and / or removing tissue, etc. Reference will now be made in detail to various aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Whenever possible, the same or similar reference numerals will be used throughout the figures to refer to the same or similar parts. The term "distal" refers to the portion of the device that is furthest from the user when the device is introduced into the patient's body. In contrast, the term "proximal" refers to the portion that is closest to the user when the device is placed into the patient's body. In all figures, the distal direction is shown as an arrow marked "D", and the proximal direction is shown as an arrow marked "P". The term "connecting tissues together" may, for example, refer to stapling, fixing, attaching, fastening or otherwise combining two parts of tissue together. The term "fastener" may include staplers, clamps, elastic bands, sutures, or any other fasteners known in the art. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of an example rather than an ideal.

[0028] Embodiments of the present disclosure can be used for visualizing, excising and / or coupling target tissue in the endoluminal space, or facilitate its process. In particular, some embodiments combine tissue excision devices with tissue stapling devices. Other embodiments may include stapling devices without excision mechanisms. For example, the device may include an excision or cutting mechanism (e.g., an integrated blade) and a stapling mechanism (stapler). The device may be coupled to an endoscope, arthroscopy, colonoscope, hysteroscope, sheath, catheter or other medical device, and may be delivered to the target tissue site via the device. In some instances, the barrel for holding a fastener (such as a stapler) may be delivered to the device via the working channel of the medical device, and the device is coupled in the working channel. All or part of the device may be metallic, plastic, or may include shape memory metal (such as nitinol), shape memory polymer, polymer, or any combination of materials. Figure 1 According to one embodiment of the present disclosure, a distal portion of a medical device 101 is shown coupled to a distal tip 100 of an endoscope 103. The device 101 may be a surgical stapling device configured to engage body tissue, apply one or more fasteners to the body tissue, and optionally form an incision in the fastened body tissue during minimally invasive surgery, such as laparoscopic or endoscopic surgery. The device 101 is removably coupled to the distal tip 100 of a medical device, such as an endoscope 103. The tip 100 is comprised of Figure 1 The apparatus 101 is covered by a portion of the apparatus 101 in the body of the device. The apparatus 101 can be used to apply surgical clips or other fasteners, but will be discussed primarily in the context of applying staples from a staple cartridge that is located in a portion of the device body, such as a loading unit.

[0029] like Figure 1As shown, the distal section of the device 101 may include a coupling body or first body 108, a second body 104 (coupled to the first body 108), an anvil 102, a cartridge 106, and two elongated bodies 110, 112 (extending from the distal section to the proximal section of the device 101). Each elongated body 110, 112 can extend any length suitable for endoscopic or laparoscopic surgery and, in some instances, can be configured to be positioned adjacent to the radially outer surface of the endoscope 103 or other medical device. The elongated bodies 110, 112 can be coupled to an actuation assembly, such as a handle having one or more actuators, at the proximal end of each elongated body 110, 112. In some instances, each elongated body 110, 112 can be flexible and / or can be rotatable about its axis. The elongated bodies 110, 112 may be positioned within the cover elongated bodies 113, 114 and may extend through the longitudinal lumens of the cover elongated bodies 111, 113. The cover elongated bodies 111, 113 may be a polymer material and may protect the elongated bodies 110, 112 from contacting the interior surfaces of the patient's body. Each elongated body 110, 112 may include a lumen for positioning an actuation wire therein.

