Systems and devices for fastening tissue

Abstract

An endoscopic tissue fastening device can include a body having a first portion and a second portion arranged side-by-side with the first portion. The second portion can extend distally of the first portion and can terminate in a distal end face of the body. The device can also include a tissue fastening assembly having a fastening head with a proximal end and a distal end. The fastening head can 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 can be movable between a non-articulated configuration and an articulated configuration. In the articulated configuration, a central longitudinal axis of the second portion of the body can be substantially parallel to a central longitudinal axis of the tissue fastening assembly.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 872,481, filed July 10, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] Various aspects of the present invention generally relate to tissue fastening. More specifically, among other things, at least some embodiments of the invention relate to systems, apparatuses, and related methods for manipulating endoscopic tissue fastening devices and fastening tissues. Background Technology

[0004] Tissue stabilization (e.g., suturing) is used in many laparoscopic surgeries. These procedures typically involve removing portions or sections of tissue, followed by closure using staples. A common example is colorectal anastomosis. In hybrid surgeries where physicians use both laparoscopic and endoscopic platforms, rigid staplers are commonly used. Linear staplers consist of long, rigid components that cannot navigate through tortuous anatomy without causing tissue trauma. Physicians are also increasingly turning to endoscopic, outpatient procedures that will require endoscopic suturing.

[0005] For the reasons mentioned above, improvements to the present invention may be useful. Summary of the Invention

[0006] Various aspects of the present invention relate, among others, to systems, apparatus, and methods for securing tissues, such as flexible endoscopic platforms with suturing capabilities. Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0007] In one example, an endoscopic tissue fastening device may include a body having a first portion and a second portion arranged side-by-side with the first portion. The second portion may extend distally to the first portion and may terminate in a distal face of the body. The device may also include a tissue fastening assembly having a fastening head having a proximal end and a distal end. The fastening head may deflect at a position between the proximal and distal ends of the fastening head. The tissue fastening assembly may be received within a cavity of the body. Furthermore, the body may be movable between a non-hinged configuration and a hinged configuration. In the hinged configuration, the central longitudinal axis of the second portion of the body may be substantially parallel to the central longitudinal axis of the tissue fastening assembly.

[0008] Examples of endoscopic tissue fastening devices may include one or more of the following features: A lumen may terminate proximally on a distal facet. The cross-section of the first portion may be circular, and the cross-section of the second portion may be D-shaped. The tissue fastening assembly may include a flexible form and a stable form. In a hinged form of the body, the tissue fastening assembly may be arranged in a flexible form. In a stable form, the fastening head of the tissue fastening assembly may extend distally to the distal facet of the body. In a stable form, the fastening head of the tissue fastening assembly may be hinged along a hinge joint proximally to the fastening head, such that the central longitudinal axis of the tissue fastening assembly may move toward or away from the central longitudinal axis of the second portion of the body. The tissue fastening assembly may include a suture cartridge, and in the flexible form, at least a portion of the suture cartridge distal to the location may be deflected relative to another portion of the suture cartridge proximally to the location. The suture cartridge may include at least one flexible joint between the proximal end and the distal end of the suture cartridge. A support may be positioned along the second portion of the body, and in the hinged form, the distal end of the tissue fastening assembly may be received within the support. At least a portion of the tissue fastening assembly is axially movable relative to the support. In a stable configuration, a flexible connector of the tissue fastening assembly may be received within the support and may be prevented from deflecting by the support. The tissue fastening assembly may include a sheath coupled to a hinge joint via a flexible connector, the flexible connector may include at least one notch therein, and the tissue fastening assembly may include a suture cartridge distal to the hinge joint. A stabilizer may be movably coupled to the suture cartridge of the tissue fastening assembly; in a first position, the stabilizer may allow the suture cartridge to bend along the joint of the suture cartridge, and in a stable configuration, the stabilizer may span the joint of the suture cartridge to prevent the suture cartridge from bending along the joint.

[0009] In another example, an endoscopic tissue fastening method may include hinged endoscopic tissue fastening devices having lumens, having tissue fastening components at least partially received within the lumens; and converting the tissue fastening components from a flexible form to a stable form, wherein in the flexible form, a first portion of the tissue fastening cartridge is movable relative to a second portion of the tissue fastening cartridge, and wherein in the stable form, movement of the first portion of the tissue fastening cartridge relative to the second portion of the tissue fastening cartridge is prevented. Additionally, the method may include ejecting one or more tissue fasteners from the tissue fastening cartridge to fasten the tissue.

[0010] Examples of this method may include one or more of the following features. The method may include, during the articulation of the endoscopic tissue fastening device, the tissue fastening assembly being arranged in a flexible configuration at the distal end of the tissue fastening device. The method may also include, in a stable configuration, articulating the tissue fastening cartridge relative to the endoscopic tissue fastening device.

