Systems, devices, and related methods for fastening tissue

Abstract

The fastening device may include a flexible longitudinal body having a central longitudinal axis and a distal end; an anvil extending distally from a distal end of the longitudinal body; and a distal body extending distally from a distal end of the longitudinal body. The distal body may be configured to removably receive a cartridge having a plurality of fasteners. At least one of the anvil and the distal body may be flexible, and may have a first configuration in which a distal portion of the at least one of the anvil and the distal body extends radially outward from the central longitudinal axis, and a second configuration in which the distal portion is closer to the central longitudinal axis than in the first configuration.

Description

This application is a divisional application of Chinese application No. 202080073246.5 entitled “System, apparatus and related methods for fastening mechanisms”. Cross-citation of relevant literature

[0001] This application claims priority to U.S. Provisional Application No. 62 / 924,557, filed October 22, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of this disclosure generally relate to tissue fastening, including tissue visualization, retraction, and connection. More specifically, at least some embodiments of this disclosure relate to systems, apparatus, and related methods for suturing tissue, among others. Background Technology

[0003] Technological advancements have enabled users of medical systems, devices, and methods to perform increasingly complex surgeries on patients. For example, ligating tissue within a patient's gastrointestinal tract is a type of surgery that can present challenges. One difficulty lies in replacing an empty suture cartridge with a new one filled with sutures during the procedure. When the user has deployed all the fasteners stored in the surgical fastener cartridge, they may need to remove the device from the patient, replace it with a cartridge filled with fasteners, and reinsert the surgical fasteners to continue securing the tissue. This removal and reinsertion of the suture device can potentially cause injury to the patient due to the additional movement of the device within the patient's body required for cartridge replacement. Furthermore, the procedure time may increase due to the process of removing and reinserting the suture device to replace the cartridge. Therefore, there is a need for suture instruments that can address this challenge. Summary of the Invention

[0004] Various aspects of this disclosure relate to, among other things, systems, apparatuses, and methods for fastening organizations. Each aspect disclosed herein may include one or more features relating to any other aspect of the disclosure.

[0005] The fastening device may include a flexible longitudinal body having a central longitudinal axis and a distal end; an anvil extending distally from the distal end of the longitudinal body; and a distal body extending distally from the distal end of the longitudinal body. The distal body may be configured to detachably receive a cartridge having a plurality of fasteners. At least one of the anvil and the distal body may be flexible and may have a first configuration in which the distal portion of at least one of the anvil and the distal body extends radially outward from the central longitudinal axis, and a second configuration in which the distal portion is closer to the central longitudinal axis than in the first configuration.

[0006] Any device disclosed herein may have any of the following features. The fastening device may include a protrusion extending from the surface of the anvil, and the protrusion may be configured to engage a distal body. At least one of the anvil and the distal body may be an anvil; while the distal body may be flexible and have a first configuration in which a distal portion of the distal body extends radially outward from a central longitudinal axis, and a second configuration in which the distal portion of the distal body is closer to the central longitudinal axis than in the first configuration. Each of the distal body and the anvil may be curved in its respective first configuration and substantially straight in the second configuration. A cartridge may be detachably coupled to the distal body. The distal body may include a recess configured to slidably receive a flange of the cartridge. The cartridge may include an actuation line extending proximally from the proximal end of the cartridge through a channel in the longitudinal body, the actuation line being configured to move proximally relative to the cartridge and the anvil to deploy a fastener from the cartridge. The distal portion of the cartridge may include a locking portion configured to be received by a locking gap in the distal body. The distal body may include a first distal body and a second distal body spaced apart from the first distal body. The cartridge may include a distal projection extending distally from a distal surface of the cartridge, the distal projection being configured to receive between the distal ends of the first and second distal bodies. The distal bodies may include a first and a second distal body separated by a gap configured to receive the cartridge. The device may further include a flexible conduit configured to translate relative to a longitudinal body, and when the flexible conduit moves distally relative to the longitudinal body, the flexible conduit may move one or more of the anvil and the distal bodies toward each other. The device may further include an I-beam including a top portion, a bottom portion, a distally facing sharp edge, and at least one actuating ramp, and a cartridge. The cartridge may be configured to receive at least one actuating ramp. The I-beam may be movable proximally and distally relative to the anvil and the distal bodies. The distally facing sharp edge may be proximal to the distal end of the I-beam and may extend between the top and bottom portions of the I-beam. The device may further include a cartridge configured to receive a plurality of fasteners and including a proximal elongation extending proximally from the proximal end of the cartridge. The proximal elongation may include a cavity and at least one actuation line positioned within the cavity. The actuation line may be configured to deploy fasteners from the cartridge and / or actuate a knife within the cartridge. Each of the distal body and the anvil may include a radially inward surface having at least one roughened surface, serrations, and teeth.

[0007] In another example, the organization fastening device may include a flexible tube and a fastening device disposed within a cavity of the flexible tube. The fastening device may include a flexible anvil having a first configuration in which a distal portion of the anvil extends radially outward from the central longitudinal axis of the fastening device, and a second configuration in which the distal portion of the anvil is closer to the central longitudinal axis of the fastening device than in the first configuration. The fastening device may also include a flexible distal body configured to removably receive a fastening cartridge. The flexible distal body may have a first configuration in which a distal portion of the flexible distal body extends radially outward from the central longitudinal axis of the fastening device, and a distal portion closer to the central longitudinal axis of the fastening device than in the first configuration. The tube may be configured to translate distally relative to the fastening device to transform each of the anvil and the flexible distal body from its respective first configuration to its respective second configuration.

[0008] Any device disclosed herein may have any of the following features: The anvil may include a protrusion extending from the surface of the anvil. The protrusion may be configured to engage with the flexible distal body. The cartridge may be detachably coupled to the flexible distal body.