[0030] These actuation wires positioned within one or more lumens of one or more elongated bodies 110, 112 may serve a variety of possible functions. In one exemplary embodiment, the first body 108 may include an internal passageway (not shown) in which the elongated bodies 110, 112 (or only the wires 110a, 112a of the bodies 110, 112) extend so that the distal ends of the bodies 110, 112 connect to the anvil 102 (to pivot the anvil 102 about the pivot point 114) and / or connect to an actuation mechanism within the second body 104 that deploys the staples. The wires 110a, 112a may extend from the anvil 102 through the lumens within the first body 108 to provide a means for actuating the anvil 102 in the open position ( Figure 1 114 and 115. The anvil 102 may be moved between an open position (not shown) and a closed position in which a portion of the anvil 102 contacts the second body 104. In other examples, wires (such as 110a, 112a) may extend from the anvil 102 to the exterior of the first body 108. In these examples, an actuation wire (such as wires 110a, 112a) may be coupled to an anvil 102 at a location such that movement of the actuation wire will cause the anvil 102 to pivot about a first pivot point 114 and a second pivot point (not shown) on an opposite side of the first body 108 from the first pivot point 114. In some examples, the biasing member may bias the anvil 102 toward the open position (not shown). Figure 1108 ), and pulling one or more wires, such as wires 110a, 112a, which are coupled to anvil 102 near pivot point 114, can move anvil 102 from an open position to a closed position. In some examples, elongated bodies 110, 112 can each be a bowden cable comprising a wire within a coil / sheath. In some examples, elongated bodies 110, 112 can be fixedly coupled to first body 108, and in other examples, elongated bodies 110, 112 can be removably or releasably coupled to first body 108. In some examples (not shown), device 101 can include only one elongated body 110, 112 or more than two elongated bodies 110, 112.

[0031] The first body 108 can be configured to support the anvil 102 and the second body 104. For example, the distal tip 100 of the endoscope 103 can be inserted into the lumen 129 of the first body 108 to couple the device 101 to the distal tip 100. In some examples, the first body 108 can be annular and / or partially annular and can be configured to receive the distal tip 100 of the endoscope 103 or other medical device. In some examples, the first body 108 can include a first annular portion 108a that receives a second annular portion 108b, and the second annular portion 108b can be configured to couple to the distal tip 100. The first body 108 can include a first radial protrusion 108c located on the radially outermost surface of the second annular portion 108b and a second radial protrusion 108d located on the radially outermost surface of the first annular portion 108a. In some examples, additional annular protrusions (not shown) may be located on the first body 108. The first and second annular protrusions 108c, 108d may include openings to the interior passage of the first body 108 and may be configured to receive the elongated bodies 110, 112, the cap elongated bodies 111, 113, and / or the wires 110a, 112a. The distal flange 108f of the first annular portion 108a may be positioned adjacent the pivot point 114 and may limit the rotation of the anvil plate 102. Figure 2 Device 101 is shown with anvil plate 102, a portion of second annular portion 108b, and elongated bodies 110, 112 removed. First body 108 may include a rough or irregular radial inner surface within lumen 129 that facilitates coupling first body 108 to endoscope 103 via a friction or interference fit.

[0032] In some examples, when fully inserted into the lumen 129 of the first body 108 , the distal front surface 120 of the distal tip 100 can contact the proximal surface of the second body 104 , such that the bodies 104 act as a stop for the insertion of the endoscope 103 .

[0033] The anvil 102 can be rotatably or pivotally coupled to the proximal portion of the first body 108 at one or more pivot points 114. The anvil 102 can be Y-shaped (e.g., having two proximal arms that each extend to a distal anvil portion 132) and can extend distally from the first body 108. In some examples, the anvil 102 can be rotationally biased and can be biased to an open configuration, i.e., biased away from the body 104 and the cartridge 106, thereby forming a space between the distal portion of the anvil 102 and the distal portions of the body 104 and the cartridge 106. The anvil 102 can be rotatable to contact the body 104 or clamp tissue between the anvil 102 and the body 104 and provide a surface for driving staples as they are ejected from the cartridge 106. A space 131 between a distal portion 132 of anvil 102 and distal front surface 120 of endoscope 103 can provide space for one or more tools that are positioned distal to distal front surface 120 of endoscope 103 when the anvil is in the closed or open position. For example, space 131 can allow a user to pull tissue between anvil 102 and second body 104, and then the user can actuate anvil 102 to clamp the tissue between anvil 102 and second body 104 without requiring a tool to prevent anvil 102 from fully closing against second body 104.

