Suture-based closure device used with endoscopes

Abstract

A suturing apparatus used in conjunction with a delivery system including a cavity extending through the delivery system, comprising a needle for carrying sutures, a distal shuttle configured to releasably secure the needle, and a cannula disposed above the distal shuttle, the distal shuttle being movable relative to the cannula between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle. The suturing apparatus includes a distal assembly having an elongated tool guide movable between a placement configuration in which the elongated tool guide is generally parallel to the distal assembly and a working configuration in which the elongated tool guide is bent away from the distal assembly.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 978,029, filed on February 18, 2020, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to apparatus for suturing tissue, and more particularly to apparatus for working with an endoscope or similar apparatus for suturing tissue using an endoscope. Background Technology

[0004] Many endoscopic treatments can create defects (or wounds) that are too large for known closure methods. Examples of such endoscopic treatments include removal of large lesions, tunneling beneath the mucosa, full-thickness tissue removal, treatment of other organs by penetrating to the outside of the gastrointestinal tract, and postoperative repair (e.g., postoperative leakage). Endoscopic treatments also include bariatric corrective surgery. Each known device and method for closing large defects using endoscopy has its own advantages and disadvantages. Summary of the Invention

[0005] This disclosure relates to several alternative designs, materials, and methods for closing large defects using an endoscope. One example is a suturing device for use in conjunction with a delivery system including an inner cavity extending through the delivery system. The suturing device includes a suture translation assembly configured to be axially translatable within the inner cavity of the delivery system and including a distal end. A guide member is configured to allow the suture translation assembly to extend through the guide member and translate relative to the guide member and an elongated tool guide member (having a distal end arranged relative to a distal assembly), the elongated tool guide member being movable between a placement configuration in which the elongated tool guide member is generally parallel to the distal assembly and a working configuration in which the elongated tool guide member is bent away from the distal assembly.

[0006] Alternatively or additionally, the distal component may define a working area between the guide member and the end cap, and when the elongated tool guide is in its working configuration, the elongated tool guide may be positioned to guide a tool extending through the elongated tool guide into the working area.

[0007] Alternatively or additionally, the elongated tool guide may include a guide structure fixedly fastened to a distal assembly, and a polymer tubular member fastened to and extending therefrom the guide structure proximally.

[0008] Alternatively or additionally, as the tool is extended distally through the elongated tool guide, the elongated tool guide can move from its placement configuration into its working configuration.

[0009] Alternatively or additionally, when the elongated tool guide is in its placement configuration, the polymer tubular member is in its retracted configuration.

[0010] Alternatively or additionally, when the elongated tool guide is in its working configuration, the polymer tubular member is in an expanded configuration.

[0011] Alternatively or additionally, the elongated tool guide may include a guide structure pivotally fastened to a distal assembly, and a polymer tubular member fastened to and extending proximally therefrom the guide structure, the guide structure and the polymer tubular member jointly defining an inner cavity. The elongated tool guide may include a pivot structure protruding into the inner cavity such that a tool extending distally through the elongated tool guide will contact the pivot structure, wherein further distal driving of the tool will cause the tool to interact with the pivot structure and cause the guide structure to pivot relative to the distal assembly, thereby moving the elongated tool guide from its placement configuration into its working configuration.

[0012] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, wherein the first cavity is configured to receive a tool extending therethrough. A metal strip may extend through the second cavity and is movable between a linear configuration in which the metal strip is straight and a memory configuration in which the metal strip is curved. The elongated structure may be straight when the metal strip is straight and curved when the metal strip is curved.

[0013] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, wherein the first cavity is configured to receive a tool extending therethrough. An elongated bistable member may extend through the second cavity and may be a member movable between a stable configuration in which the elongated bistable member is straight and an unstable configuration in which the metal strip is bent. The elongated structure may be straight when the bistable metal element is straight and may be bent when the bistable metal element is bent.

[0014] Alternatively or additionally, the elongated tool guide may include a plurality of catheter segments connected together via movable hinges formed between adjacent catheter segments, each of the plurality of catheter segments including at least one control port extending through the catheter segment and at least one control cable extending through each control port of the catheter segment. Applying an axial force to at least one control cable may cause the elongated tool guide to move between its placement configuration and its working configuration.

[0015] Alternatively or additionally, the suture translation assembly may include a needle for carrying the suture, a distal shuttle configured to releasably secure the needle, and a user interface extending proximally from the distal shuttle and configured to allow the user to releasably secure the needle.

[0016] Alternatively or additionally, the suturing device may also include a distal assembly configured to be fastened to the distal end of the delivery system and an end cap configured to releasably engage and disengage from the needle, the end cap being configured to engage the needle when the needle is moved distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is retracted proximally.

[0017] Alternatively or additionally, the end cap may include: a proximal needle opening configured to receive the needle and aligned with the longitudinal axis of the needle when the needle is moved distally into the end cap; one or more fixed openings arranged perpendicular to the proximal needle opening; and one or more fasteners disposed within the fixed openings, the one or more fasteners being configured to releasably engage with a distal stop of the needle.

[0018] Alternatively or additionally, moving the translation handle from the center position to the distal side causes the component to move to the locked position, and moving the translation handle from the center position to the proximal side causes the component to move to the unlocked position.

[0019] Alternatively or additionally, the delivery system may include an endoscope and the cavity may include the working channel of the endoscope.

[0020] Another example is a suturing device used in conjunction with an endoscope having a working channel and a distal end. This suturing device includes: a translational assembly configured to translate axially within the working channel and including a needle configured to carry a suture; a distal shuttle configured to releasably secure the needle; a cannula disposed above the distal shuttle; and a cannula movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle. The suturing device includes: a distal assembly (configured to be secured to the distal end of the endoscope and including an end cap configured to engage the needle when the needle is traveled distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is retracted proximally); and an elongated tool guide having a distal end disposed relative to the distal assembly (movable between a placement configuration generally parallel to the distal assembly and a working configuration bent away from the distal assembly).

[0021] Alternatively or additionally, the elongated tool guide may include: a guide structure fixedly fastened to a distal assembly, and a polymer tubular member fastened to and extending therefrom the guide structure proximally.

[0022] Alternatively or additionally, as the tool extends distally through the elongated tool guide, the elongated tool guide can move from its placement configuration into its working configuration.

[0023] Alternatively or additionally, the elongated tool guide may include: a guide structure (which is pivotally secured to a distal assembly) and a polymer tubular member (which is secured to and extends proximally therefrom the guide structure), the guide structure and the polymer tubular member jointly defining an inner cavity. The pivot structure may protrude into the inner cavity such that a tool extending distally through the elongated tool guide will contact the pivot structure, wherein further distal driving of the tool may cause the tool to interact with the pivot structure and cause the guide structure to pivot relative to the distal assembly, thereby moving the elongated tool guide from its placement configuration into its working configuration.

[0024] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, the first cavity being configured to receive a tool extending therethrough. A metal strip may extend through the second cavity and may move between a linear configuration in which the metal strip is straight and a memory configuration in which the metal strip is bent. The elongated structure may be straight when the metal strip is straight and may be bent when the metal strip is bent.

[0025] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, the first cavity being configured to receive a tool extending therethrough. An elongated bistable member may extend through the second cavity and may move between a stable configuration in which the elongated bistable member is straight and an unstable configuration in which the metal strip is bent. The elongated structure may be straight when the bistable metal element is straight and may be bent when the bistable metal element is bent.

[0026] Alternatively or additionally, the elongated tool guide may include a plurality of conduit segments connected together via movable hinges formed between adjacent conduit segments, each conduit segment including at least one control port extending through the conduit segment, and at least one control cable extending through each control port. Applying an axial force to the at least one control cable may cause the elongated tool guide to move between its placement configuration and its working configuration.

[0027] Another example is a suture device used in conjunction with a delivery system including an inner cavity extending through the delivery system. The delivery system includes a translational assembly configured to be axially translatable within the inner cavity of the delivery system, and the delivery system includes a distal end. The translational assembly includes: a needle that cannot carry sutures; a distal shuttle configured to releasably secure the needle; and a user interface extending proximally from the distal shuttle and configured to allow the user to releasably secure the needle. The distal assembly is configured to be secured to the distal end of the delivery system and includes an end cap configured to releasably engage and disengage from the needle. The end cap is configured to engage the needle when the needle is moved distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is retracted proximally. The distal assembly includes: a guide member configured to allow the suture translation assembly to extend through and translate relative to the guide member; and an elongated tool guide member having a distal end disposed relative to the distal assembly (movable between a placement configuration in which the elongated tool guide member is generally parallel to the distal assembly and a working configuration in which the elongated tool guide member is bent away from the distal assembly), the elongated tool guide member including a guide structure fixedly fastened to the distal assembly and a polymer tubular member fastened to and extending proximally therefrom the guide structure.

