Patent Description:
Tissue fastening (e.g., stapling) is used in many laparoscopic procedures. These procedures often involve resecting portions or sections of tissue, followed by closing using staples. An example of a common procedure would be colorectal anastomosis. In hybrid surgeries where physicians use laparoscopic and endoscopic platforms to conduct a procedure, a rigid stapler is often used. Linear staplers include long rigid members which are incapable of being navigated through tortuous anatomy without causing trauma to the tissue. Physicians also are moving towards endoscopic, outpatient procedures, which would require endoscopic stapling. <CIT> discloses a device for surgical interventions which comprises (i) an inner end guidable/steerable to an operation field, (ii) an outer end operated by user and (iii) a middle part which connects both ends together. Force transmission units extend between the outer end and the inner end. The force transmission units, the outer and the inner ends and the middle part transfer movements of the outer end to the inner end in an identical measure, as if the inner end was a straight continuation of the outer end. <CIT> discloses apparatus and methods for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies, as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites, are also provided.

It is with the above considerations in mind that the improvements of the present disclosure may be useful.

Aspects of the present disclosure relate to, among other things, systems, devices, and methods for fastening tissue, e.g., a flexible endoscope platform with stapling capability. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

The claimed invention is defined by appended independent claim <NUM>, with further embodiments of the claimed invention being described by the appended dependent claims.

According to the claimed invention, an endoscopic tissue fastening device includes a body having a first portion and a second portion arranged alongside the first portion. The second portion extends distally of the first portion and terminates in a distal end face of the body. The device further includes a tissue fastening assembly having a fastening head with a proximal end and a distal end. The fastening head is deflectable at a location between the proximal end and the distal end of the fastening head. The tissue fastening assembly is received within a lumen of the body. Further, the body is moveable between an unarticulated configuration and an articulated configuration. In the articulated configuration, a central longitudinal axis of the second portion of the body is substantially parallel with a central longitudinal axis of the tissue fastening assembly. The claimed endoscopic tissue fastening device further comprises a stabilizer moveably coupled to a staple cartridge of the tissue fastening assembly, wherein in a first position, the stabilizer permits bending of the staple cartridge along a joint of the staple cartridge, and in a second position, the stabilizer spans the joint of the staple cartridge so as to prevent bending of the staple cartridge along the joint.

The claimed endoscopic tissue fastening device may further include any one or more of the following features. The lumen may terminate proximally of the distal end face. A cross-sectional shape of the first portion may be circular, and a cross-sectional shape of the second portion may be D-shaped. The tissue fastening assembly may include a flexible configuration and a stabilized configuration. In the articulated configuration of the body, the tissue fastening assembly may be arranged in the flexible configuration. In the stabilized configuration, the fastening head of the tissue fastening assembly may extend distally of the distal end face of body. In the stabilized configuration, the fastening head of the tissue fastening assembly may be articulatable along an articulation joint proximal of the fastening head such that the central longitudinal axis of the tissue fastening assembly may be movable towards or away from the central longitudinal axis of the second portion of the body. In the flexible configuration, at least a portion of the staple cartridge distal of the location may be deflected relative to another portion of the staple cartridge proximal of the location. 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. A support may be positioned along the second portion of the body, and 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 moveable relative to the support. In the stabilized configuration, a flexible connection of the tissue fastening assembly may be received within the support and may be prevented from flexing by the support. The tissue fastening assembly may include a sheath coupled to an articulation joint via a flexible connection, the flexible connection may include at least one notch therein, and the tissue fastening assembly may include the staple cartridge distal of the articulation joint.

A method of endoscopic tissue fastening may include 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, wherein in the flexible configuration, a first portion of a tissue fastening cartridge is moveable relative to a second portion of the tissue fastening cartridge, and wherein 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 may include ejecting one or more tissue fasteners from the tissue fastening cartridge to fasten tissue.

Examples of the method may include any one or more of the following features. The method may include, during the articulating the endoscopic tissue fastening device, the tissue fastening assembly may be arranged in the flexible configuration at a distal end of the tissue fastening device. The method may further include, in the stabilized configuration, articulating the tissue fastening cartridge relative to the endoscopic tissue fastening device.

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

Examples of the endoscopic tissue fastening device may include any one or more of the following features. The flexible joint may be positioned between the proximal end and the distal end of the fastener cartridge and may include at least one notch or cutout along the fastener cartridge. The body may include a first portion with a first cross-sectional shape and a second portion with a second cross-sectional shape different than the first cross-sectional shape, and the second portion may be distal of the first portion and extends to a distal end face of the body. The at least one lumen may terminate proximally of the distal end face of the body, the cross-sectional shape of the first portion may be circular, and the cross-sectional shape of the second portion may be D-shaped.