[0034] The second body 104 can be fixedly coupled to the first body 108 and can extend distally from the first body 108. In other examples (not shown), the second body 104 can be pivotally coupled to the first body 108 and can rotate relative to the fixed anvil. When the device 101 is coupled to the endoscope 103, the second body 104 can be longitudinally aligned with the endoscope 103 so that the central longitudinal axis of the endoscope 103 is substantially parallel to the longitudinal axis of the second body 104. When the device 101 is coupled to the distal tip 100, the second body 104 can be configured to align with the working channel 116 of the endoscope 103 and / or extend adjacent to the central longitudinal axis of the working channel 116. The second body 104 can include one or more cavities at the distal portion of the second body 104, and the one or more cavities can be configured to receive one or more actuators for deploying staples, such as an actuating slide or an actuating mechanism. The chambers may be within the distal portions 132, 134 and may be configured to hold one or more actuation slides and / or one or more devices (such as blades) for cutting tissue. For example, the distal portion 128 ( Figure 2191 of the cartridge 106. The distal portion 128 and the second body 104 may be configured to receive the knife 126 for cutting tissue. In some instances, the distal portion 128 may include a pocket 135 configured to receive the knife 126 and prevent the knife 126 from contacting the patient's tissue during insertion of the device into the patient or during certain other surgical steps (such as stapling). The distal portion 128 and the pocket (or chamber) 135 may protrude from the top surface 191 of the cartridge 106 so that the anvil 102 contacts the distal portion 128 when in the closed position, thereby forming a gap between the anvil 102 and the top surface 191 of the cartridge 106. By forming a gap between the anvil 102 and the top surface 191, the gap may provide sufficient space for one or more tissue layers. In some instances, the anvil 102 may include a recess (not shown) that is configured to receive the distal portion 128 of the second body 104 when the anvil 102 is in the closed position.

[0035] In some examples, the second body 104 can include a channel 136 that supports the cartridge 106. The channel 136 can extend along the second body 104 in a direction generally parallel to the central longitudinal axis of the endoscope 103. The cartridge 106 can contain a plurality of surgical fasteners, such as staples, and can be deployed from the cartridge 106 under the influence of a driving force, such as a driving force supplied by an actuator that moves through or along the cartridge 106. A plurality of spaced longitudinal slots 122 in the cartridge 106 allow the staples to pass through the cartridge 106 and penetrate tissue. In some examples, an actuation slide or mechanism, when actuated, is movable proximally in a longitudinal direction from a distal end of the cartridge 106 and / or the second body 104, thereby contacting the fasteners within the cartridge 106 and pushing the fasteners through the longitudinal slots 122 to couple the fasteners to the tissue. In some instances, the fasteners can be deployed from the cartridge 106 in the same or similar manner as disclosed in U.S. patent application No. 62 / 812,538, filed on March 1, 2019, entitled “Systems, Devices, and Related Methods for Fastening Tissue,” the contents of which are incorporated herein by reference in their entirety. The fasteners can penetrate the tissue and contact the anvil 102 to couple the fasteners to the tissue. In some instances, a single fastener can extend through each slot 122. Each fastener can be partially within the slot 122 prior to deployment to assist in aligning the fastener with the slot 122. In some instances, different actuators may be required to actuate the fasteners of different longitudinal rows in the cartridge 106.

[0036] The cartridge 106 may further include a longitudinal slot or channel 124. The longitudinal slot 124 may be configured to receive and / or support a cutting tool, such as a knife 126 or other device for cutting tissue. The longitudinal slot 124 may be positioned in the middle of the cartridge 106 and may extend longitudinally from the proximal portion of the cartridge 106 to the distal end. In some examples, an equal number of spaced longitudinal slots 122 may be positioned on each side of the longitudinal slot 124. The anvil 102 may include a longitudinally positioned groove (not shown) that aligns with the longitudinal slot 124 when the anvil 102 is in a closed position (e.g., the anvil 102 is rotated so that the distal portion of the anvil 102 contacts the second body 104 and / or the cartridge 106, or clamps tissue between the anvil 102 and the body 104), and such a groove may be configured to receive a cutting tool (such as a knife 126 or other sharp cutting tool) within the longitudinal slot 124. The cutting tool can be actuated via an actuation wire or other mechanism to move the knife 126 proximally. The cartridge 106 can be fixedly coupled to the second body 104 or removable from the second body 104. In some examples, the cartridge 106 can be integrally formed in the second body 104. An actuation wire for an actuation sled that deploys fasteners and / or an actuation wire for moving a device that cuts tissue, such as the knife 126, can extend through one or more of the elongated bodies 110, 112 and / or the proximal elongated member 144 of the cartridge 106.