[0009] A medical method may include inserting a flexible fastening device into a flexible tube. The fastening device may include an anvil, at least one distal body, and a cartridge detachably coupled to the distal body and holding a plurality of fasteners. The method may further include inserting the tube into a natural orifice of the body. The method may further include moving the tube distally relative to the fastening device, such that the tube moves at least one of the anvil and the distal body from a first configuration in which the distal portion of at least one of the anvil and the distal body extends radially outward to a second configuration in which the distal portion is closer to the central longitudinal axis of the fastening device than in the first configuration. The method may further include deploying at least one fastener from the cartridge.

[0010] Any method disclosed herein may include any of the following steps or features. The cartridge may be a first cartridge, and the method may further include separating the first cartridge from the distal body while the fastening device is in the distal body; removing the first cartridge from the distal body by moving the first cartridge proximally; and coupling a second cartridge to the distal body; wherein the second cartridge holds a plurality of fasteners.

[0011] It is understood that, as claimed, the foregoing general description and the following detailed description are merely exemplary and illustrative, and are not intended to limit the invention. Attached Figure Description

[0012] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate exemplary aspects of this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0013] Figure 1This is a perspective view of an exemplary surgical suture system according to aspects of this disclosure.

[0014] Figure 2A and 2B These are perspective and side views of exemplary medical devices according to various aspects of this disclosure.

[0015] Figure 3 This is a perspective view of a portion of an exemplary medical device according to this disclosure.

[0016] Figure 4 This is a perspective view of a portion of an exemplary medical device according to aspects of this disclosure.

[0017] Figure 5 This is a perspective view of a portion of an exemplary medical device according to an aspect of this disclosure, wherein a portion of the medical device is shown in cross-section.

[0018] Figure 6A and 6B This is a side view of an exemplary surgical suture system according to aspects of this disclosure.

[0019] Figure 7 This is a side view of a portion of an exemplary surgical suture system according to aspects of this disclosure.

[0020] Figure 8 This is a side view of an exemplary surgical suture system according to aspects of this disclosure.

[0021] Figure 9 This is a perspective view of an exemplary surgical suture system according to aspects of this disclosure.

[0022] Figure 10 This is a perspective view of an exemplary component of a surgical suture system according to aspects of this disclosure.

[0023] Figure 11 This is a perspective view of an exemplary component of a surgical suture system according to aspects of this disclosure. Detailed Implementation

[0024] This disclosure relates to systems, apparatus, and methods for joining, cutting, and removing tissue, among other aspects. Reference will now be made in detail to various aspects of this disclosure, examples of which are illustrated in the accompanying drawings. Where possible, the same or similar reference numerals are used in the drawings to refer to the same or similar parts. The term “distal” refers to the portion furthest from the user when the device is introduced into the patient. Conversely, the term “proximal” refers to the portion closest to the user when the device is placed into the patient. The term “joining tissues together” can refer to, for example, suturing, fixing, attaching, fastening, or otherwise connecting two portions of tissue together. The term “fastener” can include suture staples, clips, elastic bands, sutures, or any other fasteners known in the art. As used herein, the terms “comprising,” “including,” or any other variation thereof are intended to cover a non-exclusive inclusion, such as a process, method, article, or apparatus that includes a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to the process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.”

[0025] Embodiments of this disclosure can be used to visualize, cut, excise, and / or join target tissues together within an endoscopic space, or to facilitate such processes. In particular, some embodiments combine a tissue excision device with a tissue suturing device. The tissue suturing device may include an excision or cutting mechanism (e.g., an integrated blade or sharp edge) and a suturing mechanism (suture device). The suturing device may be delivered to the target tissue site via an endoscopic working channel. In some examples, the suturing device may be retracted through the working channel of an endoscope, gastroscope, colonoscope, flexible catheter, or other medical device before insertion into the patient. The entire system may include a retraction mechanism, such as a tissue clamp, to pull the tissue toward the tissue suturing device. All or part of the tissue suturing device and retraction mechanism may be metal, composite material, plastic, or include shape memory metals (such as nickel-titanium alloys), shape memory polymers, polymers, or any combination of materials.

[0026] Figure 1 The distal end of an exemplary surgical system 100 according to an embodiment of the present disclosure is shown. System 100 may include a surgical suture device 101 configured to engage with body tissue, apply a plurality of surgical fasteners to the body tissue, and form an incision in the fastened body tissue. Surgical suture device 101 can be used in minimally invasive surgical procedures, such as laparoscopic or endoscopic surgery, or any other suitable medical procedure. Device 101 can 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. The device 101 shown in the figure is positioned within a flexible catheter 103 including a working channel 105, in which an elongated body 102 of device 101 is positioned.

[0027] like Figure 1 As shown, the elongated body 102 of the device 101 may be at least partially cylindrical, flexible, and configured to move through the working channel 105 of a medical device, such as a catheter 103. The elongated body 102 may extend longitudinally from a proximal end (not shown) to a distal end (in... Figure 1 (As shown in the diagram). An anvil 104 and two distal bodies 106, 107 may extend distally from the distal portion of the elongated body 102. The anvil 104 and distal bodies 106, 107 may extend from opposite portions of the elongated body 102, and in one configuration of the distal bodies 106, 107, they may bend in opposite directions or be radially outward from the longitudinal axis of the elongated body 102, in a first, such as an unconstrained or open configuration. As the conduit 103 slides distally on the elongated body 102, the distal bodies 106, 107 and the anvil 104 may move radially inward toward the central longitudinal axis of the device 101. In some examples, as the conduit 103 slides distally on the elongated body 102, the distal bodies 106, 107 may move toward the anvil 104 and change from the first configuration to a second configuration, such as a constrained or closed configuration. In some examples, the user can place the target tissue between the anvil 104 and the distal bodies 106, 107 so that the anvil 104 and the distal bodies 106, 107 clamp the target tissue as the catheter 103 slides distally on the elongated body 102. When positioned in a second configuration, such as a restraint or closure configuration, the teeth 122 of the device 101 can engage with the target tissue. The channel 140 (as shown in FIG. 2) can extend longitudinally within the radially outer surface of the elongated body 102. At least the proximal portion of the radially inward surface of each of the anvil 104 and the distal bodies 106, 107 can face each other relative to the longitudinal axis of the elongated body 102. The anvil 104 and the distal bodies 106, 107 can be flexible, and at least their distal portions can be radially outwardly biased from the longitudinal axis of the elongated body 102. These portions of the anvil 104 and distal bodies 106, 107 may be configured to bend inward toward the central longitudinal axis of the elongated body 102, thereby bringing the anvil 104 and distal bodies 106, 107 closer to the central longitudinal axis of the elongated body or at the same distance from the central longitudinal axis of the elongated body to the radially inner surface of the elongated body 102. The anvil 104 and distal bodies 106, 107 may be spring steel, shape memory alloy, or any other material capable of springing back or otherwise returning to its original shape after bending. In some examples, the elongated body 102 may be connected to an actuation line, cable, or tube (not shown) at the proximal portion of the elongated body 102, and movement of the actuation line, cable, or tube proximal or distally may move the elongated body 102 proximal or distally.