[0028] Another example is a medical device used in conjunction with a delivery system that includes an inner cavity extending through the delivery system. The medical device includes an elongated tool guide adapted to be secured relative to the distal end of the delivery system to guide a tool through an elongated tool guide portion, the elongated tool guide portion being movable between a placement configuration in which the elongated tool guide portion is generally parallel to the delivery system when secured relative to the distal end of the delivery system, and a working configuration in which the elongated tool guide portion is bent away from the distal assembly.

[0029] Alternatively or additionally, the elongated tool guide may include a guide structure adapted to be fastened relative to the distal end of the delivery system, and a polymer tubular member fastened to and extending proximally therefrom the guide structure.

[0030] Alternatively or additionally, the guide structure may be adapted to be securely fastened to an intermediate structure between the guide structure and the far end of the conveying system.

[0031] Alternatively or additionally, the elongated tool guide may be adapted to move from its placement configuration into its working configuration as the tool extends distally through the elongated tool guide.

[0032] Alternatively or additionally, the elongated tool guide may include: a guide structure (which is pivotally fastened to an intermediate structure between the guide structure and the distal end of the delivery system), a polymer tubular member (which is fastened to the guide structure and extends proximally therefrom such that the guide structure and the polymer tubular member jointly define an inner cavity), and a pivoting structure (which protrudes into the inner cavity such that a tool extending distally through the elongated tool guide will contact the pivoting structure), wherein further distal driving of the tool will cause the tool to interact with the pivoting structure and cause the guide structure to pivot relative to the distal assembly, thereby moving the elongated tool guide from its placement configuration into its working configuration.

[0033] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, wherein the first cavity is configured to receive a tool extending therethrough and a metal strip extending through the second cavity, the metal strip being movable between a linear configuration in which the metal strip is straight and a memory configuration in which the metal strip is curved. The elongated structure is straight when the metal strip is straight and curved when the metal strip is curved.

[0034] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, wherein the first cavity is configured to receive a tool extending therethrough and an elongated bistable member extending through the second cavity, the elongated bistable member being movable between a stable configuration in which the elongated bistable member is straight and an unstable configuration in which the metal strip is bent. The elongated structure is straight when the bistable metal element is straight and bends when the bistable metal element bends.

[0035] Alternatively or additionally, the elongated tool guide may include a plurality of catheter segments connected together via movable hinges formed between adjacent catheter segments, each catheter segment including at least one control cable extending through at least one control hole of the catheter segment and extending through at least one control hole of the catheter segment. Applying an axial force to at least one control cable may cause the elongated tool guide to move between its placement configuration and its working configuration.

[0036] Alternatively or additionally, the medical device may also include a distal assembly adapted to be fastened relative to the distal end of the delivery system, wherein an elongated tool guide can be fastened relative to the distal assembly, the distal assembly being adapted to receive a suture device.

[0037] Alternatively or additionally, the suturing device may include: a suture translation assembly configured to be axially translatable within the cavity of the delivery system, and a guide member configured to allow the suture translation assembly to extend through.

[0038] Alternatively or additionally, the suture translation assembly may include: a needle for carrying the suture, a distal shuttle configured to releasably secure the needle, and a user interface extending proximally from the distal shuttle, the user interface being configured to allow a user to releasably secure the needle. The suturing device may also include an end cap configured to releasably engage and disengage from the needle, the end cap being configured to engage the needle when the needle is traveled distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is retracted proximally.

[0039] Alternatively or additionally, the end cap may include: a proximal needle opening configured to receive the needle when the needle is moved distally into the end cap (the proximal needle opening being aligned with the longitudinal axis of the needle), one or more fixed openings arranged perpendicular to the proximal needle opening, and one or more fasteners disposed within the fixed openings (the one or more fasteners being configured to releasably engage with a distal stop of the needle).

[0040] Another example is a medical device used in conjunction with an endoscope having a working channel and a distal end. This medical device includes: a distal assembly adapted to be secured relative to the endoscope, and an elongated tool guide having a distal end positioned relative to the distal assembly, the elongated tool guide being movable between a placement configuration in which the elongated tool guide is generally parallel to the distal assembly and a working configuration in which the elongated tool guide is bent away from the distal assembly.

[0041] Alternatively or additionally, the elongated tool guide may include a guide structure fixedly fastened to a distal assembly, and a polymer tubular member fastened to and extending therefrom to the guide structure proximally.

[0042] Alternatively or additionally, as the tool extends distally past the elongated tool guide, the elongated tool guide can move from its placement configuration into its working configuration.

[0043] Alternatively or additionally, the elongated tool guide may include a guide structure (which is pivotally fastened to a distal assembly), a polymer tubular member (which is fastened to and extends proximally therefrom the guide structure, the guide structure and the polymer tubular member jointly defining an inner cavity), and a pivoting structure (which protrudes into the inner cavity such that a tool extending distally through the elongated tool guide will contact the pivoting structure), wherein further distal driving of the tool will cause the tool to interact with the pivoting structure and cause the guide structure to pivot relative to the distal assembly, thereby moving the elongated tool guide from its placement configuration into its working configuration.

[0044] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, wherein the first cavity is configured to receive a tool extending therethrough and a metal strip extending through the second cavity, the metal strip being movable between a linear configuration in which the metal strip is straight and a memory configuration in which the metal strip is curved. The elongated structure is straight when the metal strip is straight and curved when the metal strip is curved.

[0045] Alternatively or additionally, the elongated tool guide may include an elongated structure defining at least a first cavity and a second cavity, wherein the first cavity is configured to receive a tool extending therethrough and an elongated bistable member extending through the second cavity, the elongated bistable member being movable between a stable configuration in which the elongated bistable member is straight and an unstable configuration in which the metal strip is bent. The elongated structure is straight when the bistable metal element is straight and bends when the bistable metal element is bent.

[0046] Alternatively or additionally, the elongated tool guide may include a plurality of guide segments connected together via movable hinges formed between adjacent guide segments, each guide segment including at least one control port extending through the guide segment and at least one control cable extending through each control port. Applying an axial force to the at least one control cable causes the elongated tool guide to move between its placement configuration and its working configuration.

[0047] Another example is a medical device used in conjunction with a delivery system (which includes an interior extending through the delivery system). This medical device includes a distal assembly configured to be fastened to a distal end of the delivery system, and an elongated tool guide configured to be fastened relative to the distal assembly. The elongated tool guide is movable between a placement configuration in which the elongated tool guide is generally parallel to the distal assembly and a working configuration in which the elongated tool guide is bent away from the distal assembly. The elongated tool guide includes a guide structure fixedly fastened to the distal assembly and a polymer tubular member fastened to and extending proximally therefrom the guide structure.

[0048] The above overview of some implementations is not intended to describe all implementations or every embodiment of this disclosure. The following figures and detailed description illustrate these implementations in more detail. Attached Figure Description

[0049] This disclosure will be more fully understood when considered in conjunction with the accompanying drawings, in which:

[0050] Figure 1 This is a perspective view of an illustrative suturing apparatus according to an example of this disclosure;

[0051] Figure 2 It constitutes Figure 1 A perspective view of the distal component (shown in the extended position) of the illustrative suture device.