It may 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 which is defined by the appended set of claims, as already mentioned.

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

The present disclosure is drawn to systems, devices, and methods for coupling, cutting, and resecting tissue, among other aspects. Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient). By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject. The term "tissue fastening" may refer, for example, to stapling, fixing, attaching, fastening, or otherwise joining two portions of tissue together. The term "fastener" may include staples, clips, elastic bands, suture, or any other fastener known in the art.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "having," "including," or 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 does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example," rather than "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of the stated value unless otherwise stated.

<FIG> illustrates an endoscopic tissue fastening device <NUM> which may be a surgical stapling apparatus configured to engage body tissue, apply a plurality of surgical fasteners thereto, and form an incision in the fastened body tissue during minimally invasive surgical procedures, such as endoscopic procedures. Endoscopic tissue fastening device <NUM> may be used to apply surgical clips or other fasteners, but will be primarily discussed in the context of applying staples from a staple cartridge.

As shown, endoscopic tissue fastening device <NUM> extends between a proximal end and a distal end. At the proximal end is a handle <NUM> coupled to a longitudinally extending body <NUM>. Handle <NUM> may include one or more actuators 106A-106F for actuating various features of endoscopic tissue fastening device <NUM>, as will be described in further detail below. Although device <NUM> may be a dedicated endoscope for flexible stapling, reference to endoscopes or endoscopy should not be construed as limiting the possible applications of the disclosed aspects. For example, the disclosed aspects may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices. While <FIG> illustrates six distinct actuators, the disclosure 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 actuators 106A-106F may be actuated to initiate multiple features of endoscopic tissue fastening device <NUM>. In other words, a single actuator could be used to move an anvil <NUM> both away from and toward a staple cartridge <NUM> (or vice versa) during a stapling or tissue fastening procedure, as will be described in further detail below. Additionally, while handle <NUM> and actuators 106A-106F are illustrated schematically, such features may have any appropriate shape, configuration, and/or orientation without departing from the scope of the present disclosure. For example, handle <NUM> may be ergonomically shaped to promote secure grip by a user, while actuators 106A-106F may be any one or more of buttons, dials, rockers, sliders, etc., configured to move, deflect, bend, rotate, pivot, or otherwise be adjusted relative to handle <NUM> and/or body <NUM> to actuate various features of endoscopic tissue fastening device <NUM>, as will be described in further detail below. Additionally, it is understood that each of actuators 106A-106F may initiate/actuate features of endoscopic tissue fastening device <NUM> via an activation wire (or the like). In other words, actuation of each actuator 106A-106F may result in actuation of an activation wire (not shown) having a proximal end operatively engaged with the respective actuator 106A-106F and a distal end operatively engaged with the respective feature of endoscopic tissue fastening device <NUM>. In such a manner, an activating force may be transmitted from a user at handle <NUM> along body <NUM>, so as to actuate features of endoscopic tissue fastening device <NUM>.

As noted above, the proximal end of body <NUM> may be coupled to handle <NUM> while a distal end of body <NUM> may terminate in a distal end face <NUM>. In some arrangements, distal end face <NUM> may be a distal end face of a cap coupled (either removably or permanently) to the distal end of body <NUM>.

Endoscopic tissue fastening device <NUM> may include one or more of an illumination device <NUM>, an optics device <NUM>, one or more lumens <NUM>, and a tissue fastening assembly <NUM>. For example, illumination device <NUM> may include one or more of a fiber optic device (e.g., a light cable) or a light-emitting diode (LED) so as to provide illumination light to a location within a body of a subject distal of distal end face <NUM>. Optics device <NUM> may include any appropriate device configured to provide a visual image of an internal location of the body of the subject. For example, optics device <NUM> may include one or more optical elements (e.g., lens, cameras, etc.). The one or more lumens <NUM> of body <NUM> may be arranged at any appropriate location about distal end face <NUM> and extend proximally to handle <NUM>. In some arrangements, the one or more lumens <NUM> may be arranged to provide irrigation and/or aspiration fluid and/or may be arranged to deliver one or more medical devices (e.g., a tissue acquisition tool, forceps, graspers, etc.) In such cases, the one or more lumens <NUM> may be fluidly coupled to one or more ports (not shown) of handle <NUM>. Such ports may be, in turn, fluidly coupled to one or more sources of irrigation and/or aspiration fluid for delivery via the one or more lumens <NUM>, and/or arranged for insertion of the one or more medical devices therethrough for delivery via the one or more lumens <NUM>. Further, the one or more lumens <NUM> may be arranged to receive one or more articulation wires (not shown) or the like for imparting selective articulation to at least the distal end of body <NUM>. Additionally, one or more of actuators 106A-106F may be arranged to actuate delivery of irrigation/aspiration fluid, extension/retraction or activation of the medical device, activation of illumination device <NUM>, activation of optics device <NUM>, and/or activation/manipulation of one or more articulation wires to impart articulation of body <NUM>. For example, actuator 106A may be operably connected to one or more articulation wires such that manipulation of actuator 106A results in articulation of body <NUM>.