[0028] Anvil 104 may be configured to align with distal bodies 106, 107 as they move toward anvil 104. Anvil 104 may include textured portions, such as teeth or serrations 122, on the distal portion of anvil 104. In some examples, anvil 104 may include a recess 120 and a protrusion 118 at the distal end of anvil 104. When anvil 104 and distal portions 106, 107 are positioned substantially parallel to the longitudinal axis of elongated body 102, the teeth or serrations 122 of anvil 104 may align with the textured portions, such as teeth or serrations 124, of the distal portions 106, 107. Anvil 104 has a substantially flat upper and lower surface, a rounded or curved distal end portion, and a proximal portion extending from the distal edge of elongated body 102. The recess 120 of anvil 104 may be configured to receive fasteners, such as stitching pins. The recess 120 can be configured to align with the opening 114 of the cartridge 110. The protrusion 118 can extend radially inward from the circular distal portion of the anvil 104 relative to the central longitudinal axis of the elongated body 102. The protrusion 118 can be hook-shaped and can be configured to engage with the cartridge 110. Figure 4 As shown, the protrusion 118 may include an edge portion 140 that terminates at a sharp point at the end of the protrusion 118. The edge portion 140 may be configured to pierce tissue so that the protrusion 118 may extend through the tissue to engage or attach to at least one of the distal bodies 106, 107 and the cartridge 110 to hold the device 101 in a locked or clamped position, which may facilitate the deployment of fasteners. The radially outer surface 144 of the anvil 104 may be configured and positioned to engage with the surface of the catheter 103, such as the surface defining the lumen 105.

[0029] The distal bodies 106 and 107 may have longitudinal axes parallel to each other and may be curved toward each other at their distal ends 108 and 109. In some examples, the distal ends 108 and 109 may be spaced apart to provide a gap for receiving the distal protrusion 128 of the suture box 110 (e.g., Figure 3 (As shown). Each distal body 106, 107 may include textured protrusions, such as serrations or teeth 124 disposed at the distal portion of the distal body 106, 107. The serrated or toothed portions 124 may be configured to grasp tissue and may be disposed at or near the outer edge 125 (as shown in FIG. 2) of the distal body 106, 107. Each distal body 106, 107 may be spaced apart from the radially outermost surface 146 of the elongated body 102. The radially outer surfaces of the distal bodies 106, 107 may be configured and positioned to engage with the surface of the working channel of a medical device, such as the surface defining the lumen 105 in the catheter 103. An anvil 104 may extend from the distal edge of the elongated body 102, and the proximal space 133 between the distal bodies 106, 107 and the anvil 104 may be smaller than the diameter or cross-sectional dimension of the elongated body 102.

[0030] Any embodiment disclosed herein may have only one of anvil 104 or distal body 106, 107, which is radially outwardly curved, flexible, and transitions between a structure (for receiving tissue) spaced apart from the longitudinal axis of elongated body 102 and a suture structure that may be substantially parallel to the axis. The other (anvil 104 or distal body 106, 107) may extend substantially parallel to the longitudinal axis of elongated body 102, may be straight and / or substantially inflexible, and may not transition between the spaced-apart structure and the suture structure.

[0031] like Figure 1 As shown, the distal bodies 106 and 107 can be configured to retain the fastener box 110. Figure 5 A perspective view of distal bodies 106, 107 is shown, wherein a stapler cartridge 110 is positioned within recesses 130, 132 of distal bodies 106, 107, with portions of distal bodies 106, 107 and cartridge 110 shown in cross-section. Each recess 130, 132 of distal bodies 106, 107 extends from distal ends 108, 109 to the proximal portion of elongated body 102. Recess 130 of distal body 106 may be positioned on a first surface 157 opposite a second surface 158 of distal body 107, with recess 132 positioned on the second surface. In some examples, recesses 130, 132 may extend to the proximal end of elongated body 102. Recesses 130, 132 may be configured to slidably receive protrusions or feet 131, 133 of stapler cartridge 110, respectively.

[0032] In some examples, the distal bodies 106, 107 may include a locking gap portion 190 between the distal portions of each distal body 106, 107. Opposing surfaces 198, 199 surrounding the locking gap portions 190 of the distal bodies 106, 107 may be more spaced apart than opposing surfaces (such as the first surface 157 and the second surface 158) of the proximal portions of the distal bodies 106, 107, and bosses 195, 196 may be formed on the distal bodies 106, 107. Bosses 195, 196 may be configured to receive a locking portion 191 of the staple cartridge 110. In some examples, recesses 130, 132 may terminate at bosses 195, 196 (e.g., extending from the proximal end to bosses 195, 196). How the locking gap portion 190 prevents movement of the staple cartridge 110 and facilitates positioning of the staple cartridge 110 will be discussed further below. In some examples, the distal bodies 106, 107 may not include the locking gap portion 190.