[0052] Figure 3 The image shows the retracted position. Figure 2 A perspective view of the far-side component;

[0053] Figure 4 It is the section intercepted along line 4-4. Figure 2 A cross-sectional view of the distal component;

[0054] Figure 5 It constitutes Figure 1 An exploded view of a portion of the suture translation assembly of an illustrative suture device;

[0055] Figure 6 It is a side view of the distal shuttle and the components that make up the part of the suture translation assembly, wherein the components are shown extending in the locked position;

[0056] Figure 7 yes Figure 6 A side view of the distal shuttle and component, wherein the component is shown retracted in the unlocked position;

[0057] Figure 8 This is an example of what can be used according to this disclosure. Figure 1 A side view of the distal component of the suture device;

[0058] Figure 9 yes Figure 8 Side view of the distal component (together with the attached flexible cavity);

[0059] Figure 10 This is an example of what can be used according to this disclosure. Figure 1 A side view of the distal component of the suture device (illustrated with an attached lumen);

[0060] Figure 11 and Figure 12 It is an example of an associate of this disclosure. Figure 1 and Figure 8 The view of the tissue release mechanism used for the distal components;

[0061] Figure 13 This is an example of what can be used according to this disclosure. Figure 1 A perspective view of the distal component of the suture device;

[0062] Figure 14 This is an example of what can be used according to this disclosure. Figure 1 A perspective view of the suture line translation component of the suture device;

[0063] Figure 15 This is based on an example of this disclosure. Figure 14 A partially exploded perspective view of the suture translation component;

[0064] Figure 16 This is an example of the construction based on this disclosure. Figure 14 Perspective view of an inner component of a suture translation assembly:

[0065] Figure 17 This is an example of a locked configuration according to this disclosure. Figure 14 A perspective view of a portion of the suture translation component;

[0066] Figure 18 This is an example of an unlocked configuration illustrated in this disclosure. Figure 14 A perspective view of a portion of the suture translation component;

[0067] Figure 19 This is an example of what can be used according to this disclosure. Figure 1 A perspective view of the suture line translation component of the suture device;

[0068] Figure 20 This is based on an example of this disclosure. Figure 19 A perspective view of a suture translation assembly, showing some elements removed to reveal the internal structure, wherein the suture translation assembly is illustrated in a locked configuration;

[0069] Figure 21 yes Figure 19 A side view of a portion of the suture translation assembly, showing how the locking member engages with the inner member of the suture translation assembly and the needle (e.g., in the locking configuration) is in the locking configuration. Figure 20 (as shown in the illustration and according to an example of this disclosure);

[0070] Figure 22 The illustration is in an unlocked configuration according to an example of this disclosure. Figure 19 A perspective view of the suture translation component;

[0071] Figure 23 This is a perspective view of a sleeve that can be used as a component for suture translation assembly;

[0072] Figure 24 This is an application of an example based on this disclosure. Figure 23 The sleeve and can be used Figure 1 A perspective view of the distal component of the suture device;

[0073] Figure 25 This is a view of a needle with a needle cap according to an example of this disclosure;

[0074] Figure 26 It is the section intercepted along line 26-26. Figure 25 A cross-sectional view of the needle and needle cap;

[0075] Figure 27 This is a perspective view of a suture translation assembly according to an example of this disclosure, wherein the needle is shown in the unlocked position;

[0076] Figure 28 This is based on an example of this disclosure. Figure 27 A perspective view of the suture translation assembly, in which the needle is shown in the locked position;

[0077] Figure 29 It is the section intercepted along line 29-29. Figure 28 A cross-sectional view of the suture translation component;

[0078] Figure 30 yes Figure 28 A partially exploded view of the suture translation component;

[0079] Figure 31 This is a perspective view of a distal assembly including an elongated tool guide in a placement configuration according to an example of this disclosure, the distal assembly being used for... Figure 1 The suturing device;

[0080] Figure 32 This is a perspective view of a distal assembly including an elongated tool guide in a working configuration according to an example of this disclosure, the distal assembly being used for... Figure 1 The suturing device;

[0081] Figure 33 This is an example of what can be used according to this disclosure. Figure 1 A partial cross-sectional perspective view of the slender tool guide component of the suture device;

[0082] Figure 34 This is a perspective view of a portion of an elongated tool guide component illustrated in a placement configuration according to an example of this disclosure, the elongated tool guide component being used for... Figure 1 The suturing device;

[0083] Figure 35 This is a perspective view of a portion of an elongated tool guide component in a working configuration, according to an example of this disclosure, the elongated tool guide component being used for... Figure 1 The suturing device;

[0084] Figure 36A This is a side view of a portion of an elongated tool guide component illustrated in a placement configuration according to an example of this disclosure, the elongated tool guide component being used for... Figure 1 The suturing device;

[0085] Figure 36B This is a side view of a portion of an elongated tool guide component in a working configuration, according to an example of this disclosure, which can be used for... Figure 1 The suture device; and

[0086] Figure 36C It is the section intercepted along line 36-36. Figure 36B A cross-sectional view of a portion of a slender tool guide component.

[0087] While this disclosure may have various modifications and alternatives, its details have been revealed by example in the accompanying drawings and will be described in detail. However, it should be understood that the invention is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0088] For the purposes of all the terms defined below, these definitions shall apply unless otherwise given in the claims or elsewhere in this specification.

[0089] The following provides definitions for certain terms, which should be applied unless otherwise defined in the claims or elsewhere in this specification.

[0090] All numerical assumptions in this document are modified by the word “about,” whether explicitly stated or not. The word “about” generally refers to a series of numbers that a person skilled in the art would consider equivalent to the listed values ​​(i.e., having the same function or result). In many cases, the word “about” can be an indicator that includes numbers rounded to the nearest significant figure.

[0091] Statements of numerical ranges using endpoints include all numerical values ​​within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0092] Although some suitable dimensions, ranges and / or values ​​belonging to various components, features and / or specifications are disclosed, those skilled in the art will understand, inspired by this disclosure, that desired dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0093] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include or refer to both the singular and plural objects, unless the context clearly specifies otherwise. The word “or” as used in this specification and the appended claims is generally used to include “and / or”, unless the context clearly specifies otherwise.

[0094] The following detailed description should be read with reference to the accompanying drawings, in which similar elements are labeled with the same numbers in different drawings. The detailed description and the drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of this disclosure. The depicted illustrative embodiments are intended to be exemplary only. Selected features of any illustrative embodiment may be incorporated into another embodiment unless the contrary is expressly stated.

[0095] This disclosure relates to an apparatus configured in conjunction with an endoscope or similar delivery device for closing wounds inside the body. In some cases, the suturing devices described herein may be configured such that they can be used within a single working or available channel of an endoscope, and in some embodiments may be operated by a single individual, although in some embodiments a second individual may be included. In some embodiments, the suturing devices described herein may be considered to operate along a single line of operation. The device itself is translatable distally and proximally within the working channel, and the handle portion itself is translatable distally and proximally along the same line of operation during needle locking and unlocking, thereby enabling the needle to pass back and forth between the active and passive portions of the suturing device. The device may be configured such that the needle can be selectively locked into a more distal or more proximal position, and the device itself is translatable distally or proximally and the needle is locked in place, thereby moving the needle and thus the suture relative to the tissue being repaired.

[0096] Figure 1 This is a perspective view of a suture device 10 that can be considered configured for use with a delivery system including an endometrium extending therethrough. For example, the delivery system could be an endoscope with a working channel. The delivery system could also be a catheter. It should be understood that variations in scale exist on either side of the illustrated suture. In some embodiments, the suture device 10 can be considered to include a suture translation assembly 12 configured to be axially translatable within the endometrium of the delivery system and a distal assembly 14 configured to be secured to a distal end of the delivery system. The suture translation assembly 12 extends into the distal assembly 14 and includes a needle 16 for carrying the suture and a distal shuttle 18 configured to releasably secure the needle 16.

[0097] Component 20 may be disposed (sleeved) on the distal shuttle 18 and, as will be shown in the following figures, may be movable between a locked position in which the needle 16 is secured to the distal shuttle 18 and an unlocked position in which the needle 16 is releasable from the distal shuttle 18. In some embodiments, component 20 may be, for example, a cannula 20. A user interface may extend proximally from the distal shuttle 18 and the cannula 20 and may be configured to allow the cannula 20 to move between the locked and unlocked positions. Shaft 28 may extend distally to the suture translation assembly 12 and may be specifically coupled to the cannula 20. The user interface may take several different forms. For example, the user interface may be user interface 22 as described and illustrated in U.S. Patent Application Publication No. 2018 / 0235604, the entire disclosure of which is incorporated herein by reference. In some embodiments, the user interface may be as described in Provisional Patent Application Serial No. 62 / 794,075, filed January 18, 2019, entitled "Endoscopic Suture Control Handle," the entire contents of which are incorporated herein by reference. In some embodiments, the user interface may be as described in Provisional Patent Application Serial No. 62 / 848,853, filed May 16, 2019, entitled "Control Handle for Endoscopic Suture," the entire contents of which are incorporated herein by reference. These are merely examples.