[0037] Figure 3An exemplary cartridge 106 is shown that includes a slot 122, a longitudinal slot 124, a channel 152, a proximal elongated member 144, and a coupling protrusion 125. The channel 152 can extend longitudinally through the cartridge 106 and can be configured to receive an actuator for deploying fasteners from the slot 122. In some instances, each channel 152 can accommodate an actuator (such as an actuating sled) that can be configured to move from the distal end of the cartridge 106 to the proximal end of the cartridge 106, thereby deploying fasteners as it moves proximally. For example, the actuating sled can be an element (such as a ramp or other component) that is configured to engage the stapler and extend it in an upward direction through the longitudinal slot 122 as the actuating sled moves in a proximal direction. The proximal elongated member 144 can be fixedly coupled to the cartridge 106 and can include one or more lumens. The proximal elongated member 144 can be configured to receive one or more actuation wires extending from the cartridge 106 to a proximal portion of the proximal elongated member 144. In some examples, the proximal elongated member 144 can be flexible and can be configured to bend to allow movement through a tortuous path in the patient's body. For example, the proximal elongated member 144 can include one or more articulating joints (not shown) that allow the proximal elongated member 144 to bend through a tortuous path. Suitable articulating joints can be any joint known in the art of medical devices (including endoscopic devices, such as endoscopes) that allow the device to be hung. In some examples, the proximal end of the proximal elongated member 144 can include a spool-type handle or wheel-shaped knob configured to deploy the fastener into the cartridge 106 by pulling or rotating the spool-type handle or wheel-shaped knob (e.g., to actuate an actuation slide), but any suitable handle or actuator can be used. The cartridge 106 can be sized to fit within the working channel 116 such that a user can move the cartridge 106 through the working channel 116 and couple the cartridge 106 to the second body 104. In some embodiments, the cartridge 106 can be replaceable to deploy additional staples without removing the endoscope and device 101 from the patient's body lumen.

[0038] The coupling protrusions 125 can be positioned at a distal portion of the cartridge 106 and can extend from a surface 190 on an opposite side of the second body 104 away from a surface 191 including the slot 122. The coupling protrusions 125 can be configured to be positioned within the recesses 142 of the channel 136. In some examples, the coupling protrusions 125 can be configured to removably couple the cartridge 106 to the second body 104. The coupling protrusions 125 can include recesses 150, 151 that can be configured to receive the protrusions 143 in the recesses 142. The coupling protrusions 125 can extend from each side of the cartridge 106 (e.g., generally perpendicular to the central longitudinal axis of the endoscope 103) so that the coupling protrusions 125 are on each side of the channel 124, or the coupling protrusions 125 can extend from only one side of the channel 124. In some examples, the coupling protrusion 125 and / or the recess 142 can be one or more of a boss, protrusion, detent, fin, prong, hook, ball, notch, socket, recess, snap, tab, key, or constraint, or otherwise form a friction or interference fit. In some examples, the coupling protrusion 125 can be overmolded. The surface defining the recess 142 can be configured to deflect, bend, and / or flex when the coupling protrusion 125 moves within the recess 142 to provide a snap fit between the recess 142 and the coupling protrusion 125.