[0011] In another example, an endoscopic tissue fastening device may include a body extending between a proximal and a distal end and including at least one cavity. Additionally, an endoscopic tissue fastening device may include a tissue fastening assembly positioned within at least one cavity of the body, and the tissue fastening assembly may include a sheath coupled to a tissue fastening head via a flexible connector, a hinged joint located at the proximal end of the tissue fastening head, and a flexible joint positioned between the proximal and distal ends of a fastener housing of the tissue fastening head.

[0012] Examples of endoscopic tissue fastening devices may include one or more of the following features: A flexible joint may be positioned between the proximal and distal ends of a fastener housing and may include at least one notch or cut along the fastener housing. 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, and the second portion may be distal to the first portion and extend to the distal end face of the body. At least one cavity may terminate proximally to 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.

[0013] It is understood that the foregoing general description and the following detailed description are merely exemplary and illustrative of the claimed invention, and not restrictive. Attached Figure Description

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0015] Figure 1 This is a perspective view of an exemplary endoscopic tissue fastening device according to various aspects of the present invention.

[0016] Figures 2A to 2E The invention illustrates various aspects of the suturing process during transport, extension, articulation, opening, and tissue suturing. Figure 1 The distal end of the endoscopic tissue fastening device.

[0017] Figure 3 This is a perspective view of a stitching clip according to various aspects of the present invention.

[0018] Figure 4 It is a connection to various aspects of the present invention. Figure 3 A three-dimensional view of the stabilizer of the stitching nail box.

[0019] Figure 5A According to various aspects of the invention, the suture clip is in a first position relative to the suture clip. Figure 4 A 3D view of the stabilizer.

[0020] Figure 5BAccording to various aspects of the invention, the suture clip is in a second position relative to the suture clip. Figure 4 A 3D view of the stabilizer.

[0021] Figure 6 This is a top view of an exemplary stabilization system of an endoscopic tissue fastening device according to various aspects of the present invention.

[0022] Figure 7 This is a top view of an exemplary flexible stitcher box according to various aspects of the present invention. Detailed Implementation

[0023] Among other things, the present invention relates to systems, apparatus, and methods for joining, cutting, and removing tissue. Reference will now be made in detail to various aspects of the invention, examples of which are shown in the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term “distal” refers to the part furthest from the user when the device is inserted into a subject (e.g., a patient). Conversely, the term “proximal” refers to the part closest to the user when the device is placed into the subject. The term “tissue fastening” can refer to, for example, suturing, fixing, attaching, securing, or otherwise combining two parts of tissue. The term “fastener” can include suture staples, clips, elastic bands, sutures, or any other fastener known in the art.

[0024] The foregoing general description and the following detailed description are merely exemplary and illustrative of the claimed features, and not restrictive. As used herein, the terms “comprising,” “containing,” “having,” “including,” or other variations thereof are intended to cover non-exclusive contents such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may include other elements not expressly listed or not inherent to such process, method, article, or apparatus. Additionally, the term “exemplary” is used herein in the sense of “example” rather than “model.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a range of values ​​within + / - 5% of the stated value, unless otherwise specified.

[0025] Figure 1 An endoscopic tissue fastening device 100 is shown, which may be a surgical suturing device configured to engage body tissue, apply multiple surgical fasteners thereto, and form an incision in the fastened body tissue during minimally invasive surgical procedures, such as endoscopic surgery. The endoscopic tissue fastening device 100 may be used to apply surgical clips or other fasteners, but will be discussed primarily in the context of applying suture staples from a staple cartridge.

[0026] As shown in the figure, the endoscopic tissue fastening device 100 extends between a proximal and distal end. A handle 102, coupled to a longitudinally extending body 104, is located at the proximal end. The handle 102 may include one or more actuators 106A to 106F for actuating various features of the endoscopic tissue fastening device 100, as will be described in more detail below. Although the device 100 may be an endoscope specifically designed for flexible suturing, references to endoscopy or endoscopic examination 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 instruments or devices, or other types of medical devices. Although Figure 1 Six different actuators are shown, but the invention is not limited thereto. Conversely, more or fewer actuators may be provided without departing from the scope of this application. For example, one or more of the actuators 106A to 106F may be actuated to activate multiple features of the endoscopic tissue fastening device 100. In other words, a single actuator may be used to move the anvil 130 away from and toward (or vice versa) the suture cassette 128 during suturing or tissue fastening procedures, as will be described in more detail below. Additionally, although the handle 102 and actuators 106A to 106F are shown schematically, such features may have any suitable shape, form, and / or orientation without departing from the scope of the invention. For example, the handle 102 may have an ergonomic shape to facilitate a firm grip by the user, while the actuators 106A to 106F may be one or more of buttons, dials, joysticks, sliders, etc., configured to move, deflect, bend, rotate, pivot, or otherwise adjust relative to the handle 102 and / or the body 104 to actuate various features of the endoscopic tissue fastening device 100, as will be described in more detail below. Additionally, it should be understood that each of the actuators 106A to 106F can actuate / actuate a feature of the endoscopic tissue fastening device 100 via an actuation line (or the like). In other words, actuation of each actuator 106A to 106F can result in actuation of an actuation line (not shown) having a proximal end operatively engaged with the corresponding actuator 106A to 106F and a distal end operatively engaged with the corresponding feature of the endoscopic tissue fastening device 100. In this way, the activation force can be transmitted from the user along the body 104 at the handle 102 to actuate the features of the endoscopic tissue fastening device 100.

