System and apparatus for fastening tissue

Abstract

To provide an improved system, apparatus, and method for fastening tissues.SOLUTION: An endoscopic tissue fastening device may include a body having a first portion and a second portion disposed alongside the first portion. The second portion may extend distally from the first portion and may terminate at a distal end face of the body. The apparatus may further include a tissue fastening assembly having a fastening head with a proximal end and a distal end. The fastening head may be deflectable at a location between the proximal end and the distal end of the fastening head. The tissue fastening assembly can be received within a lumen of the body. Further, the body may be movable between an unarticulated configuration and an articulated configuration. In the articulated configuration, a central longitudinal axis of the second portion of the body may be substantially parallel to a central longitudinal axis of the tissue fastening assembly.SELECTED DRAWING: Figure 2D

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE Various aspects of the present invention relate to fastening of biological tissue, and more particularly to systems, devices, and associated methods for operating endoscopic tissue fastening devices and fastening tissue. [Background technology]

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

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

[0004] The present invention relates to systems, devices, and methods for fastening tissue, such as a flexible endoscopic platform with stapling functionality. Each embodiment disclosed herein may include one or more elements described in connection with any of the other disclosed embodiments.

[0005] In one example, the endoscopic tissue fastening device includes a body having a first portion and a second portion disposed alongside the first portion. The second portion extends distally from the first portion and terminates at a distal end face of the body. The device further includes a tissue fastening assembly having a fastener head with a proximal end and a distal end. The fastener head is deflectable at a location between the proximal and distal ends of the fastener head. The tissue fastening assembly is received within a lumen of the body. Additionally, the body is movable between a non-articulating configuration and an articulating configuration. In the articulating configuration, a central longitudinal axis of the second portion of the body is generally parallel to a central longitudinal axis of the tissue fastening assembly.

[0006] Examples of endoscopic tissue fastening devices may include any one or more of the following features: the lumen terminates proximal to the distal end face; the cross-sectional shape of the first portion is circular and the cross-sectional shape of the second portion is D-shaped; the tissue fastening assembly includes a flexible configuration and a stabilized configuration; in the articulated configuration of the body, the tissue fastening assembly is disposed in the flexible configuration; in the stabilized configuration, a fastener head of the tissue fastening assembly extends distally from the distal end face of the body; in the stabilized configuration, the fastener head of the tissue fastening assembly is articulatable along an articulation joint proximal to the fastener head such that a central longitudinal axis of the tissue fastening assembly is movable in a direction toward or away from a central longitudinal axis of the second portion of the body; the tissue fastening assembly includes a staple cartridge, and in the flexible configuration, at least a portion of the staple cartridge distal to the site may be deflected relative to another portion of the staple cartridge proximal to the site. The staple cartridge may include at least one flexible joint between a proximal end of the staple cartridge and a distal end of the staple cartridge. The support is disposed along a second portion of the body such that in the articulated configuration, a distal end of the tissue fastening assembly may be received within the support. At least a portion of the tissue fastening assembly may be axially movable relative to the support. In the stabilized configuration, a flexible connection of the tissue fastening assembly may be received within the support and prevented from bending by the support. The tissue fastening assembly may include a sheath coupled to the articulation joint via the flexible connection, the flexible connection including at least one notch therein, and the tissue fastening assembly may include a staple cartridge distal from the articulation joint. A stabilizer is movably coupled to the staple cartridge of the tissue fastening assembly such that at a first location, the stabilizer enables bending of the staple cartridge along the joint of the staple cartridge and in the stabilized configuration, the stabilizer may span the joint of the staple cartridge to prevent bending of the staple cartridge along the joint.

[0007] In a further example, an endoscopic tissue fastening method includes articulating an endoscopic tissue fastening device having a lumen with a tissue fastening assembly at least partially received within the lumen, and transitioning the tissue fastening assembly from a flexible configuration to a stabilized configuration, where in the flexible configuration a first portion of the tissue fastening cartridge is movable relative to a second portion of the tissue fastening cartridge and where in the stabilized configuration the first portion of the tissue fastening cartridge is prevented from moving relative to the second portion of the tissue fastening cartridge. Additionally, the method includes ejecting one or more tissue fasteners from the tissue fastening cartridge to fasten tissue.

[0008] Examples of the method may include any one or more of the following features: The method may include disposing a tissue fastening assembly at a distal end of the tissue fastening device in a flexible configuration while articulating the endoscopic tissue fastening device. The method may further include articulating a tissue fastening cartridge relative to the endoscopic tissue fastening device in the stabilized configuration.

[0009] In a further example, the endoscopic tissue fastening device can include a body extending between a proximal end and a distal end and including at least one lumen. Additionally, the endoscopic tissue fastening device can include a tissue fastening assembly disposed within the at least one lumen of the body, and the tissue fastening assembly can include a sheath coupled to the tissue fastening head via a flexible connection, an articulation joint located at a proximal end of the tissue fastening head, and a flexible joint disposed between the proximal and distal ends of a fastener cartridge of the tissue fastening head.

