Suture-based closure device for use with an endoscope

Abstract

To provide several alternative designs, materials and methods of devices for endoscopically closing large defects.SOLUTION: A suturing device for use in combination with a delivery system including a lumen extending therethrough includes a needle operable to hold a suture, a distal shuttle removably mounting the needle, and a sleeve positionable over the distal shuttle, the distal shuttle being movable relative to the sleeve between a locked configuration in which the needle is locked to the distal shuttle and an unlocked configuration in which the needle is releasable from the distal shuttle. The suturing device comprises a distal assembly including an elongate tool guide that is transitionable between a deployed configuration in which the elongate tool guide is substantially parallel to the distal assembly and an operational configuration in which the elongate tool guide curves away from the distal assembly.SELECTED DRAWING: Figure 31

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to a device for suturing tissue, and more particularly to a device that functions in conjunction with an endoscope or similar device to suture tissue using an endoscope. [Background technology]

[0002] Various endoscopic procedures may create defects (or wounds) that are too large for known closure methods. These procedures include resection of large lesions, submucosal tunneling, full-thickness resection of tissue, treatment of other organs by passage outside the digestive tract, and postoperative repair of postoperative leaks. Endoscopic procedures also include bariatric revision surgery. Known devices and methods for endoscopically closing large defects each have advantages and disadvantages. Summary of the Invention

[0003] The present invention relates to several alternative designs, materials, and methods of devices for endoscopically closing large defects. One example is a suturing device for use in combination with a delivery system including a lumen extending therethrough. The suturing device includes a suture moving assembly configured to be axially movable within the lumen of the delivery system and including a distal end. A guide member is configured to allow the suture moving assembly to extend through and move relative to the guide member, and an elongated tool guide having a distal end is disposed relative to the distal assembly and is transitionable between a deployed configuration in which the elongated tool guide is generally parallel to the distal assembly and an operational configuration in which the elongated tool guide is curved away from the distal assembly.

[0004] Alternatively or additionally, the distal assembly defines an operating region between the guide member and the end cap, and when the elongated tool guide is in the operating configuration, the elongated tool guide is arranged to guide a tool extending therethrough into the operating region.

[0005] Alternatively or additionally, the elongate tool guide may include a guide structure secured to the distal assembly and a polymeric tubular member secured to the guide structure and extending proximally therefrom.

[0006] Alternatively or additionally, the elongate tool guide may transition from the deployed configuration to the working configuration in response to a tool being extended distally through the elongate tool guide. Alternatively or additionally, the polymeric tubular member may be in a contracted configuration when the elongate tool guide is in the deployed configuration.

[0007] Alternatively or additionally, the polymeric tubular member may be in the expanded configuration when the elongate tool guide is in the operative configuration. Alternatively or additionally, the elongate tool guide may include a guide structure pivotally mounted relative to the distal assembly, and a polymeric tubular member secured to the guide structure and extending proximally from the guide structure, the guide structure and the polymeric tubular member together defining a lumen. The elongate tool guide may include a pivot structure projecting into the lumen for contact by a tool extending distally through the elongate tool guide, such that further distal biasing of the tool may cause the tool to interact with the pivot structure to rotate the guide structure relative to the distal assembly, transitioning the elongate tool guide from the deployed configuration to the operative configuration.

[0008] Alternatively or additionally, the elongate tool guide may include an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough. The metal ribbon may extend through the second lumen and be movable between a linear configuration in which the metal ribbon is straight and a memory configuration in which the metal ribbon is curved. When the metal ribbon is straight, the elongate structure may be straight, and when the metal ribbon is curved, the elongate structure may be curved.

[0009] Alternatively or additionally, the elongate tool guide may include an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough. The elongate bistable member may extend through the second lumen and be transitional between a stable configuration in which the elongate bistable member is straight and an unstable configuration in which the metal ribbon is curved. When the bistable metal element is straight, the elongate structure may be straight, and when the bistable metal element is curved, the elongate structure may be curved.

[0010] Alternatively or additionally, the elongate tool guide may include a plurality of conduit segments connected by living hinges formed between adjacent conduit segments of the plurality of conduit segments, each of the plurality of conduit segments including at least one control opening extending therethrough and at least one control cable extending through each of the at least one control opening in each conduit segment. The elongate tool guide may be transitioned between the deployed configuration and the operative configuration by applying an axially acting force to the at least one control cable.

[0011] Alternatively or additionally, the suture transfer assembly may include a needle usable to hold a suture, a distal shuttle configured to removably attach the needle, and a user interface extending proximally from the distal shuttle and configured to allow a user to removably attach the needle.

[0012] Alternatively or additionally, the suturing device further includes a distal assembly configured to be securable to a distal end of the delivery system, the distal assembly including an end cap configured to removably engage and disengage the needle, the end cap configured to engage the needle when the needle advances distally into the end cap and to disengage the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

[0013] Alternatively or additionally, the end cap may include a proximal needle opening configured to accommodate the needle as it advances distally into the end cap and positionally aligned with the longitudinal axis of the needle, one or more retainer openings positioned perpendicular to the proximal needle opening, and a retainer positioned within the retainer opening and configured to removably engage a distal detent on the needle.

[0014] Alternatively or additionally, movement of the movement handle distally from the neutral position may move the member to the locked position, and movement of the movement handle proximally from the neutral position may move the member to the unlocked position.

[0015] Alternatively or additionally, the delivery system may include an endoscope and the lumen may include a working channel of the endoscope. Another example is a suturing device for use in combination with an endoscope having a working channel and a distal end. The suturing device includes a translation assembly including a needle configured to be axially movable within the working channel and configured to hold a suture, a distal shuttle configured to removably mount the needle, and a sleeve positionable on the distal shuttle, the sleeve being movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is removable from the distal shuttle. The suturing device includes a distal assembly configured to be securable to a distal end of the endoscope, an end cap configured to engage the needle when the needle is advanced distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally, and an elongated tool guide having a distal end disposed relative to the distal assembly, the elongated tool guide being transitional between a deployed configuration in which the elongated tool guide is substantially parallel to the distal assembly and an actuated configuration in which the elongated tool guide is curved away from the distal assembly.

[0016] Alternatively or additionally, the elongate tool guide may include a guide structure secured to the distal assembly and a polymeric tubular member secured to the guide structure and extending proximally from the guide structure.

[0017] Alternatively or additionally, the elongate tool guide may transition from the deployed configuration to the operative configuration in response to a tool being extended distally through the elongate tool guide. Alternatively or additionally, the elongate tool guide may include a guide structure pivotally mounted to the distal assembly and a polymeric tubular member secured to and extending proximally from the guide structure, the guide structure and polymeric tubular member together defining a lumen, the pivot structure protruding into the lumen such that a tool extending distally through the elongate tool guide contacts the pivot structure, and further distal biasing of the tool is achieved by the tool interacting with the pivot structure to rotate the guide structure relative to the distal assembly and transition the elongate tool guide from the deployed configuration to the operative configuration.

[0018] Alternatively or additionally, the elongate tool guide includes an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough. The metal ribbon extends through the second lumen and can be transitional between a linear configuration in which the metal ribbon is straight and a memory configuration in which the metal ribbon is curved. The elongate structure can be straight when the metal ribbon is straight, and curved when the metal ribbon is curved.

[0019] Alternatively or additionally, the elongate tool guide includes an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough. The elongate bistable member extends through the second lumen and can be transitional between a stable configuration in which the elongate bistable member is straight and an unstable configuration in which the metal ribbon is curved. The elongate structure can be straight when the bistable metal element is straight, and curved when the bistable metal element is curved.

[0020] Alternatively or additionally, the elongate tool guide may include a plurality of conduit segments connected by living hinges formed between adjacent conduit segments of the plurality of conduit segments, each of the plurality of conduit segments including at least one control opening extending therethrough and at least one control cable extending through each of the at least one control opening in each conduit segment. The elongate tool guide may be transitioned between the deployed configuration and the operative configuration by applying an axially acting force to the at least one control cable.

