Suturing devices and related systems and methods

Abstract

Implementations of a suturing device related methods are provided. The suturing device includes a housing that defines an arcuate needle track having a first end and a second end and a gap between the first end and second end of the arcuate needle track. The suturing device further includes a drive system to advance an arcuate needle along the arcuate needle track that includes a drive member operably coupled to an elongate flexible member. The elongate flexible member can reciprocate over at least one bearing surface that directs the elongate flexible member from a first path laying in a first plane that is parallel to a centerline of the arcuate needle track to a second path laying in a second plane different from the first plane.

Description

[0001] U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 SUTURING DEVICES AND RELATED SYSTEMS AND METHODS CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present patent application claims the benefit of priority to U.S. Provisional Patent Application No.63 / 515,416 filed July 25, 2023, and U.S. Provisional Patent Application No. 63 / 653,084, filed May 29, 2024. Each of the foregoing patent applications is incorporated by reference herein in its entirety for all purposes. TECHNICAL FIELD

[0002] Aspects of the present disclosure relate to devices, systems, and methods for performing a suturing procedure. For example, aspects of the present disclosure relate to suturing devices in support of remote surgical, diagnostic, therapeutic, and other treatment procedures. Further aspects of the disclosure relate to methods of operating such devices. INTRODUCTION

[0003] Sutures are used in a variety of surgical and other applications, such as closing ruptured or incised tissue, soft tissue attachment, attachment of grafts, etc. Additionally, sutures may have other medical and / or non-medical uses. Conventionally, suturing is accomplished by penetrating tissue with the sharpened tip of a suturing needle that has a thread of suturing material attached to the opposite blunt end of the needle. The needle is then pulled through the tissue, causing the attached thread of suturing material to follow the path of the needle. Typically, a knot is tied at the trailing end of the thread to anchor the first stitch. This action is performed repetitively with application of U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 tension to the needle to pull a length of the thread through the tissue using subsequent stitches until the tissue is sutured as desired with one or more stitches.

[0004] While the above-described suturing process can be performed manually, automated suturing systems also exist. Such systems can include a needle driver device that has an open, C-shaped portion into which tissue segments are introduced. The C- shaped portion defines two arms, each with an entry / exit point for a curved needle. The curved needle is driven around a track (generally following the C-shaped portion) and across the opening in the C-shaped portion to draw a thread of suturing material into the needle driver device through the tissue segments, similar to the manual suturing process discussed above. It is desirable to provide needle driver devices that occupy a minimal amount of space relative to a size (e.g., gauge and / or radius) of the needle. Such tools are useful in space-limited applications, such as in the case of minimally invasive surgery, for example laparoscopic surgery including both manual and computer-assisted surgery. SUMMARY

[0005] Example embodiments of the present disclosure may solve one or more of the above-mentioned problems and / or may demonstrate one or more of the above- mentioned desirable features. Other features and / or advantages may become apparent from the description that follows.

[0006] In accordance with some aspects of the present disclosure, a suturing device is provided. The suturing device includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end. The U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 housing further defines a gap between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The suturing device further includes a drive system that includes a drive member operably coupled to an elongate flexible member to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The elongate flexible member can reciprocate over at least one bearing surface proximate a distal end of the housing. The at least one bearing surface can direct the elongate flexible member from a first path laying in a first plane to a second path laying in a second plane different from the first plane, wherein the first path and second path overlap when viewed along a direction normal to the first plane.

[0007] In accordance with a further aspect, the elongate flexible member can reciprocate over at least one bearing surface proximate a distal end of the housing. The at least one bearing surface can direct the elongate flexible member from a first path laying in a first plane that is parallel to a centerline of the arcuate needle track to a second path laying in a second plane different from the first plane.

[0008] In accordance with further aspects of the disclosure, the elongate flexible member can include a cable or a band, for example. The arcuate pathway can be parallel to a path traversed by the arcuate needle along at least a portion of the arcuate pathway. In some implementations, the first plane and second plane can be parallel. In other implementations, the first plane and second plane are not parallel. In some implementations, the first path and second path can overlap when viewed along a direction normal to the first plane. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0009] In some implementations, the at least one bearing surface can include a boss defined by a curved plane that is oriented obliquely with respect to the first plane. The at least one bearing surface can include at least one pulley that reciprocates about an axis of rotation. The axis of rotation can be oriented obliquely with respect to the first plane.

[0010] In accordance with further aspects of the disclosure, the housing of the suturing device can terminate distally in a first parallel arm and a second parallel arm that cooperate to at least partially define the gap. The at least one bearing surface can include a first pulley proximate a distal end of the first parallel arm and a second pulley proximate a distal end of the second parallel arm. The first pulley and the second pulley can redirect the path of travel of the elongate flexible member from the first plane into the second plane. In some implementations, the first pulley can reciprocate about a first rotational axis and the second pulley can reciprocate about a second rotational axis, wherein the first rotational axis is oriented obliquely with respect to the second rotational axis. Moreover, one or both of the first rotational axis and the second rotational axis can each be oriented obliquely with respect to the first plane and the second plane.

[0011] In accordance with further aspects of the disclosure, the elongate flexible member can traverse the arcuate pathway in the first plane that at least partially surrounds the gap. A first elongate flexible member portion can then extend distally along the first parallel arm, around the first pulley, and back along a proximal direction. A second elongate flexible member portion can extend distally along the second parallel arm, around the second pulley, and back along a proximal direction. In some implementations, U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 the first elongate flexible member portion can extend proximally to a third pulley rotatably coupled to the housing, and after passing over the third pulley the first elongate flexible member portion can pass into a first conduit that extends proximally along the suturing device. The second elongate flexible member portion can extend proximally to a fourth pulley rotatably coupled to the housing, and after passing over the fourth pulley the second elongate flexible member portion can pass into a second conduit that extends proximally along the suturing device.

[0012] In some implementations, the third pulley can reciprocate about a third rotational axis and the fourth pulley can reciprocate about a fourth rotational axis. Third rotational axis can be oriented obliquely with respect to the fourth rotational axis. In some implementations, the first conduit can include an inner tubular member that contacts the first elongate flexible member portion, and an outer tubular member that surrounds the inner tubular member. The outer tubular member can be under a compressive axial load in order to maintain tension in the first elongate flexible member portion during operation of the suturing device.

[0013] In accordance with further aspects of the disclosure, the suturing device can further include a first actuator operably coupled to the first elongate flexible member portion, wherein applying tension to the first actuator applies tension to the first elongate flexible member portion. The first actuator can be configured to be manually operated. Alternatively, the first actuator can be configured to be coupled to an automated surgical device such as a motorized actuator handle, or a surgical robot. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0014] In some implementations, the suturing device can further include a flexible sleeve surrounding the first conduit, wherein the flexible sleeve has a proximal end and a distal end. The proximal end of the flexible sleeve can be dimensioned to be advanced over a distal end portion of an endoscope, the first conduit and the second conduit. If desired, the distal end of the flexible sleeve can be coupled to the housing or be configured to be coupled to the housing. A proximal portion of the housing can define a coupling to removably attach to the distal end of the endoscope. If desired, the flexible sleeve can further include a tensioner or tension member to apply radial inward tension to the flexible sleeve to removably couple the flexible sleeve to the endoscope. The tensioner can include at least one tensioning cable that at least partially circumferentially traverses the sleeve. Applying tension to the tensioner can cause the flexible sleeve to grasp the endoscope, first conduit and second conduit in at least two axially spaced locations along the flexible sleeve. The flexible sleeve can be integrally formed with the outer tubular member of the first conduit.

[0015] In further accordance with the disclosure, the suturing device can further include a coupling to receive and couple to a distal end of an endoscope or catheter. The housing can define a deflection surface formed thereon to alter the direction of a tool as the tool is being advanced distally through the distal end of the endoscope or catheter. The deflection surface can redirect a distal portion of the tool toward the gap in the housing. The tool can include an instrumentality to engage tissue, and / or other catheter- based tools such as a cinch or lock to be directed over the suture once a suturing operation is completed. The tool is configured to grasp tissue with the instrumentality to U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 permit the tool to be pulled proximally to pull the tissue into the gap into a pathway of the arcuate needle as the needle passes across the gap. If desired, the deflection surface can be formed on a surface of a removable needle cover that is coupled to the suturing device.

[0016] In still further accordance with the disclosure, the suturing device can further include a needle track cover removably disposed on the housing. If desired, the needle track cover can be removed from the housing by advancing the needle track cover distally off the housing. Alternatively, the needle track cover can be removed from the housing by advancing the needle track cover upwardly from the housing along a direction that is orthogonal to the first plane. In some implementations, the suturing device can still further include a compressed member that urges the needle track cover off of the housing when the compressed member is in an unconstrained condition. If desired, the suturing device can further include a frangible coupling that counteracts force applied by the compressed member to hold the needle track cover in place, and a frangible coupling actuator operably coupled to the frangible coupling. Actuating the frangible coupling actuator can rupture the frangible coupling to permit the compressed member to eject the needle track cover from the housing.

[0017] In further accordance with the disclosure, the suturing device can further include at least one brake, such as a braking pawl disposed in the housing. The at least one brake extends into the arcuate needle track to engage a surface of an arcuate needle disposed in the arcuate needle track to prevent the arcuate needle from traveling along a second direction opposite to the first direction when the arcuate needle is disposed at a U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 first predetermined location along the arcuate needle track. The at least one brake can include a plurality of brakes disposed in the housing. The plurality of brakes can be spaced apart along a length of the arcuate needle track. The plurality of brakes can be disposed at least partially inside of a circular pathway defined by travel of the arcuate needle along the arcuate needle track. The at least one brake can prevent movement of the arcuate needle along the second direction while the drive member moves along the second direction to engage the arcuate needle.

[0018] The arcuate needle can be advanced from a first location to a second location along the arcuate needle track along the first direction as the drive member is advanced from the starting position to the ending position. The arcuate needle can be advanced along the first direction 360 degrees around the arcuate needle track after the drive member is advanced through a plurality of drive strokes, such as two or three drive strokes. For example, in a needle starting position, the arcuate needle can reside within the arcuate needle track and not extend into the gap in the housing. The at least one brake can engage a first needle surface when the arcuate needle is in the needle starting position to prevent the arcuate needle from traveling in the second direction. After a first drive stroke by the drive member, the arcuate needle can be advanced from the needle starting position to a second position wherein the at least one brake engages a second needle surface different from the first needle surface to prevent the arcuate needle from traveling in the second direction. The drive member can engage the arcuate needle at a first location during the first drive stroke. If desired, the second needle surface can include a trailing end of the arcuate needle. The first needle location can include a surface of an U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 indentation formed into the arcuate needle. During a second drive stroke, the drive member can engage a second needle location different from the first needle location, and the drive member can advance the arcuate needle along the arcuate needle track to a location wherein a second brake engages the arcuate needle to prevent the arcuate needle from traveling in the second direction. The second needle location can include a trailing end of the arcuate needle. During a third drive stroke, the drive member can engage a third needle location different from the first needle location and second needle location, and the drive member can advance the arcuate needle along the arcuate needle track to the needle starting location.

[0019] The disclosure further provides needles having particular aspects. In some implementations, an arcuate needle is provided having a leading end, a trailing end, and an arcuately shaped body. The arcuately shaped body can define a plurality of indentations therein. First, second and third radial inward indentations can be formed into a radially inward face of the arcuate needle. Two of said first, second and third indentations can be antipodal, and the third of said first, second, and third indentations can be located proximate one of the antipodal indentations.

[0020] In further implementations, the disclosure provides an arcuate needle having a leading end, a trailing end, and an arcuately shaped body. The arcuately shaped body can have a “D” shaped cross section along its length, wherein a flat side of said cross section can be located on an upper face of the arcuate needle. Said upper face can be parallel to a plane defined by a centerline of the arcuate needle along the length of the arcuate needle. The arcuate needle can further define at least one indentation formed U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 into a lower arcuately shaped face of said arcuate needle that is opposite the flat side of said cross section.

[0021] In accordance with further aspects of the disclosure, the suturing device can further include a movable shuttle operably coupled to the drive member and the elongate flexible member. The shuttle can include a compressible body therein that urges the drive member (such as a pawl, pin, protrusion, belt tooth or the like) into contact with the arcuate needle. The housing can include a proximal portion to be coupled to a distal end of an endoscope or catheter body, and a distal portion that includes the arcuate needle track. The proximal portion of the housing and the distal portion of the housing can be configured to align a centerline of the endoscope or catheter body toward the gap in the housing. The proximal portion of the housing and the distal portion of the housing can be pivotally coupled.