[0010] Examples of endoscopic tissue fastening devices may include any one or more of the following features: The flexible joint may include at least one notch or cutout disposed between and along the proximal and distal ends of the fastener cartridge; The body may include a first portion having a first cross-sectional shape and a second portion having a second cross-sectional shape different from the first cross-sectional shape, the second portion distal from the first portion and extending to the distal end face of the body; The at least one lumen terminates proximal to the distal end face of the body, and the cross-sectional shape of the first portion may be circular and the cross-sectional shape of the second portion may be D-shaped.

[0011] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and, together with the detailed description, serve to explain the principles of the invention. [Brief description of the drawings]

[0012] [Figure 1] 1 is a perspective view of an exemplary endoscopic tissue fastening device, in accordance with an aspect of the present invention; [Figure 2A] 2 illustrates a distal end of the endoscopic tissue fastening device of FIG. 1 during delivery, according to an embodiment of the present invention. [Figure 2B] 2 illustrates a distal end of the endoscopic tissue fastening device of FIG. 1 during extension, according to an embodiment of the present invention. [Figure 2C] 2 illustrates a distal end of the endoscopic tissue fastening device of FIG. 1 during articulation, according to an embodiment of the present invention. [Figure 2D] 2 illustrates a distal end of the endoscopic tissue fastening device of FIG. 1 during opening, according to an embodiment of the present invention. [Figure 2E] 2 illustrates a distal end of the endoscopic tissue fastening device of FIG. 1 during stapling of tissue, in accordance with an embodiment of the present invention. [Diagram 3] 1 is a perspective view of a staple cartridge according to an embodiment of the present invention; [Figure 4]FIG. 4 is a perspective view of a stabilizer coupled to the staple cartridge of FIG. 3 in accordance with an embodiment of the present invention; [Figure 5A] 5 is a perspective view of the stabilizer of FIG. 4 in a first position relative to a staple cartridge in accordance with an embodiment of the present invention; [Figure 5B] 5 is a perspective view of the stabilizer of FIG. 4 in a second position relative to the staple cartridge in accordance with an embodiment of the present invention; [Figure 6] 1 is a top view of an exemplary stabilization system of an endoscopic tissue fastening device, in accordance with an aspect of the present invention. [Figure 7] 1 is a top view of an exemplary flexible stapler cartridge in accordance with an aspect of the present invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The present invention relates to systems, devices and methods for joining, cutting and resecting tissue, among other aspects. Reference will now be made in detail to the aspects of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part of the device that is furthest from the user when the device is introduced into the subject's (e.g., patient's) body. In contrast, the term "proximal" refers to the part of the device that is closest to the user when the device is placed within the subject. The term "tissue fastening" may refer to, for example, stapling, securing, attaching, fastening or joining two pieces of tissue together. The term "fastener" may include staples, clips, elastic bands, sutures or any other fasteners known in the art.

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

[0015] 1 illustrates an endoscopic tissue fastening device 100, which may be a surgical stapling device configured to engage body tissue, apply a plurality of surgical fasteners to the body tissue, and form an incision in the fastened body tissue during a minimally invasive surgical procedure, such as an endoscopic procedure. Although endoscopic tissue fastening device 100 may be used to apply surgical clips or other fasteners, it will be described primarily in the context of applying staples from a staple cartridge.

[0016] As shown, the endoscopic tissue fastening device 100 extends between a proximal end and a distal end. The proximal end is provided with a handle 102 coupled to a longitudinally extending body 104. The handle 102 includes one or more actuators 106A-106F for actuating various elements of the endoscopic tissue fastening device 100, as described in further detail below. Although the device 100 may be a dedicated endoscope for flexible stapling, reference to an endoscope or endoscopy should not be construed as limiting possible applications of the disclosed embodiments. For example, the disclosed embodiments may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic instruments or devices, or other types of medical devices. Although FIG. 1 shows six separate actuators, the invention is not so limited. Rather, more or fewer actuators may be provided without departing from the scope of this application. For example, one or more of the actuators 106A-106F may be actuated to initiate multiple elements of the endoscopic tissue fastening device 100. In other words, as described in further detail below, a single actuator can be used to move the anvil 130 both away from and toward the staple cartridge 128 (or vice versa) during a stapling or tissue fastening procedure. Additionally, while the handle 102 and actuators 106A-106F are shown generally, such elements may have any suitable shape, form, and / or orientation without departing from the scope of the present invention. For example, the handle 102 is ergonomically shaped for a secure grip by a user, while the actuators 106A-106F may be any one or more of buttons, dials, rockers, sliders, etc., configured to move, deflect, bend, rotate, pivot, or adjust relative to the handle 102 and / or body 104 to actuate various elements of the endoscopic tissue fastening device 100, as described in further detail below. Additionally, actuators 106A-106F may each initiate / actuate elements of endoscopic tissue fastening device 100 via an activation wire (or the like).In other words, actuation of each actuator 106A-106F results in actuation of an activation wire (not shown) having a proximal end operably engaged to a respective actuator 106A-106F and a distal end operably engaged to a respective element of the endoscopic tissue fastening device 100. In this manner, an actuation force can be transmitted from a user at the handle 102 along the body 104 to actuate the elements of the endoscopic tissue fastening device 100.