[0039] Figures 4A to 4C A cross-sectional view of an exemplary coupling mechanism that may be used to couple the coupling protrusion 125 within the recess 142 is shown. Figure 4A , the coupling protrusion 125 of the cassette 106 is inserted into the recess 142. Figure 4B As shown, when the coupling protrusion 125 contacts the protrusions 401, 402 within the recess 142, the sidewalls / surfaces 404, 405 forming the recess 142 are elastically deflected or expanded outwardly from the central longitudinal axis of the recess 142 (via Figure 4B , until recesses 150, 151 are aligned with protrusions 401, 402. Once protrusions 401, 402 are positioned within recesses 150, 151, coupling protrusion 125 may be sufficiently coupled within recess 142 to withstand forces applied during a medical procedure and remain within recess 142. Figures 5A to 5C A cross-sectional view of an additional exemplary coupling mechanism is shown that may be used to couple the coupling protrusion 125 within the recess 142 and is generally similar to Figures 4A to 4C The coupling mechanism shown. Figures 5A to 5C142. In the embodiment shown in FIG. 146, a portion of the material forming the channel 142 expands outward as the coupling protrusion 125 is inserted into the recess 142. The material forming the channel 142 can be biased so that the protrusions 501, 502 move or snap into the recesses 150, 151 to couple the coupling protrusion 125 within the recess 142. To position the coupling protrusion 125 within the recess 142 and thereby couple the cartridge 106 to the second body 104 within the channel 136, the user can pull, push, rotate, or otherwise move the proximal elongated member 144, or use a separate tool inserted into the endoscope channel to couple the cartridge 106 to the second body 104. Similarly, the user can pull, push, rotate, or otherwise move the proximal elongated member 144, or use a separate tool to release the cartridge 106 from the second body 104. By providing a releasable coupling mechanism between the cartridge 106 and the second body 104, a user can exchange cartridges using the working channel 116 without removing the device 101 and the endoscope 103 from their location within the patient's body, which can prevent irritation or injury to the patient during the procedure and can reduce the overall procedure duration.

[0040] Before using the device 101 in a procedure, a user can couple the device 101 to the endoscope 103 and position the proximal elongated member 144 along with the cartridge 106 within the working channel 116. In some examples, the user can first couple the first body 108 to the distal tip 100 of the endoscope 103, and then position the proximal elongated member 144 within the working channel 116 and couple the cartridge 106 to the channel 136 of the second body 104. To use the device 101, the cartridge 106 is positioned within the channel 136 to deploy fasteners from the cartridge 106. By first positioning tissue within the active region of the device 101 between the anvil 102 and the second body 104, the user can utilize the device 101 to couple one or more fasteners to the tissue. Once the tissue is positioned within the active region of the device 101, the user can actuate the actuator via one or more of the elongated bodies 110, 112 as described above, which can then cause the anvil 102 to close over the tissue within the active region. When the user holds the anvil 102 in a closed position (thereby maintaining the clasp of the stapler device on the tissue), the user can deploy one or more staplers from the slot 122, for example, by pulling proximally on the actuator to translate the actuation wire, which is coupled to the actuation sled in the cartridge 106 or the second body 104. When the actuation sled or mechanism translates proximally via the actuation wire, the actuator can push the fasteners through the longitudinal slot 122 to pierce the tissue. When the fasteners are deployed by the actuator, the fasteners can then engage the anvil 102 and couple the tissue layers together. In some instances, the actuator can actuate the actuation wire that is coupled to both the actuation sled or mechanism and the excision tool (such as a knife 126), and can simultaneously translate the actuation sled and the excision tool to pierce the tissue and fasten the tissue with one or more fasteners and excise the tissue.

[0041] Figure 6A and Figure 6B 6. A side view of a device 601 similar to device 101 is shown, including an anvil 602, a first body 608, a second body 604, and a proximal elongated member 644 (not shown) of the cartridge extending through the second body 604. Figure 6A and Figure 6B As shown, when the device 601 is coupled to the endoscope 603, the proximal elongated member 644 can be fed rearwardly through the working channel 610 of the endoscope 603. Once the first body 608 is coupled to the distal tip of the endoscope 603, the distal front face 620 can contact a portion of the device 601.