[0027] As described above, the proximal end of the body 104 can be connected to the handle 102, while the distal end of the body 104 can terminate in the distal end face 108. In some arrangements, the distal end face 108 may be the distal end face of a cap that is (removably or permanently) connected to the distal end of the body 104.

[0028] The endoscopic tissue tethering device 100 may include one or more of an illumination device 110, an optics device 112, one or more cavities 114, and a tissue tethering assembly 116. For example, the illumination device 110 may include one or more of a fiber optic device (e.g., optical cable) or a light-emitting diode (LED) to provide illumination to a location within the subject's body distal to the distal face 108. The optics device 112 may include any suitable means configured to provide a visual image of the subject's internal body location. For example, the optics device 112 may include one or more optical elements (e.g., lenses, cameras, etc.). One or more cavities 114 of the body 104 may be disposed at any suitable location around the distal face 108 and extend proximally to the handle 102. In some arrangements, one or more cavities 114 may be configured to provide flushing and / or aspiration fluids and / or may be configured to deliver one or more medical devices (e.g., tissue retrieval tools, forceps, grippers, etc.). In this case, one or more cavities 114 may be fluidly coupled to one or more ports (not shown) of the handle 102. Such a port can then be fluidly coupled to one or more flushing and / or aspiration fluid sources for delivery via one or more cavities 114, and / or arranged to insert one or more medical devices therethrough for delivery via one or more cavities 114. Furthermore, one or more cavities 114 can be arranged to receive one or more articulated wires (not shown) for selectively articulating at least the distal end of the body 104. Additionally, one or more of actuators 106A to 106F can be arranged to actuate the delivery of flushing and / or aspiration fluid, the extension / retraction or activation of the medical device, the activation of the illumination device 110, the activation of the optics device 112, and / or the activation / manipulation of one or more articulated wires to impart articulation to the body 104. For example, actuator 106A can be operatively connected to one or more articulated wires such that manipulation of actuator 106A results in articulation of the body 104.

[0029] like Figure 1As shown, the body 104 may include a first portion 104A and a second portion 104B. For example, the first portion 104 may comprise the majority of the body 104 and include the proximal end of the body 104. The second portion 104B may comprise the remainder of the body 104, including the distal end of the body 104 and the distal end face 108. As shown, the body 104 may have varying external cross-sectional shapes and / or dimensions. For example, the first portion 104A may have a first external cross-sectional shape (e.g., circular) or size, while the second portion 104B may have a second external cross-sectional shape (e.g., D-shaped) or size. In some arrangements, such as where a cavity 118 in which the tissue fastening assembly 116 is disposed, the cavity 118 may extend along the first portion 104A of the body 104 and terminate proximally to the second portion 104B. In other words, the cavity 118 may extend only along the first portion 104A, and therefore, due to the absence of the cavity 118, the shape or size of the second portion 104B may be reduced and / or adjusted, respectively. In this way, the main body 104 can define a "bag" in which the tissue fastening assembly 116 can be arranged. In other words, the tissue fastening assembly 116 can be positioned next to the main body 104. For example, the central longitudinal axis L1 of the second part 104B can be arranged substantially parallel to the central longitudinal axis L2 of the tissue fastening assembly 116. Additionally, as... Figure 1 As shown, the support member 146 can be fixedly arranged along a portion of the second part 104B. That is, the support member 146 can be fixed relative to the second part 104B (so that it is immovable) in any suitable manner (e.g., fasteners, adhesives, etc.). The support member 146 can optionally receive at least a portion therein of the tissue fastening assembly 116 to maintain the alignment of the tissue fastening assembly 116 relative to the body 104, as will be discussed in further detail below. The support member 146 can have any suitable shape configured to support the tissue fastening assembly 116. For example, the support member 146 can be U-shaped, L-shaped, or C-shaped.