[0017] As noted above, the proximal end of the body 104 is coupled to the handle 102, while the distal end of the body 104 terminates in a distal end face 108. In some configurations, the distal end face 108 may be the distal end face of a cap that is coupled (removably or permanently) to the distal end of the body 104.

[0018] The endoscopic tissue fastening device 100 may include one or more of an illumination device 110, an optical device 112, one or more lumens 114, and a tissue fastening assembly 116. For example, the illumination device 110 includes one or more of a fiber optic device (e.g., optical cable) or light emitting diodes (LEDs) to provide illumination light to a site within the subject's body distal to the distal end face 108. The optical device 112 may include any suitable device configured to form a visual image of a site within the subject's body. For example, the optical device 112 may include one or more optical elements (e.g., lenses, cameras, etc.). The one or more lumens 114 of the body 104 are disposed at any suitable location about the distal end face 108 and extend proximally of the handle 102. In some configurations, the one or more lumens 114 may be configured to provide irrigation and / or aspiration fluids or to deliver one or more medical devices (e.g., tissue acquisition instruments, forceps, graspers, etc.). In such a case, the one or more lumens 114 are communicated to one or more ports (not shown) of the handle 102. Such ports are then communicated to one or more irrigation and / or aspiration fluid sources for delivery via the one or more lumens 114, or configured to insert one or more medical devices therethrough for delivery via the one or more lumens 114. Additionally, the one or more lumens 114 are configured to receive one or more articulation wires (not shown), or the like, to impart selective articulation to at least the distal end of the body 104. Additionally, one or more actuators 106A-106F are configured to actuate delivery of irrigation / aspiration fluid, extension / retraction or activation of a medical device, activation of the illumination device 110, activation of the optical device 112, and / or activation / operation of one or more articulation wires to impart articulation of the body 104. For example, the actuator 106A is operably connected to one or more articulation wires such that operation of the actuator 106A effects articulation of the body 104.

[0019] As shown in FIG. 1, the body 104 includes a first portion 104A and a second portion 104B. For example, the first portion 104 encompasses a majority of the body 104 and includes the proximal end of the body 104. The second portion 104B encompasses the remaining portion of the body 104, including the distal end and the distal end face 108 of the body 104. As shown, the body 104 has a variety of exterior cross-sectional shapes and sizes. For example, the first portion 104A has a first exterior cross-sectional shape (e.g., circular) or size, while the second portion 104B has a second exterior cross-sectional shape (e.g., D-shaped) or size. In some configurations, for example, the lumen 118 in which the tissue fastening assembly 116 is disposed extends along the first portion 104A of the body 104 and terminates proximal to the second portion 104B. In other words, the lumen 118 extends only along the first portion 104A, while the second portion 104B lacks the lumen 118 and may be reduced or adjusted in shape or size, respectively. In this manner, the body 104 may define a "pocket" within which the tissue fastening assembly 116 may be disposed. In other words, the tissue fastening assembly 116 is disposed side-by-side with the body 104. For example, the central longitudinal axis L1 of the second portion 104B is disposed substantially parallel to the central longitudinal axis L2 of the tissue fastening assembly 116. Additionally, as shown in FIG. 1, the support 146 is fixedly disposed along a portion of the second portion 104B. That is, the support 146 is fixed (non-movably) relative to the second portion 104B in any suitable manner (e.g., fasteners, adhesive, etc.). The support 146 may selectively receive at least a portion of the tissue fastening assembly 116 therein to maintain alignment of the tissue fastening assembly 116 relative to the body 104, as described in further detail below. The support 146 may have any suitable shape configured to support the tissue fastening assembly 116. For example, the support 146 may be U-shaped, L-shaped, or C-shaped.

[0020] The tissue fastening assembly 116 includes a sheath 120 (FIGS. 2A-2E), a flexible connection 122, an articulation joint 124, a fastening head 134 (including a cartridge housing 126, a cartridge 128, and anvil 130), and an actuation line 132 (FIGS. 2A-2E). As described in further detail below, the tissue fastening assembly 116 may include a first unconstrained, bendable, or flexible configuration as shown in FIGs. 1 and 2A, a second constrained, reinforced, or stabilized configuration as shown in FIG. 2B, an optional third articulated or biased configuration as shown in FIG. 2C, an open configuration as shown in FIG. 2D, and a fastening configuration as shown in FIG. 2E.