[0022] In further accordance with the disclosure, a suturing device is provided that includes a housing defining an arcuate needle track. The arcuate needle track has a first end and a second end, wherein the housing further defines a gap defined between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured. The suturing device further includes a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, and an elongate body having a tissue anchor at a distal end thereof. The elongate body can be advanced toward and beyond the gap to grasp tissue and retract tissue into the gap to be sutured by the suturing device. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0023] The disclosure further provides implementations of methods of performing a suturing procedure. An illustrative method includes providing a suturing device as set forth elsewhere herein, deploying an elongate tool with an anchor distally to a target region of tissue, anchoring the anchor into the target region of tissue, retracting the elongate body to pull tissue into the gap into a path of travel of the arcuate needle, and actuating a drive system to advance the arcuate needle through the tissue.

[0024] The disclosure further provides a suturing device that includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end, wherein the housing further defines a gap defined between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The device further includes a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The drive system includes a drive member operably coupled to an elongate flexible member. The drive system can be configured to reciprocate the drive member along an arcuate pathway, such as from a starting position to an ending position during a drive stroke. The device can include at least one pulley rotatably disposed in the housing, wherein the at least one pulley rotates about an axis that is oriented obliquely with respect to a plane defined by a centerline of the arcuate needle.

[0025] The disclosure further provides a suturing device that includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end, wherein the housing further defines a gap defined between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 sample therein to be sutured. The device further includes a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The drive system includes a drive member operably coupled to an elongate flexible member. The drive system can be configured to reciprocate the drive member along an arcuate pathway, such as from a starting position to an ending position during a drive stroke. The device can further include a conduit that extends proximally along the suturing device, wherein the elongate flexible member passes through the conduit toward a proximal end of the suturing device, wherein the conduit is configured to absorb an axial load in order to maintain tension in the elongate flexible member during operation of the suturing device.

[0026] The disclosure further provides a suturing device that includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end, wherein the housing further defines a gap defined between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The device further includes a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The drive system includes a drive member operably coupled to an elongate flexible member. The drive system can be configured to reciprocate the drive member along an arcuate pathway, such as from a starting position to an ending position during a drive stroke. The device can further include a needle track cover that traverses and covers at least a portion of the arcuate needle track, wherein the needle track cover is configured U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 to be ejected from the suturing device to permit the needle to be removed from the needle track.

[0027] The disclosure further provides a suturing device that includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end, wherein the housing further defines a gap defined between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The device further includes a drive member to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The drive system includes a drive member operably coupled to an elongate flexible member. The drive system can be configured to reciprocate the drive member along an arcuate pathway from a starting position to an ending position during a drive stroke. The suturing device can further include a deployable instrument configured to be deployed in a distal direction beyond a distal end of the housing, and a deflection surface to alter a trajectory of the deployable instrument as the deployable instrument is being deployed distally.

[0028] The disclosure further provides a suturing device that includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end, wherein the housing further defines a gap defined between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The device further includes a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The drive system includes a drive member operably coupled to an elongate flexible U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 member. The drive system can be configured to reciprocate the drive member along an arcuate pathway, such as from a starting position to an ending position during a drive stroke. The device can further include a plurality of brakes, such as brake pawls, clips, pins, protrusions or the like extending into the arcuate needle track to prevent the needle from moving in a second direction opposite to the first direction, wherein the arcuate needle is advanced along the first direction 360 degrees around the arcuate needle track after the drive member is advanced through a plurality of (e.g., two or three) drive strokes.

[0029] The disclosure further provides implementations of a suturing device that includes a housing. The housing defines an arcuate needle track. The arcuate needle track has a first end and a second end. The housing further defines a gap between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The suturing device further includes a drive system that includes an actuator having a first trigger, and a drive member operably coupled to an elongate flexible member to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The first trigger is operably coupled to a first end of the elongate flexible member, and the elongate flexible member is configured to reciprocate over at least one bearing surface proximate a distal end of the housing. The at least one bearing surface can be configured to direct the elongate flexible member from a first path laying in a first plane to a second path laying in a second plane different from the first plane. The first path and second path overlap when viewed along a direction normal to the first plane. In some implementations, applying tension to the first trigger applies tension to the elongate flexible member in a first direction. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0030] In accordance with further aspects of the disclosure, the actuator can be configured to be manually operated. In some implementations, the actuator can be configured to be coupled to an automated surgical device. In further implementations, the actuator can be configured to be coupled to an automated surgical device and to be manually operated.

[0031] In some implementations, the suturing device can further include a needle track cover removably disposed on the housing, and if desired, also include a compressed member, such as a spring on the like, that urges the needle track cover off of the housing when in an unconstrained condition. The suturing device can further include a frangible coupling that counteracts force applied by the compressed member to hold the needle track cover in place. The suturing device can still further include an actuator operably coupled to the frangible coupling, wherein actuating the actuator ruptures the frangible coupling to permit the compressed member to eject the needle track cover from the housing. If desired, the suturing device can further include a pull cable or filament operably coupling the frangible coupling actuator to the frangible coupling.

[0032] In some implementations, the suturing device can further include a second trigger operably coupled to a second end of the elongate flexible member, wherein applying tension to the second actuator applies tension to the elongate flexible member in a second direction. The suturing device can further include an inner tubular member directly contacting the elongate flexible member, and an outer tubular member that surrounds the inner tubular member. The suturing device can further include a proximal clamping assembly configured to receive the first end of the elongate flexible member, a U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 first end of the inner tubular member, and a first end of the outer tubular member, wherein the first end of the elongate flexible member extends through the proximal clamping assembly.

[0033] In some implementations, the suturing device can further include a trigger spool received into a lateral opening in the first trigger. At least one groove can be defined in the trigger spool that is configured to hold the first end of the elongate flexible member therein. A retainer can be provided that extends over the trigger spool to hold the first end of the elongate flexible member thereon. If desired, the first trigger can be spring biased. If desired, the first trigger can be slidably coupled to the housing. If desired, the first trigger can be rotatably coupled to the housing. In some implementations, the first trigger can be rotatably coupled to at least one force- or movement-multiplying gearing between the first trigger and the first end of the elongate flexible member. In some implementations, at least one ratchet-and-pawl or a detent mechanism can be provided that extends between the housing and the first trigger to hold the first trigger in place. The suturing device can further include at least one tactile, colored, symbolic, or alphanumeric indicator on the housing or connected to the housing indicating at least one of needle position or stroke count. In some implementations, at least one electronic or mechanical stroke counter can be provided or formed on the housing.

[0034] In some implementations, an actuator handle for a cable-driven tool is provided. The actuator handle can include a first trigger operably coupled to a housing and to a first end of an elongate flexible member, wherein applying tension to the first trigger applies tension to the elongate flexible member in a first direction, and a second U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 trigger operably coupled to a second end of the elongate flexible member. Applying tension to the second actuator can cause tension to be applied to the elongate flexible member in a second direction.

[0035] In some implementations, the actuator can be configured to be manually operated. If desired, the actuator can be configured to be coupled to an automated actuation device. The actuator can be configured to be coupled to an automated actuation device and to be manually operated. The actuator handle can further include an inner tubular member directly contacting the elongate flexible member, and an outer tubular member that surrounds the inner tubular member. In some implementations, the actuator handle can further include a proximal clamping assembly configured to receive the first end of the elongate flexible member, a first end of the inner tubular member, and a first end of the outer tubular member. The first end of the elongate flexible member can extend through the proximal clamping assembly.

[0036] In further implementations, the actuator handle can further include a trigger spool received into a lateral opening in the first trigger. At least one groove or indentation can be defined in the trigger spool holding the first end of the elongate flexible member therein. A retainer can be provided that extends over the trigger spool to hold the first end of the elongate flexible member thereon. The first trigger is spring biased, and / or can be slidably or rotatably coupled to the housing. The first trigger can be rotatably coupled to at least one force- or movement-multiplying gearing between the first trigger and the first end of the elongate flexible member. If desired, the actuator handle can further include at least one ratchet-and-pawl or a detent mechanism extending between the housing and U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 the first trigger to hold the first trigger in place. The actuator handle can further include at least one tactile, colored, symbolic, or alphanumeric indicator on the housing or connected to the housing indicating at least one of needle position or stroke count. If desired, the actuator handle can further include at least one electronic or mechanical stroke counter on the housing.

[0037] In further implementations, the disclosure provides a suturing device that includes a housing. The housing defines an arcuate needle track having a first end and a second end. The housing further defines a gap between the first end and second end of the arcuate needle track. The gap is configured to receive a tissue sample therein to be sutured. The suturing device further includes a drive to advance an arcuate needle about the arcuate needle track and across the gap along a first direction. The drive includes a drive member operably coupled to an elongate flexible member. The drive is configured to reciprocate the drive member along an arcuate pathway. The suturing device further includes a retainer extending in a proximal direction from the housing. The retainer is configured to receive a distal end portion of an endoscope therein. The retainer is configured to hold the housing in place on the endoscope in a predetermined axial and rotational orientation.

[0038] In some implementations, the retainer can include a deformable clip configured to grip the distal end portion of the endoscope. The retainer can include a guide sleeve configured to be received by an axial passage of the endoscope. The guide sleeve can be eccentrically exposed within a passageway defined by the retainer. The guide sleeve can be axially aligned with and laterally offset with respect to a central axis U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 of a passageway defined by the retainer. The guide sleeve can include an axial slit along a length thereof to permit the sleeve to be deflected laterally inwardly. The guide sleeve can extend proximally from a radially inwardly extending boss. The guide sleeve can be operably coupled to a proximally facing surface configured to contact a distal face of the endoscope.

[0039] In some implementations, the retainer can be defined by a deformable sleeve configured to slidably receive the distal end portion of the endoscope therein. The deformable sleeve can define an axial slit along its length configured to be deformed radially outwardly to receive the distal end portion of the endoscope therein. The deformable sleeve can include a proximal band configured to be clamped around the distal end portion of the endoscope by tightening a fastener coupling the proximal band to the housing of the suturing device. The deformable sleeve can include a distal portion including an alignment boss for engaging with a passageway defined in the distal end portion of the endoscope. The proximal band can be separated from the distal portion by a transverse lateral gap. The transverse lateral gap can have circumferential extent in excess of ninety degrees, for example.

[0040] Additional objects, features, and / or advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure and / or claims. At least some of these objects and advantages may be realized and attained by the elements and combinations particularly pointed out in the appended claims. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0041] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory only and are not restrictive of the claims; rather the claims should be entitled to their full breadth of scope, including equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The present disclosure can be understood from the following detailed description, either alone or together with the accompanying drawings. The drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate one or more embodiments of the present teachings and together with the description explain certain principles and operation. In the drawings,

[0043] FIG. 1 depicts an isometric view of a suturing device in accordance with some embodiments of the present disclosure coupled to a distal end portion of an endoscope, or aspects thereof.

[0044] FIGS.2-5 depict various isometric views of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0045] FIG. 6 depicts a transparent isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0046] FIG.7A depicts a partial isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0047] FIG.7B depicts a distal view of the device of FIG.1, or aspects thereof. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0048] FIGS. 8-12C depict isometric views of a removable cover portion for a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0049] FIG.13 depicts an isometric top view of a suturing device in accordance with some embodiments of the present disclosure and illustrative brakes, or aspects thereof.

[0050] FIGS. 14-20 depict isometric bottom views of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0051] FIGS. 21-29 depict isometric bottom views of a suturing device in accordance with some embodiments of the present disclosure illustrating elongate flexible member pathways, or aspects thereof.

[0052] FIGS.30-39 depict isometric views of a suturing device in accordance with some embodiments of the present disclosure illustrating aspects of a shuttle of the drive system, or aspects thereof.

[0053] FIGS. 40-41 depict partial upper and lower isometric views of a housing component for a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0054] FIGS. 42A-42B depict isometric views of tension member routing and management components for a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0055] FIGS. 43-46 depict isometric views of an arcuate needle for a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0056] FIGS. 47-53 depict views of steps for operation a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0057] FIGS.54-64 depict views of steps for operation a further suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0058] FIG.65A depicts a distal isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0059] FIG.65B depicts a field of view from a camera disposed in a distal end of an endoscope coupled to a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0060] FIG.66 depicts an isometric view of a suturing device in accordance with some embodiments of the present disclosure in combination with a tissue capture tool to facilitate suturing, or aspects thereof.