[0021] Another example is a suturing device for use in combination with a delivery system including a lumen extending therethrough, the delivery system including a moving assembly configured to be axially movable within the lumen of the delivery system, the delivery system including a distal end. The moving assembly includes a needle used to hold a suture, a distal shuttle configured to removably mount the needle, and a user interface extending proximally from the distal shuttle and configured to allow a user to removably mount the needle. The distal assembly is configured to be securable to the distal end of the delivery system and includes an end cap configured to removably engage and disengage the needle, the end cap configured to engage the needle when the needle is advanced distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally. The distal assembly includes a guide member configured to allow the suture moving assembly to extend therethrough and move relative to the guide member, and an elongated tool guide having a distal end positioned relative to the distal assembly, the elongated tool guide being transitionable between a deployed configuration in which the elongated tool guide is generally parallel to the distal assembly and an operational configuration in which the elongated tool guide is curved away from the distal assembly, the elongated tool guide including a guide structure secured to the distal assembly and a polymeric tubular member secured to the guide structure and extending proximally from the guide structure.

[0022] Another example is a medical device for use in combination with a delivery system including a lumen extending therethrough, the medical device including an elongated tool guide configured to be secured relative to a distal end of the delivery system for guiding a tool extending therethrough, the elongated tool guide being transitionable between a deployed configuration in which the elongated tool guide is generally parallel to the delivery system when secured relative to the distal end of the delivery system, and an actuated configuration in which the elongated tool guide is curved away from the distal assembly.

[0023] Alternatively or additionally, the elongate tool guide may include a guide structure configured to be secured to the distal end of the delivery system, and a polymeric tubular member secured to the guide structure and extending proximally from the guide structure.

[0024] Alternatively or additionally, the guide structure may be configured to be rigidly secured relative to an intervening structure between the guide structure and the distal end of the delivery system. Alternatively or additionally, the elongate tool guide may be configured to transition from the deployed configuration to the operative configuration in response to a tool being distally extended through the elongate tool guide.

[0025] Alternatively or additionally, the elongate tool guide may include a guide structure pivotally mounted relative to an intervening structure between the guide structure and the distal end of the delivery system; a polymer tubular member secured to the guide structure and extending proximally from the guide structure such that the guide structure and the polymer tubular member together define a lumen; and a pivot structure projecting into the lumen such that a tool extending distally through the elongate tool guide contacts the pivot structure, wherein further distal bias of the tool causes the tool to interact with the pivot structure and rotate the guide structure relative to the distal assembly, thereby transitioning the elongate tool guide from the deployed configuration to the operative configuration.

[0026] Alternatively or additionally, the elongate tool guide may include an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough, and a metal ribbon extending through the second lumen, the metal ribbon being transitionable between a linear configuration in which the metal ribbon is straight and a memory configuration in which the metal ribbon is curved, such that when the metal ribbon is straight the elongate structure is straight and when the metal ribbon is curved the elongate structure is curved.

[0027] Alternatively or additionally, the elongate tool guide may include an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough, and an elongate bistable member extending through the second lumen, the elongate bistable member being transitional between a stable configuration in which the elongate bistable member is straight and an unstable configuration in which the metal ribbon is curved, such that when the bistable metal element is straight the elongate structure is straight and when the bistable metal element is curved the elongate structure is curved.

[0028] Alternatively or additionally, the elongate tool guide may include a plurality of conduit segments connected by living hinges formed between adjacent conduit segments of the plurality of conduit segments, each of the plurality of conduit segments including at least one control opening extending therethrough and at least one control cable extending through each of the at least one control opening in each conduit segment, wherein application of an axial force to the at least one control cable may transition the elongate tool guide between the deployed configuration and the operative configuration.

[0029] Alternatively or additionally, the medical device further comprises a distal assembly configured to be fixed to the distal end of the delivery system, the elongated tool guide being fixable to the distal assembly, and the distal assembly configured to house the suturing device.

[0030] Alternatively or additionally, the suturing device may include a suture moving assembly configured to be axially movable within the lumen of the delivery system, and a guide member configured to allow the suture moving assembly to extend therethrough.

[0031] Alternatively or additionally, the suture transfer assembly may include a needle usable to hold a suture, a distal shuttle configured to removably load the needle, and a user interface extending proximally from the distal shuttle and configured to allow a user to removably load the needle. The suturing device further includes an end cap configured to removably engage and disengage the needle, the end cap configured to engage the needle as the needle advances distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

[0032] Alternatively or additionally, the end cap may include a proximal needle opening configured to accommodate the needle as it advances distally into the end cap, the proximal needle opening being positionally aligned with the longitudinal axis of the needle, one or more fastener openings positioned perpendicular to the proximal needle opening, and one or more fasteners positioned within the fastener openings and configured to removably engage distal detents on the needle.

[0033] Another example is a medical device for use in combination with an endoscope having a working channel and a distal end, the medical device including a distal assembly configured to be fixed relative to the endoscope and an elongated tool guide having a distal end disposed relative to the distal assembly, the elongated tool guide being transitionable between a deployed configuration generally parallel to the distal assembly and an operational configuration curved away from the distal assembly.

[0034] Alternatively or additionally, the elongate tool guide may include a guide structure secured to the distal assembly and a polymeric tubular member secured to the guide structure and extending proximally from the guide structure.

[0035] Alternatively or additionally, the elongate tool guide may transition from the deployed configuration to the operative configuration in response to a tool being extended distally through the elongate tool guide. Alternatively or additionally, the elongate tool guide includes a guide structure pivotally mounted relative to the distal assembly and a polymeric tubular member secured to the guide structure and extending proximally therefrom, the guide structure and polymeric tubular member together defining a lumen and a pivot structure protruding into the lumen such that a tool extending distally through the elongate tool guide contacts the pivot structure, and further distal biasing of the tool can cause the tool to interact with the pivot structure and rotate the guide structure relative to the distal assembly, thereby transitioning the elongate tool guide from the deployed configuration to the operative configuration.

[0036] Alternatively or additionally, the elongate tool guide may include an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough, and a metal ribbon extending therethrough, the metal ribbon being transitionable between a linear configuration in which the metal ribbon is straight and a memory configuration in which the metal ribbon is curved, such that when the metal ribbon is straight the elongate structure is straight and when the metal ribbon is curved the elongate structure is curved.

[0037] Alternatively or additionally, the elongate tool guide may include an elongate structure defining at least a first lumen and a second lumen, the first lumen configured to accommodate a tool extending therethrough, and an elongate bistable member extending through the second lumen, the elongate bistable member being transitional between a stable configuration in which the elongate bistable member is straight and an unstable configuration in which the metal ribbon is curved, such that when the bistable metal element is straight the elongate structure is straight, and when the bistable metal element is curved the elongate structure is curved.

[0038] Alternatively or additionally, the elongate tool guide includes a plurality of conduit segments connected by living hinges formed between adjacent conduit segments of the plurality of conduit segments, each conduit segment of the plurality of conduit segments including at least one control opening extending therethrough and at least one control cable extending through each of the at least one control opening in each conduit segment, wherein application of an axially acting force to the at least one control cable can transition the elongate tool guide between the deployed configuration and the operative configuration.

[0039] Another example is a medical device for use in combination with a delivery system including a lumen extending therethrough, the medical device including: a distal assembly securably configured to a distal end of the delivery system; and an elongated tool guide securably configured relative to the distal assembly, the elongated tool guide being transitionable between a deployed configuration generally parallel to the distal assembly and an operational configuration curved away from the distal assembly, the elongated tool guide including a guide structure affixed to the distal assembly and a polymeric tubular member secured to the guide structure and extending proximally therefrom.

[0040] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments.