[0021] As described in further detail below, manipulation of the actuation line 132 may facilitate transitioning the tissue fastening assembly 116 between the first and second configurations. The actuation line 132 is any suitable longitudinally extending member configured to impart an axial force to one or both of the fastening head 134 and the sheath 120. For example, the actuation line 132 may be a rod, wire, tube, hypotube, or the like. A proximal end of the actuation line 132 is coupled to one of the actuators 106A-106F of the handle 102. In this manner, a user may actuate the actuation line 132 via manipulating one of the actuators 106A-106F. For example, the actuation line 132 is operably coupled to the actuator 106B, and actuation of the actuator 106B may effect axial advancement or retraction of the actuation line 132, thereby effecting axial advancement or retraction of one or both of the sheath 120 and the fastening head 134, relative to the body 104, as described in further detail below.

[0022] The sheath 120 terminates at (or is coupled to) a flexible connection 122. The flexible connection 122 may facilitate flexing / bending of the tissue fastening assembly 116. For example, the flexible connection 122 may allow for bending or deflection of the fastening head 134 relative to the sheath 120. In fact, the flexible connection 122 may be fabricated from any suitable material, e.g., polymeric and / or metallic materials, and configured to enable or promote bending. That is, the flexible connection 122 may have one or more portions of reduced thickness, cutouts, grooves, notches, etc., configured to bendable. For example, as shown in FIG. 1, the flexible connection 122 includes one or more notches 140. The notches 140 may be generally V-shaped as shown in FIG. 1, although the invention is not so limited. In fact, the notches 140 may have any suitable shape configured to enable or promote bending. Additionally, although two notches 140 are shown longitudinally spaced apart and positioned on opposite sides of the flexible connection 122 (see, e.g., FIG. 2A), any number, arrangement, orientation, or size may be used without departing from the scope of the invention.

[0023] The flexible connection 122 terminates at (or is coupled to) an articulation joint 124. The articulation joint 124 may include any suitable mechanical connection configured to permit movement of the fastening head 134 relative to the body 104 (see, e.g., FIGS. 2A and 2C-E). For example, the articulation joint 124 may comprise a pivot, a hinge, and / or a ball and socket connection. The articulation joint 124 is operably coupled (e.g., via wires or the like) to one of the actuators 106A-106F, for example, 106C. Thus, manipulation of the actuator 106C may result in articulation of the fastening head 134 relative to the body 104. Alternatively, the fastening head 134 may be operably coupled (e.g., via wires or the like) to the actuator 106C such that manipulation of the actuator 106C results in articulation of the fastening head 134 relative to the body 104 via the articulation joint 124. Indeed, upon actuation of the actuator 106C, the fastening head 134 may move toward or away from the body 104. For example, the fastening head 134 may be moved (e.g., articulated at an articulated position) toward the central longitudinal axis L1 of the second portion 104B so as to be disposed in front of the distal end face 108, or moved away from the central longitudinal axis L1 of the second portion 104B so as to extend away from the distal end face 108.

[0024] As described above, the fastening head 134 collectively includes the cartridge housing 126, the cartridge 128, and the anvil 130, and is coupled to the articulation joint 124. The cartridge housing 126 is configured to receive the cartridge 128 therein. The cartridge 128 is removable from the cartridge housing 126 (e.g., the cartridge housing 126 is reloaded with a new cartridge, if necessary). However, in some examples, the cartridge 128 is integrally formed with the cartridge housing 126 and is therefore non-removable. The anvil 130 is rotatably or pivotally coupled to the cartridge housing 126. In some examples, the anvil 130 is rotatably biased toward an open configuration (FIG. 2D), e.g., biased away from the cartridge housing 126 and the cartridge 128, thereby creating a space between the anvil 130 and the cartridge housing 126 / cartridge 128. Alternatively, the anvil 130 is rotatably biased toward the fastening configuration (FIG. 2E), e.g., toward the cartridge housing 126 and cartridge 128. In either configuration, the anvil 130 can be moved toward or away from the cartridge housing 126 and cartridge 128 via actuation of one of the actuators 106A-106F, e.g., 106D. That is, upon actuation / operation of the actuator 106D, the anvil 130 can be moved toward the open configuration or moved toward the fastening configuration. That is, the anvil 130 can be rotated / pivoted about an axis to contact the cartridge housing 126 / cartridge 128 to sandwich tissue T (FIG. 2E) between the anvil 130 and the cartridge housing 126 / cartridge 128 to provide a surface against which the staples may be driven as they are expelled from the cartridge 128.