As shown in <FIG>, body <NUM> may include a first portion 104A and a second portion 104B. For example, first portion <NUM> may encompass a majority of body <NUM>, and include the proximal end of body <NUM>. Second portion 104B may encompass a remainder of body <NUM>, including the distal end and distal end face <NUM> of body <NUM>. As shown, body <NUM> may have a varied exterior cross-sectional shape and/or size. For example, first portion 104A may have a first exterior cross-sectional shape (e.g., circular) or size, while second portion 104B may have a second exterior cross-sectional shape (e.g., D-shaped) or size. In some arrangements, for example, a lumen <NUM>, in which tissue fastening assembly <NUM> is arranged, may extend along first portion 104A of body <NUM> and terminate proximally of second portion 104B. Said differently, lumen <NUM> may extend along only first portion 104A, and therefore, second portion 104B may be reduced and/or adjusted in shape or size, respectively, due to the absence of lumen <NUM>. In such a manner, body <NUM> may define a "pocket" within which tissue fastening assembly <NUM> may be arranged. In other words, tissue fastening assembly <NUM> may be positioned alongside body <NUM>. For example, a central longitudinal axis L1 of second portion 104B may be arranged substantially parallel to a central longitudinal axis L2 of tissue fastening assembly <NUM>. Additionally, as shown in <FIG>, a support <NUM> may be fixedly arranged along a portion of second portion 104B. That is, support <NUM> may be secured (so as to not be moveable) relative to second portion 104B in any appropriate manner (e.g., fasteners, adhesives, etc.). Support <NUM> may selectively receive at least a portion of tissue fastening assembly <NUM> therein to maintain an alignment of tissue fastening assembly <NUM> relative to body <NUM>, as will be discussed in further detail below. Support <NUM> may have any appropriate shape configured to support tissue fastening assembly <NUM>. For example, support <NUM> may be U-shaped, L-shaped, or C-shaped.

Tissue fastening assembly <NUM> may include a sheath <NUM> (<FIG>), a flexible connection <NUM>, an articulation joint <NUM>, a fastening head <NUM> (including a cartridge housing <NUM>, a cartridge <NUM>, and an anvil <NUM>), and an actuation line <NUM> (<FIG>). As discussed in further detail below, tissue fastening assembly <NUM> may include a first unrestrained, bendable, or otherwise flexible configuration as shown in <FIG> and <FIG>, a second restrained, stiffened, or otherwise stabilized configuration as shown in <FIG>, an optional third articulated or deflected configuration as shown in <FIG>, an open configuration as shown in <FIG>, and a fastening configuration as shown in <FIG>.

As will be described in further detail below, manipulation of actuation line <NUM> may facilitate transitioning tissue fastening assembly <NUM> between the first configuration and the second configuration. Actuation line <NUM> may be any appropriate longitudinally extending member configured to impart an axial force on one or both of the fastening head <NUM> and sheath <NUM>. For example, actuation line <NUM> may be a rod, wire, tube, hypotube, etc. A proximal end of actuation line <NUM> may be coupled to one of actuators 106A-106F of handle <NUM>. In such a manner, a user may actuate actuation line <NUM> via manipulation of the one of actuators 106A-106F. For example, actuation line <NUM> may be operatively coupled to actuator 106B, and actuation of actuator 106B may result in axial advancement or retraction of actuation line <NUM>, thereby resulting in axial advancement or retraction of one or both sheath <NUM> and fastening head <NUM> relative to body <NUM>, as will be described in further detail below.