[0061] FIGS.67A-67D depict a front right side isometric view, a right side isometric view, a front left side isometric view, and a partial rear left isometric view of a variation of a suturing device in accordance with some embodiment of the disclosure that includes an alignment sleeve to facilitate receipt of a distal end of an endoscope into the suturing device. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0062] FIGS.68A-81 depict isometric views of a proximal actuator mechanism for operating a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0063] FIG. 82 is a schematic diagram for a robotically-assisted manipulator system, according to some examples.

[0064] FIG. 83A is a schematic diagram of an instrument system according to examples described herein.

[0065] FIG.83B illustrates a distal portion of the instrument system of FIG. 82A with an extended example of an instrument according to examples described herein. DETAILED DESCRIPTION

[0066] The present disclosure provides various embodiments of suturing devices, systems, and methods. Suturing devices according to various embodiments of the present disclosure include features that facilitate suturing operations, particularly in endoscopic procedures.

[0067] In accordance with some aspects of the present disclosure, a suturing device is provided. The suturing device includes a housing that defines an arcuate needle track.

[0068] For purposes of illustration, and not limitation, a representative implementation of a suturing device is presented in FIGS. 1-7B. A directional axis is depicted indicating proximal and distal directions with reference to device 100. The depicted directional axis applied in kind to the other figures in the present disclosure. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0069] The suturing device 100 of FIG.1 includes a housing 110 that defines an arcuate needle track 120. The arcuate needle track 120 has a first end 122 and a second end 124. The housing 110 further defines a gap 112 between the first end 122 and second end 124 of the arcuate needle track 120. The gap 112 is configured to receive a tissue sample therein to be sutured, discussed in further detail below. The suturing device 100 further includes a drive system 130 to advance an arcuate needle 200 about the arcuate needle track 120 and across the gap 112 along a first direction A as indicated by an arrow. FIG. 1 presents an isometric upper view of the suturing device 100. Not pictured but forming a part of the suturing device include cable sheaths 174 containing inner sleeves 172 (FIGS.42A-42B) to route tension cables to one or more proximally located actuators 180, such as hand actuated devices (FIGS.68A-81) or an automated or robotic surgical system (FIGS. 82-83B), discussed below. The return side of the member 150 can be spring loaded such that only one direction of shuttle movement needs to be actively actuated, and upon releasing tension on that side the shuttle 140 can be pulled back into its starting position due to a persistent spring force pulling on the return side of the member 150.

[0070] Endoscope 300 can be a standard endoscope that is removably received by a retainer of the suturing device 100 such as a split clamping sleeve 119 formed at a proximal end of the suturing device. The proximal section of the housing 110 and the distal portion of the housing 110 containing the needle track 120 can be integrally formed in a manner that the bore of the sleeve is oriented obliquely with respect to a plane defined by a centerline of the needle 200 when it is situated in the needle track 120. A needle U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 drive system 130, discussed in further detail below, provides functionality to effect movement of the needle about the needle track 120 to advance the needle 200 through tissue to be sutured that is present within the gap 112. FIG.3 presents a further isometric view underneath the suturing device 100 illustrating relative placement of a cable routing system that includes inner and outer sleeves 172 and 174 respectively for each length of cable. In certain embodiments, inner sleeve 172 is a polytetrafluoroethylene (PTFE) tube. In certain embodiments, outer sleeve 174 is a coil pipe or coil tube, which may be embedded in a polymer tube, allowing it to take compressive loads while remaining flexible.

[0071] FIG.4 presents a further isometric upper view of the suturing device 100. From this angle, the first end 122 of the needle track 120 is visible. An upper surface 162 of a removable cover 160 that covers the needle track 120 is also apparent. The cover 160 is discussed below with reference to FIGS.8-12. FIG.5 presents an enlarged upper isometric view of the suturing device 100. FIG. 6 presents a transparent view of the suturing device revealing the relative locations of internal components including pulleys, elongate flexible members / cables and the like. FIG. 7A depicts a view of the suturing device 100 with the needle 200 removed. FIG. 7B presents a plan distal view of the suturing device 100 with the endoscope 300 disposed therein. As can be observed in this distal plan view, the device distally projects a shape of a circle, or nearly so. The manner in which the elongate flexible member or cable 150 is routed about pulleys 134A, 134B, 136A, 136B help reduce the profile of the device to provide a correspondingly larger tissue gap 112 and needle track to capture and suture tissue. The depicted device 100 is U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 configured so that a significant portion of device 100 aligns with the axial “shadow” or projection of the endoscope, reducing the effective insertion diameter of the device and endoscope assembly compared to if the device were extending in a direction orthogonal to the endoscope axis well beyond the outer diameter of the endoscope.

[0072] FIGS. 8-9 and 11-12C illustrate various views of a first representative implementation of a needle track cover 160 in accordance with the present disclosure. FIG.10 depicts a further implementation of a needle track cover 160’ in accordance with the present disclosure. As depicted, the cover 160, 160’ includes an upper arcuately shaped plate 162 that is joined about a “U” shaped inner periphery to a downwardly depending wall formed from an arcuate segment 164 that extends distally into two straight wall sections 166A, 166B that extend to a distal end face of the housing 110 when the cover 160, 160’ is installed in the housing 110. Optional tabs 165A, 165B are illustrated for providing a location for boreholes to accommodate a threaded fastener. It will be appreciated that such tabs and fasteners are optional and that the cover can be configured to snap fit into place and the like.

[0073] Wall 166B defines therein an opening 163B that aligns with the first end 122 of the needle track 120. Wall 166A defines therein a second opening 163A that aligns with the second end 124 of the needle track 120. With reference to FIGS.11 and 12B, it will be noted that the opening 163B, where the needle enters the needle track at location 122, is defined in part by a ramped surface or boss 163C that extends into the tissue gap 112. As depicted, the boss 163C has a trapezoidal cross section, and the opening 163B U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 is actually defined in the angled surface 163D that is either slightly oblique or orthogonal to the direction of travel of the needle.

[0074] The boss 163C and angled surface 163D can help to keep tissue stable during the period when the needle 200 is pushing through tissue. By reducing how much the tissue can slide along the bearing surface, a counter-traction can be generated on the tissue such that it will be less likely to fold into the needle entry port ahead of the needle, and thus makes it more likely that the needle will cleanly penetrate the tissue. In FIGS. 11-12B, the surface 164D has been angled to be perpendicular to the tangent of the needle path as the needle enters the housing 110. This provides a more stable surface for the tissue to bear against, and reduces likelihood of tissue layers sliding as bearing forces are generated by the advancing needle.

[0075] Additionally, the boss 163C defines additional surfaces to increase the amount of friction tissue generates to further reducing the likelihood of tissue sliding into the needle track 120. For example, a chamfered surface 163E is defined around the periphery of the opening 163B. The inner perimeter of the opening of 163B is surrounded by a crescent-shaped raised ridge 163F that then in turn defines a crescent shaped valley 163G behind it, in cooperation with chamfered surface 163E. This creates a raised sharp ridge and valley around the needle entry port. The height of the ridge and valley, the sharpness of the top of the ridge, and the number of ridges and valleys can be varied to achieved desired performance.

[0076] FIG.12C depicts a further implementation of a needle track entry area that can create similar counter traction in tissue. A plurality of projections 163H that may be U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 sharp can extend outwardly from a location near the needle track entrance which bite into tissue and keep it from sliding along the bearing surface and into the needle track. For example, small depressions or holes 163I can be formed in the surfaces surrounding the needle entry port to permit the installation of very small wires or filaments which project out and pierce the bearing tissue. The exposed length of these projections can be on the order of 0.1 to 1mm, or any increment therebetween of about .05 mm, such that they do not cause excess trauma to tissue, sufficiently penetrate the tissue to provide a traction surface. The diameter, exposed length, sharpness, projection angle, and placement in the array of these wires can be varied as desired to achieve a desired result with different types of tissue.

[0077] With reference to FIG.10, cover 160’ further includes a lower lip that passes over lower housing portions 117A, 117B. Removal of cover 160’ from the housing 110 therefore includes sliding the cover 160’ distally off of the housing. Alternatively, the needle track cover 160 can be removed from the housing 110 by advancing the needle track cover 160 upwardly from the housing 110 along a direction that is orthogonal to a plane defined by a centerline defined along the suturing needle 200. In some implementations, the suturing device can still further include a compressed member (not shown) such as a compressive coil spring or a leaf spring or an elastomer spring disposed in a bore in an upper face of the housing 110 underneath the needle track cover 160 that urges the needle track cover off of the housing 110 when the compressed member is in an unconstrained condition. Moreover, the spring can be formed as a leaf spring integrally with an underside of the cover 160, if desired. Moreover, the suturing device 100 can U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 further include a frangible coupling (not shown) that counteracts force applied by the compressed member to hold the needle track cover 160 in place, and a frangible coupling actuator (not shown) operably coupled to the frangible coupling, although a suitable actuator can be provided in accordance with the discussion relating to FIGS. 82-83B. Actuating the frangible coupling actuator can rupture the frangible coupling to permit the compressed member to eject the needle track cover 160 from the housing in an upward direction off of the needle track. With respect to the embodiment of FIG. 10, a similar mechanism can be provided to eject the needle track cover 160’ off the device in a distal direction. It can be desirable to remotely remove the needle track cover 160, 160’ during a medical procedure while the suturing device 100 is still inside the patient. For example, if the needle 200 should become jammed inside the device, the cover 160, 160’ can be ejected from outside the patient and the device 100 can be removed. Thereafter, if desired, the needle can be retrieved laparoscopically as well as the cover 160. In some implementations, the cover can have an emergency tether (not shown) that will permit the cover 160, 160’ to dangle from the housing 110 if it is ejected to facilitate removal of the needle 200 from the needle track 120, but still permit the cover 160, 160’ to be withdrawn with the device 110. In a further implementation, the cover 160, 160’ can be formed from bioresorbable material so that it need not be removed from the patient if ejected from the suturing device 100.

[0078] FIG.13 depicts an isometric top view of a suturing device in accordance with some embodiments of the present disclosure and illustrative brakes, such as braking pawls, or aspects thereof. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0079] For purposes of illustration only, FIG.13 illustrates housing 110 of device 100 with the cover 160 / 160’ removed from the needle track to fully expose the needle track 120. The housing 110 can be made from an injection molded material such as a polymer, or can be formed from metallic and / or polymeric material by way of additive manufacturing (e.g., 3D printing) techniques. Moreover, housing 110 can be formed via metal injection molding (“MIM”) techniques, or may be machined in part from a solid material. FIG 13 illustrates that the arcuate needle track 120 is generally “C” shaped and occupies slightly more than 270 degrees of a circle in extent. The needle track 120 is formed into an upper surface of the housing 110, and a raceway or shuttle track 120A is formed into a lower facing surface of the housing 110 (FIG.24). The needle track 120 and shuttle track are both arcuate and are separated by a separating wall 120C from each other that defines a flat plane on either side thereof that is parallel to a plane that is traced out by the point 202 of the needle 200 as the needle 200 traverses the needle track 120 when the device 100 is operated. The separating wall 120C also defines an arcuately shaped groove 120B formed therein that joins the volume of the arcuate cavity defined by the needle track 120 with the volume of the arcuate cavity defined by the shuttle track 120A. As further illustrated in FIG.13, a drive member 132, such as a drive pin, a drive pawl, or the like, extending from the shuttle 140 (discussed below) extends through the groove 120B from the shuttle track 120A into the needle track where the drive member 132 is configured to engage either of two drive notches 220, 222 in needle 200 or the trailing end 204 of the needle, 200, discussed in further detail below. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0080] FIG.13 also depicts the positions of brakes, such as brake pawls or brake clips 113, 115. As depicted, brake pawls 113, 115 are presented as “U” or “V” shaped members made from a resilient and spring-like material such as a metal or a stiff polymer. It will be appreciated that the brakes 113, 115 can likewise be protrusions extending from a floor of the needle track or downwardly from the cover 160 into the needle track. A brake may also be provided that protrudes into the needle track that is substantially the same as drive member 132 in any desired location along the needle track that pushes up into the needle or radially inwardly or outwardly into the needle 200. Each brake clip 113, 115 is received by a corresponding “V”-shaped cavity formed into the housing 110. The cavities are formed so as to orient one tip of each of the clips 113, 115 into the needle track along a direction that is oblique to the direction of travel of the needle such that each brake clip can engage the front wall of braking notches 214, 216, 218 formed into needle 200 (FIG.43). The housing 110 also includes a plurality of bores formed therein to receive a respective end of each of four axles that correspondingly support pulleys or wheels 134A, 134B and 136 A, 136B. The housing 110 is generally “U” shaped in a top plan view or bottom plan view to provide the structure needed to house the needle track 120 and tissue capture gap 112.