[0025] The cartridge 128 may include a plurality of surgical fasteners, such as staples, that are deployed from the cartridge 128 when under the influence of a driving force exerted by an actuation sled (not shown). A plurality of spaced longitudinal slots 150 (FIGS. 2D, 3, 5A, 5B) in the cartridge 128 allow the staples to pass through the cartridge 128 and penetrate tissue, as described in further detail below. In some examples, the actuation sled is positioned to move longitudinally proximally from a distal end of the cartridge 128 toward a proximal end of the cartridge 128 upon actuation, contacting fasteners in the cartridge 128 and pushing the fasteners through the longitudinal slots 150 to couple the fasteners to tissue. Alternatively, in some examples, the actuation sled may be configured to move longitudinally distally from a proximal end of the cartridge 128 toward a distal end of the cartridge 128 upon actuation. In either method, the actuation sled may be actuated via one of the actuators 106A-106F, for example 106E (e.g., via a wire operably connected to the actuator 106E). For example, actuation or manipulation of the actuator 106E may eject or deploy a fastener into tissue. In some examples, a single fastener extends through each slot 150. Each fastener may be partially within the slot 150 prior to deployment to aid in alignment of the fastener with the slot 150. In some examples, two (or more) actuation sleds (not shown) may be required to actuate two (or more) different longitudinal rows of fasteners within the cartridge 128.

[0026] The cartridge 128 may also include an elongated longitudinal slot 148 (FIGS. 3, 5A, 5B). The elongated longitudinal slot 148 is configured to receive or support a cutting instrument, such as a knife blade (not shown). The elongated longitudinal slot 148 is disposed on the side of the cartridge 128 and extends longitudinally from a proximal end to a distal end of the cartridge 128. The anvil 130 includes a longitudinally disposed groove (not shown) that may align with the elongated longitudinal slot 148 when the anvil 130 is in the fastening configuration (FIG. 2E), the groove being configured to receive the cutting instrument. The cutting instrument may be operably coupled to one of the actuators 106A-106F, for example, 106F. Thus, upon actuation / manipulation of the actuator 106F, the cutting instrument may be moved axially along the elongated longitudinal slot 148 and the groove to resect, slice, separate, or cut tissue. In some configurations, a common (e.g., the same) actuator may simultaneously actuate both the actuation sled and the cutting instrument, i.e., in some configurations, a single actuator, such as actuator 106E, may be used to both eject fasteners from cartridge 128 into tissue and to cut tissue disposed along elongated longitudinal slot 148.

[0027] In particular, the fastener head 134 may include a flexible joint 154 between the proximal and distal ends of the cartridge 128. That is, the fastener head 134 including the cartridge 128 may be flexible / bendable along its length (e.g., along its longitudinal axis). The joint 154 may include any one or more of a pivot, a hinge, and / or a ball and socket. In some configurations, the joint 154 may include a flexible element such that one or more portions of the fastener head 134 / cartridge 128 may be bent or deflected relative to one or more other portions of the fastener head 134 / cartridge 128. Indeed, the fastener head 134 / cartridge 128 may be fabricated from any suitable material, e.g., polymeric and / or metallic materials, and configured to enable or facilitate bending. That is, the fastener head 134 / cartridge 128 may include one or more portions of reduced thickness, cutouts, grooves, notches, etc., arranged to enable bending. For example, as shown in Figures 3, 5A and 5B, the joint 154 of the cartridge 128 may include one or more notches 156. The notches 156 are generally V-shaped as shown in Figure 3, but the invention is not so limited. Indeed, the notches 156 may have any suitable shape configured to allow or facilitate bending. Additionally, while two notches 156 are shown disposed on opposite sides of the cartridge 128, any number, arrangement, orientation or size may be used without departing from the scope of the invention. Additionally, as shown in Figure 3, one or more openings 158 or slots 160 extend from the proximal end of the cartridge 128 toward the distal end of the cartridge 128. Such openings 158 or slots 160 are configured to receive one or more actuation lines connected to one or more of the actuators 106A-106F, as described in further detail below.

[0028] In use, a user may deliver the endoscopic tissue fastening device 100 into the subject's body, for example, through the subject's tortuous natural body lumen, while the endoscopic tissue fastening device 100 is positioned in the flexible configuration (FIGS. 1 and 2A). In the flexible configuration, the tissue fastening assembly 116 may bend or deflect with the body 104 as the body 104 is articulated via manipulation of the actuator 106A coupled to one or more articulation wires. That is, as the body 104 bends and deflects during positioning within the subject's body, the tissue fastening assembly 116 bends and deflects as well. In fact, the tissue fastening assembly 116 may bend and deflect with the body 104 via one or both of the flexible connection 122 and the joint 154. As shown in FIG. 1 and FIG. 2A, at least a portion of the tissue fastening assembly 116 is supported on (e.g., by / received within) a support 146 secured to the body 104. Thus, articulation or deflection of the body 104 results in a similar movement of at least a portion of the tissue fastening assembly 116. That is, while in the flexible configuration, the tissue fastening assembly 116 maintains a generally parallel alignment between a central longitudinal axis L1 of the second portion 104B and a central longitudinal axis L2 of the tissue fastening assembly 116. In this manner, the endoscopic tissue fastening device 100 allows for increased flexibility for precise positioning and delivery of the endoscopic tissue fastening device 100 within the body of a subject.