[0098] In some embodiments, the distal assembly 14 includes a body 29 having a proximal connector 30 configured to attach to the distal end of an endoscope or other delivery system. In some embodiments (as shown), the proximal connector 30 may include a retaining feature 401. As will be described with respect to the following figures, the retaining feature 401 (which may be considered as a retaining flange 401 in some embodiments) facilitates securing the distal assembly 14 to the distal end of an endoscope or other delivery system using a split ring attachment mechanism.

[0099] Body 29 includes an arm 32 extending to end cap 34. As will be described, end cap 34 may be configured to releasably engage and disengage from needle 16. In some embodiments, for example, end cap 34 may be configured to engage needle 16 when the needle 16 is traveled distally into end cap 34, and to release needle 16 when needle 16 is locked into distal shuttle 18 (as will be described) and distal shuttle 18 is retracted proximally. Distal assembly 14 may be considered to include guide member 36 which may be fastened to or integrally formed with body 29 and allows suture translation assembly 12 to extend through and translate relative to guide member 36. In some embodiments, body 29 may include aperture 27 through which other devices can be inserted. In some cases, as will be described with respect to the following figures, aperture 27 may be configured to receive a side-saddled lumen attachment element. In some embodiments, hole 27 may include one or more of pin holes 31a and 31b, which may be used, for example, to mount the aforementioned side saddle cavity connecting element or may have other features.

[0100] Figure 2 and Figure 3 A suture translation assembly 12, extending through guide member 36 and entering distal assembly 14, is shown. Figure 2 In the diagram, the suture translation assembly 12 is shown in the extended position, with the needle 16 extending into the end cap 34, while... Figure 3 The mid-suture translation assembly 12 is illustrated in the retracted position (where the needle 16 has been retracted proximally from the end cap 34). In some embodiments, as can be seen in the figure, the end cap 34 includes a proximal needle opening 37 configured to facilitate guiding the needle 16 into the end cap 34 and to receive the needle 16 when it is moved distally into the end cap 34. In some embodiments, the proximal needle opening 37 may extend all the way through the end cap 34, while in other cases the proximal needle opening 37 may not extend all the way through the end cap 34. In some cases (as shown in the figure), the proximal needle opening 37 may be considered aligned with the longitudinal axis 38 of the needle 16 (e.g., Figure 3 (as shown in the image).

[0101] One or more retaining openings 40 may be arranged perpendicular to the proximal needle opening 37 and one or more retainers 42, which are configured to be disposed within the one or more retaining openings 40 and releasably engage with the distal stop of the needle 16 (as will be described). In some embodiments, a pair of retaining openings 40 may be present, one of which is on one side of the end cap 34. In some embodiments, a pair of retainers 42 may be present, with one retainer disposed within each retaining opening of the pair of retaining openings 40. In some embodiments, although schematically shown, one or more retainers 42 may be, for example, springs or coils.

[0102] Figure 4 This is a cross-sectional view of the distal component 14, in which the suture translation component 12 is disposed within the distal component 14. Figure 5 This is an exploded view of the suture translation assembly 12. The needle 16 can be considered to include a distal region 44 and a proximal region 46. In some embodiments, the distal region 44 may include a distal stop (stop recess) 48 for releasable engagement with the end cap 34, and the proximal region 46 may include a proximal stop 50 for releasable engagement with the distal shuttle 18. As shown, the needle 16 may include a hole 52 (which is for receiving a suture passing through it).

[0103] In some embodiments, the distal shuttle 18 may be considered to include a distal needle opening 54 configured to receive the needle 16 and align with the longitudinal axis 38 of the needle 16 when the distal shuttle 18 travels over the needle 16. One or more ball bearing openings 56 may be arranged perpendicular to the distal needle opening 54 such that the one or more ball bearing openings 56 are aligned with the proximal stop 50 when the needle 16 is secured to the distal shuttle 18. In some embodiments, one or more balls 58 may be disposed within one or more ball bearing openings 56 and may be configured to be disposed within the proximal stop 50 when the needle is secured to the distal shuttle 18.

[0104] In some embodiments, the distal shuttle 18 includes an inner gap 60 and a sleeve-catching member 62 slidably disposed within the inner gap 60. In some embodiments, the sleeve-catching member 62 is connectable to a cable 64 that extends distally within the shaft 28 into a cable hole 66 and is secured by a crimp or other mechanical connection 68. In some embodiments, the sleeve-catching member 62 is connectable to the sleeve 20 via a pin 70 that extends through first and second sleeve connection holes 72, 74 and a corresponding hole 76 that extends through the sleeve-catching member 62 and through the inner gap 60.

[0105] In some embodiments, the sleeve 20 includes one or more sleeve openings 80, which are smaller in diameter or width than the diameter of one or more bearing balls 58. In some embodiments, the sleeve 20 may include a pair of sleeve openings 80 corresponding to a pair of bearing ball openings 56 and a pair of bearing balls 58. When the sleeve 20 is in the locked position (e.g., in...), Figure 6 As shown in the diagram, one or more sleeve openings 80 are misaligned with one or more bearing ball openings 56, thus causing one or more bearing balls 58 to engage with the proximal stop 50 of the needle 16. The sleeve 20 prevents one or more bearing balls 58 from being pushed out of the proximal stop 50.

[0106] Conversely, when sleeve 20 is in the unlocked position (e.g., in...) Figure 7 As shown in the diagram, one or more sleeve openings 80 are aligned with one or more bearing ball openings 56. This allows one or more bearing balls 58 to move radially a distance into one or more sleeve openings 80 in response to a force applied by the needle 16 to the one or more bearing balls 58, a distance sufficient to allow the one or more bearing balls 58 to exit the proximal stop 50 of the needle 16. (See reference...) Figure 4 Although the suture translation assembly 12 is shown traveling into the distal assembly 14, the sleeve 20 is in the unlocked position relative to the distal shuttle 18, so one or more bearing balls 58 can be seen partially extending into one or more sleeve openings 80.

[0107] In some implementations, it should be understood that the distal shuttle 18 and sleeve 20 together provide an active engagement with the needle 16, while the distal cap 34 provides a passive engagement with the needle 16. If the needle 16 is moved distally into the distal cap 34, the distal cap 34 will grip the needle 16 with one or more retainers 42 engaging with the distal stop 48. If the needle 16 is subsequently moved proximally, the applied axial force overcomes any resistance provided by the one or more retainers 42, and the needle 16 is able to move proximally. However, the active engagement with the needle 16 provided by the distal shuttle 18 and sleeve 20, on the contrary, requires action to move the sleeve 20 relative to the distal shuttle 18 between a locked position and an unlocked position. The user interface provides mechanisms for reliably moving the sleeve 20 between the locked and unlocked positions.

[0108] Figure 8 It is, for example, available for Figure 1The image shows a side view of the distal assembly 14a of the suture device 10. This distal assembly 14a is similar to the distal assembly 14 shown in previous figures, but includes a side saddle-shaped cavity connecting element 120 coupled to the body 29 of the distal assembly 14a. In some embodiments, the side saddle-shaped cavity connecting element 120 may include one or both pins 122 embedded in pin holes 31a and 31b (pin hole 31a is visible in this view), thus enabling the side saddle-shaped cavity connecting element 120 to pivot relative to the body 29 of the distal assembly 14a. In some embodiments, the side saddle-shaped cavity connecting element 120 includes a ring 124 from which the pins 122 extend, a distal region 126, and a body 128, which in some cases has an arcuate shape.

[0109] In some embodiments, the distal region 126 and the body 128 have a semi-circular profile to accommodate an inner cavity, such as a flexible inner cavity 130, which can be fitted by friction or compression (e.g. Figure 9 (As shown in the diagram) and engaged within the side-saddle cavity connecting element 120. The flexible cavity 130 may be polymer or metal. After the flexible cavity 130 has been placed relative to the cavity attachment element 120 with the side saddle, the polymer cavity can be expanded to its full working size, for example, by extending a mandrel through the flexible cavity 130.

[0110] In some embodiments, the lateral saddle attachment element 120 (and the accompanying flexible lumen 130) can serve as a second working channel and can accommodate sutures used during the procedure. In some embodiments, the attachment element 120 may be large enough to accommodate second tools used during the procedure for tissue capture or manipulation, thus allowing the use of second tools without requiring a dedicated dual-channel delivery system (such as a dual-channel endoscope). If needed, a dual-channel delivery system can provide even more options during the procedure. The lateral saddle attachment element 120 may have an outlet in the distal assembly 14a such that the second tool extends along an axis suitable for tissue manipulation. This axis may pass through the axis of the suture-carrying element, allowing the second tool to pull tissue into the protruding path of the suture-carrying element. For example, this can be used to pull tissue in accordance with a needle, thereby facilitating the drive of the needle 16 through the tissue. Maintaining tension on the suture using the lateral saddle attachment element 120 prevents the suture from interfering with the procedure.