[0081] FIGS 14-29 illustrate further aspects of the drive system with related components shuttle and elongate flexible member.

[0082] For purposes of illustration, and not limitation, as embodied herein, FIG.14 illustrates a lower isometric view of suturing device 100. As depicted, the housing 110 of the suturing device can terminate distally in a first parallel arm 110a and a second parallel U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 arm 110b that cooperate to at least partially define the gap 112. Further illustrated are the second end 124 of needle track 120, and one end of the shuttle track or raceway 120A that is disposed parallel to the needle track as described elsewhere herein. Housing 110 as depicted includes two lower housing cover sections 117A, 117B. While cover sections 117A, 117B are depicted as being held in place by fasteners (e.g., 117C), the cover portions may be a single piece and may be attached to the housing 110 by any desired technique including fasteners, adhesive, welding and the like. Further illustrated are proximal drive elongate flexible member portions 156A, 156B that are routed to a proximal portion of the device (not shown) via cable sheath components (e.g., 172A, 174A).

[0083] FIG.15 highlights cover section 117B that is coupled to housing. FIGS.16A- 16B depict a first view of cover segment 117B depicted with its lower face showing as depicted in FIG.15. Also depicted is the upper face 117B5 of cover segment 117B that faces and mates to a lower surface of the housing 110. As depicted, the upper face 117B5 of cover segment 117B includes distal and proximal bores 117B1, 117B3 for receiving a fastener therethrough, if desired, as well as axle bore 117B2 that receives an off-axis axle therethrough for receiving pulley 134B (discussed below). An off-axis plane 117B4 is further molded or otherwise formed into cover segment 117B that is not parallel to upper face 117B5 of cover segment 117B. A channel 117B6 is further defined in the upper face 117B5 of cover segment 117B to receive elongate flexible member or cable segment 154B, discussed below.

[0084] FIG.17 depicts device 100 with cover portion 117B removed, revealing the routing of inner elongate flexible member or cable portion 152B that traverses a path that U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 can be parallel to the needle track 120 and shuttle track 120A along at least a portion of the length of cable portion 152B. Elongate flexible member or cable portion 152 continues distally to a location where it is directed around pulley 134B (not shown; see FIG.24), after which proximally directed portion 154B is directed toward pulley 136B. After passing over pulley 136B, portion 156B of elongate flexible member proceeds through a channel defined in the housing into a cable sheathing assembly, discussed in further detail below. Although obscured by cover portion 117A, pulley 136 A is partially visible from which extends elongate flexible member or cable segment 156A.

[0085] For purposes of further illustration, FIG. 18 highlights cover portion 117A which is illustrated in further detail in FIG. 19A-19B. FIG. 19B depicts the upper face 117A5 of cover segment 117A that faces and mates to a lower surface of the housing 110. As depicted, the upper face 117A5 of cover segment 117A includes distal and proximal bores 117A1, 117A3 for receiving a fastener therethrough, if desired, as well as axle bore 117A2 that receives an off-axis axle therethrough for receiving pulley 134A (discussed below). An off-axis plane 117A4 is further molded or otherwise formed into cover segment 117B that is not parallel to upper face 117A5 of cover segment 117A. A channel 117A6 is further defined in the upper face 117A5 of cover segment 117A to receive elongate flexible member or cable segment 154A, discussed below.

[0086] FIG. 20 depicts device 100 with cover portion 117A removed as well, revealing the routing of elongate flexible members or cable portions and their relative placements to the shuttle track 120A. As depicted, shuttle 140 is situated in arcuate shuttle track 120A, which is coupled to elongate flexible member or cable 150 at a center U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 portion thereof. Cable or elongate flexible member portions 152A, 152B traverse in a distal direction from the shuttle 140 along respective arcuate paths around gap 112 until wrapping around distal pulleys 134A, 134B (not shown), after which proximally directed portions 154A, 154B of cable are directed toward pulleys 136A, 136B. After passing over pulleys 136A, 136B, portions 156A, 156B of elongate flexible member or cable 150 proceed through a channels defined in the housing into cable sheathing assemblies.

[0087] The elongate flexible member 150 can include a cable or a band, for example. The present disclosure uses the terms elongate flexible member and cable somewhat interchangeably. However, the term elongate flexible member is meant to encompass any sort of tether, band, cable, or the like that can be used to move the shuttle 140. For example, the elongate flexible member can be made from metallic, polymeric, and / or composite material, and may include one or more coatings to enhance lubricity and operation, as desired. The physical structure of the elongate flexible member 150 may include a braided cable or tube, a woven tube of textile material, or a drawn wire of any suitable material. In some implementations, the elongate flexible member can include a band or a belt formed from one or more materials having any desired cross section, including rectangular, rounded, trapezoidal, oval, triangular, and the like.

[0088] One or more bearing surfaces can be provided in or on the housing to redirect the elongate flexible member along a predetermined path.

[0089] For purposes of illustration, and not limitation, the bearing surface includes a first pulley 134A proximate a distal end of the first parallel arm and a second pulley 134B proximate a distal end of the second parallel arm. Other mechanical components U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 can be used in lieu of pulleys, such as curved surfaces, bosses, or passageways formed into the housing having a lubricious or other low-friction coating, or lubricious lengths of tubing surrounding the elongate flexible member (e.g., 152, 154, 156) within the housing 110 at locations where the elongate flexible member (e.g., 150) changes direction, such as the locations where pulleys 134A, 134B, 136A, 136B are present. Such implementations can include materials such as fluoropolymers or other hydrophobic, or hydrophilic materials. For example, in some implementations, a cable can bear upon a fixed rod or pin, with that pin being at an angle not normal to the first plane, and allow the cable to be redirected the same way a pulley would redirect the cable but with a stationary element instead of a freely rotating one like a pulley.

[0090] As illustrated, the first pulley 134A and the second pulley 134B are configured to redirect the path of travel of the elongate flexible member 150 from a first plane, such as a plane parallel to wall 120C or elongate flexible member lengths 152A, 152B into a second plane, such as a plane containing both elongate flexible member lengths 154A, 154B. In some implementations, the aforementioned first plane and second plane can be parallel. In other implementations, the first plane and second plane are not parallel. In some implementations, the first path and second path can overlap when viewed along a direction normal to the first plane. This can be viewed in the plan views presented in FIGS.22-25.

[0091] In some implementations, the first pulley can reciprocate about a first rotational axis and the second pulley can reciprocate about a second rotational axis, wherein the first rotational axis is oriented obliquely with respect to the second rotational U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 axis. Moreover, one or both of the first rotational axis and the second rotational axis can each be oriented obliquely with respect to the first plane and the second plane.

[0092] For purposes of illustration, and not limitation, with continuing reference to FIG.20, pulley 134A rotates about an axle portion 134A’ (see also FIG.27) that has a centerline, forming an axis of rotation X1A. Pulley 134B rotates about an axle portion 134B’ (not shown) that has a centerline, forming an axis of rotation X1B. As can be seen, axes of rotation X1A, X1B are neither normal to, nor parallel to a plane defined by the travel of tip of needle 200 or wall 130C. Axes X1A, X1B may be oriented obliquely or perpendicularly with respect to one another, if desired. The elongate flexible member 150 can traverse an arcuate pathway in a plane that at least partially surrounds the gap. The plane can be defined by the elongate flexible member 150 itself as it traverses an arcuate path about gap 112. As illustrated, a first elongate flexible member portion 152A can then extend distally along a first parallel arm 110A of the housing, around the first pulley 134A, and back along a proximal direction. A second elongate flexible member portion, such as 152B can extend distally along the second parallel arm 110A of housing 110, around the second pulley 134B, and back along a proximal direction.

[0093] As further depicted in FIG.20, elongate flexible member portion 154A can extend proximally to a pulley 136A rotatably coupled to the housing 110. After passing over pulley 136, elongate flexible member 156A can pass into a first conduit, such as that defined by tubular member 172A that extends proximally along the suturing device 100. Elongate flexible member portion 154B can likewise extend proximally to pulley 136B rotatably coupled to the housing 110. After passing over pulley 136B, elongate flexible U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 member portion 156B can pass into a second conduit (not specifically illustrated) that extends proximally along the suturing device 100. It will be appreciated that both portions 156A, 156B can be directed through a single suitably configured conduit.

[0094] As further illustrated in FIG. 20, pulley 136A is configured to reciprocate about rotational axis X2A and pulley 136B can reciprocate about fourth rotational axis X2B. Axis X2A can be oriented obliquely (or perpendicularly) with respect to the rotational axis X2B.

[0095] As further illustrated in FIGS.20-26, the drive 130 includes a drive member 132 operably coupled to an elongate flexible member 150 via a shuttle 140. The drive 130 is configured to reciprocate the drive member 132 along an arcuate pathway from a starting position to an ending position during a drive stroke. FIG.20 presents a bottom isometric view of the housing and elongate flexible member routing and pulley locations. FIG.21 alternatively provides a top isometric view of this assembly without the housing components in place. Depicted are the sections of the elongate flexible member 150 (152A, 152B, 154A, 154B, 156A, 156B), and their relative location in space with respect to pulleys 134A, 136A and 136B. Shuttle 140 is held in place on elongate flexible member 150 through any suitable means, and follows the elongate flexible member 150 as it reciprocates back and forth over the pulleys. As the elongate flexible member 150 reciprocates, the shuttle 140 and drive member 132 follow an arcuate path that follows the path of the needle 200 in the needle track 120. Also depicted in FIGS.21-23 are brake pawls or clips 113, 115 to show relative placement of components. FIG.22 presents a bottom isometric view of the elongate flexible member 150, pulleys 134, 136A, 136B, U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 shuttle 140, and brake pawls or clips 113, 115. FIG.23 presents a top isometric view of these components. As can be seen, elongate flexible member portions 152A, 154A and 152B, 154B overlap, or overlay in these views.

[0096] FIG.24 is a bottom plan view of the device 100 illustrating the pathway of the elongate flexible member, and the direction each elongate flexible member segment follows during operation of the device when moving the shuttle 140 from a starting position to an ending position along the shuttle track or raceway 120A along a counter-clockwise direction around tissue gap 112. When moving along this direction, elongate flexible member 154A moves distally and elongate flexible member 154B moves proximally. When returning shuttle to its starting point when moving in a clockwise direction around gap 112, the direction of rotation of the pulleys reverses as does the direction of travel of the elongate flexible member 150. FIG. 25 presents a similar view of the device 100 showing needle 200 in the needle track. FIG.26 is a cross section along the direction indicated in FIG.25. In this figure, drive member 132 is cut along its centerline to illustrate how the drive member 132 moves downward into the shuttle and upward to engage a notch in needle 200 so that the drive member 132 and shuttle 140 carry the needle 200 along the needle track 120 when the shuttle is moving from the shuttle starting position to the shuttle ending position. FIG. 27 presents a distal end plan view of the drive components including the segments of elongate flexible member 150, the brake clips 113, 115, pulleys 134A, 136A, 136B, and shuttle 140. The relative angulation of the axes about which the pulleys rotate facilitate creating a device of a smaller width profile than if pulleys 134A, 134B reciprocated about axes that were vertical in this figure. FIG.28 is the same U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 view as in FIG. 27 with the pulleys removed showing the elongate flexible member sections clearly and the relative location of the shuttle. FIG.29 is an opposing view of this assembly when viewed along a distal direction.

[0097] FIGS.30-39 relate to the construction and configuration of shuttle 140. As depicted in FIG.30, shuttle 140 is formed from a main body portion 141 and a lower plate or bottom portion 142 that cooperate to define one or more cavities (144A, 144B) therebetween. The main body portion 141 is generally rectangularly shaped, but may include a slight arcuate curvature when viewed in top plan view to better fit into the arcuately shaped raceway or shuttle track 120A. Shuttle 140 includes two upper guides or bosses 141 that are slidably received within the groove or channel 120B that is defined through wall 120C to help guide the shuttle 140 and drive member 132 along an arcuate path to drive the needle 200.