[0041] The present invention may be more fully understood in consideration of the following description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0042] [Figure 1] 1 is a perspective view of an exemplary suturing device according to one example of the present invention; [Figure 2] 2 is a perspective view of a distal assembly forming part of the exemplary suturing device of FIG. 1 shown in an extended position. [Figure 3] FIG. 3 is a perspective view of the distal assembly of FIG. 2 shown in a retracted position. [Figure 4] 4 is a cross-sectional view of the distal assembly of FIG. 2 taken along line 4-4. [Figure 5] 2 is an exploded view of a portion of a suture transfer assembly forming part of the exemplary suturing device of FIG. 1; [Figure 6] FIG. 10 is a side view of the distal shuttle and members forming part of the suture transfer assembly, with the members shown extended in a locked position. [Figure 7] 7 is a side view of the distal shuttle and member of FIG. 6, with the member shown retracted to an unlocked position. [Figure 8] 2 is a side view of a distal assembly usable with the suturing device of FIG. 1 according to an example of the present invention. [Figure 9] FIG. 9 is a side view of the distal assembly of FIG. 8 in combination with an attached flexible lumen. [Figure 10] 2 is a side view of a distal assembly usable with the suturing device of FIG. 1 shown with an attached lumen, according to one example of the present invention. [Figure 11] 10 illustrates a tissue detachment mechanism that may be used in combination with the distal assembly of FIGS. 1 and 8, according to one example of the present invention. [Figure 12] 10 illustrates a tissue detachment mechanism that may be used in combination with the distal assembly of FIGS. 1 and 8, according to one example of the present invention. [Figure 13] 2 is a perspective view of a distal assembly usable with the suturing device of FIG. 1 according to one example of the present invention; [Figure 14] 2 is a perspective view of a suture moving assembly that can be used with the suturing device of FIG. 1 according to one example of the present invention; [Figure 15] 15 is a partially exploded perspective view of the suture transfer assembly of FIG. 14 according to an example of the present invention. [Figure 16] 15 is a perspective view of an inner member forming part of the suture transfer assembly of FIG. 14, according to an example of the present invention. [Figure 17] 15 is a perspective view of a portion of the suture transfer assembly of FIG. 14 shown in a locked configuration, according to an example of the present invention. [Figure 18]15 is a perspective view of a portion of the suture transfer assembly of FIG. 14 shown in an unlocked configuration, according to an example of the present invention. [Figure 19] 2 is a perspective view of a suture moving assembly that can be used with the suturing device of FIG. 1 according to one example of the present invention; [Figure 20] 20 is a perspective view of the suture transfer assembly of FIG. 19 with some elements removed to show the internal structure, the suture transfer assembly being shown in a locked configuration, according to one example of the present invention; [Figure 21] 20 is a side view of a portion of the suture transfer assembly of FIG. 19 illustrating how a locking member engages with the inner member and needle of the suture transfer assembly in a locked configuration as shown in FIG. 20, according to one example of the present invention. [Figure 22] 20 is a perspective view of the suture transfer assembly of FIG. 19 shown in an unlocked configuration, according to an example of the present invention. [Figure 23] FIG. 10 is a perspective view of a sleeve that can be used as part of a suture transfer assembly. [Figure 24] 24 is a perspective view of a distal assembly that uses the sleeve of FIG. 23 and that can be used with the suturing device of FIG. 1, according to one example of the present invention. [Figure 25] 1 illustrates a needle with a needle cap according to an example of the present invention. [Figure 26] 26 is a cross-sectional view of the needle and needle cap of FIG. 25 taken along line 26-26. [Figure 27] FIG. 1 is a perspective view of a suture moving assembly with a needle shown in an unlocked position, according to an example of the present invention. [Figure 28] 28 is a perspective view of the suture transfer assembly of FIG. 27, with the needle shown in a locked position, according to an example of the present invention. [Figure 29] 29 is a cross-sectional view of the suture transfer assembly of FIG. 28 taken along line 29-29. [Figure 30] FIG. 29 is a partially exploded view of the suture transfer assembly of FIG. 28. [Figure 31] 2 is a perspective view of a distal assembly usable with the suturing device of FIG. 1 including an elongated tool guide in a deployed configuration according to one example of the present invention; [Figure 32] 2 is a perspective view of a distal assembly usable with the suturing device of FIG. 1 including an elongated tool guide in an operative configuration according to one example of the present invention; [Figure 33] 2 is a partial cross-sectional perspective view of an elongated tool guide that can be used with the suturing device of FIG. 1 according to an example of the present invention. [Figure 34] 2 is a perspective view of a portion of an elongated tool guide usable with the suturing device of FIG. 1 shown in a deployed configuration, according to an example of the present invention. FIG. [Figure 35] 2 is a perspective view of a portion of an elongated tool guide usable with the suturing device of FIG. 1 shown in an operational configuration, according to an example of the present invention; FIG. [Figure 36A] 2 is a side view of a portion of an elongated tool guide usable with the suturing device of FIG. 1 shown in a deployed configuration, according to an example of the present invention. FIG. [Figure 36B] 2 is a side view of a portion of an elongated tool guide shown in an operational configuration that can be used with the suturing device of FIG. 1, according to an example of the present invention. [Figure 36C] 36C is a cross-sectional view of a portion of the elongated tool guide of FIG. 36B taken along line 36-36. DETAILED DESCRIPTION OF THE INVENTION

[0043] The invention is susceptible to various modifications and alternative forms, details of which are shown by way of example in the drawings and will be described in detail below. However, the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

[0044] For the following defined terms, these definitions shall be applied unless a different definition is given in the claims or elsewhere in this specification. Definitions of certain terms are set forth below and these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0045] All numerical values ​​herein, whether expressly stated or not, are deemed to be modified by the term "about." The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may indicate that a number is rounded to the nearest significant figure.

[0046] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although certain suitable dimensions, ranges and / or values ​​are disclosed for various components, features and / or specifications, one skilled in the art inspired by the present invention will understand that the desired dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0047] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or refer to plural referents as well as singular referents, unless the context clearly dictates otherwise. As used in this specification and the appended claims, the word "or" is generally used to include "and / or" unless the context clearly dictates otherwise.

[0048] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict exemplary embodiments and are not intended to limit the scope of the invention. The exemplary embodiments shown are intended as examples only. Selected features of any exemplary embodiment may be incorporated into further embodiments, unless expressly stated otherwise.

[0049] The present invention relates to a device configured to be used in combination with an endoscope or similar delivery device to close internal wounds. In some instances, the suturing device described herein may be configured for use within a single working channel, i.e., available channel, of an endoscope, and in some embodiments, may be operated by a single individual, or in some embodiments, may involve the involvement of another individual. In some embodiments, the suturing device described herein may be thought of as operating along a single line of control. The device itself is movable distally and proximally within the working channel, and the handle portion is itself movable distally and proximally along the same line of control, allowing the needle to be advanced back and forth between the active and passive portions of the suturing device upon locking and unlocking the needle. The device is configured to allow the needle to be selectively locked in either a more distal or more proximal position, and the device itself may be moved distally or proximally with the needle locked in place to move the needle, and therefore the suture, against the tissue to be repaired.

[0050] FIG. 1 is a perspective view illustrating a suturing device 10 configured to be used in combination with a delivery system including a lumen extending therethrough. The delivery system may be an endoscope having a working channel. The delivery system may also be a catheter. It will be understood that the illustration is to scale on either side of the illustrated break line. In some embodiments, the suturing device 10 includes a suture transfer assembly 12 configured to be axially movable within the lumen of the delivery system and a distal assembly 14 configured to be secured to the distal end of the delivery system. The suture transfer assembly 12 extends within the distal assembly 14 and includes a needle 16 used to hold a suture and a distal shuttle 18 configured to removably mount the needle 16.

[0051] The member 20 is disposed on the distal shuttle 18 and is movable between a locked position, in which the needle 16 is attached to the distal shuttle 18, and an unlocked position, in which the needle 16 is disengaged from the distal shuttle 18, as shown in subsequent figures. In some embodiments, the member 20 is a sleeve 20. A user interface extends proximally from the distal shuttle 18 and the sleeve 20 and is configured to move the sleeve 20 between the locked and unlocked positions. A shaft 28 extends distally to the suture transfer assembly 12 and may be coupled to the sleeve 20, among other things. The user interface can take many different forms. For example, the user interface may be the user interface 22 described and illustrated in U.S. Patent Application Publication No. 2018 / 0235604, which is incorporated herein by reference in its entirety. In some embodiments, the user interface may be as described in Provisional Application No. 62 / 794,075, filed January 18, 2019, entitled "ENDOSCOPIC SUTURING CONTROL HANDLE," which is incorporated herein by reference in its entirety. In some embodiments, the user interface may be as described in Provisional Application No. 62 / 848,853, filed May 16, 2019, entitled "CONTROL HANDLE FOR ENDOSCOPIC SUTURING," which is incorporated herein by reference in its entirety. These are merely examples.