[0042] Figure 7An alternative embodiment of a cassette 706 and a proximal elongated member 761 is shown, wherein the proximal elongated member 761 extends away from the working channel 716 of the distal end 700 of the medical device. The cassette 706 may include a coupling protrusion 725 having any one or more features of the coupling protrusion 125. The surface of the cassette 706 may include cutouts, slots, ridges, or other features that increase the flexibility of the cassette 706, thereby allowing the cassette 706 to extend more easily through the channel 716. The cassette 706 may be coupled to the proximal elongated member 761 via a coupler 763. The coupler 763 may engage the cassette 706 and may be releasable via an actuator. In some instances, the coupler 763 may include an overmolded feature 726 in the shape of the cassette 706, and the overmolded feature 726 may be cylindrical. In some instances, the overmolded feature 726 of the connector 763 may be overmolded into the shape of the cartridge 706 such that once the cartridge 706 is closed onto tissue, the tension applied by the operator to the entire assembly exceeds the material strength of the connector 763 and, thereby, the elongated member 761 may be pushed into the material of the connector 763, which may then release the cartridge 706.

[0043] Figure 8 A perspective view of a portion of the second body 804 is shown, which is generally similar to the second body 104. The cartridge 806 is shown coupled to the second body 804, and the knife 826 has been moved from a chamber within the distal portion 828 of the second body 804 into the channel 824 of the cartridge 806. The knife 826 can be moved through the channel 824 to cut the patient's tissue before, during, or after deploying fasteners from the cartridge 806 into the patient's tissue. The knife 826 includes a proximally facing cutting edge 833 and a blunt or otherwise atraumatic distally facing edge 835; the blunt or otherwise atraumatic distally facing edge 835 can prevent accidental cutting of tissue during operation (as the device moves distally).

[0044] Figure 9 A perspective view of an alternative embodiment of a second body 904 is shown for use in a device generally similar to device 101. Figure 9 924. In the embodiment of the present invention, the cartridge 906 is located on only one side of the channel 924 and extends parallel to the channel 924. The channel 924 receives the knife 926 from a cavity or insert pocket 940 within the distal portion 928 of the second body 904. By providing the cartridge 906 on only one side of the channel 924, the user can cut the patient's tissue and only fasten or staple a single side of the cut tissue. Either the second body 804 or the second body 904 can incorporate and / or have any of the features previously described with respect to the device 101.

[0045] Figure 10A and Figure 10BA perspective view of a portion of device 1001 is shown, which may include any of the features previously described with respect to device 101. Device 1001 may include a first body 1008, a second body 1004, a cartridge 1006 including a slot 1022 for a fastener, and a channel 1024 configured to receive a blade 1026. Second body 1004 may include a channel 1036 configured to receive cartridge 1006. A pair of flanges or tangs 1075, 1076 may extend from a surface defining channel 1036 and may be flexible. Tangs 1075, 1076 may be configured to flex so that a user can slide cartridge 1006 within channel 1036, and tangs 1075, 1076 will flex as a bottom surface 1080 of cartridge 1006 moves distally and contacts the surface defining channel 1036. When the recess 1078 in the bottom surface 1080 is aligned with the tangs 1075, 1076, the tangs 1075, 1076 can spring and / or move into the recess 1078. The tangs 1075, 1076 can include a curved distal portion 1077 ( Figure 11 1036 ). The curved distal portion 1077 can be configured to slide along the surface of the cartridge 1006 to facilitate positioning of the tangs 1075, 1076 within the recess 1078 of the cartridge 1006. The curved distal portion 1077 can curve downwardly away from the channel 1036. In some examples, when the distal surface 1097 of the recess 1078 contacts the tangs 1075, 1076 as the cartridge 1006 moves proximally, the curved distal portion 1077 can facilitate proximal movement of the cartridge 1006 by deflecting the tangs 1075, 1076 downwardly away from the channel 1036. The edge projections 1070, 1071 can extend above the upper surface of the inserted cartridge 1006 into the distal portion of the channel 1036 to retain the cartridge 1006 within the channel 1036. For example, as the user moves the cartridge 1006 distally and positions the distal portion of the cartridge 1006 below the edge projections 1070, 1071 (along the Figure 10B The line 11-11 is shown in cross-section. Figure 111036 ), the user can slide the cartridge 1006 within the channel 1036 and bend the tangs 1075, 1076. The recess 1078 of the cartridge 1006 can be positioned so that when the distal portion of the cartridge 1006 is positioned below the edge projections 1070, 1071, the tangs 1075, 1076 are received by the recess 1078. The combination of the tangs 1075, 1076 positioned within the recess 1078 and the edge projections 1070, 1071 on the cartridge 1006 can retain the cartridge 1006 within the channel 1036. The recess 1078 of the bottom surface 1080 can include an inclined proximal surface 1096 and an inclined distal surface 1097, and the angle of the inclined distal surface 1097 can be set to less than ninety degrees relative to the longitudinal axis of the cartridge 1006. In some examples, the angled distal surface 1097 can be positioned at an angle relative to the longitudinal axis of the cartridge 1006 that is greater than the angle relative to the longitudinal axis of the proximal surface 1096. The distal surface 1097 can be at a greater angle relative to the proximal surface 1096 such that a greater force is required to remove the cartridge 1006 from the channel 1036 of the second body 1004 (e.g., by moving the cartridge 1006 proximally) than to insert the cartridge 1006 into the channel 1036 (e.g., to position the tangs 1075, 1076 within the recess 1078 by moving the cartridge 1006 distally). An intermediate surface 1098 of the recess 1078 can be located between the proximal surface 1096 and the distal surface 1097, and the intermediate surface 1098 can be generally parallel to the longitudinal axis of the cartridge 1006.