[0098] FIGS. 31A-31C present rear isometric, front isometric and side isometric views of shuttle, respectively. As is evident, shuttle defines a first central window 143B in a front face of the shuttle 140, and side windows 143A, 143C in the side walls of the main body portion 141 of the shuttle. An opening is defined through a top wall of the main body portion 141 of the shuttle 140 to permit drive member 132 to pass through the top wall of the shuttle, between the guides 141A through arcuate groove 120B into the needle track 120 where it can engage the needle 200. When the bottom plate 142 of the shuttle is removed, grooves 143A and 143C are open and can receive elongate flexible member 150 therein, and more particularly, a crimp or boss 150A formed or crimped onto the elongate flexible member 150. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0099] FIGS.31D-31F present section views of the main body and bottom plate components 141, 142 of the shuttle 140 cut along a vertical plane through one of the bosses 141A. As can be seen, the shuttle is shaped to contain a distal interior compartment 144A that contains and traps the crimp 150A formed onto the elongate flexible member 150, and a proximal compartment 144B that receives the drive member 132 and an elastic block underneath the drive member 132 to permit the drive member 132 to be pushed downwardly into the shuttle cavity 144B when the shuttle is traveling across a surface of the needle prior to encountering a drive notch or rear surface of the needle, at which time the elastic material 137 pushes the drive member 132 into engagement with the needle 200. FIG.32 is a view along a distal direction of the suturing device showing the relative placement of the drive member 132 and crimp 150A, whereas FIG.33 presents this view along a distal direction. FIG.34 presents a transparent bottom isometric view of shuttle 140 illustrating relative placement of internal component drive member 132 that contacts compressible elastic block 137 within cavity 144B of housing main body portion 141. Also illustrated is relative placement of crimp 150A within compartment 144A of main body portion 141. FIG.35 presents a partial bottom isometric view showing boss 141A received by slot or groove 12B formed into wall 120C within housing 110 of device 100. FIG. 36 presents a top partial isometric view of these components illustrating boss 141A being received by groove 120B and drive member 132 passing through groove 120B to engage a rear surface 204 of needle 200. FIG.37 is an upper isometric transparent view of shuttle 140 illustrating relative placement of crimp 150A within cavity 144A and drive member 132 and elastic block 137 received within U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 cavity 144B of housing portion 141. FIG. 38 presents a cross section of some of the components of shuttle 140 along a vertical centerline of drive member 132, and FIG.39 shows a full cross section of this region of device 100 showing relative placement of the housing 110, drive member 132, needle 200, and lower cover 117A. Also pictured are a portion of cover 160’ showing lower flange 168 of cover 160’ as well as a distal end of an endoscope 300 received by housing 110. FIGS.40-41 present top isometric and lower isometric views of the housing 110 with all other components removed illustrating the full extent of the needle track 120, shuttle track or raceway 120A and channel or groove 120B along with cavities and / or bores formed to receive brake clips 113, 115 and the axles, pulleys and fasteners discussed elsewhere herein.

[0100] With reference to FIG. 42A, the conduit that guides the elongate flexible member 150 proximally along the device can include an inner tubular member 172A that directly contacts the elongate flexible member 150, and an outer tubular member 174A that surrounds the inner tubular member 172A. The outer tubular member 174A can be under a compressive axial load in order to maintain tension in the elongate flexible member 150 during operation of the suturing device. As illustrated, elongate flexible member or cable segment 156B passes over pulley 136B and travels in a proximal direction through a first channel 171B configured to permit the cable to pass through, preferably without touching the housing 110. Channel 171B widens into a channel 173B of a relatively larger width having a proximally facing distal wall and circumferential wall that is configured to slidably receive a distal end of inner tubular member 172B. Inner tubular member is preferably formed from a polymeric tubular material that is lubricious U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 material, such as PTFE, or includes a lubricious coating such that any relative sliding contact between cable or elongate flexible member 156B and the inner wall of tubular member 172B does not cause significant frictional resistance. Channel 173B widens further into a larger channel 175B that includes a proximally facing distal wall and circumferential wall to receive a distal end therein of outer tubular member 174B.

[0101] In a complete assembly, cables 172, 174 are located along both sides of the device 100 to accommodate a respective end of the elongate flexible member 150. These ends of the elongate flexible member and inner and outer sleeves are then operably coupled with the actuator 180, including but not limited to an actuator of a robotic surgical system depicted in FIGS.82-83B and a hand-actuated actuator depicted in FIGS. 68A-81, described in detail further below. In use, the suturing device 100 receives a distal end of an endoscope 300, and the cables 174A, 174B can be clipped or otherwise attached to the endoscope at discrete locations along its length.

[0102] Alternatively, outer tubular members can be received through a sleeve assembly that also receives endoscope 300 and tubular members 174A, 174B therein to maintain relative spacing of components. For example, with reference to FIG. 42B, a sleeve assembly 178 can be coupled to the suturing device 100 and slid around the endoscope 300 and tubular members 174A, 174B. For example, sleeve 178 can be made from a relatively thin tubular material that is foldable and can be coupled at a distal end over the suturing device after the endoscope is attached thereto. Alternatively, the sleeve 178 can be pre-attached to the suturing device 100, and a proximal end of the sleeve can be slid over the length of the endoscope 300. Sleeve 178 can be provided with a cinching U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 mechanism or tether arrangement 179 that, when pulled, cinches the sleeve down around the endoscope and tubular members 174A, 174B, thus applying a radially inward force to compress the assembly to minimize its width profile. For example, as illustrated, the tether 179 can include a single tether, or one or more tethers that loop about the sleeve 178 and pass through a grommet or other structural bearing surface 179C at the location of each loop 178. By pulling on tether 179, the sleeve 178 can be cinched around the endoscope and tubular members 174A, 174B. In an alternative implementation, the sleeve can be made from a relatively stiffer material and the tubular members 174A, 174B can be integrally formed with the sleeve 178. Such a material can act as a strain relief for the conduits, or a strain relief can be formed into or attached to a proximal end of the housing 110 to achieve this objective.

[0103] The disclosure further provides suturing needles having particular aspects. For purposes of illustration, and not limitation, as illustrated in FIGS.43-46, an arcuate needle 200 is provided having a pointed leading end 202, a trailing end 204, and an arcuately shaped body. The arcuately shaped body can define a plurality of indentations (e.g., 214, 216, 218, 220, 222) formed therein. For example, first, second and third radial inward indentations (e.g., 214, 216, 218) can be formed into a radially inward face 210 of the arcuate needle 200. Two of said first, second and third indentations (e.g., 216, 218) can be antipodal (e.g., about 180 degrees apart), and the third of said first, second, and third indentations (e.g., 214) can be located proximate one of the antipodal indentations (e.g., 216). U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0104] As illustrated, the arcuately shaped body of the needle 200 can have a “D” shaped cross section along its length (see, e.g., FIG.43), wherein a flat side (e.g., 206) of the cross section can be located on an upper face of the arcuate needle 200 and may be guided by or contact a lower surface of a needle track cover (e.g., 160, 160’). The upper face 206 can be parallel to a plane defined by a centerline of the arcuate needle along the length of the arcuate needle 200. A needle 200 with rectangular (or square) cross section, potentially with sharp, chamfered, or radiused corners may be used, as well as a circular cross section needle, and the like. As further depicted, the arcuate needle can further define at least one indentation (e.g., 220, 222) formed into a lower arcuately shaped face (e.g., 208) of said arcuate needle 200 that is opposite the flat side (e.g., 206) of said cross section. Alternatively, the curved lower surface of the needle 208 can be flattened similar to the upper surface 206 of the needle 200.

[0105] With continuing reference to FIG. 44, one or more bores or indentations 232, 234 can be provided in the needle to receive a leading edge of a suturing material therein (not shown). Additionally or alternatively, the trailing edge 204 of the needle 200 can be provided with one or more bores to receive a suturing material. The suturing material may be held in place in the needle 200 by adhesive, crimping, an interference fit, and the like.

[0106] One or more of the notches or indentations formed into the needle can have a “V” shape, or a different shape to facilitate interaction with components of the suturing device 100. One or more of the notches or indentations for example can have a first “vertical” wall (e.g., 216A) that is perpendicular (or approximately perpendicular) to an U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 arcuate centerline of the needle. Such a wall can be a wall of the notch or indentation that is closest to a leading edge of the needle. A second wall or surface can adjoin the first wall and form a second angled wall of the needle that is ramp shaped (e.g., 216C). Alternatively, a second flat wall (e.g., 216B) can be provided at a bottom of the notch or indentation that is perpendicular, or approximately perpendicular to the first wall (e.g., 216A). For example, notch or indentation 216 is comprised of a first “vertical” wall (e.g., 216A), a second “horizontal” surface (e.g., 216B) that is parallel to an arcuate centerline of the needle, and a third “ramped” surface (e.g., 216C) that traverses toward the upper surface 208 of the needle. As depicted, each of notches 214, 216, 218, 220, 222 have such an arrangement, wherein notches 214, 220 overlap to form a compound notch or indentation, wherein two notches that are oriented normal with respect to each other overlaps and share a common leading vertical surface 214A, 220A, and further wherein the horizontal or bottom surfaces 214B, 220B of each notch or indentation intersect at a common edge, and each ramped surface 214C, 220C, intersects along a common edge (FIG.46). The needle 220 can be formed in a coining process, or can be formed by way of metal injection molding, or by additive manufacturing techniques, among others.

[0107] As discussed above, the suturing device can further include at least one brake pawl, or clip. Such a clip or pawl (e.g., 113, 115) can be disposed in the housing. With reference to FIGS. 47-53 each of brake pawls or clips 113, 115 extend into the arcuate needle track 120 to engage a surface of an arcuate needle 200 disposed in the arcuate needle track to prevent the arcuate needle from traveling along a second direction opposite to the first direction when the arcuate needle is disposed at a first predetermined U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 location along the arcuate needle track 120. As depicted, brake pawls or clips 113, 115 are spaced apart along a length of the arcuate needle track 120. As illustrated, the brake pawls or clips 113, 115 can be disposed at least partially inside of a circular pathway defined by travel of the arcuate needle along the arcuate needle track.

[0108] With continuing reference to FIGS.47-48, the arcuate needle 200 can be advanced from a first location to a second location along the arcuate needle track 120 along the first direction as the drive member 132, which is movably disposed in the shuttle 140, is advanced from the starting position, as illustrated in FIG.47, to the ending position, as illustrated in FIG.48. The arcuate needle 200 can be advanced along the first direction 360 degrees around the arcuate needle track after the drive member 132 is advanced through a plurality of drive strokes. In the depicted implementation, a complete revolution is accomplished in three drive strokes, wherein each drive stroke involves a forward and return movement of shuttle 140.

[0109] For example, in a needle starting position as depicted in FIG. 47, the arcuate needle 200 can reside within the arcuate needle track 120 and not extend into the gap 112 defined by the housing 110. Brake pawl or clip 113 can engage a first needle surface 216a when the arcuate needle 200 is in the needle starting position to prevent the arcuate needle 200 from traveling in the second direction.

[0110] In a first drive stroke, the drive member 132 engages second notch 222 formed into needle 200 in FIG.47, wherein the shuttle 140 moves from its starting position depicted in FIG.47, along an arcuate path to the second position in FIG.48. The arcuate needle 200 is thus advanced from the needle starting position in FIG. 47 to a second U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 position in FIG. 48 wherein the at least one brake 113 can engage a second needle surface (e.g., 204) different from the first needle surface to prevent the arcuate needle from traveling in the second direction. For example, from FIG.48 to FIG.49, the shuttle 140 returns to its starting position. In so doing, the tip of the drive member 132 slides out of drive notch 222 and over the trailing end of the needle 204. In so doing, frictional force can cause the needle to back up slightly until the trailing end 204 of the needle 200 contacts brake clip 213.

[0111] During a second drive stroke as depicted in FIGS.49-50, the drive member 132 has not moved clockwise enough to engage proximal drive notch 220 of needle 200. Rather, shuttle 140 with drive member 132 are moved counterclockwise again, and the drive member 132 of shuttle 140 catches the distal face 204 of the needle and pushes it forward to the position shown in FIG.50. Next, when shuttle 140 is retracted clockwise, needle 200 may back up slightly but will be stopped by brake 115 engaging surface 214a of notch 214. Next, during a third drive stroke starting in FIG.51, the drive member 132 can engage a third needle location different from the first needle location and second needle location, in this case, notch 220, and the drive member 132 can advance the arcuate needle along the arcuate needle track as depicted in FIG.52. As the shuttle 140 next returns to the start position, the needle moves backwards until brake clip 113 again engages notch 216.

[0112] FIGS. 54-64 illustrate a variation 100’ of the embodiment 100 described previously that reduces the travel of shuttle 140 at the ending position of the shuttle 140. The shuttle therefore traverses a shorter path as compared to the implementation of U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 FIGS.47-53. This implementation facilitates placement, or “landing” of the needle 200’ in relative closer proximity to the brake pawls or clips 113’, 115’. As a consequence, the leading end of the needle will not protrude from the needle track 120’ after the third drive stroke.