[0033] Cartridge 110 may be configured to be positioned between distal bodies 106, 107. Cartridge 110 may include an opening 114 configured to deploy fasteners and a longitudinal slot 116 configured to receive cutting equipment (such as a knife). The distal portion 126 of cartridge 110 may be angled relative to the longitudinal axis of cartridge 110. Cartridge 110 may also include shanks 131, 133 extending transversely to the longitudinal axis of cartridge 110. Shanks 131, 133 may be sized to be received within recesses 130, 132. In some examples, shanks 131, 133 may be sized to fit into recesses 130, 132 and allow cartridge 110 to slide in a proximal-distal direction, and to move slightly laterally and / or up-down in the transverse proximal-distal direction. In some embodiments, the handles 131, 133 and / or the recesses 130, 132 may include a taper so that the handles 131, 133, when positioned in the distal bodies 106, 107, can form a secure engagement in the recesses 130, 132. For example, pushing the cartridge 110 distally relative to the distal bodies 106, 107 can engage and secure the cartridge 110 in the desired position. When it is necessary to remove and / or replace the cartridge 110, the cartridge can be operated by pulling it proximally relative to the distal bodies 106, 107 to disengage from the tapered portions of the handles 131, 133 and / or the recesses 130, 132. Furthermore, the cartridge 110 may include one or more cavities 150, 151 (e.g., ...). Figure 5 (As shown). Cavities 150, 151 may be configured to receive one or more actuators, one or more fasteners, one or more pistons or gaskets, and / or one or more knives. A proximal elongation 112 may extend from the proximal portion of the cartridge 110. The proximal elongation 112 may be cylindrical and may include a cavity (not shown) for receiving one or more actuation lines to deploy fasteners and / or move one or more cutting devices (such as knives). The proximal elongation 112 may be flexible and may be configured to move through the elongation 102. The proximal elongation 112 may be rigid enough to translate the cartridge 110 distally when the user moves the proximal portion of the proximal elongation 112 distally. In some examples, the proximal end of the proximal elongation 112 may include a pivot-type handle, a wheel-shaped knob, and / or any other suitable actuation mechanism known in the art to deploy fasteners by pulling or rotating. The housing 110 may include a distal protrusion 128, which may be configured to be located within a gap 137 between the distal portions 108 and 109 of the distal bodies 106 and 107.

[0034] 6A and 6B are side views of an exemplary surgical suture device 601 that is substantially similar to device 101. Any features discussed in relation to device 101 may be included in device 601. The illustrated device 601 is positioned within a flexible conduit 603 (shown in cross-section). Device 601 includes a distal body 606, an anvil 604 including a protrusion 618, a suture cassette 610, an elongated body 602, and a proximal elongated member 612. Device 601 may also include a second distal body, such as distal body 107, but... Figures 6A-6B It is not shown in the view. Figure 6A In this configuration, device 601 is positioned such that anvil 604 and distal body 606 are separated in an expanded, open configuration. In some examples, device 601 can be reverse-directed into flexible catheter 603, which may involve moving the proximal end (not shown) of device 601 through the distal opening 601 of flexible catheter 603 to position anvil 604 and distal body 606 close to the distal opening 601. The user may first place tissue within the space 698 (the active area of ​​device 601) between anvil 604 and distal body 606. The user may then move flexible catheter 603 distally relative to device 601, bringing the curved outer surface portions of anvil 604 and distal body 606 into contact with the inner surface of flexible catheter 603. By moving flexible catheter 603 distally relative to device 601, anvil 604 and distal body 606 may move toward each other to clamp tissue between anvil 604 and distal body 606. In other embodiments, as described above, one of the anvil 604 or the distal body 606 may be substantially straight, substantially inflexible, extend substantially parallel to the longitudinal axis of the elongated body 602, and remain in the same position as the flexible conduit 603 is moved distally, resulting in only the other of the anvil 604 or the distal body 606 moving radially inward as the flexible conduit 603 is moved distally.

[0035] In some examples, the protrusion 618 of the anvil 604 may assist in holding the anvil 604 and the distal body 606 in a closed configuration (clamped together) to allow the user to deploy suture pins or other fasteners. For example, the protrusion 618 may include a flange 619 that may engage with the outer surface of the suture pin cartridge 610 and / or the distal body 606 to hold the distal body 606 (such as...) Figure 6B(As shown) is held in a clamped position, preventing radial outward movement of the distal body 606 relative to the longitudinal axis of the elongated body 602. By clamping the anvil 604 and the distal body 606 together, the protrusion 618 allows the user to stop moving the flexible conduit 603 distally, moving the device 601 proximally, and / or applying force toward the distal end of the conduit 603 (in order to clamp the anvil 604 and the distal body 606 together), as the anvil 604 and the distal body 606 will be held in a closed, clamped position. The user can then proceed to deploy suture staples from the staple cartridge 610. In some examples, the user can pull an actuator, which may be located within the proximal elongated member 612, to deploy suture staples from the staple cartridge 610 when the anvil 604 and the distal body 606 are clamped together. Figure 6B (As shown). This section is about... Figure 7 An example illustrating this actuation is provided. To release the protrusion 618 from the nail cartridge 610, the user can move the flexible conduit 603 distally to contact the flange 619, and move the flange 619 distally to release the contact between the nail cartridge 610 and the flange 619. Because the distal body 606 can be oriented towards... Figure 6A The open position shown is biased such that when the flange 619 moves distally outward to contact the staple cartridge 610, the distal body 606 will move radially outward and away from the anvil 604. Alternatively, the user can pull the staple cartridge 610 proximally to disengage the flange 619 from contact with the staple cartridge 610. In some examples, the anvil 604 may not include the protrusion 618, and the user can hold the anvil 604 and distal body 606 in a closed clamped position by holding the flexible catheter 603 in a position that forces the anvil 604 and distal body 606 into a clamped position. Although the device 601 shown is positioned within the flexible catheter 603, it can be operated in the same manner as described above when the device 601 is positioned within the working channel of another type of medical device, such as an endoscope, gastroscope, colonoscope, ureteroscope, or similar device.