[0029] Once the endoscopic tissue fastening device 100 is positioned at or near a target site within a subject's body, the user transitions the endoscopic tissue fastening device 100 to a stabilized configuration, as shown in FIG. 2E. The user may then actuate / manipulate the actuator 106B to move one or both of the sheath 120 and the fastening head 134 via the actuation line 132. Such actuation may be performed in two stages. In a first stage, actuation of the actuator 106B moves both the sheath 120 and the fastening head 134 axially (e.g., distally along the central longitudinal axis L2 of the tissue fastening assembly 116). Thus, in some configurations, the actuation line 132 has an engagement element (not shown) configured to interface with a corresponding engagement element (not shown) of the sheath 120 such that application of an axial force (e.g., in a distal direction) to the actuation line 132 imparts a similar axial force (e.g., in a distal direction) to the sheath 120. Additionally, because the sheath 120 is connected to the fastener head 134 via the flexible connection 122, application of an axial force to the sheath 120 imparts a similar axial force to the fastener head 134. In other words, in a first stage, actuation of the actuator 106B advances or extends both the sheath 120 and the fastener head 134 until the articulation joint 124 is located adjacent to or distal to the distal end face 108. Then, in a second stage of actuation, the engaging elements of the actuation line 132 are disengaged from the engaging elements of the sheath 120, such that actuation of the actuator 106B results in axial movement of the actuation line 132 relative to the sheath 120 and fastener head 134. In this manner, continued application of an axial force to the actuation line 132 causes the actuation line 132 to move along the sheath 120 and through the fastener head 134. For example, the actuation line 132 may be advanced axially through one or more openings 158 or slots 160 until the actuation line 132 spans the joint 154 (e.g., within the fastener head 134) (FIG. 3). However, in some configurations, the actuation line 132 may be advanced axially alongside (e.g., outside and next to) the fastener head 134.Additionally or alternatively, stabilizer 162 (FIGS. 4, 5A, 5B) is coupled to actuation line 132 such that axial advancement of actuation line 132 spans joint 154, as described in further detail below. When actuation line 132 (or stabilizer 162) is so positioned, actuation line 132 (or stabilizer 162) may prevent bending or flexing of fastener head 134 along joint 154. In other words, when actuation line 132 (or stabilizer 162) spans, covers, or extends through joint 154, fastener head 134 is stabilized such that distal portion 134B of fastener head 134 does not bend or deflect relative to proximal portion 134A of fastener head 134.

[0030] In some configurations, the engaging elements of the actuation line 132 may include radially outer protrusions, rings, etc. that may selectively engage with radially inner protrusions, rings, etc. of the sheath 120. In some configurations, one or both of the engaging elements are deflectable, bendable, or flexible to permit movement of the actuation line 132 relative to the sheath 120 and fastening head 134 during actuation (e.g., axial advancement) by bending or flexing such that the engaging elements disengage from one another upon application and / or cessation of opposing axial forces. Such opposing axial forces or cessation may occur when an abutment surface 166 (FIG. 2B) of the flexible joint 122 interacts with or abuts an edge of the support 146. Alternatively, the engaging elements may have a first radial orientation in which the engaging elements are oriented to interfere with one another, and a second radial orientation in which the engaging elements do not interfere with one another. That is, in the first radial orientation, the engaging elements of the actuation line 132 are oriented to transfer an axial force applied to the actuation line 132 to the engaging elements of the sheath 120, and in the second radial orientation, the engaging elements of the actuation line 132 are oriented such that an axial force applied to the actuation line 132 is not applied to the engaging elements of the sheath 120. In such a case, the actuation line 132 is rotated to move between the first and second radial orientations such that when the abutment surface 166 of the flexible joint 122 abuts the edge of the support 146, the user receives tactile feedback in the form of resistance, at which point the user can rotate the actuation line 132 to transition to the second radial orientation relative to the sheath 120, thereby allowing the actuation line 132 (and / or stabilizer 162) to continue advancing the joint 154 until it is stabilized.

[0031] 2C , optionally, once stabilized, a user may articulate the fastening head 134 at the articulation joint 124 to direct the fastening head 134 to any suitable location. For example, as described above, upon actuation of the actuator 106C, the fastening head 134 may be moved toward the central longitudinal axis L1 of the second portion 104B to be disposed in front of the distal end face 108, or moved away from the central longitudinal axis L1 of the second portion 104B to extend away from the distal end face 108. In a configuration in which the actuation line 132 spans the articulation joint 124, it is understood that the actuation line 132 includes a portion configured to enable articulation along the articulation joint 124. For example, the portion of the actuation line 132 that spans the articulation joint 124 may be relatively more flexible than the remaining portion of the actuation line 132. Indeed, the portion of the actuation line 132 that spans the articulation joint 124 may have one or more portions that are reduced in cross-sectional size (e.g., thinned). In this manner, the actuation line 132 provides sufficient columnar support to extend through (or alongside) the articulation joint 124 toward the fastener head 134 while still allowing articulation movement along the articulation joint 124.