[0113] FIG.54 depicts suturing device 100’ with the needle track cover 160’’ in place, and FIG. 55 shows device 100’ with cover 160’’ removed. Shuttle 140’ is in its starting position in FIG.55, wherein the drive member 132’ is engaged with (or about to engage with) indentation 222’ in needle 200’.

[0114] FIGS.56-57 illustrate the device 100’ without the needle in place to better illustrate movement of the shuttle 140’ and drive member 132’. The shuttle is in the start position in FIG.56, wherein the shuttle is in a location slightly clockwise with respect to brake 115’. FIG.57 illustrates shuttle 140’ at the end position at the end of the drive stroke wherein the drive member has traveled slightly less than 180 degrees, such as about 175 degrees.

[0115] With reference to FIGS.58-60, the movement of the needle 200’ is depicted with the drive member 132’. In FIG.58, the drive member 132’ is in the start position and engages the second drive notch 222’ in needle 200’. In FIG.59, after the first drive stroke, the drive member 132’ and notch 222’ have moved about 175 degrees. In this position, brake drive member 113’ engages braking notch 218’ in needle 200. This permits shuttle 140’ to be withdrawn clockwise back to its starting position as depicted in FIG.60.

[0116] Next, as with the previous embodiment 100, the shuttle 140’ is advanced to engage the trailing end of the needle and push it to the shuttle end position as depicted U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 in FIG.61. Upon reaching that position, notch 214’ engages with brake 115’ to prevent rearward movement of needle 200’ when shuttle 140’ is moved clockwise. The shuttle 140’ cycles clockwise to its start position in FIG.62, wherein the drive member 132’ has passed by the drive notch 220’. When the shuttle moves forward again as indicated in FIG.63, the drive member 132’ has caught notch 220’, bringing notch 220’ and notch 214’ to the starting location once again, wherein brake 113’ once again engages notch 216’ of needle 200’.

[0117] In further accordance with the disclosure, the suturing device can further include a coupling to receive and couple to a distal end of an endoscope or catheter.

[0118] For purposes of illustration, and not limitation, as depicted in FIGS 1 and 65A, suturing device 100 can terminate in a proximal region by way of a retainer or clip 119 that is configured to removably receive a distal end of an endoscope 300. The retainer 119 can be a split sleeve retainer that expands to accommodate the endoscope 300. The retainer can be located on, or comprise, a proximal section of housing 110 of device 100. The proximal portion of the housing including the retainer 119 can, in some implementations, be pivotally coupled to a distal portion of the housing 110 containing the needle track 120 to permit adjustability. In accordance with a further implementation, the housing can be configured to rotate about a point located within the tissue gap 112 to permit the housing to be pointed in a desired direction. Alternatively, the housing can be formed in a manner wherein it is not pointed distally, but instead at an angle with respect to the distal direction, such as any angle between 2 and 45 degrees, or any increment therebetween of 1 degree. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0119] As depicted in FIGS.1 and 65A, a central longitudinal axis of the endoscope 300 is oriented obliquely with respect to a plane defined by a centerline of the needle 200. This facilitates viewing the passage of the needle across the gap 112 using a camera(s) disposed in one (or more) of a plurality of passageways 303A-303e defined along the length of the endoscope 300. Having the plane of the needle be oblique to the endoscope axis also facilitates deeper tissue retraction (with device 150) prior to suturing with needle 200, yielding more efficacious suturing due to higher likelihood of full thickness sutures. The oblique angle decouples the maximum possible bite depth from the diameter of the needle body. In plane, the max tissue retraction could be limited by the diameter of the needle body. If a camera were disposed in passage 303B with a lens at a distal end of the endoscope 300, an illustrative view from such a camera is depicted in FIG. 65B. Endoscope 300 may be a conventional endoscope, or an endoscope that is specially configured for use with suturing device 100.

[0120] The disclosed suturing devices (e.g., 100, 100’, 100’’, 100’’’) can be used to perform various suturing procedures, such as laparoscopic and other procedures. In some implementations, it can be advantageous to provide an additional tool in suturing device 100 to help capture and pull tissue into gap 112 to suture. This can be particularly useful when the tissue being sutured is not compliant, or when it is desired to grasp a planar surface that would not naturally fall into the tissue gap 112, and it is necessary to form a fold, or plication of such a tissue structure to be pulled into gap 112. Implementations of devices in accordance with the present disclosure can be used to perform an Endoscopic Sleeve Gastroplasty (“ESG”) procedure, wherein a device 100’ U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 can be deployed into a patient’s stomach, and elongate tool 350’’ can be used to grab portions of the stomach lining to form a plication, and the plication cab then be held in place by passing needle 200’ through the plication. This procedure can be repeated until all desired plications are formed. Tension can then be applied to the suture passing through the plications to reduce the volume of the stomach.

[0121] Thus, as depicted in FIG.66, a suturing device 100’’ is provided to grasp and pull tissue into the path of a suturing needle 200’’. Device 100’’, as with prior embodiments, includes a housing, needle track, drive and the like, as well as a gap 112’’ defined between the first end and second end of the arcuate needle track to receive a tissue sample therein to be sutured.

[0122] Device 100’’ however further includes an elongate body 350’’ having a tissue anchor at a distal end thereof. Elongate body 350’’ can be slidably disposed along an additional passageway 303F’’ formed along a length of the endoscope 300’’ and controlled from a proximal location outside of a patient by a manual operator, or automated actuator, as desired (FIGS. 82-83B). The elongate body 350’’ can be advanced toward and beyond the gap to grasp tissue and retract tissue into the gap to be sutured by the suturing device. The depicted anchor is a helical member with a sharpened tip that, when rotated into tissue, eventually gains enough tissue purchase to permit a tissue structure to be retraced into the gap 112’’ by pulling on the elongate body 350’’. But, it will be appreciated that elongate body 350’’ can comprise any suitable grasping or plication device. A distal face 300A’’ can be configured to abut a proximally facing surface U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 (not shown) within the bore of the retainer 119’’, a version of which being illustrated as surface 363’’’ in FIG.67D, discussed below.

[0123] With continuing reference to FIG.66, the needle track cover, or other portion of the housing of device 100’’ can include or define a deflection surface 162A’’ to redirect the elongate member 350 after it emerges from the distal end of passage 303F’’ the endoscope 300. Deflection facilitates “aiming” the tool 350’’ toward the gap 112’’ such that the tool can be used to target and capture tissue that is along a line of sight passing between or near the gap 112’’. Thus, the deflection surface 162’’ can be configured to alter the direction of a tool 350’’ as the tool 350’’ is being advanced distally through the distal end of the endoscope 300. The net effect is that the tool can be used to grasp tissue to permit the tool to be pulled proximally to pull the tissue into the gap 112’’ into a pathway of the arcuate needle 200’’ as the needle passes across the gap 112’’. If desired, the tool can additionally or alternatively be configured to have shape memory near the distal tip thereof such that once it exits the passageway 303F’’ of the catheter it becomes unconstrained and bends upwardly to approach the gap 112’’. For example, a polymer forming an outer structure of the tool 350’’ can be formed with a gentle bend that straightens while in the endoscope 300’’ but regains its shape upon exiting the distal end of the endoscope 300’’. By using device 100’’ therefore, it is possible to grasp and pull tissue into the gap 112’’ and suture the tissue under direct visualization of a camera 320’’ depicted in passageway 302’’. The disclosure thus further provides implementations of methods of performing a suturing procedure. An illustrative method includes providing a suturing device as set forth elsewhere herein (100, 100’, 100’’, 100’’’ (discussed below)), U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 deploying an elongate tool with an anchor distally to a target region of tissue, anchoring the anchor into the target region of tissue, retracting the elongate body to pull tissue into the gap into a path of travel of the arcuate needle, and actuating a drive to advance the arcuate needle through the tissue.

[0124] For purposes of further illustration, and not limitation, in accordance with the present disclosure, FIGS.67A-67D depict a front right side isometric view, a right side isometric view, a front left side isometric view, and a partial rear left isometric view of a variation of a suturing device in accordance with some embodiment of the disclosure that includes an alignment sleeve assembly to facilitate receipt of a distal end of an endoscope into the suturing device.

[0125] As depicted in FIGS. 67A-67D suturing device 100’’’ includes a housing 110’’’ that defines an arcuate needle track 120’’’ therein having a first end 122’’’ and a second end 124’’’. The housing 110’’’ further defines a gap 112’’’ between the first end 122’’’ and second end 124’’’ of the arcuate needle track 120’’’. The gap 112’’’ is configured to receive a tissue sample therein to be sutured. As with previously discussed implementations, the suturing device 100’’’ further includes a drive to advance an arcuate needle about the arcuate needle track 120’’’ and across the gap 112’’’ along a first direction.

[0126] With continuing reference to FIGS. 67A-67D, the suturing device 100’’’ further includes a retainer 119’’’ that may be provided with an alignment sleeve assembly 360’’’ that extends in a proximal direction from the housing 110’’’. The retainer 119’’’, which can include the alignment sleeve assembly 360’’’ is configured to receive a distal U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 end portion of an endoscope (e.g., 300). The retainer 119’’’ is configured to hold the housing 110’’’ in place on the endoscope 300 in a predetermined axial and rotational orientation with respect to the endoscope, which can be facilitated by providing the retainer 119’’’ with the alignment sleeve assembly 360’’’. This ensures that the endoscope 300 will not rotate within the retainer 119’’’ without the suturing device 100’’’ rotating with the endoscope 300.

[0127] As described with respect to previous implementations, and with respect to the implementation of FIGS.67A-67D, the retainer 119’’’ can include a deformable clip configured to grip the distal end portion of the endoscope 300.

[0128] As depicted in FIGS.67A-67D, the retainer 119’’’ can include a guide sleeve assembly 360’’’ that in turn includes a guide sleeve 366’’’ that is configured to be received by an axial passage (e.g., 303A in FIG.65A) of the endoscope 300. The guide sleeve 366’’’ can be eccentrically exposed within a passageway 119E’’’ defined by the retainer 119’’’. The guide sleeve 366’’’ can be axially aligned with and laterally offset with respect to a central axis X of passageway 119E’’’ defined by the retainer 119’’’. In some implementations the guide sleeve 366’’’ can define an axial slit 368’’’ along a length thereof to permit the sleeve 366’’’ to be deflected laterally inwardly. The guide sleeve 366’’’ can extend proximally from a radially inwardly extending boss formed from a radially inwardly extending arm 364’’’ coupled to a circumferential frame 362’’’ that grips or is otherwise coupled to the sleeve 366’’’. The alignment sleeve assembly 360’’’ can thus include guide sleeve 366’’’ that is operably coupled to a proximally facing surface 363’’’ U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 of the arm 364’’’ that is in turn configured to contact and act as an axial stop that contacts a distal face (FIG.66, 300A) of the endoscope 300.

[0129] In previous implementations, (e.g., FIG. 66) The deformable sleeve can define an axial slit 119F’’ along its length configured to be deformed radially outwardly to receive the distal end portion of the endoscope 300 therein in an interference fit, for example. Alternatively, in the implementation of FIGS.67A-67D, the deformable sleeve can include a proximal band 119B’’’ configured to be clamped around the distal end portion of the endoscope 300 by tightening a fastener 119C’’’ coupling the proximal band 119B’’’ to a proximal segment 110C’’’ of the housing 110’’’ of the suturing device 100’’’. The deformable sleeve can further include a distal portion 110a’’’ that includes an alignment boss (e.g., alignment sleeve assembly 360’’’ ) to engage with a passageway (e.g., 303A in FIG. 65A) defined in the distal end portion of the endoscope 300 as mentioned above. The proximal band can be separated from the distal portion by a transverse lateral gap or slit 119D’’’. The transverse lateral gap or slit 119D’’’ can have circumferential extent in excess of ninety degrees, such as 90 to more than 180 degrees, or an any increment therebetween of one degree.

[0130] As depicted in FIGS.68A-81, the suturing device 100 can further include an actuator 180 operably coupled to the elongate flexible member or cable 150, wherein applying tension to the actuator 180 applies tension to the elongate flexible member or cable 150. The actuator 180 can be configured to be manually operated, mechanically operated, as desired. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0131] As shown in FIG.78, in alternative embodiments the actuator 180 can be configured to be coupled to an automated surgical device 198 such as a motorized actuator handle, or a surgical robot. In certain embodiments, the actuator 180 can be configured to be coupled to the automated surgical device 198 but may be removed from the automated surgical device and used manually. Such utility may be an option for surgery or used to control the suturing device 100 in an emergency situation if there is a loss of power or control of the automated surgical device 198.