[0030] Tissue fastening assembly 116 may include sheath 120 ( Figures 2A to 2E ), flexible connector 122, hinge joint 124, fastening head 134 (including housing 126, housing 128 and anvil 130) and actuation wire 132 ( Figures 2A to 2E As discussed in further detail below, the organization fastening assembly 116 may include, for example, Figure 1 and Figure 2A The first unconstrained, bendable, or otherwise flexible form shown is, for example... Figure 2B The second restricted, reinforced, or otherwise stabilized form shown is as follows: Figure 2C The optional third hinge or deflection configuration shown is as follows: Figure 2D The opening shape shown and as Figure 2E The fastening configuration is shown.

[0031] As will be described in further detail below, manipulation of the actuation line 132 can facilitate the transition of the tissue fastening assembly 116 between a first and a second configuration. The actuation line 132 can be any suitable longitudinally extending member configured to apply axial force to one or both of the fastening heads 134 and the sheath 120. For example, the actuation line 132 can be a rod, wire, tube, thiourea tube, etc. The proximal end of the actuation line 132 can be coupled to one of the actuators 106A to 106F of the handle 102. In this way, a user can actuate the actuation line 132 by manipulating one of the actuators 106A to 106F. For example, the actuation line 132 can be operatively coupled to actuator 106B, and actuation of actuator 106B can cause axial advance or retraction of the actuation line 132, thereby causing axial advance or retraction of one or both of the sheath 120 and the fastening heads 134 relative to the body 104, as will be described in more detail below.

[0032] The sheath 120 may terminate at (or be coupled to) the flexible connector 122. The flexible connector 122 may facilitate the flexure / bending of the tissue fastening assembly 116. For example, the flexible connector 122 may allow the fastening head 134 to bend or deflect relative to the sheath 120. In fact, the flexible connector 122 may be made of any suitable material, such as polymers and / or metals, and may be configured to allow or facilitate bending. That is, the flexible connector 122 may have one or more reduced-thickness portions, cutouts, grooves, notches, etc., arranged to allow bending. For example, as... Figure 1 As shown, the flexible connector 122 may include one or more recesses 140. (As illustrated...) Figure 1 As shown, the notch 140 can typically be V-shaped, but the invention is not limited to this. In fact, the notch 140 can have any suitable shape, configured to allow or facilitate bending. Additionally, although two longitudinally spaced notches 140 are shown arranged on opposite sides of the flexible connector 122 (see example...), Figure 2A However, any quantity, arrangement, orientation or size may be used without departing from the scope of the invention.

[0033] The flexible connector 122 may terminate at (or be coupled to) the articulated joint 124. The articulated joint 124 may include any suitable mechanical connection configured to allow movement of the fastening head 134 relative to the body 104 (see, for example...). Figure 2A and Figures 2C to 2EFor example, the hinge joint 124 may include a pivot, hinge, and / or ball-and-socket connection. The hinge joint 124 may be operatively coupled (e.g., via a wire, etc.) to one of the actuators 106A to 106F, such as 106C. Thus, actuation of the actuator 106C may result in the hinge of the fastening head 134 relative to the body 104. Alternatively, the fastening head 134 may be operatively coupled (e.g., via a wire, etc.) to the actuator 106C such that actuation of the actuator 106C may result in the hinge of the fastening head 134 relative to the body 104 via the hinge joint 124. In fact, when the actuator 106C is actuated, the fastening head 134 may move toward or away from the body 104. For example, the fastening head 134 may be moved toward the central longitudinal axis L1 of the second part 104B (e.g., hinged at a hinged position) to be positioned in front of the distal end face 108 and / or may be moved away from the central longitudinal axis L1 of the second part 104B to extend away from the distal end face 108.

[0034] As described above, the fastening head 134 collectively includes a housing 126, a cartridge 128, and an anvil 130, and can be coupled to the hinged joint 124. The housing 126 can be arranged to receive the cartridge 128 therein. The cartridge 128 can be removed from the housing 126 (e.g., the housing 126 can be reloaded with a new cartridge if needed). However, in some examples, the cartridge 128 may be integrally formed in the housing 126 and therefore non-removable. The anvil 130 may be rotatably or pivotally coupled to the housing 126. In some examples, the anvil 130 may be rotatably oriented toward an open configuration (…). Figure 2D The anvil is biased, for example, away from the housing 126 and the cartridge 128, thereby creating space between the anvil 130 and the housing 126 / cartridge 128. Alternatively, the anvil 130 may be rotatably oriented toward a fastening configuration. Figure 2E The anvil 130 is biased, for example, toward the housing 125 and the cartridge 128. In any arrangement, the anvil 130 can be moved toward or away from the housing 126 and the cartridge 128 via actuation of one of the actuators 106A to 106F, for example, 106D. That is, when the actuator 106D is actuated / operated, the anvil 130 can move toward an open configuration and / or toward a locked configuration. That is, the anvil 130 can rotate / pivot about an axis to contact the housing 126 / cartridge 128 to clamp tissue T between the anvil 130 and the housing 126 / cartridge 128. Figure 2E This provides a surface into which the stitching pin can be driven when ejected from cartridge 128.