[0046] like Figure 10B As shown, some embodiments of the device may include a knife 1026, which is positioned near the distal end of the cartridge 1006, including near some of the distal most slots 1022 and related fasteners. By positioning the knife 1026 near the distal end of the cartridge 1006 and in a starting position near the distal most slot 1022 of the cartridge 1006, the user can staple the entire length of the tissue that the knife 1026 cuts when moving toward the proximal side. For example, the user can hold the tissue between the second body 1004 and anvil (similar to anvil 102) to staple the tissue together, and then the blade 1026 can be actuated to move the blade 1026 toward the proximal side and cut a portion of the tissue that is adjacent to a portion of the stapled tissue without cutting beyond the distal end of the stapled tissue. Additionally, the distal front surface 1028 of the second body 1004 is distal to the blade 1026 and can prevent the blade 1026 from contacting tissue when the blade 1026 is located at the distal end of the channel 1024. For example, the distal front surface 1028 can extend radially inward relative to the central longitudinal axis of the second body 1008 and, in some examples, can be angularly aligned with an edge of the blade 1026.

[0047] Each of the aforementioned devices and apparatuses can be used to visualize, connect, and / or cut tissue. In some instances, a user can load the proximal elongated member 144 of the cartridge 106 into the working channel of the endoscope by feeding the proximal elongated member 144 backward through the distal end of the working channel of the endoscope to position a portion of the proximal elongated member 144 within the working channel. Once the proximal elongated member 144 is positioned within the working channel, a handle assembly or an actuator assembly can be coupled to the proximal end of the proximal elongated member 144. In other instances, the user can move the cartridge 106 and proximal elongated member 144 from the proximal portion of the endoscope 103 through the working channel 116 and couple the cartridge 106 to the second body 104 by moving the proximal portion of the proximal elongated member 144 to move the cartridge 106 within the channel 136 and couple the protrusion 125 within the recess 142. The user can then introduce the endoscope 103 into the patient's body and move the endoscope 103 toward the target area. By directly visualizing the target area using an image sensor, the user can use the endoscope to locate the target area (such as a tumor or other diseased tissue) present in the patient's body lumen. When the distal end of the endoscope is positioned at the target area, the user can actuate the device 101 to move the anvil 102 to an open position, thereby forming a space between the anvil 102 and the second body 104 of the stapler. The user can then move the tissue from between the active parts of the device 101 or close to the target area (e.g., the space between the anvil 102 and the second body 104 of the stapler device). The user can use a tissue collection device (such as a gripper located in the working channel 116 of the endoscope 103) to pull the tissue to the active part of the device 101. Once the tissue is located in the active part of the stapler device, the user can move the anvil 102 of the stapler device to a closed position and clamp it on the grasped tissue with the device 101. The user can then actuate the actuator to pull the actuation wire, thereby moving the actuation slide of the device toward the proximal side. By moving the actuation slide or mechanism proximally via the actuator, the user can deploy fasteners from cartridge 106 into the clamped tissue and against anvil 102. In some examples, the user can actuate knife 126 in device 101 to cut portions of target tissue before or after fastening the tissue together via the fasteners.