[0111] Figure 10 This is a perspective view of the distal assembly 14b, including the shorter side saddle-shaped cavity connecting element 120a, which is pivotally fastened to the body 29 via one or more posts 122a extending into pin holes 31a, 31b. A cavity 130a is coupled to the side saddle-shaped cavity connecting element 120a to provide an inner cavity through which sutures or other tools can extend.

[0112] Figure 11 and Figure 12 This is a view of a tissue release mechanism 150 that can be fitted onto the arm 32. In some embodiments, the tissue release mechanism 150 assists in the surgical procedure by helping to remove tissue that may become adherent to the needle 16. In some cases, the tissue release mechanism 150 may be spring-loaded to engage with the needle 16, or the tissue release mechanism 150 may be actuated separately and independently. In some cases, the tissue release mechanism 150 includes a crossbar 152 that provides additional surfaces that can push tissue away from the needle 16.

[0113] When preparing the suture device 10 for use, the distal assembly 14 can be secured to a delivery device (such as an endoscope). In some embodiments, an attachment facilitator (such as a flexible silicone tube) can be deployed along the delivery device to hold the distal assembly 14 in place and prevent rotation of the distal assembly 14 relative to the delivery device. In some embodiments, if necessary, the side saddle-type cavity connecting element 120 (or 120a) can be secured to the distal assembly 14. The suture can be passed through the needle 16 and fed rearward toward the user interface. The device 10 can extend through the body to the defect site.

[0114] Figure 13 It is, for example, available for Figure 1 The diagram shows a perspective view of the distal component 14c of the suture device 10. The distal component 14c is similar to the distal component 14 shown in previous figures, but includes several modifications particularly suitable for bariatric corrective surgery. Bariatric surgery generally refers to procedures in which the effective volume of a patient's stomach can be surgically reduced to achieve long-term weight loss, and which can be performed laparoscopically. Bariatric corrective surgery is a procedure performed endoscopically, in which modifications can be made to the initial surgery performed on the patient's stomach. In some embodiments, the distal component 14c can also be used for other suture procedures, such as, but not limited to, full-tissue thickness repair and / or partial-tissue thickness repair.

[0115] The distal assembly 14c may include a body 29a having a proximal connector 30a, which may be configured, for example, to be coupled to the distal end of an endoscope or other delivery system. In some embodiments (as shown), the proximal connector 30a may include a retaining feature (such as a retaining flange 401). The body 29a includes an arm 32a extending to an end cap 34a. In some embodiments, the body 29a (which includes the arm 32a) may be similar to the body 29 and arm 32 previously cited with respect to distal assemblies 14, 14a, and 14b. However, in some cases, the body 29a and arm 32a may be adapted to accommodate thicker tissue, which, for example, refers to a variation in the overall shape of the body 29a and / or arm 32a relative to the body 29 and / or arm 32. In some embodiments, the body 29a and / or arm 32a may simply be larger to accommodate thicker tissue. The distal component 14c may be considered to include a guide member 36a that can be fastened to or integrally formed with the body 29a, and may be configured to allow suture translation (as in...). Figures 14 to 18 The suture translation assembly 12, suture translation assembly 12a, or shown Figures 19 to 22 The suture translation component 12b shown extends through the guide member 36a and translates relative to the guide member 36a.

[0116] In some embodiments (as shown), guide member 36a includes channel 300. In some embodiments, channel 300 allows sutures to pass between the suture translation assemblies 12, 12a, 12b and the working channel of the endoscope or other delivery device to which the distal assembly 14c is attached. For example, channel 300 may be designed to include a guide that helps align the suture with channel 300 when the suture translation assemblies 12, 12a, 12b are passed through the working channel of the endoscope or other delivery device. In some embodiments, it is preferable to load the suture before passing the suture translation assemblies 12, 12a, 12b through the working channel of the endoscope or other delivery device.

[0117] In some embodiments, the distal assembly 14c includes a guide structure 27a attached to or integrally formed with the body 29a. In some embodiments, the guide structure 27a is pivotally attached to the body 29a. The guide structure 27a may be configured to receive a polymer tubular member attached thereto, thereby guiding the tool through the endoscope to the appropriate position relative to the working site. In some embodiments, the guide structure 27a may be configured to receive a metal tubular member attached thereto. In some embodiments, for example, the guide structure 27a and the attached tubular member (not shown) may receive a gripper or similar tool to allow a user to grasp tissue and pull it into place so that the needle 16 can pass through the tissue. In some embodiments, the relative position or offset of the guide structure 27a may be greater than the illustrated relative position or offset with respect to the distal assembly 14, distal assembly 14a, or distal assembly 14b, thereby providing more space for the tool and / or accommodating larger and / or thicker portions of tissue.

[0118] End cap 34a includes one or more retaining openings 40a, which (as can be seen in the figure) are perpendicular to the proximal needle opening (not shown, e.g., in... Figure 3 The needle is arranged in a manner shown in the diagram (proximal needle opening 37). One or more retainers 42a may be correspondingly disposed within one or more retaining openings 40a. In some embodiments, one or more retainers 42a may be coil springs correspondingly disposed within one or more retaining openings 40a. The retainers 42a may releasably engage with a stop on the needle 16, as described with respect to the distal assembly 14.

[0119] In some embodiments, the fixing opening 40a may have a diameter larger than the overall diameter of the fastener 42a, and the fixing opening 40a may gradually narrow to a diameter (not shown) on the opposite side that is approximately the same as the diameter of the fastener 42a. In some embodiments, the fastener 42a may be welded, soldered, adhesively fixed, or attached to the left side of the fixing opening 40a, and may be slightly free to move on the right side of the fixing opening 40a. In some cases, the distal assembly 14c may include an opening 302 perpendicular to the fixing opening 40a. This opening 302 may be threaded to engage with a set screw 304. In some embodiments (as shown), the opening 302 may be offset closer to the right side of the fixing opening 40a, away from the fixed end of the fastener 42a, so that the set screw 304 may be considered to support the free end of the fastener 42a. Rotating the set screw 304 in a first direction (e.g., clockwise) causes it to translate toward the retainer 42a, thereby increasing the interference between the retainer 42a and the pin 16 and increasing the retaining force that can be applied to the pin 16. Conversely, rotating the set screw in a second direction (e.g., counterclockwise) causes it to translate away from the retainer 42a, thereby reducing the retaining force that can be applied to the pin 16. This can, for example, help adjust manufacturing tolerances.

[0120] As described above, for example, the distal component 14c may be together with the aforementioned Figure 5 The described suture translation component 12 is used. The distal component 14c can also be used with... Figures 14 to 18 The suture translation component 12a shown is used together with, and with Figures 19 to 22 It is used together with the suture translation component 12b shown. Figure 14 This is a perspective view of the suture translation assembly 12a, which is held by the needle 16 in the diagram. Figure 15 This is a partially exploded view of the suture translation component 12a. (See also...) Figure 15 As can be seen more clearly, the suture translation assembly 12a includes an inner member 310 that holds the needle 16. A locking member 312 is slidably disposed above the inner member 310. As can be seen in the figure, the inner member 310 includes a pin 314 that extends radially outward from the inner member 310 and through a corresponding groove 316 formed in the locking member 312. The pin 314 serves to prevent relative rotation between the inner member 310 and the locking member 312. The pin 314 also serves to limit the translation of the locking member 312 relative to the inner member 310.

[0121] The control member 318 is fixed relative to the proximal end 320 of the locking member 312 and extends distally to the handle such as the translation handle 26. Figure 1 Therefore, the locking member 312 can be translated distally and / or proximally relative to the inner member 310. (As in...) Figure 14 As seen, the suture translation assembly 12a includes an outer tube 330 that can be secured to the inner member 310 using a pin 314. For example, the outer tube 330 can be coupled to a coil 332. In some embodiments, the outer tube 330 may be a single tubular member. In some embodiments (e.g., in...) Figure 15 As shown, the outer sheath 330 may actually include one or more of an outer sheath 334, a grooved sleeve 336, and an inner outer sheath 338. The grooved sleeve 336 may be configured to allow sutures to pass through it. This is illustrative only and is not intended to be limiting in any way.