[0035] The cartridge 128 may contain multiple surgical fasteners, such as suture pins, and the fasteners can be deployed from the cartridge 128 under the influence of a driving force applied by an actuating slider (not shown). Multiple spaced longitudinal slots 150 in the cartridge 128 ( Figure 2D , Figure 3 , Figure 5A , Figure 5B This allows the suture staple to pass through the cartridge 128 and pierce the tissue, as will be described in more detail below. In some examples, the actuating slider can be arranged to move proximally in the longitudinal direction from the distal end of the cartridge 128 toward the proximal end of the cartridge 128 when actuated, thereby contacting the fastener within the cartridge 128 and pushing the fastener through the longitudinal slot 150 to engage the fastener with the tissue. Alternatively, in some examples, the actuating slider can be arranged to move distally in the longitudinal direction from the proximal end of the cartridge 128 toward the distal end of the cartridge 128 when actuated. In either case, the actuating slider can be actuated via one of actuators 106A to 106F, such as 106E (via a wire operatively connected to actuator 106E, etc.). For example, actuation or manipulation of actuator 106E can eject or deploy the fastener into the tissue. In some examples, a single fastener can extend through each slot 150. Each fastener may be partially located within slot 150 before deployment to aid in fastener alignment with slot 150. In some examples, two (or more) actuating sliders (not shown) may be required to actuate two (or more) fasteners in different longitudinal rows in cartridge 128.

[0036] The box 128 may also include an elongated longitudinal slot 148. Figure 3 , Figure 5A , Figure 5B The elongated longitudinal slot 148 can be configured to receive and / or support a cutting tool, such as a blade (not shown). The elongated longitudinal slot 148 can be positioned on one side of the cartridge 128 and can travel longitudinally from the proximal end to the distal end of the cartridge 128. The anvil 130 may include a longitudinally positioned recess (not shown) when the anvil 130 is in a secured position. Figure 2E When the device is in the slot, the groove can be aligned with the elongated longitudinal slot 148, and this groove can be configured to receive a cutting tool. The cutting tool can be operatively coupled to one of actuators 106A to 106F, for example, 106F. Thus, when actuator 106F is actuated / operated, the cutting tool can be axially translated along the elongated longitudinal slot 148 and the groove to cut, slit, separate, or otherwise cleave tissue. In some arrangements, a common (e.g., identical) actuator can simultaneously actuate both the actuation slider and the cutting tool. That is, in some arrangements, a single actuator, such as actuator 106E, can be used both to eject fasteners from cartridge 128 into tissue and to cut tissue positioned along the elongated longitudinal slot 148.

[0037] It is worth noting that the fastening head 134 may include a flexible joint 154 between the proximal and distal ends of the housing 128. That is, the fastening head 134 including the housing 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, hinge, and / or ball socket. In some arrangements, the joint 154 may include flexible features to allow bending or deflection of one or more portions of the fastening head 134 / housing 128 relative to one or more other portions of the fastening head 134 / housing 128. In fact, the fastening head 134 / housing 128 may be made of any suitable material, such as polymers and / or metallic materials, and may be configured to allow or facilitate bending. That is, the fastening head 134 / housing 128 may include one or more reduced-thickness portions, cutouts, grooves, notches, etc., arranged to allow bending. For example, as Figure 3 , Figure 5A and Figure 5B As shown, the connector 154 of the housing 128 may include one or more recesses 156. (As indicated...) Figure 3 As shown, the notch 156 can typically be V-shaped, but the invention is not limited to this. In fact, the notch 156 can have any suitable shape configured to allow or facilitate bending. Furthermore, although two notches 156 arranged on opposite sides of the housing 128 are shown, any number, arrangement, orientation, or size can be used without departing from the scope of the invention. Additionally, as Figure 3 As shown, one or more openings 158 or slots 160 may extend from the proximal end of the housing 128 toward the distal end of the housing 128. Such openings 158 or slots 160 may be arranged to receive one or more actuation lines coupled to one or more of the actuators 106A to 106F, as will be described in further detail below.