[0036] Figure 7 An enlarged cross-sectional view of an exemplary suture device 701 is shown, which includes an anvil 704, a distal body 706, a staple cartridge 710 with fasteners 745 (staples), and an actuation slider 741 with an actuator 743. Any component of device 701 may include any features discussed herein that relate to components of other suture devices 101, 601. Components shown within staple cartridge 710 may be positioned relative to cavities 150, 151, a single cavity within the staple cartridge, or multiple cavities within the staple cartridge. Figure 7 The device 701 illustrates the deployment of a fastener 745 onto tissue 749. An actuated slider 741 engages with a piston or washer 751, which then engages with the fastener 745 to deploy the fastener 745. Figure 7As shown, when the actuated slider 741 moves in the proximal direction P, the actuated slider 741 engages with the piston or washer 751. Each piston or washer 751 may be configured to translate within the nail cartridge 710 and may be sized to engage only one fastener 345. In other examples, each piston or washer 751 may be sized to engage multiple fasteners 345, or one or more pistons or washer 751 may be sized to engage multiple fasteners 345, while one or more other pistons or washer 751 may be sized to engage only one fastener 345. The actuated slider 741 may be configured to move each piston or washer 751 in a direction transverse to the longitudinal axis of the distal body 706.

[0037] For example, the actuating slider 741 and the actuator 743 (which may be a line or cable extending to the proximal handle) can be pulled proximally, causing the ramp 742 (including a first portion 790 and a second portion 791) to contact one or more pistons or washers 751 and push the one or more pistons or washers 751 to deploy one or more fasteners 745 from the rivet cartridge 710. The first portion 790 of the ramp 742 may have a steeper inclination relative to the second portion 791. Each piston or washer 751 may have an upper surface aligned and / or flush with a portion of each respective fastener 745. For example, each fastener 745 may be a stitching pin that may include three generally flat sections (e.g., “U-shaped”), with the middle generally flat section aligned with the top surface of each washer 751. Each piston or washer 751 may be rigid enough to move upward uniformly when the ramp 742 of the actuating slider engages with the corner of the piston or washer 751. In some examples, each piston or gasket 751 may be coupled to the nail cartridge 710 to prevent [damage / damage] along the longitudinal axis of the nail cartridge 710, or [damage / damage]. Figure 7 The movement is shown in the proximal P or distal D direction, while allowing movement in a direction perpendicular to the longitudinal axis of the staple cartridge 710. A piston or washer 751 in the staple cartridge 710 prevents the fasteners 745 (such as suture staples) from being partially deployed and avoids incorrect suturing caused by the distal portion of the suture staple moving upwards when the proximal portion of the suture staple is not moving. By providing washer 751 with a flat top surface aligned with the fastener 745, the ramp 742 of the actuating slider 741 can move proximally and uniformly push each fastener 745 upwards by engaging with each washer 751. When the fastener 745 is deployed from the staple cartridge 710, the fastener 745 can engage, for example, a groove 760 of the anvil 704 for fastening to tissue 749.

[0038] After the user has deployed all the fasteners 745 from the cartridge 710, the user can remove the cartridge 710 from the distal body 706 and replace the cartridge 710 with a new cartridge filled with fasteners. For example, refer to Figure 1 and Figure 5 The user can move the cartridge 110 proximally by pulling the proximal elongated part 112, and the cartridge 110 can slide proximally across the elongated body 102 within the grooves 130, 132, and be removed by the user at the proximal portion of the elongated body 102. Once completely removed from the device 101, the user can replace the cartridge 110 with a new cartridge filled with fasteners. The user can then place the new cartridge within the grooves 130, 132 and move it distally to the distal bodies 106, 107. Once the new cartridge is positioned distally to the distal ends of the distal bodies 106, 107, the user can continue to use the new cartridge to fasten tissue. By providing a method for removing and replacing the cartridge without having to remove the entire suture device 101 from the working channel, the user can avoid or minimize unnecessary harm to the patient caused by removing and reinserting the device 101 from the patient's body during surgery. Moreover, replacing the empty suture cassette with a new cassette, without having to remove the entire suture device 101 from the patient's body, can reduce surgical time.

[0039] In some examples, any of the nail cartridges 110, 610, 710 discussed herein may include a locking portion 191. The locking portion 191 may be configured to be received by a locking gap portion 190 between the distal bodies 106, 107. The locking portion 191 may be positioned between the distal bodies 108, 109, while the shanks 131, 133 may be positioned within recesses 130, 132 of the distal bodies 106, 107. As the nail cartridge moves from the proximal portion of the distal bodies 106, 107 to the locking gap portion 190, the outermost portion of the locking portion 190, radially outermost from the central longitudinal axis of the nail cartridge 110, may be positioned adjacent to and slidably engaged with the distal bodies 106, 107. For example, when the locking portion 191 is positioned adjacent to the distal bodies 106, 107, the nail cartridge 110 may move distally or proximally, with the shanks 131, 133 positioned within recesses 130, 132. When the nail cartridge 110 is positioned such that the locking portion 191 is distal to the bosses 195, 196 of the distal bodies 106, 107, the locking portion 191 can move upward (or away from the anvil 104) to a position within the locking gap portion 190 between the distal bodies 106, 107. Once the locking portion 191 is within the locking gap portion 190, the bosses 195, 196 prevent the nail cartridge 110 from moving proximally, while the distal portions 108, 109 of the distal bodies 106, 107 prevent the nail cartridge 110 from moving distally. In some examples, when the locking portion 191 is correctly positioned within the locking gap portion 190, the distal protrusion 128 can provide visual notification to the user, as the user can recognize it when the distal protrusion 128 is positioned within the gap 137, for example via an image sensor such as the image sensor 864 described herein. When a user wants to remove the nail cartridge 110 from the locking gap portion 191, the user can move the nail cartridge 110 in a direction transverse to the longitudinal axis of the distal bodies 106, 107 until the locking portion 191 is no longer in contact with the bosses 195, 196, and then move the nail cartridge 110 proximally.