Sheath <NUM> may terminate in (or be coupled to) flexible connection <NUM>. Flexible connection <NUM> may facilitate flexing/bending of tissue fastening assembly <NUM>. For example, flexible connection <NUM> may permit bending or deflecting of fastening head <NUM> relative to sheath <NUM>. Indeed, flexible connection <NUM> may be made of any appropriate material, e.g., a polymeric and/or a metallic material, and may be configured to permit or promote bending. That is, flexible connection <NUM> may have one or more portions of reduced thickness, cut-outs, grooves, notches, or the like arranged to permit bending. For example, as shown in <FIG>, flexible connection <NUM> may include one or more notches <NUM>. Notches <NUM> may be generally v-shaped, as shown in <FIG>, although the disclosure is not so limited. Indeed, notches <NUM> may have any appropriate shape configured to permit or promote bending. Additionally, while two notches <NUM> longitudinally spaced apart and arranged on opposing sides of flexible connection <NUM> are shown (see, e.g., <FIG>), any number, arrangement, orientation, or size may be used without departing from the scope of the present disclosure.

Flexible connection <NUM> may terminate in (or be coupled to) articulation joint <NUM>. Articulation joint <NUM> may include any appropriate mechanical connection configured to permit movement of fastening head <NUM> relative to body <NUM> (see, e.g., <FIG>, and <FIG>). For example, articulation joint <NUM> may comprise a pivot, hinge, and/or ball and socket connection. Articulation joint <NUM> may be operatively coupled (e.g., via a wire or the like) to one of actuators 106A-106F, e.g., 106C. Accordingly, manipulation of actuator 106C may result in articulation of fastening head <NUM> relative to body <NUM>. Alternatively, fastening head <NUM> may be operatively coupled (e.g., via a wire or the like) to actuator 106C such that manipulation of actuator 106C may result in articulation of fastening head <NUM> relative to body <NUM> via articulation joint <NUM>. Indeed, upon actuation of actuator 106C, fastening head <NUM> may move toward or away from body <NUM>. For example, fastening head <NUM> may move (e.g., articulate at an articulation location) toward the central longitudinal axis L1 of second portion 104B so as to be arranged in front of distal end face <NUM>, and/or may be moved away from central longitudinal axis L1 of second portion 104B to so as to extend away from distal end face <NUM>.

As noted above, fastening head <NUM> collectively includes cartridge housing <NUM>, cartridge <NUM>, and anvil <NUM>, and may be coupled to articulation joint <NUM>. Cartridge housing <NUM> may be arranged so as to receive cartridge <NUM> therein. Cartridge <NUM> may be removable from cartridge housing <NUM> (e.g., cartridge housing <NUM> may be reloaded with a new cartridge, if needed). In some examples, however, cartridge <NUM> may be integrally formed in cartridge housing <NUM>, and therefore, non-removable. Anvil <NUM> may be rotatably or pivotably coupled to cartridge housing <NUM>. In some examples, anvil <NUM> may be rotatably biased toward the open configuration (<FIG>), e.g., biased away from cartridge housing <NUM> and cartridge <NUM>, thereby creating a space between the anvil <NUM> and cartridge housing <NUM>/cartridge <NUM>. Alternatively, anvil <NUM> may be rotatably biased toward the fastening configuration (<FIG>), e.g., biased toward the cartridge housing <NUM> and cartridge <NUM>. In either arrangement, anvil <NUM> may be moved toward or away from cartridge housing <NUM> and cartridge <NUM> via actuation of one of actuators 106A-106F, e.g., 106D. That is, upon actuation/manipulation of actuator 106D, anvil <NUM> may move toward the open configuration and/or move toward the fastening configuration. That is, anvil <NUM> may be rotated/pivoted about an axis so as to contact cartridge housing <NUM>/cartridge <NUM> to pinch tissue T (<FIG>) between anvil <NUM> and cartridge housing <NUM>/cartridge <NUM>, so as to provide a surface for which staples may be driven into when ejected from cartridge <NUM>.

Cartridge <NUM> may contain a plurality of surgical fasteners, such as staples, and the fasteners may be deployed from cartridge <NUM> when under the influence of a driving force exerted by an actuation sled (not shown). A plurality of spaced apart longitudinal slots <NUM> (<FIG>, <FIG>) in cartridge <NUM> may permit staples to pass through cartridge <NUM> and pierce tissue, as will be described in further detail below. In some examples, the actuation sled may be arranged to move proximally in a longitudinal direction from a distal end of cartridge <NUM> toward a proximal end of cartridge <NUM> when actuated, contacting fasteners within cartridge <NUM> and pushing the fasteners through longitudinal slots <NUM> in order to couple fasteners to tissue. Alternatively, in some examples, the actuation sled may be arranged to move distally in a longitudinal direction from a proximal end of cartridge <NUM> toward a distal end of cartridge <NUM> when actuated. In either manner, actuation sled may be actuated via one of actuators 106A-106F, e.g., 106E (via a wire or the like operatively connected to actuator 106E). For example, actuation or manipulation of actuator 106E may eject or deploy fasteners into tissue. In some examples, a single fastener may extend through each slot <NUM>. Each fastener may be partially within slot <NUM> prior to deployment to assist with alignment of the fastener with the slot <NUM>. In some examples, two (or more) actuation sleds (not shown) may be required to actuate two (or more) different longitudinal rows of fasteners in cartridge <NUM>.