[0032] Next, as shown in FIG. 2D, the anvil 130 may be moved toward or away from the cartridge housing 126 and cartridge 128 via the actuation actuator 106D. That is, upon actuation / operation of the actuator 106D, the anvil 130 may be moved toward an open configuration to form a tissue receiving space between the anvil 130 and the cartridge housing 126 / cartridge 128 to receive tissue between the anvil 130 and the cartridge housing 126 / cartridge 128 and then closed in a fastening configuration to sandwich tissue T (FIG. 2E) between the anvil 130 and the cartridge housing 126 / cartridge 128. Once so positioned, actuation or operation of the actuator 106E may eject or deploy fasteners into the tissue T. Additionally, upon actuation / operation of the actuator 106F, a resection instrument (not shown) may be moved axially along the elongated longitudinal slots 148 and grooves to resect, slice, separate, or cut tissue. As described above, a single actuator, for example actuator 106E, may be used to both eject fasteners from cartridge 128 into tissue and to cut tissue positioned along elongated longitudinal slot 148.

[0033] In a configuration in which a stabilizer 162 is used, as shown in Figures 4, 5A, and 5B, the stabilizer 162 may be advanced axially until the stabilizer 162 spans the joint 154. The stabilizer 162 may thus prevent bending or flexing of the fastener head 134 along the joint 154. For example, the joint 154 may include a notch 156, as described above. Similarly, the stabilizer 162 may include one or more notches, spaces, or notches 168. When the notch 156 is longitudinally aligned with the notch 168, as shown in Figure 5A, the cartridge 128 (or the fastener head 134) may be flexible or bendable. However, as shown in FIG. 5B, when notch 156 is not longitudinally aligned with notch 168 (e.g., when a solid, rigid, or unnotched portion of stabilizer 162 straddles notch 156), cartridge 128 (or fastener head 134) is prevented from bending or flexing. Thus, cartridge 128 (or fastener head 134) may be considered stabilized. Additionally, as shown in FIG. 4, cartridge 128 and / or cartridge housing 126 may include guide slots, grooves, or channels 170 configured to receive protrusions or posts (not shown) of stabilizer 162 to maintain alignment between stabilizer 162 and cartridge 128 and / or cartridge housing 126 during advancement and retraction of stabilizer 162. It will be appreciated that in further configurations, the cartridge 128 and / or cartridge housing 126 may include posts, while the stabilizer 162 may include channels 170, without departing from the scope of the present invention.

[0034] FIG. 6 is a top view of an exemplary stabilizer of the endoscopic stapling apparatus 200. The endoscopic stapling apparatus 200 is similar to the endoscopic tissue fastening apparatus 100, and thus like components are referred to herein with like reference numerals, plus 100. For example, as shown in FIG. 6, the support 146 and the stabilizer 162 may be replaced with a stabilization system 262. The stabilization system 262 includes a first portion 262A and a second portion 262B. The first portion 262A is disposed distally from the second portion 262B. For example, the first portion 262A is spaced apart from the second portion 262B by a distance X. Additionally, the first portion 262A may be selectively coupled to the second portion 204B of the body 204. For example, the first portion 262A may include a connection element 264 configured to cooperate within a connection recess 266 of the second portion 204B of the body 204. As shown in FIG. 6, the connection element 264 may include a protrusion, post, extension, or the like extending radially outward of the first portion 262A, while the connection recess 266 may be an indent, channel, groove, or notch extending radially into the second portion 204B of the body 204. The first portion 262A of the stabilizer system 262 may be selectively coupled to the second portion 204B of the body 204 through an interaction between the connection element 264 and the connection recess 266. So coupled, when an axial force in direction A is applied to the fastener head 234 / cartridge 228, resistance between the connection element 264 and the connection recess 266 may permit movement of the fastener head 234 / cartridge 228 relative to the first portion 262A. In contrast, the second portion 262B of the stabilizer system 262 may be secured to the fastener head 234 / cartridge 228 in any suitable manner for movement therewith. Thus, when an axial force in direction A is applied to the fastener head 234 / cartridge 228, the second portion 262B of the stabilizer system 262 may be moved in direction A as well.

[0035] When advanced in direction A, the fastening head 234 / cartridge 228, together with the second portion 262B of the stabilizer system 262, is advanced toward the first portion 262A, thereby decreasing the distance X between the first portion 262A and the second portion 262B. However, if the distance X is equal to a value of zero (e.g., if there is no space between the first portion 262A and the second portion 262B), continued application of force in direction A will result in a similar force on the first portion 262A. That is, the surface (e.g., the distal end face) of the second portion 262B abuts or contacts the proximal end face of the first portion 262A, and application of force in direction A may result in the first portion 262A being pushed or advanced in direction A. If the force in direction A is sufficient, it may overcome the resistance between the connecting element 264 and the connecting recess 266. That is, the connection element 264 may be deflected or bent away from the connection recess 266 or removed from the connection recess 254. Thus, the first portion 262A may no longer be coupled to the second portion 204B of the body 204, and may instead move with the fastener head 234 / cartridge 228 along with the second portion 262B of the stabilizer system 262. However, when the first and second portions 262A, 262B of the stabilizer system contact / abut one another, the stabilizer system 262 is positioned to span (e.g., cover) the joint 254 along the fastener head 234 / cartridge 228. In this manner, the stabilization system 262 may stabilize the fastener head 234 / cartridge 228.