[0132] As depicted in FIGS. 68A-80, actuator 180 includes proximal clamping assembly 181A or coupling to receive a proximal end of filament or cable 156A, proximal end of inner sheath 172A and proximal end of outer sheath 174A. Actuator 180 further includes a second proximal clamping assembly 181B to receive a second proximal end of filament or cable 156B, proximal end of inner sheath 172B and proximal end of outer sheath 174B. The proximal end of filament or cable 156A extends through proximal clamping assembly 181A and is coupled to trigger 186A, whereas the proximal end of filament or cable 156B extends through proximal clamping assembly 181B and is coupled to trigger 186B. Pulling on trigger 186A and releasing tension on trigger 186B can cause shuttle 140 to move backward from its finishing position to its start position. If desired, pulling on trigger 186B and releasing tension on trigger 186A can causes shuttle 140 to move forward from its starting position to its finishing position, as illustrated in FIG.24.

[0133] With continuing reference to the embodiments shown in FIGS.68A-80, the actuator 180 is formed from an outer housing 182 that in turn slidably receives two triggers 186A, 186B therein. The housing 182 may include one or more clips or releasable U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 fasteners 190 to couple the actuator 180 to an automated surgical device such as a robot, or into a hand-held actuator handle. The illustrated housing 182 defines two elongate channels 185A, 185B therein for slidably receiving triggers 186A, 186B therein. In certain embodiments, the triggers 186A, 186B may include a ratchet-and-pawl or a detent mechanism (not shown) interacting with the housing 182 to hold the triggers 186A, 186B in place between completion of each stroke.

[0134] In certain embodiments at least one of the triggers 186A, 186B may be spring-biased in a proximal and / or distal direction. In the embodiment seen in FIG.80, a spring 196 is connected to trigger 186B. Pulling on trigger 186A causes shuttle 140 to move backward from its finishing position to its start position and loads tension on the spring 196 connected to trigger 186B. Upon releasing trigger 186A, spring 196 automatically contracts, pulling on trigger 186B and causing shuttle 140 to move forward from its starting position to its finishing position.

[0135] As seen in FIGS. 79A and 79B certain embodiments of the housing 182 may include tactile, colored, symbolic, and / or alphanumeric indicators signaling needle position and / or stroke count. By way of non-limiting example, the indicators may be part of an electronic or mechanical stroke counter (not shown). By way of further non-limiting example, the indicators may be a visual and / or tactile mark or marks 195 on the handle indicating variously the needle position or actuation level of the triggers 186A, 186B.

[0136] In the embodiment shown in FIG.79A, a projection 195C extends from at least one of the triggers 186A, 186B through an elongate slot 195D defined through a wall of the housing to align with the indicator marks 195. By way of further non-limiting U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 example, the needle position indicator may include a haptic feedback from the handle indicating that the triggers 186A, 186B have been fully actuated, such as by one of the triggers 186A, 186B passing by a detent resulting in a clicking noise.

[0137] By way of further illustrative example, in the embodiment shown in FIG. 79B, an indicator 199 may be provided including gearing, for example, that is configured to cooperate with indicia on an outer surface of the indicator 199. Indicator 199 may include a pinion or spur gear 199A connected by a rack or rolling arrangement 199B attached to at least one of the triggers 186A, 186B. A radially outer surface 199C of the pinion or spur gear 199A may be visible to a user and may include colored, symbolic, and / or alphanumeric indicators 199D on the indicator wheel 199A that correlate with needle position or actuation level of the triggers 186A, 186B. For example, a tactile or visible indicia 199D can indicate a position of the needle when it achieves registration with the location where it encounters an outer surface of the housing 182.

[0138] With continuing reference to the embodiment shown in FIGS.68-80, each trigger 186A, 186B in turn includes a respective trigger spool 188 that is received into a lateral opening in each respective trigger 186A, 186B. Each trigger spool 188 can include one or more spool grooves 189 to trap a respective proximal end of cable 156A, 156B therein. A slot 187 (FIG. 74) can be defined through the housing 182 to permit the passage of a respective cable or filament 150, 156B therethrough. To hold the cable 156 in place, a free end of cable 156 is wrapped around a respective spool 188. Each spool 188 can also include a retainer or clip 194 extending over the trigger spool 188 to hold the respective proximal end of cable 156A, 156B thereon in a wound configuration. The U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 clip 194 is preferably formed from a semi-rigid material to allow it to deform sufficiently to attach to the trigger spool 188 but still retain the cable 156. FIGS.75C and 75D show longitudinal and latitudinal cross-sections, respectively, of the assembly of the clip 194 connected to the trigger spool 188.

[0139] In certain embodiments, as shown in FIG. 80, an intermediate pulley (or gear) set may operably interconnect the cable 156 and the trigger 186. The intermediate pulley set may include a large-radius pulley 197A having a radius R1 and a small-radius pulley 197B having a radius R2, where R1 is larger than R2. Such an embodiment may thus provide a trigger force- and / or movement-multiplying by coupling trigger 186 to the large-radius pulley 197A and the cable 156 to the small-radius pulley 197B. Another embodiment may include trigger force- and / or movement-division by coupling trigger 186 to the small-radius pulley 197B and the cable 156 to the large-radius pulley 197A.

[0140] Each trigger 186A, 186B may also include at least one user interface 192 or gripping surface which directly contacts the user or actuating device. In the embodiment shown in FIGS.68A, 68B, the user interface 192A, 192B is a finger aperture extending through each trigger 186A, 186B. An embodiment for use with an automated surgical device 198 may also or instead include projections (not shown) for connection to the automated surgical device 198.

[0141] As illustrated in FIGS.71A-71B, housing 182 couples to distal plate 183 that includes the clamping assemblies 181A, 181B and can define grooves 184 to permit installation and passage of filaments or cables 156A, 156B. The cable 156 is passed through the groove 184 in the distal plate 183 to extend into the inner sheath 172 and U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 outer sheath 174. In certain embodiments, the distal plate 183 is an aluminum block removably connected to the housing 182. If desired, interlocking features, such as keys 187A and corresponding slots 187B can be provided on the plate 183 or housing 182 to permit the housing 182 and plate 183 to be joined by first bringing the components into contact, and then sliding them laterally with respect to each other to cause the keys 187A and slots 187B to interlock.

[0142] While clamping assemblies 181A, 181B may be provided, the entire actuator assembly can be molded and integrated into an integral assembly when mass produced, if desired. Each clamping assembly 181A, 181B can include a respective clamping plate 191 that backstops or holds the proximal ends of inner and outer sheaths 172A, 172B and 174A, 174B in place. In such a configuration, the outer sheaths 174A, 174B abut the grooves 184 in the distal plate 183. Certain embodiments of the housing 182 also include the frangible coupling actuator discussed above. In such embodiments, the frangible coupling actuator can be operably coupled to the frangible coupling by a pull cable (not shown), ejecting the needle track cover from the point of the housing 182 to permit the needle to be removed.

[0143] In the implementation of FIG. 81, the actuator 180 can include a compressible lever arm 186C with a spring-biased return. In this embodiment, the actuator 180 includes proximal clamping assembly 181A or coupling to receive a proximal end of the filament or cable 156A, proximal end of inner sheath 172A and proximal end of outer sheath 174A. Actuator 180 further includes a second proximal clamping assembly 181B to receive a second proximal end of filament or cable 156B, proximal end of inner U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 sheath 172B and proximal end of outer sheath 174B. The proximal end of filament or cable 156A is coupled to a compressible lever arm 186C serving as the trigger, while the proximal end of filament or cable 156B is coupled to a spring-biased spool 186D.

[0144] Compressing the trigger 186C (by moving its respective free end in a distal direction in FIG.81) causes the elongate flexible member or cable 150 to move forward as it winds out from the spool, and shuttle 140 to move forward from its starting position to its finishing position, as illustrated in FIG. 24. Releasing the trigger 186 causes the elongate flexible member or cable 150 to move backward as it winds up to the spool, and shuttle 140 to move backward from its finishing position to its start position, as illustrated in FIG. 24. Certain embodiments may use a second spool 186E interconnecting the trigger 186 and the proximal end of the filament or cable 156A. In various embodiments, either the second spool or the trigger 186 may be spring-biased. The elongate flexible member or cable 150 is wound around the second spool when the trigger 186 is compressed. Such an embodiment may also include force- and / or movement-multiplying gearing between the second spool and the trigger 186 or step down in axle diameter within the actuator 180, similarly to the pulley set shown in FIG.80.

[0145] Aspects of this disclosure herein can be part of a computer-assisted teleoperational manipulator system, sometimes referred to as a robotically-assisted manipulator system or a robotic system. The manipulator system can include one or more manipulators that can be operated with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments when coupled to the manipulators. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0146] FIG. 82 illustrates an embodiment of a robotically-assisted manipulator system for use with the tools described herein. The manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by the reference numeral 1100. As shown in FIG.82, a robotically- assisted manipulator system 1100 can include one or more manipulator assemblies 1102 for operating one or more medical instrument systems 1104 in performing various procedures on a patient P positioned on a table T in a medical environment 1101. For example, the manipulator assembly 1102 can drive catheter or end effector motion, can apply treatment to target tissue, and / or can manipulate control members. The manipulator assembly 1102 can be teleoperated, non-teleoperated, or a hybrid teleoperated and non- teleoperated assembly with select degrees of freedom of motion that can be motorized and / or teleoperated and select degrees of freedom of motion that can be non-motorized and / or non-teleoperated. An operator input system 1106, which can be inside or outside of the medical environment 1101, generally includes one or more control devices for controlling manipulator assembly 1102. Manipulator assembly 1102 supports medical instrument system 1104 and can optionally include a plurality of actuators or motors that drive inputs on medical instrument system 1104 in response to commands from a control system 1112. The actuators can optionally include drive systems that when coupled to medical instrument system 1104 can advance medical instrument system 1104 into a naturally or surgically created anatomic orifice. Other drive systems can move the distal end of medical instrument in multiple degrees of freedom, which can include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). The manipulator assembly 1102 can support various other systems for irrigation, treatment, or other purposes. Such systems can include fluid systems (including, for example, reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.

[0147] Robotically-assisted manipulator system 1100 also includes a display system 1110 for displaying an image or representation of the surgical site and medical instrument system 1104 generated by an imaging system 1109 which can include an imaging system, such as an endoscopic imaging system. Display system 1110 and operator input system 1106 can be oriented so an operator O can control medical instrument system 1104 and operator input system 1106 with the perception of telepresence. A graphical user interface can be displayable on the display system 1110 and / or a display system of an independent planning workstation.

[0148] In some examples, the endoscopic imaging system components of the imaging system 1109 can be integrally or removably coupled to medical instrument system 1104. However, in some examples, a separate imaging device, such as an endoscope, attached to a separate manipulator assembly can be used with medical instrument system 1104 to image the surgical site. The endoscopic imaging system 1109 can be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of the control system 1112. It will be appreciated that either an U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 integrated endoscopic device or a separate endoscope can serve as an endoscope that supports the suturing device (e.g., 100, 100’, 100’’) set forth herein.

[0149] Robotically-assisted manipulator system 1100 can also include a sensor system 1108. The sensor system 1108 can include a position / location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and / or shape of the medical instrument system 1104. The sensor system 1108 can also include temperature, pressure, force, or contact sensors or the like.

[0150] Robotically-assisted manipulator system 1100 can also include a control system 1112. Control system 1112 includes at least one memory 1116 and at least one computer processor 1114 for effecting control between medical instrument system 1104, operator input system 1106, sensor system 1108, and display system 1110. Control system 1112 also includes programmed instructions (e.g., a non-transitory machine- readable medium storing the instructions) to implement a procedure using the robotically- assisted manipulator system including for navigation, steering, imaging, engagement feature deployment or retraction, applying treatment to target tissue (e.g., via the application of energy), or the like.

[0151] Control system 1112 can optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument system 1104 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system can be based upon reference to an acquired pre- U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 operative or intra-operative dataset of anatomic passageways. The virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The control system 1112 can use a pre-operative image to locate the target tissue (using vision imaging techniques and / or by receiving user input) and create a pre-operative plan, including an optimal first location for performing treatment. The pre-operative plan can include, for example, a planned size to expand an expandable device, a treatment duration, a treatment temperature, and / or multiple deployment locations.

[0152] FIG. 83A shows a medical instrument system 1200 according to some embodiments. In some embodiments, medical instrument system 1200 can be used in an image-guided medical procedure. In some examples, medical instrument system 1200 can be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. In some embodiments, medical instrument system 1200 is interchangeable with, or a variation of, medical instrument system 1104 of FIG.82.