[0052] In some embodiments, the distal assembly 14 includes a body 29 having a proximal connector 30 configured to couple to the distal end of an endoscope or other delivery system. In some embodiments, as shown in the figures, the proximal connector 30 may include a locking mechanism 401. As described in subsequent figures, in some embodiments, the locking mechanism 401, which may be thought of as a locking flange 401, serves to secure the distal assembly 14 to the distal end of an endoscope or other delivery system using a split-ring attachment mechanism.

[0053] The body 29 includes an arm 32 that extends to an end cap 34. As described below, the end cap 34 is configured to removably engage and disengage the needle 16. In some embodiments, for example, the end cap 34 is configured to engage the needle 16 when the needle 16 is advanced distally into the end cap 34 and to disengage from the needle 16 when the needle 16 is locked within the distal shuttle 18 and the distal shuttle 18 is withdrawn proximally (as described below). The distal assembly 14 may include a guide member 36 fixed to or integrally formed with the body 29, allowing the suture moving assembly 12 to extend within and move relative to the guide member 36. In some embodiments, the body 29 may include an opening 27 that allows another device to be inserted therein. In some instances, as described with respect to subsequent figures, the opening 27 may be configured to accommodate a side-saddled lumen attachment element. In some embodiments, opening 27 may include one or more pin openings 31a and 31b, which may be used to attach, for example, the aforementioned side-saddle lumen attachment elements, or other mechanisms.

[0054] 2 and 3 show the suture transfer assembly 12 extending through the guide member 36 and into the distal assembly 14. In FIG. 2, the suture transfer assembly 12 is shown in an extended position with the needle 16 extending into the end cap 34, while in FIG. 3, the suture transfer assembly 12 is shown in a retracted position with the needle 16 withdrawn proximally from the end cap 34. In some embodiments, as shown in the drawings, the end cap 34 includes a proximal needle opening 37 configured to accommodate the needle 16 and to help guide the needle 16 into the proximal needle opening 37 as the needle 16 advances distally into the end cap 34. In some embodiments, the proximal needle opening 37 may extend completely through the end cap 34, while in other cases, the proximal needle opening 37 may not extend completely through the end cap 34. In some examples, as shown in the drawings, the proximal needle opening 37 is positionally aligned with the longitudinal axis 38 of the needle 16 (as shown in FIG. 3).

[0055] The one or more fastener openings 40 may be disposed perpendicular to the proximal needle opening 37 and one or more fasteners 42 disposed within the one or more fastener openings 40 and configured to releasably engage a distal detent (as described below) of the needle 16. In some embodiments, one of a pair of fastener openings 40 may be on each side of the end cap 34. In some embodiments, there may be a pair of fasteners 42, one disposed within each of the pair of fastener openings 40. In some embodiments, while shown schematically, the one or more fasteners 42 may be, for example, a spring or a coil.

[0056] Figure 4 is a cross-sectional view of the distal assembly 14 with the suture transfer assembly 12 disposed therein. Figure 5 is an exploded view of the suture transfer 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 can include a distal detent 48 for releasably engaging the end cap 34, and the proximal region 46 can include a proximal detent 50 for releasably engaging the distal shuttle 18. The needle 16 can include an opening 52 for accommodating a suture therethrough, as shown.

[0057] In some embodiments, the distal shuttle 18 may include a distal needle opening 54 configured to receive the needle 16 when the distal shuttle 18 is advanced distally over the needle 16 and positionally aligned with the longitudinal axis 38 of the needle 16. One or more bearing ball openings 56 may be positioned perpendicular to the distal needle opening 54 such that the one or more bearing ball openings 56 are positionally aligned with the proximal detents 50 when the needle 16 is secured to the distal shuttle 18. In some embodiments, the one or more bearing balls 58 may be configured to be disposed within the one or more bearing ball openings 56 and within the proximal detents 50 when the needle is secured to the distal shuttle 18.

[0058] In some embodiments, the distal shuttle 18 includes an interior cavity 60 and a sleeve capture member 62 slidably disposed within the interior cavity 60. In some embodiments, the sleeve capture member 62 is coupled to a cable 64 that extends distally within the shaft 28 and into a cable opening 66 and may be secured by a crimp or other mechanical connection 68. In some embodiments, the sleeve capture member 62 may be coupled to the sleeve 20 by a pin 70 that extends through first and second sleeve connection openings 72, 74 and corresponding openings 76 that extend through the sleeve capture member 62 as well as the interior cavity 60.

[0059] In some embodiments, the sleeve 20 includes one or more sleeve openings 80 that may be smaller in diameter or width than the diameter of the one or more bearing balls 58. In some embodiments, the sleeve 20 may include a pair of bearing ball openings 56 and a pair of sleeve openings 80 that correspond to the pair of bearing balls 58. For example, as shown in FIG. 6 , when the sleeve 20 is in the locked position, the one or more sleeve openings 80 are misaligned or not aligned with the one or more bearing ball openings 56, causing the one or more bearing balls 58 to engage the proximal detents 50 of the needle 16. The sleeve 20 prevents the one or more bearing balls 58 from being pushed out of the proximal detents 50.

[0060] Conversely, as shown in FIGURE 7, when sleeve 20 is in the unlocked position, one or more sleeve openings 80 are positionally aligned with one or more bearing ball openings 56. This allows one or more bearing balls 58 to move radially outward and into one or more sleeve openings 80 a sufficient distance to allow them to disengage from proximal detents 50 of needle 16 in response to a force exerted on one or more bearing balls 58 by needle 16. Referring to FIGURE 4, while suture transfer assembly 12 has been advanced within distal assembly 14, sleeve 20 is in the unlocked position relative to distal shuttle 18, whereby one or more bearing balls 58 are seen to extend partially into one or more sleeve openings 80.

[0061] In some embodiments, the distal shuttle 18 and sleeve 20 combination actively connects to the needle 16, while the distal end cap 34 passively connects to the needle 16. When the needle 16 is moved distally into the distal end cap 34, the distal end cap 34 grips the needle 16 with one or more fasteners 42 engaging distal detents 48. When the needle 16 is then moved proximally, the applied axial force overcomes any resistance provided by the one or more fasteners 42, allowing the needle 16 to move proximally. However, for the distal shuttle 18 and sleeve 20 to actively connect to the needle 16, the sleeve 20 must be moved between a locked and unlocked position relative to the distal shuttle 18. The user interface provides a mechanism for moving the sleeve 20 between the locked and unlocked positions.

[0062] 8 is a side view of a distal assembly 14a usable with the suturing device 10 shown in FIG. The distal assembly 14a is similar to the distal assembly 14 shown in the previous figures, but includes a side-saddle lumen attachment element 120 coupled to the body 29 of the distal assembly 14a. In some embodiments, the side-saddle lumen attachment element 120 may include one or two pegs 122 that fit into pin openings 31a, 31b (pin opening 31a is visible in this view) to allow the side-saddle lumen attachment element 120 to rotate relative to the body 29 of the distal assembly 14a. In some embodiments, the side-saddle lumen attachment element 120 includes a ring 124 from which the pegs 122 extend, a distal region 126, and a body 128 that, in some instances, has a curved portion.

[0063] In some embodiments, distal region 126 and body 128 have a semicircular profile to accommodate a lumen, such as flexible lumen 130, which may engage the interior of side-saddle lumen attachment element 120 via a friction or compression fit, as shown in FIG. 9. Flexible lumen 130 may be polymeric or metallic. The polymeric lumen may be expanded to its full working dimension, for example, by stretching a mandrel into flexible lumen 130 after it is positioned relative to side-saddle lumen attachment element 120.