[0038] In use, the user can deliver the endoscopic tissue fastening device 100 into the subject's body, for example, through the subject's tortuous natural body cavity, while the endoscopic tissue fastening device 100 is positioned in a flexible shape ( Figure 1 and Figure 2A (In the flexible configuration), when the body 104 is hinged via actuators 106A coupled to one or more actuation lines, the tissue fastening assembly 116 can bend or deflect with the body 104. That is, the tissue fastening assembly 116 will also bend or deflect when the body 104 is positioned within the subject's body. In fact, the tissue fastening assembly 116 can bend and deflect with the body 104 via one or both of the flexible connector 122 and the joint 154. Figure 1 and Figure 2AAs shown, at least a portion of the tissue fastening assembly 116 is supported (e.g., received or located therein) by a support member 146 fixed to the body 104. Therefore, hinged or deflected body 104 will result in the same movement of at least a portion of the tissue fastening assembly 116. That is, in its flexible configuration, the tissue fastening assembly 116 can be maintained in a substantially parallel alignment between the central longitudinal axis L1 of the second portion 104B and the central longitudinal axis L2 of the tissue fastening assembly 116. In this way, the endoscopic tissue fastening device 100 allows for increased flexibility for precise positioning and delivery of the endoscopic tissue fastening device 100 within the subject's body.

[0039] Once the endoscopic tissue fastening device 100 is positioned at or near the target location within the subject's body, the user can switch the endoscopic tissue fastening device 100 to a stable position, such as... Figure 2E As shown. Therefore, the user can activate / manipulate actuator 106B to move one or both of the sheath 120 and the fastening head 134 via actuation line 132. This actuation can be performed in two stages. In the first stage, actuation of actuator 106B can axially move both the sheath 120 and the fastening head 134 (e.g., distally along the central longitudinal axis L1 of the tissue fastening assembly 116). Therefore, in some arrangements, actuation line 132 may have engagement features (not shown) configured to abut with a corresponding engagement feature (not shown) of the sheath 120, such that applying an axial force (e.g., in the distal direction) to actuation line 132 imparts the same axial force (e.g., in the distal direction) to the sheath 120. Furthermore, since the sheath 120 is connected to the fastening head 134 via flexible connector 122, applying an axial force to the sheath 120 results in the same axial force being applied to the fastening head 134. In other words, in the first stage, actuation of actuator 106B can advance or extend both sheath 120 and fastening head 134 until the articulated joint 124 is located near or distal to the distal end face 108. Next, in the second stage of actuation, the engagement feature of actuation line 132 can disengage from the engagement feature of sheath 120, such that actuation of actuator 106B can cause axial movement of actuation line 132 relative to sheath 120 and fastening head 134. In this way, continued application of axial force to actuation line 132 can cause actuation line 132 to move along sheath 120 and through fastening head 134. For example, actuation line 132 can be axially advanced through one or more openings 158 or slots 160 (…). Figure 3 ), until the actuation line 132 crosses the connector 154 (e.g., within the fastening head 134). However, in some arrangements, the actuation line 132 may be axially advanced alongside (e.g., outside and near) the fastening head 134. Alternatively or alternatively, the stabilizer 162 ( Figure 4 , Figure 5A , Figure 5B A coupling can be made to actuation line 132 such that axial advancement of actuation line 132 causes stabilizer 162 to cross joint 154, as will be described in further detail below. Once actuation line 132 (or stabilizer 162) is positioned in this way, actuation line 132 (or stabilizer 162) prevents fastening head 134 from bending or deflecting along joint 154. In other words, once actuation line 132 (or stabilizer 162) crosses, covers, or extends through joint 154, fastening head 134 is stabilized such that the distal portion 134B of fastening head 134 does not bend or deflect relative to the proximal portion 134A of fastening head 134.

[0040] In some arrangements, the engagement features of the actuation line 132 may include radially outward protrusions, rings, etc., which may selectively engage with radially inward protrusions, rings, etc., of the sheath 120. In some arrangements, one or both engagement features may be deflectable, flexible, or otherwise flexible, such that during actuation (e.g., axial advance), when an opposing axial force and / or stop is applied, the engagement features may bend or flex to disengage from each other, thereby allowing movement of the actuation line 132 relative to the sheath 120 and the fastening head 134. When the abutment surface 166 of the flexible joint 122 ( Figure 2B When the actuation line 132 interacts with or abuts the edge of the support 146, it may experience such opposing axial forces or stops. Alternatively, the engagement features may have a first radial orientation in which the engagement features are oriented to interfere with each other; and a second radial orientation in which the engagement features do not interfere with each other. That is, in the first radial orientation, the engagement features of the actuation line 132 may be oriented to transmit the axial force applied to the actuation line 132 to the engagement features of the sheath 120, and in the second radial orientation, the engagement features of the actuation line 132 may be oriented such that the axial force applied to the actuation line 132 is not applied to the engagement features of the sheath 120. In this configuration, the actuation line 132 can be rotated to move between a first radial orientation and a second radial orientation, and when the abutment surface 166 of the flexible connector 122 interacts with or abuts the edge of the support 146, the user receives tactile feedback in the form of resistance. At this point, the user can rotate the actuation line 132 relative to the sheath 120 to switch to the second radial orientation, thereby allowing the actuation line 132 (and / or stabilizer 162) to continue advancing until the connector 154 is stable.