[0122] The inner component 310 includes a plurality of arms 322, such as those shown on the right side of the inner component 310. Figure 16 As seen, these arms include arcuate protrusions 324 (configured to engage with corresponding stop recesses in the pin 16). Although a total of four arms 322 are shown, it should be understood that the inner member 310 may include any number of arms 322. It should be understood that the arms 322 are relatively long and therefore can be considered relatively flexible. As the locking member 312 extends distally into the locking configuration (e.g., in...), Figure 17 As shown in the diagram, the locking member 312 prevents the arm 322 from moving outward. Therefore, the arcuate protrusion 324 still engages with the corresponding stop recess of the needle 16, and the needle 16 remains locked to the suture translation assembly 12a. As the locking member 312 is retracted proximally into the unlocking configuration (e.g., in...), Figure 18 As shown in the diagram, arm 322 moves freely radially outward, thereby releasing the arcuate protrusion 324 from the stop in needle 16 and allowing needle 16 to move distally relative to inner member 310.

[0123] Figure 19 It is a perspective view of the suture translation component 12b, which can be used in conjunction with any of the components of distal component 14, distal component 14a, distal component 14b and / or distal component 14c. Figure 20 This is a perspective view of the suture translation assembly 12b, in which the outer layer, such as the outer sheath 350, is positioned. Figure 19 The inner member 340 of the retaining needle 16a is removed to expose it. In some embodiments, the outer tube 350 may be a single tubular member. In some cases, the outer tube 350 may include several elements, as described with respect to the outer tube 330. Figure 15 ).

[0124] In some embodiments (as shown), needle 16a has a distal stop 342 and a proximal stop 344 with shapes different from the corresponding stop in needle 16. Figure 21(See image). The suture translation assembly 12b includes a locking member 346 slidably disposed relative to the inner member 340. A pin 352 is attached to the inner member 340 and extends through a corresponding groove 354 formed in the locking member 342. The pin 352 restricts translation of the locking member 342 relative to the inner member 340 and also prevents relative rotational movement of the locking member 342. The locking member 342 is fastened to a control member 318 that extends distally to a handle such as a translation handle 26. Figure 1 Therefore, the locking member 342 can be translated distally and / or proximally relative to the inner member 340.

[0125] In some embodiments, the outer tube 350 may define a groove 370 including an axially extending groove 372 and a shorter radially extending groove 374. In some embodiments, the axially extending groove 372 allows the pin 352 to move within the axially extending groove 372, thereby allowing the needle 16a to be fully retracted into the suture translation assembly 12b for travel through the endoscope or other delivery device. Once the suture translation assembly 12b has traveled through the endoscope or other delivery device, the inner member 340 and the locking member 342 may travel distally through the outer tube 350 until the pin 352 is aligned with the radially extending groove 374. By rotating the translation handle 26, the pin 352 can be rotated into position within the radially extending groove 374 so that the locking member 342 can be translated relative to the inner member 340.

[0126] In some embodiments (as shown), the locking member 342 includes a pair of arms 358 extending distally from the locking member 342. For example, in Figure 21 As seen, arm 358 includes a protrusion 360, when the suture translation assembly 12b is in the position as Figure 20 and Figure 21 In the locking configuration shown, the protrusion 360 extends through a groove 362 formed in the inner member 340. Therefore, the protrusion 360 can extend through the groove 362 and engage with the proximal stop 344 of the pin 16a. Although a pair of arms 358 are illustrated, it should be understood that the locking member 342 may include any number of arms 358 and, of course, a corresponding number of grooves 362.

[0127] In order to move the suture translation component 12b into the unlocking configuration (e.g., in Figure 22 As shown in the diagram, the locking member 342 can be moved 340 distally relative to the inner member. For example, it can be... Figure 22 As seen, the protrusion 360 has been moved out of the groove 362 (only one groove 362 is visible), and the needle 16a moves freely relative to the suture translation assembly 12b. As the locking member 342 moves distally, the inclined surface 364 pushes against the groove 362 and moves outward.

[0128] In relation to Figure 13 In some embodiments, guide member 36a includes channel 300 configured to allow suture passage between the working channels of suture translation assemblies 12, 12a, 12b and other delivery devices to which the endoscope or distal assembly 14c is attached. Channel 300 may, for example, be designed to include a guide wire that will facilitate alignment of the suture with channel 300 when the suture translation assemblies 12, 12a, 12b are passed through the working channels of the endoscope or other delivery devices. In some embodiments, it is desirable to load the suture before passing the suture translation assemblies 12, 12a, 12b through the working channels of the endoscope or other delivery devices.

[0129] In some cases (e.g., in Figure 23 As shown in the diagram, instead of placing the channel 300 in the guide member 36a, the suture translation components 12, 12a, 12b can be modified to accommodate the suture passing through the suture translation components 12, 12a, 12b. Figure 23 This is a perspective view of the cannula 20a, which can be used to form part of the suture translation assemblies 12, 12a, 12b. It can be seen that the cannula 20a includes a groove 20b extending to the length of the cannula 20a. Figure 24 A sleeve 20a is shown extending through a guide member 36a, wherein a suture 299 extends through a groove 20b.

[0130] In some embodiments, it is desirable to protect the distal end of needle 16 as the suture translation assemblies 12, 12a, 12b travel through the delivery system (e.g., an endoscope). In some embodiments, needle 16 may damage the working passage of the endoscope, for example, due to potential damage. In some embodiments, during loading, the cannulas 20, 20a and the distal shuttle 18 covering needle 16 may be... Figures 1-5 The needle 16 may be exposed if the cannulas 20, 20a are moved proximally. In some embodiments, it may be difficult to load the needle through bends in the working channel of the endoscope when the cannulas 20, 20a are extended above the needle 16.

[0131] Figure 25 and Figure 26 The illustration shows an example in which the needle cap 500 has been positioned above the distal region 44 of the needle 16. Figure 25 It is a side view. Figure 26 It is along Figure 25The cross-sectional view is taken along line 26-26. In some embodiments, the needle cap 500 can be removed from outside the patient after the suture translation components 12, 12a, 12b have been loaded into the endoscope but before the endoscope has been inserted into the patient. In some embodiments, the needle cap 500 can be removed from the needle 16 from inside the patient. When performing procedures using multiple needles and sutures (e.g., but not limited to endoscopic cannulated gastrectomy), it is desirable to remove the needle cap 500 from inside the patient with the endoscope so that the endoscope does not have to be removed and inserted multiple times. In some embodiments, the needle cap 500 can be removed from the needle 16 by moving the cannulas 20, 20a distally. In some embodiments, the needle cap 500 can be configured to separate when the needle cap 500 contacts the distal caps 14, 14a, 14b, 14c.

[0132] The needle cap 500 includes a cylindrical needle cap body 503 defining an aperture 501 configured to mount over the needle 16. The needle cap 500 also includes a non-invasive tip 505, which is integrally formed with or attached to the cylindrical needle cap body 503. In some embodiments, the needle cap 500 includes one or more elongated slots 509 that extend axially along the cylindrical needle cap body 503 and provide sufficient flexibility to allow the needle cap 500 to bend sufficiently to travel onto the needle 16. In some embodiments, two slots 509 may be present, although... Figure 25 and Figure 26 Only one is visible. The needle cap 500 includes one or more protrusions 520 configured to embed in the distal stop 48 of the needle 16.

[0133] Figures 27 to 30 Another view shows the prevention of the needle 16 from damaging the interior of the endoscope or itself. Figures 27 to 30 These are various views of the suture translation assembly 530, which provides a reduced overall length to facilitate loading into the endoscope. In some cases, the suture translation assembly 530 is short enough to allow easy passage of the endoscope via a cannula at a position above the needle. In some embodiments, the control of the suture translation assembly 530 is reversed compared to the suture translation assemblies 12, 12a, 12b described with respect to the preceding figures. Figure 27 The suture translation assembly 530 is shown in the unlocked position, wherein the needle 16 is unlocked relative to the distal shuttle and can access the distal caps 14, 14a, 14b, 14c. Figure 28A suture translation assembly 530 in the locked position is shown, with the needle 16 locked to the distal shuttle. As can be seen in the figure, the suture translation assembly 530 includes a cannula 518 and a suture conduit 590. In some embodiments (as shown in the figure), the suture conduit 590 is a coil. The cannula 518 has a pair of slots 560 (only one slot 560 is visible in the illustrated orientation) to accommodate movement of the distal shuttle, as described below. The cannula 518 also includes a pair of cannula openings 580 (only one is visible), which allow a bearing ball 58 (not shown) to move in and out relative to the distal shuttle, thereby locking and unlocking the needle 16.