Cartridge <NUM> may also include an elongate longitudinal slot <NUM> (<FIG>). The elongate longitudinal slot <NUM> may be configured to receive and/or support a resecting tool, such as a knife blade (not shown). The elongate longitudinal slot <NUM> may be positioned on a side of cartridge <NUM> and may run longitudinally from the proximal end to the distal end of cartridge <NUM>. Anvil <NUM> may include a groove (not shown) positioned longitudinally that may align with elongated longitudinal slot <NUM> when anvil <NUM> is in the fastening configuration (<FIG>) and such groove may be configured to receive the resecting tool. The resecting tool may be operably coupled to one of actuators 106A-106F, e.g., 106F. As such, upon actuation/manipulation of actuator 106F, the resecting tool may be axially translated along elongate longitudinal slot <NUM> and the groove to resect, slice, separate, or otherwise cut tissue. In some arrangements, a common (e.g., same) actuator may simultaneously actuate both the actuating sled and the resecting tool. That is, in some arrangements, a single actuator, e.g., actuator 106E may be used to both eject fasteners from cartridge <NUM> into tissue and to sever tissue positioned along elongated longitudinal slot <NUM>.

Notably, fastening head <NUM> may include a flexible joint <NUM> between a proximal end and a distal end of cartridge <NUM>. That is, fastening head <NUM>, including cartridge <NUM>, may be flexible/bendable along a length thereof (e.g., along a longitudinal axis thereof). Joint <NUM> may include any one or more of a pivot, hinge, and/or ball and socket. In some arrangements, joint <NUM> may include a flexible feature so as to permit bending or deflecting one or more portions of fastening head <NUM>/cartridge <NUM> relative to one or more other portions of fastening head134 /cartridge <NUM>. Indeed, fastening head <NUM>/cartridge <NUM> may be made of any appropriate material, e.g., a polymeric and/or a metallic material, and may be configured to permit or promote bending. That is, fastening head <NUM>/cartridge <NUM> may include one or more portions of reduced thickness, cut-outs, grooves, notches, or the like arranged to permit bending. For example, as shown in <FIG>, joint <NUM> of cartridge <NUM> may include one or more notches <NUM>. Notches <NUM> may be generally v-shaped, as shown in <FIG>, although the disclosure is not so limited. Indeed, notches <NUM> may have any appropriate shape configured to permit or promote bending. Additionally, while two notches <NUM> arranged on opposing sides of cartridge <NUM> are shown, any number, arrangement, orientation, or size may be used without departing from the scope of the present disclosure. Additionally, as shown in <FIG>, one or more openings <NUM> or slots <NUM> may extend from a proximal end of cartridge <NUM> towards a distal end of cartridge <NUM>. Such openings <NUM> or slots <NUM> may be arranged to receive one or more actuation lines coupled to one or more of actuators 106A-106F, as will be described in further detail below.

In use, a user may deliver endoscopic tissue fastening device <NUM> into the body of the subject, e.g., via a tortuous natural body lumen of the subject, while the endoscopic tissue fastening device <NUM> is arranged in the flexible configuration (<FIG> and <FIG>). In the flexible configuration, as body <NUM> is articulated via manipulation of actuator 106A coupled to one or more articulation wires, tissue fastening assembly <NUM> may bend or deflect with body <NUM>. That is, as body <NUM> bends and deflects during positioning within the body of the subject, so too does the tissue fastening assembly <NUM>. Indeed, tissue fastening assembly <NUM> may bend and deflect with body <NUM> via one or both of flexible connection <NUM> and joint <NUM>. As shown in <FIG> and <FIG>, at least a portion of tissue fastening assembly <NUM> is supported (e.g., received by/within) support <NUM> secured to body <NUM>. As such, articulation or deflection of body <NUM> will result in likewise movement of at least a portion of tissue fastening assembly <NUM>. That is, while in the flexible configuration, tissue fastening assembly <NUM> may maintain generally parallel alignment between the central longitudinal axis L1 of second portion 104B and the central longitudinal axis of L2 of tissue fastening assembly <NUM>. In such a manner, endoscopic tissue fastening device <NUM> permits increased flexibility for precise positioning and delivery of endoscopic tissue fastening device <NUM> within the body of the subject.