[0041] like Figure 2CAs shown, optionally, once stable, the user can hinge the fastening head 134 at the hinge joint 124 to guide the fastening head 134 into any suitable position. For example, as described above, when actuating the actuator 106C, the fastening head 134 can be moved toward the central longitudinal axis L1 of the second portion 104B to be positioned in front of the distal end face 108 and / or can be moved away from the central longitudinal axis L1 of the second portion 104B to extend away from the distal end face 108. In the arrangement where the actuation line 132 crosses the hinge joint 124, it should be understood that the actuation line 132 may include a portion configured to allow a movable connection along the hinge joint 124. For example, the portion of the actuation line 132 crossing the hinge joint 124 may be relatively more flexible than the rest of the actuation line 132. In fact, the portion of the actuation line 132 crossing the hinge joint 124 may have one or more portions with reduced cross-sectional dimensions (e.g., it may be thinned). In this way, the actuation line 132 provides sufficient columnar support to extend through (or beside) the hinge joint 124 and toward the fastening head 134, while still allowing for a movable connection along the hinge joint 124.

[0042] Next, as Figure 2D As shown, the anvil 130 can be moved toward or away from the cartridge housing 126 and the cartridge 128 via the actuating actuator 106D. That is, when the actuator 106D is actuated / operated, the anvil 130 can move toward an open configuration to form a tissue receiving space between the anvil 130 and the cartridge housing 126 / cartridge 128, and after receiving tissue therebetween, it can close to clamp tissue T between the anvil 130 and the cartridge housing 126 / cartridge 128 in a secured configuration. Figure 2E Once arranged in this manner, actuation or manipulation of actuator 106E can eject or deploy the fastener into tissue T. Additionally, upon actuation / manipulation of actuator 106F, a cutting tool (not shown) can be axially translated along the elongated longitudinal slot 148 and groove to cut, sever, separate, or otherwise cleave tissue. As described above, a single actuator, such as actuator 106E, can be used both to eject the fastener from cartridge 128 into tissue and to cut tissue positioned along the elongated longitudinal slot 148.

[0043] In the setup using stabilizer 162, such as Figure 4 , Figure 5A and Figure 5B As shown, stabilizer 162 can be axially advanced until stabilizer 162 crosses joint 154. Therefore, stabilizer 162 can prevent fastening head 134 from bending or deflecting along joint 154. For example, joint 154 may include notch 156, as discussed above. Similarly, stabilizer 162 may include one or more cuts, spaces, or notches 168. When notch 156 is longitudinally aligned with notch 168, as... Figure 5A As shown, the housing 128 (or fastening head 134) can be flexible or bendable. However, when the notch 156 is not longitudinally aligned with the notch 168 (e.g., when a solid, rigid, or otherwise unnotched portion of the stabilizer 162 crosses the notch 156), as... Figure 5B As shown, this prevents the housing 128 (or fastening head 134) from flexing or bending. Therefore, the housing 128 (or fastening head 134) can be considered stable. Additionally, as... Figure 4 As shown, the cartridge 128 and / or cartridge housing 126 may include guide slots, recesses, or channels 170 configured to receive protrusions or posts (not shown) of the stabilizer 162 to maintain alignment between the stabilizer 162 and the cartridge 128 and / or cartridge housing 126 during the advance and retraction of the stabilizer 162. In further arrangements, it should be understood that the cartridge 128 and / or cartridge housing 126 may include posts, and the stabilizer 162 may include channels 170, without departing from the scope of the invention.

[0044] Figure 6 This is a top view of an exemplary stabilizer of the endoscopic suturing device 200. The endoscopic suturing device 200 is similar to the endoscopic tissue fastening device 100, and therefore, similar components will be indicated herein by similar reference numerals followed by 100. For example, as... Figure 6 As shown, the support 146 and stabilizer 162 can be replaced by a stabilization system 262. The stabilization system 262 may include a first portion 262A and a second portion 262B. The first portion 262A may be disposed distal to the second portion 262B. For example, the first portion 262A may be spaced apart from the second portion 262B by a distance X. Alternatively, 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 feature 264 configured to engage within a connection recess 266 of the second portion 204B of the body 204. Figure 6As shown, the connecting feature 264 may include a protrusion, post, extension, etc., extending radially outward from the first portion 262A, while the connecting recess 266 may be a pit, 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 via an interaction between the connecting feature 264 and the connecting recess 266. When such coupling occurs and an axial force in direction A is applied to the fastening head 234 / cassette 228, the resistance between the connecting feature 264 and the connecting recess 266 may allow the fastening head 234 / cassette 228 to move relative to the first portion 262A. Conversely, the second portion 262B of the stabilizer system 262 may be secured to the fastening head 234 / cassette 228 in any suitable manner to move with it. Therefore, when an axial force is applied to the fastening head 234 / cassette 228 in direction A, the second part 262B of the stabilizer system 262 can also move in direction A.