[0064] In some embodiments, the side-saddled attachment element 120 (and associated flexible lumen 130) may be used as a secondary working channel and may contain sutures used in surgery. In some embodiments, the side-saddled attachment element 120 may be large enough to accommodate a secondary tool, allowing its use during surgery for tissue harvesting or manipulation without the need for a dedicated dual-channel delivery system, such as a dual-channel endoscope. If desired, a dual-channel delivery system may be used to provide additional options for surgery. The side-saddled attachment element 120 may have an exit port at the distal assembly 14a to allow the secondary tool to extend along an axis appropriate for tissue manipulation. This axis intersects with the axis of the suture retaining element, allowing the secondary tool to pull tissue into the protruding path of the suture retaining element. For example, this may be used to pull tissue along the needle to assist in driving the needle 16 through the tissue. Maintaining tension on the suture passing through the side-saddled attachment element 120 may prevent the suture from interfering with the surgery.

[0065] 10 is a perspective view of distal assembly 14b including a shorter side-saddle lumen attachment element 120a that is pivotally secured to body 29 by one or more pegs 122a that extend into pin openings 31a, 31b. Lumen 130a is coupled to side-saddle lumen attachment element 120a to form a working channel through which a suture or other tool may extend.

[0066] 11 and 12 illustrate a tissue detachment mechanism 150 that can fit onto arm 32. In some embodiments, tissue detachment mechanism 150 can aid in surgery by assisting in removing tissue that may be stuck to needle 16. In some examples, tissue detachment mechanism 150 can be spring loaded to engage needle 16 or can be independently actuated separately. In some examples, tissue detachment mechanism 150 includes a crossbar 152 that forms an additional surface against which tissue can be pushed off needle 16.

[0067] In preparing the suturing device 10 for use, the distal assembly 14 is secured to a delivery device, such as an endoscope. In some embodiments, an attachment, such as flexible silicone tubing, may be placed 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, a side-saddled lumen attachment element 120 (or 120a) may be secured to the distal assembly 14, if desired. The suture may be threaded through the needle 16 and fed back toward the user interface. The device 10 may be extended through the body to the defect site.

[0068] FIG. 13 is a perspective view of a distal assembly 14c that can be used with the suturing device 10 shown in FIG. 1, for example. The distal assembly 14c is similar to the distal assembly 14 shown in the previous figures, but includes several modifications that may be particularly useful in bariatric revision surgery. Bariatric surgery generally refers to a procedure that surgically reduces the effective volume of a patient's stomach to provide long-term weight loss for the patient and may be performed laparoscopically. Bariatric revision surgery is a procedure performed endoscopically that allows for modifications to be made to the patient's stomach that were originally performed. In some embodiments, the distal assembly 14c may also be used in other suturing procedures, such as, but not limited to, full-thickness and / or partial-thickness tissue repair.

[0069] Distal assembly 14c includes a body 29a having a proximal connector 30a configured to couple to the distal end of, for example, an endoscope or other delivery system. In some embodiments, as shown, proximal connector 30a may include a locking mechanism, such as a locking flange 401. Body 29a includes arms 32a extending to end cap 34a. In some embodiments, body 29a, including arms 32a, may be similar to the body 29 and arms 32 described with respect to distal assembly 14, distal assembly 14a, and distal assembly 14b. However, in some instances, body 29a and arms 32a may be configured to accommodate thicker tissue, which may mean, for example, changing the overall shape of body 29a and / or arms 32a relative to body 29 and / or arms 32a. In some embodiments, body 29a and / or arms 32a may simply be larger to accommodate thicker tissue. Distal assembly 14c may include a guide member 36a fixed to or integrally formed with body 29a and configured to allow a suture moving assembly (such as suture moving assembly 12 shown in Figures 14-18, suture moving assembly 12a, or suture moving assembly 12b shown in Figures 19-22) to extend through guide member 36a and to allow the suture moving assembly to move relative to guide member 36a.

[0070] In some embodiments, as shown in the figures, guide member 36a includes a channel 300. In some embodiments, channel 300 allows a suture to pass between suture transfer assembly 12, 12a, 12b and a working channel of an endoscope or other delivery device to which distal assembly 14c is attached. Channel 300 may be designed to include, for example, a lead-in portion that helps to positionally align channel 300 with the suture when passing suture transfer assembly 12, 12a, 12b through the working channel of an endoscope or other delivery device. In some embodiments, it may be desirable to load a suture before passing suture transfer assembly 12, 12a, 12b through the working channel of an endoscope or other delivery device.

[0071] In some examples, distal assembly 14c includes guide structure 27a attached to or integrally formed with body 29a. In some embodiments, guide structure 27a may instead be pivotally attached to body 29a. Guide structure 27a may be configured to accommodate a polymeric tubular member attached to guide a tool through the endoscope to a location associated with the work site. In some examples, guide structure 27a may be configured to accommodate a metallic tubular member attached to guide structure 27a. In some embodiments, guide structure 27a and associated tubular member (not shown) may accommodate a grasper or similar tool that allows a user to grasp tissue and pull it into position for passing needle 16 through the tissue. In some embodiments, the relative position or offset of guide structure 27a with respect to the illustrated relative positions or offsets with respect to distal assembly 14, distal assembly 14a, or distal assembly 14b may be greater to provide more space for the tool and to accommodate larger and / or thicker portions of tissue.

[0072] End cap 34a includes one or more fastener openings 40a, as can be seen in the drawings, which may be positioned orthogonally to a proximal needle opening (not shown), such as proximal needle opening 37 shown in FIG. 3. One or more fasteners 42a are correspondingly positioned within one or more fastener openings 40a. In some embodiments, one or more fasteners 42a may be coil springs positioned within one or more fastener openings 40a. The fasteners 42a may removably engage detents on needle 16, as described with respect to distal assembly 14.

[0073] In some embodiments, the fastener opening 40a may have a diameter that exceeds the overall diameter of the fastener 42a, and the fastener opening 40a may taper to a diameter (not visible) 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 secured, or attached to the left side of the fastener opening 40a and may move freely slightly to the right of the fastener opening 40a. In some examples, the distal assembly 14c may include an opening 302 that is perpendicular to the fastener opening 40a. The opening 302 may be threaded to engage with a set screw 304. In some embodiments, as shown in the drawings, the opening 302 may be offset away from the fixed end of the fastener 42a and closer to the right side of the fastener opening 40a so that the set screw 304 supports the free end of the fastener 42a. Rotating the set screw 304 in a first direction, e.g., clockwise, may move the set screw 304 toward the fixture 42a, thereby increasing the interference between the fixture 42a and the needle 16 and increasing the holding force that can be applied to the needle 16. Conversely, rotating the set screw in a second direction, e.g., counterclockwise, may move the set screw 304 away from the fixture 42a, thereby decreasing the holding force that can be applied to the needle 16. This may be useful, for example, to compensate for manufacturing tolerances.

[0074] As noted, distal assembly 14c may be used in combination with suture transfer assembly 12, for example, as described with respect to FIG. 5. Distal assembly 14c may be used with suture transfer assembly 12a shown in FIGS. 14-18 or with suture transfer assembly 12b shown in FIGS. 19-22. FIG. 14 is a perspective view of suture transfer assembly 12a, which holds needle 16, and FIG. 15 is a partially exploded view of suture transfer assembly 12a. As shown in FIG. 15, suture transfer assembly 12a includes an inner member 310 that holds needle 16. Locking member 312 is slidably disposed on inner member 310. As shown, inner member 310 includes a pin 314 that extends radially outward from inner member 310 and extends through a corresponding slot 316 formed in locking member 312. Pin 314 helps prevent relative rotation between inner member 310 and locking member 312. The pin 314 also helps limit the movement of the locking member 312 relative to the inner member 310 .

[0075] The control member 318 is fixed to the proximal end 320 of the locking member 312 and extends distally to a handle, such as the movement handle 26 (FIG. 1). As a result, the locking member 312 can be moved distally and / or proximally relative to the inner member 310. As shown in FIG. 14, the suture moving assembly 12a includes an outer sleeve 330 that can be secured to the inner member 310 by a pin 314. The outer sleeve 330 can be coupled to, for example, a coil 332. In some embodiments, the outer sleeve 330 can be a single tubular member. In some embodiments, as shown in FIG. 15, for example, the outer sleeve 330 can actually include one or more of an outer sleeve 334, a slotted sleeve 336, and an inner-outer sleeve 338. The slotted sleeve 336 can be configured to allow a suture to pass therethrough. This is merely exemplary and is not intended to be limiting in any way.