Once endoscopic tissue fastening device <NUM> is positioned at or near a target location within the body of the subject, a user may transition the endoscopic tissue fastening device <NUM> to the stabilized configuration, as shown in <FIG>. As such, a user may activate/manipulate actuator 106B to move one or both of sheath <NUM> and fastening head <NUM> via actuation line <NUM>. Such actuation may be performed in two stages. In a first stage, actuation of actuator 106B may move both sheath <NUM> and fastening head <NUM> axially (e.g., distally along central longitudinal axis L2 of tissue fastening assembly <NUM>). Accordingly, in some arrangements, actuation line <NUM> may have an engagement feature (not shown) configured to interface with a corresponding engagement feature (not shown) of sheath <NUM> such that application of an axial force (e.g., in the distal direction) to actuation line <NUM> imparts a likewise axial force (e.g., in the distal direction) to sheath <NUM>. Moreover, as sheath <NUM> is connected to fastening head <NUM> via flexible connection <NUM>, application of an axial force to sheath <NUM> results in a likewise axial force being applied to fastening head <NUM>. Said differently, in the first stage, actuation of actuator 106B may advance or extend both of sheath <NUM> and fastening head <NUM> until articulation joint <NUM> is located adjacent distal end face <NUM> or distal of distal end face <NUM>. Next, in a second stage of actuation, the engagement feature of actuation line <NUM> may be disengaged from the engagement feature of sheath <NUM> such that actuation of actuator 106B may result in axial movement of actuation line <NUM> relative to sheath <NUM> and fastening head <NUM>. In such a manner, continued application of the axial force to actuation line <NUM> may result in actuation line <NUM> moving along sheath <NUM> and through fastening head <NUM>. For example, actuation line <NUM> may be axially advanced through the one or more openings <NUM> or slots <NUM> (<FIG>) until actuation line <NUM> spans joint <NUM> (e.g., within fastening head <NUM>). In some arrangements, however, actuation line <NUM> may be axially advanced alongside (e.g., outside of and next to) fastening head <NUM>. In embodiments according to the invention a stabilizer <NUM> (<FIG>) may be coupled to actuation line <NUM> such that axial advancement of the actuation line <NUM> results in stabilizer <NUM> spanning joint <NUM>, as will be described in further detail below. Once actuation line <NUM> (or stabilizer <NUM>) is so positioned, actuation line <NUM> (or stabilizer <NUM>) may prevent bending or flexing of fastening head <NUM> along joint <NUM>. Said differently, once actuation line <NUM> (or stabilizer <NUM>) spans, covers, or extends through joint <NUM>, fastening head <NUM> may be stabilized such that a distal portion 134B of fastening head <NUM> does not bend or deflect relative to proximal portion 134A of fastening head <NUM>.

In some arrangements, the engagement feature of actuation line <NUM> may include a radially outward protrusion, ring, or the like that may selectively engage with a radially inward protrusion, ring, or the like of sheath <NUM>. In some arrangements, one or both of the engagement features may be deflectable, bendable, or otherwise flexible such that during actuation (e.g., axial advancement), upon the application of an opposing axial force and/or stop, the engagement features may bend or flex so as to disengage from one another, thereby permitting movement of actuation line <NUM> relative to sheath <NUM> and fastening head <NUM>. Such an opposing axial force or stop may be experienced when an abutment surface <NUM> (<FIG>) of flexible joint <NUM> interacts or abuts an edge of support <NUM>. Alternatively, the engagement features may have a first radial orientation in which the engagement features are orientated to interfere with one another, and a second radial orientation in which the engagement features do not interfere with one another. That is, in the first radial orientation, the engagement feature of the actuation line <NUM> may be oriented so as to transmit an axial force imparted on the actuation line <NUM> to the engagement feature of sheath <NUM>, and in the second radial orientation, the engagement feature of the actuation line <NUM> may be oriented so such that an axial force imparted on the actuation line <NUM> is not imparted to the engagement feature of sheath <NUM>. In such cases, actuation line <NUM> may be rotated so as to move between the first radial orientation and the second radial orientation, and when the abutment surface <NUM> of flexible joint <NUM> interacts or abuts with an edge of support <NUM>, the user may receive tactile feedback in the form of resistance at which point, the user may rotate the actuation line <NUM> relative to the sheath <NUM> to transition to the second radial orientation, thereby permitting actuation line <NUM> (and/or stabilizer <NUM>) to continue advancing until joint <NUM> has been stabilized.