[0134] exist Figure 29 In the middle (especially along) Figure 28 (The sectional view intercepted by line 29-29) and Figure 30 (that is) Figure 28 The internal structure of the suture translation assembly 530 can be better seen in the partially exploded view. As can be seen in the figure, the control line 592 extends through the suture conduit 590 and terminates inside the yoke 604. The cannula 518 is connected to the suture conduit 590 via the connector 602. In some embodiments, the cannula 518 may be welded to the suture conduit 590, either directly or by welding to the connector 602. Therefore, the cannula 518 does not move relative to the suture conduit 590.

[0135] Pin 570 extends through yoke 602 and into hole 606 formed inside distal shuttle 600, thereby operably coupling control line 592 to distal shuttle 600. Pin 570 extends to and is guided by a pair of grooves 560 formed in sleeve 518. This prevents rotation of distal shuttle 600 relative to sleeve 518. In some embodiments, distal shuttle 600 includes recess 610 that allows suture to extend from needle 16 and axially through sleeve 518.

[0136] The distal shuttle 600 also includes a pair of bearing ball openings 608. As previously described, when the bearing ball openings 608 are aligned with the sleeve opening 580, the bearing ball 58 (not shown) moves freely and sufficiently radially outward to disengage from the proximal stop 50 of the needle 16, thereby unlocking the needle 16 from the distal shuttle 600. Conversely, when the bearing ball openings 608 are not aligned with the sleeve opening 580, the bearing ball 58 (not shown) cannot disengage from the proximal stop 50 of the needle 16, and the needle 16 remains locked to the distal shuttle 600. Therefore, moving the control line 592 in the proximal direction moves the distal shuttle 600 relative to the sleeve 518. This causes the sleeve opening 580 to misalign with the bearing ball openings 608 and locks the needle 16 to the sleeve 518. Conversely, moving the control line 592 in the distal direction moves the distal shuttle 600 relative to the sleeve 518 in the distal direction.

[0137] Figure 31 and Figure 32 It is, for example, available for Figure 1 A perspective view of the distal component 14d of the suture device 10 shown. Figure 31 The diagram shows the elongated tool guide 720 positioned on the distal assembly 14d of the placement configuration, while... Figure 32 The distal assembly 14d in the working configuration is shown, in which the elongated tool guide 722 is positioned. It should be understood that in the placement configuration, the distal assembly 14d is more compact because the structure of the elongated tool guide 720 is closer to the distal assembly 14d. The distal assembly 14d is similar to the distal assembly 14 shown in previous figures, but includes modifications that facilitate the transport of the distal assembly 14d and the subsequent delivery of the tool to the working area.

[0138] The distal assembly 14d may include a body 29a having a proximal connector 30a, which may be configured to attach to the distal end of an endoscope or other delivery system. In some embodiments (as shown in the figures), the proximal connector 30a may include an inner clamp connector 702 that engages with a fixing feature 401 (not visible in this figure) and an outer clamp connector 704 that threadedly engages with the inner clamp connector 702. Both the inner clamp connector 702 and the outer clamp connector 704 are used to secure the distal assembly 14d to the endoscope body 706. The body 29a includes an arm 32a extending to an end cap 34a. In some embodiments, the body 29a (including the arm 32a) may resemble the body 29 and arm 32 previously referenced with respect to distal assemblies 14, 14a, 14b, and 14c. The distal assembly 14d can be considered to include a guide member 36a, which can be fastened to or integrally formed with the body 29a, and can be configured to allow suture translation (e.g.) Figures 14 to 18The suture translation component 12, suture translation component 12a, or shown in the figure Figures 19 to 22 The suture translation component 12b shown extends through the guide member 36a and translates relative to the guide member 36a.

[0139] In some implementation schemes (such as) Figure 32 (As illustrated in the diagram), guide member 36a includes channel 300. In some embodiments, channel 300 allows sutures to pass between the working channels of suture translation assemblies 12, 12a, 12b and other delivery devices to which the endoscope or distal assembly 14d is attached. Channel 300 may, for example, be designed to include a guide that will help align the suture with channel 300 as the suture translation assemblies 12, 12a, 12b pass through the working channels of the endoscope or other delivery device. In some embodiments, it would be desirable to load the suture before passing the suture translation assemblies 12, 12a, 12b through the working channels of the endoscope or other delivery device.

[0140] End cap 34a includes one or more retaining openings 40a, which (as can be seen) are perpendicular to the proximal needle opening (not shown), for example in Figure 3 The proximal needle opening 37 is shown in the figure, and is arranged accordingly. One or more retainers 42a may be correspondingly disposed within one or more retaining openings 40a. In some embodiments, one or more retainers 42a may be coil springs disposed within one or more retaining openings 40a. The retainers 42a may releasably engage with a stop on the needle 16, as described with respect to the distal assembly 14.

[0141] In some embodiments, the fixing opening 40a may have a diameter larger than the overall diameter of the fixing member 42a, and the fixing opening 40a may gradually narrow to a diameter on the opposite side (not seen) that is approximately the same as the diameter of the fixing member 42a. In some embodiments, the fixing member 42a may be fused, welded, adhesively fixed, or attached to the left side of the fixing opening 40a, and may be freely slightly movable on the right side of the fixing opening 40a. In some cases, the distal assembly 14c may include an opening 302 perpendicular to the fixing opening 40a. This opening 302 may be threaded to engage with a set screw 304. In some embodiments, as shown, the opening 302 may be offset away from the fixed end of the fixing member 42a to the right side closer to the fixing opening 40a, so that the set screw 304 may be considered to support the free end of the fixing member 42a. Rotating the set screw 304 in a first direction (e.g., clockwise) causes the screw 304 to translate toward the retainer 42a, thereby increasing the interference between the retainer 42a and the pin 16 and increasing the retaining force that can be applied to the pin 16. Conversely, rotating the set screw in a second direction (e.g., counterclockwise) causes the set screw 304 to translate away from the retainer 42a, thereby reducing the retaining force that can be applied to the pin 16. This can help, for example, adjust manufacturing tolerances.

[0142] As described above, in some cases, the distal component 14d includes an elongated tool guide 720. This elongated tool guide 720 can take various forms. For example... Figure 31 and Figure 32 As shown, the elongated tool guide 720 includes a guide structure 722 attached to or integrally formed with the body 29a. A polymer tubular member 724 is fastened to and extends through the guide structure 722. The polymer tubular member 724 extends proximally from the distal assembly 14d, allowing various tools to travel through the polymer tubular member 724 and thus reach the working area, which can be considered as the region between the guide member 36a and the end cap 34a. Figure 31 In this configuration, the polymer tubular member 724 can be viewed as being recessed downwards and abutting against the distal component 14d in a placement configuration that minimizes the overall size of the distal component 14d. Figure 32 In this configuration, the polymer tubular member 724 can be considered to be in a working configuration in which the polymer tubular member 724 is bent in a manner away from the distal component 14d.

[0143] In some cases, the polymer tubular member 724 may include a distal region 726 and a proximal region 728. In some cases, the distal region 726 may be made of a polymer with relatively low hardness, meaning that the distal region 726 is more flexible, while the proximal region 728 may be made of a polymer with relatively high hardness, meaning that the proximal region 728 is less flexible. This facilitates the movement of the polymer tubular member 724 between a placement configuration and a working configuration. The distal region 726 and the proximal region 728 may be made of two different polymers or the same polymer with different hardnesses. In some cases, although described as a polymer, it is possible that the polymer tubular member 724 may be made of a metallic material. It is conceivable that by extending a tool distally through the polymer tubular member 724, the polymer tubular member 724 can be moved from a state of being retracted downward and abutting against the distal component 14d.