[0076] As shown in FIG. 16 , which illustrates a distal portion of the inner member 310, the inner member 310 includes a number of arms 322, each including a curved tab 324 configured to engage a corresponding detent in the needle 16. While a total of four arms 322 are shown, the inner member 310 may include any number of arms 322. The arms 322 may be considered to be relatively long and, therefore, relatively flexible. When the locking member 312 is distally extended to a locked configuration, as shown in FIG. 17 , for example, the locking member 312 prevents outward movement of the arms 322. As a result, the curved tabs 324 remain engaged with corresponding detents on the needle 16, and the needle 16 remains locked to the suture moving assembly 12 a. For example, as shown in FIG. 18 , when locking member 312 is retracted proximally to an unlocked configuration, arms 322 are free to move radially outward, thereby releasing curved tabs 324 from detents on needle 16 and allowing needle 16 to move distally relative to inner member 310.

[0077] FIG. 19 is a perspective view of suture transfer assembly 12b that may be used in combination with distal assembly 14, distal assembly 14a, distal assembly 14b, and / or distal assembly 14c. FIG. 20 is a perspective view of suture transfer assembly 12b with outer portions, such as outer sleeve 350 (FIG. 19), removed to show inner member 340 that holds needle 16a. In some embodiments, outer sleeve 350 may be a single tubular member. In some examples, outer sleeve 350 may include several elements, as described with respect to outer sleeve 330 (FIG. 15).

[0078] In some embodiments, as shown, needle 16a has distal detents 342 and proximal detents 344 (shown in FIG. 21 ) that are shaped differently than the corresponding detents on needle 16. Suture transfer assembly 12b includes a locking member 346 that is slidably positionable relative to inner member 340. A pin 352 is attached to inner member 340 and extends through a corresponding slot 354 formed in locking member 342. Pin 352 limits movement of locking member 342 relative to inner member 340 and also prevents relative rotation of locking member 342. Locking member 342 is secured to control member 318, which extends distally to a handle, such as transfer handle 26 ( FIG. 1 ). As a result, locking member 342 can be moved distally and / or proximally relative to inner member 340.

[0079] In some embodiments, outer sleeve 350 may define a slot 370 including an axially extending slot portion 372 and a shorter radially extending slot portion 374. In some embodiments, axially extending slot portion 372 allows pin 352 to move within axially extending slot portion 372 to allow needle 16a to be fully retracted within suture transfer assembly 12b for advancement through an endoscope or other delivery device. As suture transfer assembly 12b is advanced through an endoscope or other delivery device, inner member 340 and locking member 342 may be advanced distally through outer sleeve 350 until pin 352 and radially extending slot portion 374 are positionally aligned. Rotating movement handle 26 may rotate pin 352 into position within radially extending slot portion 374, thereby moving locking member 342 relative to inner member 340.

[0080] In some embodiments, as shown in the figures, the locking member 342 includes a pair of arms 358 extending distally from the locking member 342. As shown in FIG. 21 , the arms 358 include tabs 360 that extend into slots 362 formed in the inner member 340 when the suture moving assembly 12b is in the locked configuration, as shown in FIGS. 20 and 21 . As a result, the tabs 360 can extend through the slots 362 to engage the proximal detents 344 of the needle 16a. Although a pair of arms 358 are shown, the locking member 342 may include any number of arms 358 and a corresponding number of slots 362.

[0081] As shown in Figure 22, to transition suture transfer assembly 12b to the unlocked configuration, locking member 342 can be moved distally relative to inner member 340. As shown in Figure 22, tabs 360 extend out of slots 362 (only one slot 362 is visible), allowing needle 16a to move freely relative to suture transfer assembly 12b. As locking member 342 is moved distally, ramped surface 364 pushes against slot 362 and is moved outward.

[0082] 13 , guide member 36a includes a channel 300 configured to allow a suture to be routed between suture transfer assembly 12, 12a, 12b and the working channel of an endoscope or other delivery device to which distal assembly 14c is attached. Channel 300 may be designed to include a lead-in portion that helps to positionally align the suture with channel 300 when suture transfer assembly 12, 12a, 12b is advanced through the working channel of the endoscope or other delivery device. In some embodiments, it may be desirable to load a suture before advancing suture transfer assembly 12, 12a, 12b into the working channel of the endoscope or other delivery device.

[0083] In some examples, as shown in FIG. 23, instead of providing a channel 300 in the guide member 36a, the suture moving assembly 12, 12a, 12b may be modified to accommodate a suture passing along the suture moving assembly 12, 12a, 12b. FIG. 23 is a perspective view of a sleeve 20a that may be used to form part of the suture moving assembly 12, 12a, 12b. It can be seen that the sleeve 20a includes a groove 20b that extends along the entire length of the sleeve 20a. FIG. 24 shows the sleeve 20a extending through the guide member 36a, with a suture 299 extending through the groove 20b.

[0084] In some embodiments, it may be desirable to protect the distal end of the needle 16 when advancing the suture transfer assembly 12, 12a, 12b through a delivery system, such as an endoscope. Otherwise, in some embodiments, the needle 16 may damage the working channel of the endoscope. In some instances, it may be desirable to protect the needle 16 itself from damage. In some embodiments, the sleeve 20, 20a (FIGS. 1-5) covering the needle 16 and distal shuttle 18 may displace proximally during deployment, exposing the needle 16. In some embodiments, it may be difficult to deploy the sleeve 20, 20a through a bend in the working channel of the endoscope when it is extended over the needle 16.

[0085] 25 and 26 show examples of needle caps 500 positioned on the distal region 44 of the needle 16. FIG. 25 is a side view, and FIG. 26 is a cross-sectional view taken along line 26-26. In some embodiments, the needle cap 500 may be removed outside the patient's body after the suture transfer assembly 12, 12a, 12b is attached to the endoscope and before the endoscope is inserted into the patient's body. In some embodiments, the needle cap 500 on the needle 16 may be pushed off within the patient's body. When performing procedures using multiple needles and sutures, such as, but not limited to, endoscopic sleeve gastroplasty, it may be desirable to remove the needle cap 500 via an endoscope within the patient's body so as to avoid the need to remove and insert the endoscope multiple times. In some embodiments, the needle cap 500 can be pushed off the needle 16 by moving the sleeve 20, 20a distally. In some embodiments, the needle cap 500 may be configured to split when the needle cap 500 contacts the distal end cap 14, 14a, 14b, 14c.

[0086] The needle cap 500 includes a cylindrical needle cap body 503 defining a cavity 501 configured to fit over the needle 16. The needle cap 500 also includes an atraumatic tip 505 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 extending axially along the cylindrical needle cap body 503 and providing sufficient flexibility to allow the needle cap 500 to bend sufficiently to advance over the needle 16. Although only one slot is visible in FIGS. 25 and 26 , in some embodiments, there may be two slots 509. The needle cap 500 includes one or more convex protrusions 520 configured to fit within the distal detent 48 of the needle 16.

[0087] 27-30 illustrate another method of protecting the needle 16 from damage within the endoscope or from damage to the endoscope itself. FIGS. 27-30 illustrate a suture transfer assembly 530 having a reduced overall length for easier attachment to the endoscope. In some examples, the suture transfer assembly 530 is sufficiently short so that it can be easily advanced through an endoscope with a sleeve in place over the needle. In some embodiments, the control of the suture transfer assembly 530 is reversed relative to the suture transfer assemblies 12, 12a, and 12b described with reference to the previous figures. FIG. 27 illustrates the suture transfer assembly 530 in an unlocked position, in which the needle 16 is unlocked from the distal shuttle and can enter the distal end cap 14, 14a, 14b, and 14c. FIG. 28 illustrates the suture transfer assembly 530 in a locked position with the needle 16 locked to the distal shuttle. As can be seen, the suture transfer assembly 530 includes a sleeve 518 and a suture catheter 590. In some embodiments, as shown in the drawings, the suture catheter 590 is a coil. The sleeve 518 has a pair of slots 560 (only one slot 560 is visible in the orientation shown) to accommodate movement of the distal shuttle, as described below. The sleeve 518 also includes a pair of sleeve openings 580 (only one is visible) that allow a bearing ball 58 (not shown) to move in and out of the distal shuttle, thereby locking and unlocking the needle 16.