As shown in <FIG>, optionally, once stabilized, the user may articulate fastening head <NUM> at articulation joint <NUM> to direct fastening head <NUM> in any appropriate position. For example, as noted above, upon actuation of actuator 106C, fastening head <NUM> may move toward the central longitudinal axis L1 of second portion 104B so as to be arranged in front of distal end face <NUM>, and/or may be moved away from central longitudinal axis L1 of second portion 104B to so as to extend away from distal end face <NUM>. In arrangements in which actuation line <NUM> spans across articulation joint <NUM>, it is understood that actuation line <NUM> may include a portion configured to permit articulation along articulation joint <NUM>. For example, the portion of actuation line <NUM> spanning articulation joint <NUM> may be relatively more flexible than a remainder of actuation line <NUM>. Indeed, the portion of actuation line <NUM> spanning articulation joint <NUM> may have one or more portions of reduced cross-sectional size (e.g., may be thinned). In such a manner, actuation line <NUM> provides sufficient columnar support so as to extend through (or alongside) articulation joint <NUM> and toward fastening head <NUM> while still permitting articulation along articulation joint <NUM>.

Next, as shown in <FIG>, anvil <NUM> may be moved toward or away from cartridge housing <NUM> and cartridge <NUM> via actuation actuator 106D. That is, upon actuation/manipulation of actuator 106D, anvil <NUM> may move toward the open configuration to form a tissue receiving space between anvil <NUM> and cartridge housing <NUM>/cartridge <NUM>, and after receiving tissue therebetween, may be closed so as to pinch tissue T (<FIG>) between anvil <NUM> and cartridge housing <NUM>/cartridge <NUM> in the fastening configuration. Once so arranged, actuation or manipulation of actuator 106E may eject or deploy fasteners into tissue T. Additionally, upon actuation/manipulation of actuator 106F, the resecting tool (not shown) may be axially translated along elongate longitudinal slot <NUM> and the groove to resect, slice, separate, or otherwise cut tissue. As noted above, a single actuator, e.g., actuator 106E may be used to both eject fasteners from cartridge <NUM> into tissue and to sever tissue positioned along elongated longitudinal slot <NUM>.

In arrangements in which stabilizer <NUM> is used, as shown in <FIG>, stabilizer <NUM> may be axially advanced until stabilizer <NUM> spans joint <NUM>. As such, stabilizer <NUM> may prevent bending or flexing of fastening head <NUM> along joint <NUM>. For example, joint <NUM> may include notches <NUM>, as discussed above. Likewise, stabilizer <NUM> may include one or more cut-outs, spaces, or notches <NUM>. When notches <NUM> longitudinally align with notches <NUM>, as shown in <FIG>, cartridge <NUM> (or fastening head <NUM>) may be flexible or bendable. However, when notches <NUM> do not longitudinally align with notches <NUM> (e.g., when a solid, rigid, or otherwise un-notched portion of stabilizer <NUM> spans notches <NUM>) as shown in <FIG>, cartridge <NUM> (or fastening head <NUM>) may be prevented from flexing or bending. As such, cartridge <NUM> (or fastening head <NUM>) may be considered stabilized. Additionally, as shown in <FIG>, cartridge <NUM> and/or cartridge housing <NUM> may include a guide slot, groove, or channel <NUM> configured to receive a protrusion or post (not shown) of stabilizer <NUM> so as to maintain alignment between stabilizer <NUM> and cartridge <NUM> and/or cartridge housing <NUM> during advancement and retraction of stabilizer <NUM>. In further arrangements, it is understood that cartridge <NUM> and/or cartridge housing <NUM> may include the post while stabilizer <NUM> may include the channel <NUM>, without departing from the scope of the present disclosure.

<FIG> is a top-view of an exemplary stabilizer of an endoscopic stapling device <NUM>. Endoscopic stapling device <NUM> is similar to endoscopic tissue fastening device <NUM>, and therefore, similar components will be referred to herein with similar reference numbers with the addition of <NUM>. For example, as shown in <FIG>, support <NUM> and stabilizer <NUM> may be replaced with stabilization system <NUM>. Stabilization system <NUM> may include a first portion 262A and a second portion 262B. First portion 262A may be arranged distally of second portion 262B. For example, first portion 262A may be spaced a distance of X apart from second portion 262B. Additionally, first portion 262A may be selectively coupled to second portion 204B of body <NUM>. For example, first portion 262A may include a connection feature <NUM> configured to cooperate within a connection recess <NUM> of second portion 204B of body <NUM>. As shown in <FIG>, connection feature <NUM> may include a protrusion, post, extension, or the like extending radially outwardly of first portion 262A, while connection recess <NUM> may be an indent, channel, groove, or notch extending radially into second portion 204B of body <NUM>. First portion 262A of stabilizer system <NUM> may be selectively coupled to second portion 204B of body <NUM> via interaction between connection feature <NUM> and connection recess <NUM>. When so coupled and an axial force in the direction A is applied to fastening head <NUM>/cartridge <NUM>, resistance between connection feature <NUM> and connection recess <NUM> may permit movement of fastening head <NUM>/cartridge <NUM> relative to first portion 262A. In contrast, second portion 262B of stabilizer system <NUM> may be secured in any appropriate manner to fastening head <NUM>/cartridge <NUM> for movement therewith. Accordingly, when an axial force in the direction A is applied to fastening head <NUM>/cartridge <NUM>, second portion 262B of stabilizer system <NUM> may likewise be moved in the direction A.