[0045] When advancing in direction A, the second portion 262B of the fastening head 234 / cassette 228, together with the stabilizer system 262, can advance toward the first portion 262A, thereby reducing the distance X between the first portion 262A and the second portion 262B. However, when the distance X is zero (e.g., when there is no space between the first portion 262A and the second portion 262B), continuing to apply force in direction A will result in the same force on the first portion 262A. That is, the surface of the second portion 262B (e.g., the distal surface) can abut or contact the proximal surface of the first portion 262A, and applying force in direction A can cause the first portion 262A to be pushed or advanced in direction A. If the force in direction A is sufficient, the resistance between the connecting feature 264 and the connecting recess 266 can be overcome. That is, the connecting feature 264 can deflect or bend away from the connecting recess 266, or in other cases, can be removed from the connecting recess 254. Therefore, the first part 262A may no longer be connected to the second part 204B of the main body 204, but may instead move together with the second part 262B of the stabilizer system 262 along with the fastening head 234 / cassette 228. However, when the first and second parts 262A, 262B of the stabilizer system are in contact / adjacent to each other, the stabilizer system 262 will be positioned to cross (e.g., cover) the connector 254 along the fastening head 234 / cassette 228. In this way, the stabilization system 262 can stabilize the fastening head 234 / cassette 228.

[0046] Figure 7This is a top view of an exemplary flexible suture cartridge 328 according to various aspects of the invention. The suture cartridge 328 may be constructed of any suitable elastomeric material, polymer, or other flexible material to allow lateral flexure during insertion or positioning within a subject's body. Additionally, the suture cartridge 328 may include a liner 352 lining each of one or more slots 350 of the suture cartridge 328. The liner 352 may be made of a relatively rigid material to maintain the shape of the one or more slots 350 and to receive / protect one or more suture staples and / or firing pistons located within the one or more slots 350. In other words, while the suture cartridge 328 itself may be flexible and / or bendable, the liner 328 may be substantially incompressible to support the one or more slots 350 during suturing procedures.

[0047] Endoscopic tissue fastening devices 100 and 200 may be disposable for single use or may be fitted for multiple uses. For example, in some arrangements, endoscopic tissue fastening devices 100 and 200 may be sterile, single-use devices, while in other arrangements, they may be reusable.

[0048] It will be apparent to those skilled in the art that various modifications and variations can be made to 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 based on consideration of the description and practice of the features disclosed herein. The description and examples are intended to be illustrative only.

Claims

1. An endoscopic tissue fastening device comprising: a tissue fastening assembly having a fastening head, the fastening head having a proximal end and a distal end, wherein the fastening head includes a staple cartridge, wherein the fastening head is deflectable at a location between the proximal and distal ends of the fastening head; and a stabilizer movably coupled to the staple cartridge of the tissue fastening assembly; wherein in a first position, the stabilizer allows the staple cartridge to bend along a joint of the staple cartridge, and in a stabilized configuration, the stabilizer spans the joint of the staple cartridge to prevent the staple cartridge from bending along the joint.

2. The endoscopic tissue fastening device of claim 1, further comprising a body having a first portion and a second portion arranged side-by-side with the first portion, wherein the second portion extends distally of the first portion and terminates in a distal end face of the body, wherein the tissue fastening assembly is received within a lumen of the body, and wherein the lumen terminates proximally of the distal end face.

3. The endoscopic tissue fastening device of claim 2, wherein a cross-section of the first portion is circular, and wherein a cross-section of the second portion is D-shaped.

4. The endoscopic tissue fastening device according to claim 2, wherein the body is movable between an unarticulated configuration and an articulated configuration, and wherein, 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, wherein, in the articulated configuration of the body, the stabilizer is arranged in the first position.

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

6. The endoscopic tissue fastening device of any one of claims 4-5, wherein in the stabilized configuration, the fastening head of the tissue fastening assembly is articulatable along an articulation joint proximal of the fastening 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 portion of the body.

7. The endoscopic tissue fastening device of claim 4, further comprising: a support positioned 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.

8. The endoscopic tissue fastening device of claim 7, wherein at least a portion of the tissue fastening assembly is axially movable relative to the support.

9. The endoscopic tissue fastening device of claim 7, wherein in the stabilized configuration, a flexible link of the tissue fastening assembly is received within the support and is prevented from flexing by the support.

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

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