[0048] According to an exemplary embodiment, a stapler instrument comprises a fastener box that can be removed and replaced by the working channel of a medical device during surgery. Utilizing such an instrument can reduce the duration of surgery and limit the irritation and / or damage to the patient caused by the repeated removal and repeated insertion of the medical device into the patient's body (caused by the demand for replacing the fastener box of the stapler). Endoscopic stapling can be particularly useful in endoscopic, outpatient surgery. The scope of the present disclosure is limited by the appended claims and cannot solve specific problems.

[0049] 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 from consideration of the specification and practice of the features disclosed herein. This specification and examples are for illustrative purposes only.

Claims

1. A fastening device comprising: A coupling body, the coupling body comprising: a portion configured to be coupled to a distal end of a medical device, cassette holder, and an anvil pivotally coupled to the cartridge holder, wherein the cartridge holder and anvil extend distally from the portion and are configured to extend distally from a distal-most end face of the medical device when the portion is coupled to the distal end of the medical device; a flexible member configured to extend through a working channel of the medical device; and a fastener cartridge coupled to the distal end of the flexible member, comprising at least one fastener, and configured to releasably couple to the cartridge holder, wherein disengagement of the fastener cartridge from the cartridge holder is configured to disengage the flexible member from the coupling body, wherein the flexible member and fastener cartridge are configured to be movable proximally through the working channel after disengagement of the fastener cartridge from the cartridge holder. 2 . The apparatus of claim 1 , wherein the fastener cassette includes a protrusion, and wherein the cassette holder includes a recess configured to receive the protrusion.

3. The apparatus of claim 2, wherein the recess is a first recess and the protrusion is a first protrusion, and the fastener cassette includes a second protrusion, and wherein the cassette holder includes a second recess configured to receive the second protrusion.

4. The device according to any one of the preceding claims, further comprising a knife for cutting tissue.

5. The apparatus of claim 4, wherein the knife is configured to move from a cavity within the magazine holder through a passageway of the fastener magazine.

6. The apparatus of claim 5, wherein a distal-most end of the fastener magazine is distal to the cavity when the fastener magazine is coupled to the magazine holder.

7. The device of claim 4, wherein the knife is configured to move proximally from a cavity at a distal portion of the magazine holder, wherein as the knife moves proximally, the knife is positioned adjacent to the fastener magazine and within the channel of the magazine holder.

8. The device of claim 4, wherein the knife comprises a first proximally facing sharp edge.

9. The apparatus of claim 4, wherein the cutting board includes a channel configured to receive the knife.

10. The apparatus of claim 1 , wherein the cartridge holder comprises: a channel for receiving the fastener cassette; and at least one tang extending into the channel; wherein the fastener magazine includes at least one recess configured to receive the at least one tang, and wherein the at least one tang is positioned within the at least one recess when the fastener magazine is coupled to the magazine holder.

11. The device of claim 1 , wherein the anvil comprises a distal portion and two spaced apart proximal portions extending from a proximal end of the distal portion, wherein each of the two proximal portions is pivotally coupled to the coupling body.

12. The device of claim 1 , wherein the flexible member is a first flexible member, and wherein the device further comprises: a second flexible member coupled to the coupling body and configured to extend to a proximal portion of the medical device, and An actuation wire extends through the second flexible member, wherein the actuation wire is configured to move the anvil toward and / or away from the cartridge holder.

13. The device of claim 1 , wherein the cartridge holder includes a protrusion at a distal portion of the cartridge holder, wherein the protrusion is configured to contact the anvil when the anvil moves toward the cartridge holder to stop movement of the anvil toward the cartridge holder and to leave space between the fastener cartridge and the anvil.

14. The apparatus of claim 1, wherein the coupling body includes a flange configured to limit movement of the anvil block relative to the cartridge holder.

15. The device of claim 1, wherein the flexible member comprises at least one actuation wire configured to deploy the at least one fastener from the fastener magazine.

Images