When advanced in the direction A, fastening head <NUM>/cartridge <NUM>, along with second portion 262B of stabilizer system <NUM>, may be advanced toward first portion 262A, thereby reducing the distance X between first portion 262A and second portion 262B. However, when the distance X is equal to a value of zero (e.g., when there is no space between first portion 262A and second portion 262B), continued application of a force in the direction A will cause likewise force on first portion 262A. That is, a surface (e.g., distal end face) of second portion 262B may abut or contact a proximal end face of first portion 262A, and application of a force in the direction A may result in first portion 262A being pushed or advanced in the direction A. If the force in the direction A is sufficient, resistance between connection feature <NUM> and connection recess <NUM> may be overcome. That is, connection feature <NUM> may deflect or bend away from connection recess <NUM>, or otherwise may be removed from connection recess <NUM>. As such, first portion 262A may no longer be coupled to second portion 204B of body <NUM>, and instead, may move with fastening head <NUM>/cartridge <NUM>, along with second portion 262B of stabilizer system <NUM>. However, when the first and second portions 262A, 262B of stabilizer system contact/abut one another, stabilizer system <NUM> will be positioned so as to span (e.g., cover) a joint <NUM> along fastening head <NUM>/cartridge <NUM>. In such a manner, stabilization system <NUM> may stabilize fastening head <NUM>/cartridge <NUM>.

<FIG> is a top-view of an exemplary flexible staple cartridge <NUM>, according to aspects of the present disclosure. Staple cartridge <NUM> may be comprised of any appropriate elastomeric material, polymer, or otherwise flexible material so as to permit staple cartridge <NUM> to flex laterally during insertion into, or positioning within, the body of the subject. Additionally, staple cartridge <NUM> may include liners <NUM> lining each of the one or more slots <NUM> of staple cartridge <NUM>. Liners <NUM> may be made of a relatively rigid material so as to maintain a shape of the one or more slots <NUM>, and house/protect one or more staples and/or firing piston located within the one or more slots <NUM>. In other words, while the staple cartridge <NUM> itself may be flexible and/or bendable, the liners <NUM> may be substantially noncompressible so as to support the one or more slots <NUM> during a stapling procedure.

Endoscopic tissue fastening device <NUM>, <NUM> may be either disposable for single use, or may be equipped for multiple uses. For example, in some arrangements, endoscopic tissue fastening device <NUM>, <NUM> may be a sterile single-use device, while in other arrangements endoscopic tissue fastening device <NUM>, <NUM> may be reusable.

Claim 1:
An endoscopic tissue fastening device (<NUM>, <NUM>), comprising:
a body (<NUM>) having a first portion (104A) and a second portion (104B) arranged alongside the first portion, wherein the second portion extends distally of the first portion and terminates in a distal end face (<NUM>) of the body;
a tissue fastening assembly (<NUM>), having a fastening head (<NUM>) with a proximal end and a distal end, wherein the fastening head is deflectable at a location between the proximal end and the distal end of the fastening head, wherein the tissue fastening assembly is received within a lumen (<NUM>) that extends along the first portion of the body and terminates proximally of the second portion (104B); and
the tissue fastening assembly comprising a cartridge (<NUM>, <NUM>, <NUM>), whereby the cartridge comprises a joint (<NUM>, <NUM>); a stabilizer (<NUM>, <NUM>) moveably coupled to the staple cartridge (<NUM>, <NUM>, <NUM>) of the tissue fastening assembly;
wherein the body is moveable between an unarticulated configuration and an articulated configuration, and wherein, in the articulated configuration, a central longitudinal axis (L1) of the second portion of the body is substantially parallel with a central longitudinal axis (L2) of the tissue fastening assembly; and
characterized in that
in a first position, the stabilizer permits bending of the staple cartridge along the joint (<NUM>, <NUM>) of the staple cartridge, and in a second position, the stabilizer spans the joint of the staple cartridge so as to prevent bending of the staple cartridge along the joint.