[0036] 7 is a top view of an exemplary flexible staple cartridge 328, in accordance with an embodiment of the present invention. The staple cartridge 328 may be constructed from any suitable elastomeric, polymeric, or otherwise flexible material to allow the staple cartridge 328 to flex laterally during insertion or positioning into the subject's body. Additionally, the staple cartridge 328 may include a liner 352 lining each of the one or more slots 350 of the staple cartridge 328. The liner 352 may be fabricated from a relatively rigid material to maintain the shape of the one or more slots 350 and may house or protect one or more staples and / or firing pistons disposed within the one or more slots 350. In other words, the staple cartridge 328 itself may be flexible or bendable, but the liner 352 may be substantially incompressible to support the one or more slots 350 during the stapling procedure.

[0037] The endoscopic tissue fastening devices 100, 200 may be disposable for a single use or may be equipped for multiple uses. For example, in some configurations, the endoscopic tissue fastening devices 100, 200 may be sterile, single-use devices, while in other configurations, the endoscopic tissue fastening devices 100, 200 may be reusable.

[0038] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as illustrative only.

Claims

1. a body having a first portion and a second portion disposed alongside the first portion, the second portion extending distally from the first portion and terminating at a distal end surface of the body; a tissue fastener assembly having a fastener head with a proximal end and a distal end, the fastener head being deflectable at a location between the proximal end and the distal end of the fastener head, the tissue fastener assembly being received within a lumen of the body; Equipped with the body is movable between a non-articulated configuration and an articulated configuration, and in the articulated configuration, a central longitudinal axis of the second portion of the body is parallel to a central longitudinal axis of the tissue fastening assembly; Endoscopic tissue fastening device.

2. The endoscopic tissue fastening device of claim 1 , wherein the lumen terminates proximally of the distal end face.

3. The endoscopic tissue fastening device according to any one of claims 1 to 2, wherein the first portion has a circular cross-sectional shape, and the second portion has a D-shaped cross-sectional shape.

4. The endoscopic tissue fastening device of any one of claims 1 to 3, wherein the tissue fastening assembly includes a flexible configuration and a stabilizing configuration.

5. The endoscopic tissue fastening device of claim 4 , wherein in the articulated configuration of the body, the tissue fastening assembly is disposed in the flexible configuration.

6. The endoscopic tissue fastening device of claim 4 or 5, wherein in the stabilized configuration, the fastening head of the tissue fastening assembly extends distally from the distal end face of the body.

7. 7. The endoscopic tissue fastening device of claim 4, wherein in the stabilized configuration, the fastener head of the tissue fastening assembly is articulatable along a proximal articulation joint of the fastener head such that the central longitudinal axis of the tissue fastening assembly is movable toward or away from the central longitudinal axis of the second body portion.

8. The endoscopic tissue fastening device of any one of claims 4 to 7, wherein the tissue fastening assembly includes a staple cartridge, and in the flexible configuration, at least a portion of the staple cartridge distal to the site is deflectable relative to another portion of the staple cartridge proximal to the site.

9. The endoscopic tissue fastening device of claim 8 , wherein the staple cartridge includes at least one flexible joint between a proximal end of the staple cartridge and a distal end of the staple cartridge.

10. 5. The endoscopic tissue fastening device of claim 4, further comprising a support disposed along the second portion of the body, wherein in the articulated configuration a distal end of the tissue fastening assembly is received within the support.

11. The endoscopic tissue fastening device of claim 10 , wherein at least a portion of the tissue fastening assembly is axially movable relative to the support.

12. The endoscopic tissue fastening device of claim 10 , wherein in the stabilized configuration, a flexible connection of the tissue fastening assembly is received within and prevented from flexing by the support.

13. 2. The endoscopic tissue fastening device of claim 1, wherein the tissue fastening assembly includes a sheath coupled to an articulation joint via a flexible connection, the flexible connection including at least one notch therein, and the tissue fastening assembly includes a staple cartridge distal from the articulation joint.

14. a stabilizer movably coupled to a staple cartridge of the tissue fastening assembly; The endoscopic tissue fastening device of claim 1 further comprising:

15. 15. The endoscopic tissue fastening device of claim 14, wherein in a first position, the stabilizer allows bending of the staple cartridge along a joint of the staple cartridge, and in a stabilized configuration, the stabilizer spans the joint of the staple cartridge to prevent bending of the staple cartridge along the joint.

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