[0040] In some examples, the nail cartridge 110 can be moved distally or proximally with the protrusions 131, 133 of the locking portion 191 positioned within the recesses 130, 132, thereby causing the distal bodies 106, 107 to be moved radially outward due to the locking portion 191 being positioned between the distal bodies 106, 107. The recesses 130, 132 can extend to the distal ends of the distal bodies 106, 107. When the nail cartridge 110 is positioned such that the locking portion 191 is distal to the bosses 195, 196 of the distal bodies 106, 107, the distal bodies 106, 107 can be moved radially inward toward the locking portion 191 to a position where the distal bodies 106, 107 engage with the locking portion 191 within the locking gap portion 190. Once the locking portion 191 is within the locking gap portion 190, the bosses 195 and 196 prevent the nail cartridge 110 from moving proximally, while the distal portions 108 and 109 of the distal bodies 106 and 107 prevent the nail cartridge 110 from moving distally.

[0041] Figure 8 An embodiment of a cartridge 810 and a proximal elongated member 861 extending into a working channel 816 of a distal end 800 of a medical device, such as an endoscope or any other device mentioned herein, is shown. The distal end 800 may include one or more image sensors 864 and one or more illuminators 865. The cartridge 810 may be configured to operate with embodiments of suture devices similar to devices 101 or 601, which do not require suture actuators, such as actuated slider 741, as part of the cartridge 810, such as the suture device 901 discussed below. The cartridge 810 may include a coupling protrusion 867 configured to mate with a connector 863. The surface of the cartridge 810 may include incisions, slots, ridges, or other features that increase the flexibility of the cartridge 810, allowing the cartridge 810 to extend more easily through the working channel 816. Similarly, the proximal elongated member 861 may be flexible yet sufficiently rigid to move the cartridge 810 through the working channel 816. The cartridge 810 can be connected to the proximal elongated member 861 via a connector 863. In some examples, the elongated member 861 can be configured to be fed in reverse through the endoscope working channel or other medical device before the cartridge 810 is connected to the elongated member 861.

[0042] The cross-section of connector 863 is in Figure 8As shown in the figure. In some examples, the connector 863 may engage with the cartridge 810 and may be released via an actuator. In some examples, the connector 863 may be released without an actuator. The proximal end of the elongated member 861 may have at least one user interface for releasing the connector 863 from the cartridge 810. The connector 863 may be cylindrical, may cover portions of both the proximal elongated member 861 and the cartridge 810, and may include a cavity 875 extending through a central longitudinal axis of the connector 863. In some examples, the connector 863 may include a radially outer surface 890 extending toward the central longitudinal axis of the connector 863 as the radially outer surface moves from its longitudinal midpoint toward the proximal end 891 and the distal end 892 of the connector 863. In some examples, a chamfered tip 868 of the elongated member 861 may be configured to be received by the connector 863 to engage the cartridge 810 to the elongated member 861. The chamfered tip 868 can be rigid and can be positioned within the cavity 875 of the connector 863 (e.g., Figure 8(As shown). The connector 863 may be flush with and / or in contact with the outer surface of the elongated member 861 at a portion proximal to the chamfered tip 868. The chamfered tip 868 facilitates the breakage of the connector 863 to release the cartridge 810 from the elongated member 861. For example, a user may pull the elongated member 861 proximally to pull the connector 863 proximally so that the outer surface of the connector 863 contacts the distal end 800. For example, the connector 863 may contact the distal front of the distal end 800 at a portion near the edge of the working channel 816. When the connector 863 contacts the distal end 800, the chamfered tip 868 may be pulled proximally to apply pressure against the inner surface of the connector 863. This can be achieved by the proximal movement of the chamfered tip 868 and the engagement of the connector 863 with the distal end 800, thereby clamping the connector 863. Crushing the connector 863 between the distal end 800 and the chamfered tip 868 may cause the connector 863 to break and release the cartridge 810 from the connector 863. In some examples, the connector 863 may break into several pieces and be released into the patient during surgery. In some examples, the connector 863 may be cylindrical and may include an internal portion configured to receive the proximal elongated member 861 and the cartridge 810. The connector 863 may be overmolded and / or include an overmolded feature that is shaped like the cartridge 810. In some examples, the overmolded feature of the connector 863 may be overmolded onto the cartridge 810, such that once the cartridge 810 is closed onto the tissue to deploy suture staples from the cartridge 810, the tension applied across the entire assembly due to the operator using the cartridge 810 to suture the tissue exceeds the material strength of the connector 863 and causes the connector 863 to break, at which point the cartridge 810 can be released. In some examples, the connector 863 may be biodegradable and / or digestible and may be configured to detach from the elongated member 861 and remain in the patient's body. In some examples, the cartridge 810 is manufactured to house a portion of the connector 863 within a recess 871 of the cartridge 810. A user may use the connector 863 and the proximal elongated member 861 to deliver the cartridge 810 to a suturing device, such as suturing device 901, to attach the cartridge 810 to the suturing device 901, and to release the cartridge 810 from the connector 863. In some examples, the connector 863 may be configured to detach from the cartridge 810 after the cartridge has been secured to or clamped to tissue. In some examples, the elongated member 861 and the connector 863 may be used to retrieve an empty cartridge from a device, such as device 901. The cartridge 810 may include teeth on its surface configured to engage with one or more distal bodies (such as distal bodies 906, 907) to facilitate attaching the cartridge 810 to one or more distal bodies.

[0043] In some examples, the user can use the proximal elongated member 861 and the connector 863 to transport the cartridge 810 to the distal portion of the distal bodies 906, 907 (in... Figure 9 (As shown in the diagram). The user can move the proximal elongated member 861 to attach the cartridge 810 to the distal bodies 907, 908; in some examples, this may be a snap-fit ​​engagement. Once the cartridge 810 is securely attached to the distal bodies 907, 908, the user can pull the proximal elongated member 861 proximally. When the proximal elongated member 861 is pulled proximally, the chamfered tip 868 applies pressure against the inner surface of the connector 863, as the cartridge 810 prevents the connector 863 from moving proximally with the proximal elongated member 861. In some examples, the pressure generated by the user pulling the proximal elongated member 861 proximally and the chamfered tip 868 contacting the inner surface of the connector 863 may cause the connector 863 to break, releasing the cartridge 810 from the connector 863. In some examples, after the connector 863 is released from the cartridge 810, the cartridge 810 remains securely attached to the distal bodies 907, 908.