[0088] The internal structure of suture moving assembly 530 can be better understood in FIG. 29, a cross-sectional view taken along line 29-29 of FIG. 28, and FIG. 30, a partially exploded view of FIG. 28. As shown in the drawing, a control wire 592 extends through suture catheter 590 and terminates in a yoke 604. A sleeve 518 is coupled to suture catheter 590 by a connector 602. In some embodiments, sleeve 518 may be welded to suture catheter 590 directly or by being welded to connector 602. As a result, sleeve 518 does not move relative to suture catheter 590.

[0089] The pin 570 extends through the yoke 602 and into an opening 606 formed in the distal shuttle 600, thereby operably coupling the control wire 592 to the distal shuttle 600. The pin 570 extends to and is guided by a pair of slots 560 formed in the sleeve 518, thereby preventing rotation of the distal shuttle 600 relative to the sleeve 518. In some embodiments, the distal shuttle 600 includes a groove 610 that allows a suture to extend from the needle 16 and axially through the sleeve 518.

[0090] The distal shuttle 600 also includes a pair of bearing ball openings 608. As described above, when the bearing ball openings 608 are positionally aligned with the sleeve openings 580, the bearing balls 58 (not shown) move sufficiently radially outward to disengage from the proximal detents 50 of the needle 16, thereby unlocking the needle 16 from the distal shuttle 600. Conversely, when the bearing ball openings 608 are not positionally aligned with the sleeve openings 580, the bearing balls 58 (not shown) do not disengage from the proximal detents 50 of the needle 16, and the needle 16 remains locked to the distal shuttle 600. Thus, by moving the control wire 592 proximally, the distal shuttle 600 is moved proximally relative to the sleeve 518. This causes the sleeve openings 580 to become misaligned with the bearing ball openings 608, thereby locking the needle 16 to the sleeve 518. Conversely, by moving control wire 592 distally, distal shuttle 600 is moved distally relative to sleeve 518 .

[0091] 31 and 32 are perspective views of a distal assembly 14d that can be used with the suturing device 10 shown in FIG. 31 shows the distal assembly 14d with the elongated tool guide 720 in a deployed configuration, and FIG. 32 shows the distal assembly 14d with the elongated tool guide 722 in an operative configuration. When in the deployed configuration, the elements of the elongated tool guide 720 are closer to the distal assembly 14d, making the distal assembly 14d more compact. The distal assembly 14d is similar to the distal assembly 14 shown in the previous figures, but includes modifications that aid in both delivery of the distal assembly 14d and subsequent delivery of the tool to the work site.

[0092] Distal assembly 14d may include a body 29a having a proximal connector 30a configured to couple to the distal end of an endoscope or other delivery system. In some embodiments, as shown in the drawings, proximal connector 30a may include an inner collet adapter 702 that engages with locking mechanism 401 (not visible in this drawing) and an outer collet adapter 704 that threads onto inner collet adapter 702. The inner collet adapter 702 and outer collet adapter 704 may be used together to secure distal assembly 14d to an endoscope body 706. Body 29a includes arms 32a that extend to end cap 34a. In some embodiments, body 29a, including arms 32a, may be similar to the bodies 29 and arms 32 previously referenced with respect to distal assembly 14, distal assembly 14a, distal assembly 14b, and distal assembly 14c. Distal assembly 14d may include a guide member 36a fixed to or integrally formed with body 29a and configured to allow a suture moving assembly (such as suture moving assembly 12 shown in Figures 14-18, suture moving assembly 12a, or suture moving assembly 12b shown in Figures 19-22) to extend therethrough and move relative to guide member 36a.

[0093] 32, the guide member 36a includes a channel 300. In some embodiments, the channel 300 allows a suture to pass between the suture transfer assembly 12, 12a, 12b and the working channel of the endoscope or other delivery device to which the distal assembly 14d is attached. The channel 300 may be designed to include a lead-in portion that helps to positionally align the channel 300 with the suture when the suture transfer assembly 12, 12a, 12b is passed through the working channel of the endoscope or other delivery device. In some embodiments, it may be desirable to load a suture before passing the suture transfer assembly 12, 12a, 12b through the working channel of the endoscope or other delivery device.

[0094] End cap 34a includes one or more retainer openings 40a, as can be seen in the drawings, which may be positioned orthogonally to a proximal needle opening (not shown), such as proximal needle opening 37 shown in FIG. 3. One or more retainers 42a may be correspondingly positioned within one or more retainer openings 40a. In some embodiments, one or more retainers 42a may be coil springs positioned within one or more retainer openings 40a. The retainers 42a may removably engage detents on needle 16, as described with respect to distal assembly 14.

[0095] In some embodiments, the fastener opening 40a may have a diameter that exceeds the overall diameter of the fastener 42a, and the fastener opening 40a may taper to a diameter (not visible) 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 secured, or otherwise attached to the left side of the fastener opening 40a and may move freely slightly to the right of the fastener opening 40a. In some examples, the distal assembly 14c may include an opening 302 that is perpendicular to the fastener opening 40a. The opening 302 may be threaded to engage with a set screw 304. In some embodiments, as shown in the drawings, the opening 302 may be offset closer to the right side of the fastener opening 40a, away from the fixed end of the fastener 42a, so that the set screw 304 supports the free end of the fastener 42a. Rotating the set screw 304 in a first direction, clockwise, may move the set screw 304 toward the fixture 42a, thereby increasing the interference between the fixture 42a and the needle 16 and increasing the holding force that can be applied to the needle 16. Conversely, rotating the set screw in a second direction, counterclockwise, may move the set screw 304 away from the fixture 42a, thereby decreasing the holding force that can be applied to the needle 16. This helps to compensate for manufacturing tolerances.

[0096] As noted above, in some examples, the distal assembly 14d includes an elongated tool guide 720. The elongated tool guide 720 may take a variety of forms. As shown in FIGS. 31 and 32 , the elongated tool guide 720 includes a guide structure 722 attached to or integrally formed with the body 29a. A polymeric tubular member 724 is secured to and extends through the guide structure 722. The polymeric tubular member 724 extends proximally from the distal assembly 14d, and various tools may extend through the polymeric tubular member 724 to reach a work site, which may be considered the area between the guide member 36a and the end cap 34a. In FIG. 31 , the polymeric tubular member 724 is shown in a retracted position relative to the distal assembly 14d in a deployed configuration that minimizes the overall size of the distal assembly 14d. In FIG. 32, the polymeric tubular member 724 is shown in an actuated configuration in which the polymeric tubular member 724 is curved away from the distal assembly 14d.

[0097] In some examples, 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 formed of a polymer having a relatively low durometer, meaning the distal region 726 is more flexible, while the proximal region 728 may be formed of a polymer having a relatively high durometer, meaning the proximal region 728 is less flexible. This may aid in the transition of the polymer tubular member 724 between the deployed and operative configurations. The distal and proximal regions 726 and 728 may be composed of two different polymers or may be formed of the same polymer with different durometers. Although described as being polymeric, in some cases, the polymer tubular member 724 may instead be formed of a metallic material. It is contemplated that the polymer tubular member 724 may be transitioned from a contracted state relative to the distal assembly 14d by extending a tool distally through the polymer tubular member 724.

[0098] FIG. 33 is a schematic diagram of an elongated tool guide 720a that may be used. The elongated tool guide 720a includes a guide structure 722a that is pivotally mounted to a distal assembly (not shown in this view) by a pivot point 730. The elongated tool guide 720a also includes a polymeric tubular member 724a that is secured to and extends through the guide structure 722a. The elongated tool guide 720a includes a pivot structure 732. The pivot structure 732 may be a ball, ramp, or other shape that extends at least partially into a lumen 734 that extends through the guide structure 722a. As a result, as a tool 736 (shown as a forceps) extends distally through the polymeric tubular member 724a, continued distal pressure applied by the tool 736 rotates the guide structure 722a about the pivot point 730. As a result, elongate tool guide 720a can be rotated from a deployed configuration to an actuated configuration in which the polymeric tubular member is labeled 724a' and the tool is labeled 736'. By comparing Figure 33 with Figure 32, it can be seen that in the actuated configuration, tool 736' is positioned to easily access the work site.