[0144] Figure 33 This is a schematic diagram of a usable elongated tool guide 720a. The elongated tool guide 720a includes a guide structure 722a that can be pivotally fastened relative to a distal assembly (not shown in this figure) via a pivot point 730. The elongated tool guide 720a also includes a polymer tubular member 724a fastened to and extending through the guide structure 722a. The elongated tool guide 720a includes a pivot structure 732. The pivot structure 732 may be a ball, a ramp, or other cavity 734 shape that at least partially extends into a cavity 734 extending through the guide structure 722a. Therefore, when a tool 736 (illustrated as pliers) extends distally through the polymer tubular member 724a, the continuous distal pressure applied by the tool 736 will cause the guide structure 722a to rotate about the pivot point 730. Therefore, the elongated tool guide 720a can be rotated from a placement configuration to a working configuration, wherein the polymer tubular member is designated 724a' and the tool is designated 736'. Through the... Figure 33 and Figure 32 In comparison, it should be understood that in the working configuration, tool 736' is positioned to facilitate easy access to the aforementioned working area.

[0145] Figure 34 and Figure 35 This is a perspective view of a tubular member 740 that can be used as a guide for an elongated tool. The tubular member 740 includes at least a first cavity 742 and a second cavity 744. The first cavity 742 can be considered configured to receive a tool (e.g., but not limited to...) through it. Figure 33 (The clamp shown). The second cavity 744 can be considered configured to receive an elongated member 746 extending through the second cavity 744. In some cases, the elongated member 746 can be used to control, for example, Figure 34 The placement configuration shown is similar to that of... Figure 35 The movement between the working configurations shown.

[0146] In some cases, the elongated member 746 may be a strip made of a metallic or polymeric shape memory material having an initial configuration (e.g., linear) and a memory configuration (e.g., curved). It should be understood that the elongated tool guide formed using the tubular member 740 may begin in a placement configuration (where the elongated member 746 is in a linear configuration). Before extending the tool distally through the tubular member 740, the elongated member 746 may be actuated into its memory configuration, for example, by applying an electric current to the elongated member 746. In some cases, the elongated member 746 may not be inserted into the second cavity 744 until the time is reached to move the tubular member 740 from the placement configuration to the working configuration.

[0147] In some cases, the elongated member 746 can be a bistable material, thus having a stable linear configuration. When the tool is conveyed through the first cavity 742, the action of the tool impacting the sidewall of the elongated member 746 and thus applying a small force to the elongated member 746 can cause the elongated member 746 to reverse to its unstable bending configuration.

[0148] Figure 36A , Figure 36B and Figure 36C The illustration shows a tubular member 750 that can be used as a guide for a slender tool. Figure 36A The tubular member 750 in the placement configuration is shown. Figure 36B A tubular member 750 in its working configuration is shown. As can be seen in the figure, the tubular member 750 is composed of several conduit segments 752, each connected together via movable hinges 754. It should be understood that each movable hinge 754 is a hinge formed by the flexible portion of the material of two conduit segments 752 constituting on either side of the movable hinge 754. As shown, a first cable 756 and a second cable 758 each extend through each conduit segment 752. Figure 36C (It is along) Figure 36B As shown in the cross-sectional view (sectioned along line 36-36), each conduit segment 752 includes a first cable hole 760 and a second cable hole 762, wherein a first cable 756 extends through the first cable hole 756 and a second cable 758 extends through the second cable hole 762. It should be understood that by applying appropriate force to the first cable 756 and / or the second cable 758, the tubular member 750 can be caused to... Figure 36A The placement configuration shown is moved to Figure 36B The working configuration is shown in the figure. In some cases, the tubular member 750 may consist of only a single cable (such as the second cable 758).

[0149] It should be understood that a variety of different materials can be used to construct the device described herein. In some embodiments, a variety of different metals may be used. Illustrative but non-limiting examples of suitable metals include: titanium, stainless steel, magnesium, cobalt, chromium, and other metals. In some embodiments, such as the device described herein, any suitable polymeric material may be incorporated, including biocompatible materials (such as polyurethane or silicone). Other suitable polymers include, but are not limited to: polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorinated ethylene-propylene copolymer (FEP), and polyoxymethylene (POM, for example, available from DuPont). ), polyether-ester block copolymers, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., those purchased from DSM Engineering Plastics). ), ether- or ester-based copolymers (e.g., polybutylene terephthalate and / or other polyester elastomers, such as those available from DuPont). ), polyamide (e.g., available from Bayer). Or purchased from Elf Atochem. ), elastomer polyamide, polyamide / ether block copolymer, polyether block amide (PEBA, for example, by trade name) Purchased), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g.) Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., Polysulfone, nylon, nylon-12 (if available from EMS American Grilon) Perfluoropropyl vinyl ether (PFA), ethylene-vinyl alcohol copolymers, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) triblock copolymers (e.g., SIBS and / or SIBS 50A), polycarbonates, ionically crosslinked polymers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc.

[0150] Those skilled in the art will recognize that this disclosure may take many forms different from the specific embodiments contemplated herein. Therefore, deviations in form and detail may be made without departing from the scope and spirit of this disclosure as described in the appended claims.

Claims

1. A medical device for use in conjunction with a delivery system, the delivery system including a lumen extending therefrom, the medical device comprising: A distal assembly adapted to be fastened relative to the distal end of the delivery system, the distal assembly being adapted to accommodate a suture device. An elongated tool guide member having a cavity defined therethrough and adapted to be fastened relative to the distal end of the delivery system to guide a tool extending through the cavity of the elongated tool guide member, the elongated tool guide member being movable between a placement configuration and a working configuration, in which the elongated tool guide member is substantially parallel to the delivery system when fastened relative to the distal end of the delivery system, and in the working configuration, the elongated tool guide member is bent away from the distal assembly. The elongated tool guide member is capable of being secured relative to the distal assembly, and the elongated tool guide member includes: A guide structure, which is pivotally fastened to an intermediate structure between the guide structure and the distal end of the conveying system; A polymer tubular member, fastened to and extending proximally therefrom the guide structure, the guide structure and the polymer tubular member jointly defining an inner cavity; and A pivoting structure protrudes into the cavity such that a tool extending distally through the elongated tool guide will contact the pivoting structure, wherein further distal pushing of the tool will cause the tool to interact with the pivoting structure and cause the guide structure to pivot relative to the distal assembly, thereby moving the elongated tool guide from its placement configuration into its working configuration.

2. A medical device for use in conjunction with a delivery system, the delivery system including a lumen extending therefrom, the medical device comprising: A distal assembly adapted to be fastened relative to the distal end of the delivery system, the distal assembly being adapted to accommodate a suture device. An elongated tool guide member is provided, adapted to be secured relative to the distal end of the conveying system to guide a tool extending through the elongated tool guide member. The elongated tool guide member is movable between a placement configuration and a working configuration. In the placement configuration, when secured relative to the distal end of the conveying system, the elongated tool guide member is substantially parallel to the conveying system. In the working configuration, the elongated tool guide member is bent away from the distal assembly. The elongated tool guide component is capable of being secured relative to the distal assembly, and the elongated tool guide component includes: An elongated structure defining at least a first inner cavity and a second inner cavity; The first cavity is configured to accommodate a tool extending therethrough; An elongated bistable member extends through the second inner cavity, the elongated bistable member being movable between a stable configuration in which the elongated bistable member is straight and an unstable configuration in which the elongated bistable member is curved; The elongated structure is straight when the elongated bistable member is straight, and the elongated structure bends when the elongated bistable member bends.

3. The medical device of claim 2, wherein the elongated tool guide comprises: A guide structure adapted to be fastened relative to the distal end of the conveying system, wherein the elongated structure is fastened to the guide structure and extends thereto to the proximal side.

4. The medical device of claim 3, wherein the guide structure is adapted to be securely fixed to an intermediate structure between the guide structure and the distal end of the delivery system.

5. The medical device of claim 1 or 2, wherein the suturing device comprises: A suture translation assembly configured to be axially movable within the cavity of the delivery system; and A guide member configured to allow the suture translation assembly to extend through.

6. The medical device of claim 5, wherein the suture translation component comprises: Needles that can be used to carry sutures; A distal shuttle configured to releasably secure the needle; and A user interface extending from the distal shuttle toward the proximal side is configured to allow the user to releasably fasten the needle; and The suturing device further includes an end cap configured to releasably engage and disengage from the needle, the end cap being configured to engage the needle when the needle is traveled distally into the end cap, and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is retracted proximally.

7. The medical device of claim 6, wherein the end cap comprises: A proximal needle opening is configured to receive the needle when the needle is advanced distally into the end cap, and the proximal needle opening is aligned with the longitudinal axis of the needle. One or more fixed openings are arranged perpendicular to the proximal needle opening; and One or more fasteners are disposed inside the fixed opening, the one or more fasteners being configured to releasably engage with the distal stop of the needle.

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