[0044] Figure 9 Another embodiment of a suture device 901 is shown, which includes an anvil 904 and distal bodies 906, 907 positioned within a flexible conduit 903. Device 901 may have any of the features previously described relating to other devices of this disclosure. Device 901 may include an I-beam 964 partially surrounding at least the proximal portion of the anvil 904 and distal bodies 906, 907. Anvil 904 and distal bodies 906, 907 may be bent and biased into an open position in the same manner as distal bodies 106, 107 and anvil 104. Figure 9(As shown). Anvil 904 may include a first anvil body 960 and a second anvil body 961, which are substantially aligned with distal bodies 906 and 907, respectively. The proximal portion of each of the first anvil body 960, the second anvil body 961, and the distal bodies 906 and 907 may be positioned between a top portion 970 and a bottom portion 971 of I-beam 964. I-beam 964 may be positioned within the lumen of a flexible catheter 903 or within the working channel of an endoscope or other medical device. I-beam 964 may be connected to a flexible wire (not shown) at the proximal portion of I-beam 964. The flexible wire may extend proximally to a handle / actuator that can be actuated by a user to move I-beam 964 proximally and distally relative to anvil 904 and distal bodies 906 and 907. The cartridge 910 may be coupled to the distal bodies 906, 907 via a protrusion (not shown) that engages between the distal bodies 106, 107, forming a snap-fit ​​connection, one or more hooks, or other coupling mechanisms including those described in other embodiments herein. In some embodiments, the cartridge 910 may be coupled to the distal bodies 906, 907 via a protrusion extending from the cartridge 910, the protrusion receiving within a recess in the distal bodies 906, 907 to slidably receive the protrusion of the sewing machine cartridge 110 or the foot 131, 133 (e.g., ...) with the recess 130, 132. Figure 5 (As shown) It is basically the same way.

[0045] The I-beam 964 may include a top portion 970, a bottom portion 971, an intermediate portion 965 connecting the top portion 970 and the bottom portion 971, and two inclined actuators 968, 969. The top portion 970 and the bottom portion 971 may be curved and may be configured to move within the working channel of a medical device or the lumen of a flexible catheter 903. In some examples, the top portion 970 and the bottom portion 971 may have substantially the same length and width relative to their longitudinal axis, may have substantially the same radius of curvature, and / or may otherwise be mirror images of each other. The intermediate portion 965 may be flat, having a flat surface and a distal edge 966. The distal edge 966 may be sharp and may be configured to cut tissue. The intermediate portion 965 may extend longitudinally substantially parallel to the longitudinal axis of the top portion 964 and the bottom portion 971, and the longitudinal end of the edge 966 may engage with the radially inner surfaces of the top portion 964 and the bottom portion 971. In some examples, the I-beam 964 may include two inclined plane actuators 968, 969 configured to deploy fasteners from the housing 910. The inclined plane actuators 968, 969 can be deployed from the bottom portion 971 (e.g., Figure 10(As shown) or the radially inner surface of the top portion 970 extends inward. Each inclined actuator 968, 969 may include a radially inward surface extending proximally from the radially inward surface of the bottom portion 971. The inclined actuators 968, 969 may be configured to align with the channel of the housing 910. The I-beam 964 may be configured to move via the aforementioned line connected to the proximity portion of the I-beam 964.

[0046] Figure 11 Another embodiment of an I-beam 1164 is shown, having a top portion 1170, a bottom portion 1171, a middle portion 1165, an edge 1166, and a single inclined actuator 1168. The I-beam 1164 may have any of the features previously described related to the I-beam 964. The single inclined actuator 1168 may extend distally from a radially inward surface of the bottom portion 1171 and may include a curved distal end.

[0047] The cartridge 910 may include any of the features previously described relating to cartridges 110, 610, 710, and 810. The cartridge 910 may include an opening 914 configured to deploy fasteners and a longitudinal slot 916 configured to receive a cutting device, such as an edge 966 of an I-beam 964. The distal portion 926 of the cartridge 910 may be angled relative to the longitudinal axis of the cartridge 910. Furthermore, the cartridge 910 may include one or more cavities configured to receive one or more actuating ramps 968, 971, and 1168. The cartridge 910 may be configured to align with the distal bodies 906 and 907. In some examples, the anvil 904 and / or the distal bodies 906 and 907 may extend to the proximal end of the device 901. In some examples, the proximal end of the distal bodies 906 and 907 may be coupled to a control line, and the control line may be configured to pull from the proximal end toward the proximal side to move the anvil 904 and the distal bodies 906 and 907 to a closed position.

[0048] A user can use device 901 to attach one or more fasteners to tissue by first positioning the tissue between anvil 904 and distal bodies 906, 907. In some examples, the user can first load the I-beam 964, which includes a line connecting the proximal portion of the I-beam 964, the anvil 904, and the distal bodies 906, 907, posteriorly through the working channel of the endoscope, and remove the line and the proximal portion of the anvil 904 and the distal bodies 906, 907 from the proximal endoscope before inserting device 901 into the patient's body. Then, in some examples, the user can use a gripper or other tool to grasp the tissue to move it between the anvil 904 and the distal bodies 906, 907. Once the tissue is positioned within the active area of ​​device 901, the user can translate the line connected to the I-beam 964 distally, causing the I-beam 964 to be pushed radially inward due to the connection between the top portion 970 and the bottom portion 971, and the connection between the anvil 904 and the distal bodies 906, 907. Moving the I-beam 964 distally may cause the anvil 904 and the distal bodies 906, 907 to close or clamp the tissue. As the I-beam 964 is pushed distally toward the tissue, edge 966 engages and cuts the tissue. When cartridge 910 is positioned between the top portion 970 and the bottom portion 971, actuating ramps 968, 969 can move into the cavity of cartridge 910 and contact one or more pistons, similar to... Figure 7 The piston or space 751 is shown. When the user moves the I-beam 964 distally, the actuating ramps 968, 969 can deploy fasteners from the opening 914 by moving the piston within the nail cartridge 910. As the user continues to move the I-beam distally, the edge 966 and the middle portion 965 can be positioned within the channel 916. Due to the radial outward offset of the anvil 904 and the distal bodies 906, 907, the anvil and the distal bodies 906, 907 can slide into the I-beam 964 to maintain the anvil 904 and the distal bodies 906, 907 in a closed, clamped position while deploying fasteners from the cartridge 910.