[0099] 34 and 35 are perspective views illustrating a tubular member 740 that may be used as part of an elongate tool guide. The tubular member 740 includes at least a first lumen 742 and a second lumen 744. The first lumen 742 may be configured to accommodate a tool (such as, but not limited to, a forceps as shown in FIG. 33 ) therethrough. The second lumen 744 may be configured to accommodate an elongate member 746 extending therethrough. In some cases, the elongate member 746 may be used to control the transition between a deployed configuration, as shown in FIG. 34 , and an actuated configuration, as shown in FIG. 35 .

[0100] In some cases, elongate member 746 may be a ribbon formed of a metallic or polymeric shape memory material having an original configuration (e.g., linear) and a memory configuration (e.g., curved). An elongate tool guide formed using tubular member 740 may start in a deployed configuration in which elongate member 746 is in a linear configuration. Prior to extending a tool distally through tubular member 740, elongate member 746 may be actuated to the memory configuration by energizing elongate member 746. In some cases, elongate member 746 may not be inserted into second lumen 744 until it is time to transition tubular member 740 from the deployed configuration to the operative configuration.

[0101] In some cases, the elongate member 746 may be a bistable material that has a stable linear configuration. The action of the tool striking the sidewall of the elongate member 746, i.e., applying a small force to the elongate member 746, when delivering a tool through the first lumen 742 may cause the elongate member 746 to return to the unstable curved configuration.

[0102] Figures 36A, 36B, and 36C illustrate a tubular member 750 that may be used as part of an elongate tool guide. Figure 36A illustrates the tubular member 750 in a deployed configuration, and Figure 36B illustrates the tubular member 750 in an operational configuration. As shown in the figures, the tubular member 750 is formed of a plurality of conduit segments 752, each connected by a living hinge 754. Each living hinge 754 is formed from a flexible section of material forming two conduit segments 752 on either side of the living hinge 754. As shown in the figures, a first cable 756 and a second cable 758 each extend through one of the conduit segments 752. As shown in Figure 36C, which is a cross-sectional view taken along line 36-36 in Figure 36B, each conduit segment 752 includes a first cable opening 760 and a second cable opening 762, with a first cable 756 extending through the first cable opening 756 and a second cable 758 extending through the second cable opening 762. By applying an appropriate force to the first cable 756 and / or the second cable 758, the tubular member 750 may be transitioned from the deployed configuration shown in Figure 36A to the operated configuration shown in Figure 36B. In some cases, the tubular member 750 may include only a single cable, such as the second cable 758.

[0103] It will be appreciated that a variety of different materials may be used in forming the devices 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 chrome, and the like. In some embodiments, the devices described herein may comprise any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Other suitable polymers include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-esters (e.g., DSM Engineering Plastics), and the like. ARNITEL® available from DuPont Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (e.g., polyether block amide (PEBA) available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), and the like.copolymer), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS American Grillon) The polymers may include, but are not limited to, polyethylene terephthalate (PE), polyethylene glycol (PE), polyethylene glycols (e.g., GRILAMID® available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like.

[0104] Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departures may be made in form and detail without departing from the scope and spirit of the present invention as set forth in the appended claims.

Claims

1. 1. A medical device for use in combination with a delivery system including a lumen extending therethrough, comprising: a medical device comprising an elongated tool guide secured to a distal end of the delivery system for guiding a tool extending therethrough, the elongated tool guide being movable between a deployed configuration in which the elongated tool guide is substantially parallel to the delivery system when secured to the distal end of the delivery system, and an operational configuration in which the elongated tool guide is curved away from the distal assembly.

2. The elongated tool guide comprises: a guide structure fixed relative to the distal end of the delivery system; a polymeric tubular member secured to and extending proximally from the guide structure; The medical device of claim 1 , comprising:

3. The medical device of claim 2 , wherein the guide structure is secured to an intervening structure between the guide structure and the distal end of the delivery system.

4. The medical device of claim 3 , wherein the elongate tool guide moves from the deployed configuration to the operative configuration in response to a tool being distally extended through the elongate tool guide.

5. The elongated tool guide comprises: a guide structure pivotally mounted relative to an intervening structure between the guide structure and the distal end of the delivery system; a polymeric tubular member attached to and extending proximally from the guide structure, the guide structure and the polymeric tubular member together defining a lumen; 5. The medical device of claim 1, further comprising: a pivot structure projecting into the lumen for contact by a tool extending distally through the elongate tool guide, wherein further distal biasing of the tool causes the tool to interact with the pivot structure to pivot the guide structure relative to the distal assembly, thereby moving the elongate tool guide from a deployed configuration to an operative configuration.

6. The elongated tool guide comprises: an elongate structure defining at least a first lumen and a second lumen; the first lumen for accommodating a tool extending therethrough; a metal ribbon extending through the second lumen and movable between a straight linear configuration and a curved memory configuration; The medical device of any one of claims 1 to 4, wherein when the metal ribbon is straight, the elongated structure is straight, and when the metal ribbon is curved, the elongated structure is curved.

7. The elongated tool guide comprises: an elongate structure defining at least a first lumen and a second lumen; the first lumen configured to accommodate a tool extending therethrough; an elongate bistable member extending through the second lumen, the elongate bistable member being movable between a stable configuration in which the elongate bistable member is straight and an unstable configuration in which the metal ribbon is curved; A medical device according to any one of claims 1 to 4, wherein when the bistable metal element is linear, the elongated structure is linear, and when the bistable metal element is curved, the elongated structure is curved.

8. The elongated tool guide comprises: a plurality of conduit segments connected by living hinges formed between adjacent conduit segments, each conduit segment of the plurality of conduit segments including at least one control opening extending therethrough; at least one control cable extending through each control opening of the at least one control opening of each conduit segment; The medical device of any one of claims 1 to 4, wherein application of an axially acting force to the at least one control cable moves the elongate tool guide between a deployed configuration and an operative configuration.

9. 9. The medical device of claim 1, further comprising a distal assembly secured to a distal end of the delivery system, the elongated tool guide being securable relative to the distal assembly, and the distal assembly configured to house a suturing device.

10. The suturing device comprises: a suture moving assembly axially movable within the lumen of the delivery system; a guide member allowing the suture moving assembly to extend therethrough; The medical device of claim 9 , comprising:

11. The suture moving assembly includes: a needle that can be used to hold a suture; a distal shuttle to removably mount the needle; a user interface extending proximally from the distal shuttle to allow for removably attaching the needle; 11. The medical device of claim 10, wherein the suturing device further comprises an end cap configured to releasably engage and disengage the needle, the end cap engaging the needle as the needle advances distally into the end cap and locking the needle to the distal shuttle to release the needle as the distal shuttle is withdrawn proximally.

12. The end cap is a proximal needle opening that receives the needle as it advances distally into the end cap, the proximal needle opening being aligned with a longitudinal axis of the needle; one or more fastener openings positioned perpendicular to the proximal needle opening; one or more fasteners disposed within the fastener opening for releasably engaging a distal detent of the needle; The medical device of claim 11 , comprising:

13. 1. A medical device for use in combination with an endoscope having a working channel and a distal end, comprising: a distal assembly fixed relative to the endoscope; an elongate tool guide having a distal end disposed on the distal assembly and movable between a deployed configuration generally parallel to the distal assembly and an operational configuration curved away from the distal assembly; 2. A medical device comprising:

14. The elongated tool guide comprises: a guide structure secured to the distal assembly; a polymeric tubular member secured to and extending proximally from the guide structure; The medical device of claim 13 , comprising:

15. The medical device of claim 14 , wherein the elongate tool guide moves from the deployed configuration to the operative configuration in response to distal extension of a tool through the elongate tool guide.

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