[0049] Each of the aforementioned devices and apparatuses can be used to grasp, attach, and / or cut tissue. In some examples, the user may insert the proximal portion of the suture device into the working channel of the endoscope by reverse-feeding the proximal portion through the distal end of the endoscope's working channel to position a portion of the elongated body within the working channel. Once the proximal portion is positioned within the working channel, a handle assembly with one or more actuating devices can be coupled to the proximal end of the device. The user may then introduce the endoscope into the patient's body and move it toward the target area. The user can locate the target area (such as a tumor or other lesion tissue) within the subject's body cavity using the endoscope by directly observing the target area using an image sensor. Once the user has positioned the distal end of the endoscope near the target area, the user may place a tissue retrieval tool within the working channel of the endoscope, if such a tool is not already present. When the distal end of the endoscope is positioned at the target area, the user may position tissue between or near the moving parts of the device, such as the space between the anvil and the distal body of the device. Once the tissue is positioned within the moving part of the suture device, the user can move the anvil and distal body of the suture device to the closed position and clamp the grasped tissue with the device. The user can then actuate an actuator to deploy a fastener into the clamped tissue and abut against the anvil of the suture device. In some examples, the user can actuate the blade in the device to cut portions of the target tissue before, during, or after the tissue is secured together by the fastener.

[0050] By providing a suture device, users can replace an empty suture cartridge with a cartridge filled with fasteners without having to remove the suture device from the patient's body during surgery. This reduces the overall surgical time and avoids unnecessary harm to the patient caused by repeatedly removing and reinserting the suture device when changing to an empty cartridge.

[0051] 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 this disclosure. Other aspects of this disclosure will become apparent to those skilled in the art upon consideration of this specification and the features disclosed herein. The specification and examples are intended to be regarded as illustrative only.

Claims

1. A fastening apparatus, comprising: a flexible longitudinal body comprising a central longitudinal axis and a distal end; an anvil extending distally from the distal end of the longitudinal body; a first distal body extending distally from the distal end of the longitudinal body; and a second distal body extending distally from the distal end of the longitudinal body, wherein the first distal body and the second distal body are configured to receive a magazine having a plurality of fasteners.

2. The fastening apparatus of claim 1, wherein the anvil further comprises a protrusion extending from a distal portion of the anvil, wherein the protrusion is configured to engage one or more of the first distal body or the second distal body.

3. The fastening apparatus of claim 1, wherein the anvil is flexible and has a first configuration in which a distal portion of the anvil extends radially outward from the central longitudinal axis and a second configuration in which the distal portion is closer to the central longitudinal axis than in the first configuration.

4. The fastening apparatus of claim 1 or claim 3, wherein each of the first distal body and the second distal body is flexible, wherein each of the first distal body and the second distal body is movable between a first configuration and a second configuration, wherein in the first configuration a distal portion of each of the first distal body and the second distal body extends radially outward from the central longitudinal axis, and wherein in the second configuration the distal portion of each of the first distal body and the second distal body is closer to the central longitudinal axis than in the first configuration.

5. The fastening apparatus of claim 4, wherein each of the first distal body, the second distal body, and the anvil is curved in the first configuration and substantially straight in the second configuration.

6. A fastening apparatus, comprising: an anvil; and a distal body configured to receive a fastener magazine, wherein at least one of the anvil or the distal body is configured to transition from the anvil or the distal body being curved in an open configuration to the anvil or the distal body being straight in a closed configuration.

7. The fastening apparatus of claim 6, wherein in the open configuration both the anvil and the distal body are curved, and wherein in the closed configuration both the anvil and the distal body are straight.

8. The fastening apparatus of claim 6, wherein the magazine and the distal body are configured such that the magazine is removable when the fastening apparatus is positioned within a patient.

9. The fastening apparatus of claim 8, wherein the distal body comprises a recess, wherein the magazine comprises a tang configured to fit within the recess to detachably secure the magazine to the distal body.

10. The fastening apparatus of claim 9, wherein an elongate member extends proximally from the magazine, wherein a force acting on the elongate member is configured to translate the magazine proximally within the recess of the distal body to decouple the magazine from the distal body.

11. A fastening apparatus, comprising: ​ a flexible longitudinal body comprising a central longitudinal axis and a distal end; an anvil extending distally from the distal end of the longitudinal body; a first distal body extending distally from the distal end of the longitudinal body, wherein the first distal body comprises a first recess; a second distal body extending distally from the distal end of the longitudinal body, wherein the second distal body comprises a second recess; and a cartridge configured to be secured between the first distal body and the second distal body, the cartridge comprising a first tang and a second tang, wherein the first tang is configured to be detachably received within the first recess, and wherein the second tang is configured to be detachably received within the second recess.

12. The fastening apparatus of claim 11, wherein the first recess and the second recess each extend to a proximal end of the longitudinal body.

13. The fastening apparatus of claim 11 or claim 12, wherein the cartridge is configured to be removed by translating the first tang along the first recess and translating the second tang along the second recess when the anvil and the first distal body are located within a patient.

14. The fastening apparatus of claim 11 or claim 12, wherein a gap is positioned between the first distal body and the second distal body, wherein the cartridge further comprises a distal protrusion configured to be detachably positioned within the gap.

15. The fastening apparatus of claim 11 or claim 12, wherein the first distal body further comprises a first ledge, wherein the second distal body further comprises a second ledge, wherein the cartridge further comprises a locking portion, and wherein the cartridge is configured to be secured between the first distal body and the second distal body when the locking portion of the cartridge is positioned: (1) distally of the first ledge; (2) distally of the second ledge; and (3) between the first distal body and the second distal body.

Images