[0153] Medical instrument system 1200 includes elongate flexible device 1202, such as a flexible catheter or endoscope (e.g., gastroscope, bronchoscope), coupled to a drive unit 1204. Elongate flexible device 1202 includes a flexible body 1216 having proximal end 1217 and distal end, or tip portion, 1218. In some embodiments, flexible body 1216 has an approximately 14-20 mm outer diameter. Other flexible body outer U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 diameters can be larger or smaller. Flexible body 1216 can have an appropriate length to reach certain portions of the anatomy, such as the lungs, sinuses, throat, or the upper or lower gastrointestional region, when flexible body 216 is inserted into a patient’s oral or nasal cavity. The suturing device (e.g., 100, 100’, 100’’, 100’’’) can be coupled to elongate flexible device 1202 as desired in lieu of endoscope 300.

[0154] Medical instrument system 1200 optionally includes a tracking system 1230 for determining the position, orientation, speed, velocity, pose, and / or shape of distal end 1218 and / or of one or more segments 1224 along flexible body 1216 using one or more sensors and / or imaging devices. The entire length of flexible body 1216, between distal end 1218 and proximal end 1217, can be effectively divided into segments 1224. Tracking system 1230 can optionally be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of control system 1112 in FIG. 82.

[0155] Tracking system 1230 can optionally track distal end 1218 and / or one or more of the segments 1224 using a shape sensor 1222. In some embodiments, tracking system 1230 can optionally and / or additionally track distal end 1218 using a position sensor system 1220, such as an electromagnetic (EM) sensor system. In some examples, position sensor system 1220 can be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point or five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047

[0156] Flexible body 1216 includes one or more channels 1221 sized and shaped to receive one or more medical instruments 1226. In some embodiments, flexible body 1216 includes two channels 1221 for separate instruments 1226, however, a different number of channels 1221 can be provided. FIG.83B is a simplified diagram of flexible body 1216 with medical instrument 1226 extended according to some embodiments. In some embodiments, medical instrument 1226 can be used for procedures and aspects of procedures, such as surgery, biopsy, ablation, mapping, imaging, illumination, irrigation, or suction. Medical instrument 1226 can be deployed through channel 1221 of flexible body 1216 and used at a target location within the anatomy. Medical instrument 1226 can include, for example, image capture devices, biopsy instruments, ablation instruments, catheters, laser ablation fibers, and / or other surgical, diagnostic, or therapeutic tools. Medical tools can include end effectors having a single working member such as a scalpel, a blunt blade, a lens, an optical fiber, an electrode, and / or the like. Other end effectors can include, for example, forceps, graspers, balloons, needles, scissors, clip appliers, and / or the like. Other end effectors can further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, imaging devices and / or the like. Medical instrument 1226 can be advanced from the opening of channel 1221 to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument 1226 can be removed from proximal end 1217 of flexible body 1216 or from another optional instrument port (not shown) along flexible body 1216. The medical instrument 1226 can be used with an image capture U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 device (e.g., an endoscopic camera) also within the elongate flexible device 1202. Alternatively, the medical instrument 1226 can itself be the image capture device.

[0157] Medical instrument 1226 can additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 1226. Flexible body 1216 can also house cables, linkages, or other steering controls (not shown) that extend between drive unit 1204 and distal end 1218 to controllably bend distal end 1218 as shown, for example, by broken dashed line depictions 1219 of distal end 1218. In some examples, at least four cables are used to provide independent “up-down” steering to control a pitch motion of distal end 1218 and “left-right” steering to control a yaw motion of distal end 1218. In embodiments in which medical instrument system 1200 is actuated by a robotically- assisted assembly, drive unit 1204 can include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some embodiments, medical instrument system 1200 can include gripping features, manual actuators, or other components for manually controlling the motion of medical instrument system 1200. The information from tracking system 1230 can be sent to a navigation system 1232 where it is combined with information from visualization system 1231 and / or the preoperatively obtained models to provide the physician or other operator with real-time position information.

[0158] This description and the accompanying drawings that illustrate various embodiments should not be taken as limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 scope of this description and the invention as claimed, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated features that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to another embodiment, the element may nevertheless be claimed as included in the other embodiment.

[0159] For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities, percentages, or proportions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about,” to the extent they are not already so modified. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0160] It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

[0161] Further, this description’s terminology is not intended to limit the invention. For example, spatially relative terms—such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like—may be used to describe one element’s or feature’s relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the illustrative term “below” can encompass both positions and orientations of above and below. A device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0162] Further modifications and alternative embodiments will be apparent to those of ordinary skill in the art in view of the disclosure herein. For example, the devices and methods may include additional components or steps that were omitted from the diagrams and description for clarity of operation. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the present teachings. It is to be understood that the various embodiments shown and described herein are to be taken as illustrative. U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 Elements and materials, and arrangements of those elements and materials, may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the present teachings may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of the description herein. Changes may be made in the elements described herein without departing from the spirit and scope of the present teachings and following claims.

[0163] It is to be understood that the particular examples and embodiments set forth herein are non-limiting, and modifications to structure, dimensions, materials, and methodologies may be made without departing from the scope of the present teachings.

[0164] Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as illustrative and for example only, with the following claims being entitled to their fullest breadth, including equivalents, under the applicable law.

Claims

U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 CLAIMS What is claimed is:

1. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; a drive system comprising a drive member operably coupled to an elongate flexible member to advance an arcuate needle about the arcuate needle track and across the gap along a first direction; wherein the elongate flexible member reciprocates over at least one bearing surface proximate a distal end of the housing; and wherein the at least one bearing surface directs the elongate flexible member from a first path laying in a first plane to a second path laying in a second plane different from the first plane, wherein the first path and second path overlap when viewed along a direction normal to the first plane.

2. The suturing device of Claim 1, wherein the elongate flexible member includes a cable.

3. The suturing device of Claim 1, wherein the elongate flexible member includes a band.

4. The suturing device of Claim 1, wherein the arcuate pathway is parallel to a path traversed by the arcuate needle along at least a portion of the arcuate pathway.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 5. The suturing device of Claim 1, wherein the first plane and second plane are parallel.

6. The suturing device of Claim 1, wherein the first plane and second plane are not parallel.

7. The suturing device of Claim 1, wherein the first path and second path cross in at least one location when viewed along a direction normal to the first plane.

8. The suturing device of Claim 1, wherein the at least one bearing surface includes a boss defined by a curved plane that is oriented obliquely with respect to the first plane.

9. The suturing device of Claim 1, wherein the at least one bearing surface includes at least one pulley that reciprocates about an axis of rotation that is oriented obliquely with respect to the first plane.

10. The suturing device of Claim 9, wherein the housing of the suturing device terminates distally in a first parallel arm and a second parallel arm that at least partially define the gap, and further wherein the at least one bearing surface includes a first pulley proximate a distal end of the first parallel arm and a second pulley proximate a distal end of the second parallel arm, and further wherein the first pulley and second pulley redirect the path of travel of the flexible member from the first plane into the second plane.

11. The suturing device of Claim 10, wherein the first pulley reciprocates about a first rotational axis and the second pulley reciprocates about a second rotational axis, wherein the first rotational axis is oriented obliquely with respect to the second rotational axis.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 12. The suturing device of Claim 11, wherein the first rotational axis and second rotational axis are each oriented obliquely with respect to the first plane and the second plane.

13. The suturing device of Claim 10, wherein: the elongate flexible member traverses the arcuate pathway in the first plane that at least partially surrounds the gap; a first elongate flexible member portion extends distally along the first parallel arm, around the first pulley, and along a proximal direction; and a second elongate flexible member portion extends distally along the second parallel arm, around the second pulley, and along a proximal direction.

14. The suturing device of Claim 13, wherein: the first elongate flexible member portion extends proximally to a third pulley rotatably coupled to the housing, and after passing over the third pulley the first elongate flexible member portion passes into a first conduit that extends proximally along the suturing device; and the second elongate flexible member portion extends proximally to a fourth pulley rotatably coupled to the housing, and after passing over the fourth pulley the second elongate flexible member portion passes into a second conduit that extends proximally along the suturing device.

15. The suturing device of Claim 14, wherein the third pulley reciprocates about a third rotational axis and the fourth pulley reciprocates about a fourth rotational axis, wherein the third rotational axis is oriented obliquely with respect to the fourth rotational axis.

16. The suturing device of Claim 14, wherein:U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 the first conduit comprises an inner tubular member that contacts the first flexible member portion; and an outer tubular member that surrounds the inner tubular member; and the outer tubular member is under a compressive axial load to maintain tension in the first flexible member portion during operation of the suturing device.

17. The suturing device of Claim 16, further comprising a first actuator operably coupled to the first elongate flexible member portion, wherein applying tension to the first actuator applies tension to the first elongate flexible member portion.

18. The suturing device of Claim 17, wherein the first actuator is configured to be manually operated.

19. The suturing device of Claim 17, wherein the first actuator is configured to be coupled to an automated surgical device.

20. The suturing device of Claim 16, further comprising a flexible sleeve surrounding the first conduit having a proximal end and a distal end, the proximal end of the flexible sleeve being dimensioned to be advanced over a distal end portion of an endoscope, the first conduit and the second conduit.

21. The suturing device of Claim 20, wherein the distal end of the flexible sleeve is coupled to the housing.

22. The suturing device of Claim 20, wherein the distal end of the flexible sleeve is configured to be coupled to the housing, and further wherein a proximal portion of the housing defines a coupling to removably attach to the distal end of the endoscope.

23. The suturing device of Claim 22, wherein the flexible sleeve further comprises a tensioner to apply radial inward tension to the flexible sleeve to removably couple the flexible sleeve to the endoscope.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 24. The suturing device of Claim 22, wherein the tensioner includes at least one tensioning cable that at least partially circumferentially traverses the sleeve, and further wherein applying tension to the tensioner causes the flexible sleeve to grasp the endoscope, first conduit and second conduit in at least two axially spaced locations along the flexible sleeve.

25. The suturing device of Claim 20, wherein the flexible sleeve is integrally formed with the outer tubular member of the first conduit.

26. The suturing device of Claim 1, further comprising a coupling to receive a distal end of an endoscope or catheter, and further wherein the housing defines a deflection surface formed thereon to alter the direction of a tool as the tool is being advanced distally through the distal end of the endoscope or catheter.

27. The suturing device of Claim 26, wherein the deflection surface redirects a distal portion of the tool toward the gap in the housing.

28. The suturing device of Claim 27, wherein the tool includes an instrumentality to engage tissue, wherein the tool is configured to grasp tissue with the instrumentality to permit the tool to be pulled proximally to pull the tissue into the gap into a pathway of the arcuate needle as the needle passes across the gap.

29. The suturing device 26, wherein the deflection surface is formed on a surface of a removable needle cover coupled to the suturing device.

30. The suturing device of Claim 1, further comprising a needle track cover removably disposed on the housing.

31. The suturing device of Claim 30, wherein the needle track cover can be removed from the housing by advancing the needle track cover distally off the housing.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 32. The suturing device of Claim 30, wherein the needle track cover can be removed from the housing by advancing the needle track cover upwardly from the housing along a direction that is orthogonal to the first plane.

33. The suturing device of Claim 30, further comprising a compressed member that urges the needle track cover off of the housing when in an unconstrained condition.

34. The suturing device of Claim 33, further comprising: a frangible coupling that counteracts force applied by the compressed member to hold the needle track cover in place; and an actuator operably coupled to the frangible coupling, wherein actuating the actuator ruptures the frangible coupling to permit the compressed member to eject the needle track cover from the housing.

35. The suturing device of Claim 1, further comprising at least one brake disposed in the housing, said at least one brake extending into the arcuate needle track to engage a surface of an arcuate needle disposed in the arcuate needle track to prevent the arcuate needle from traveling along a second direction opposite to the first direction when the arcuate needle is disposed at a first predetermined location along the arcuate needle track.

36. The suturing device of Claim 35, wherein the at least one brake includes a plurality of brakes disposed in the housing, the plurality of brakes being spaced apart along a length of the arcuate needle track.

37. The suturing device of Claim 36, wherein the plurality of brakes are disposed at least partially inside of a circular pathway defined by travel of the arcuate needle along the arcuate needle track.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 38. The suturing device of Claim 35, wherein the at least one brake prevents movement of the arcuate needle along the second direction while the drive member moves along the second direction to engage the arcuate needle.

39. The suturing device of Claim 38, wherein the arcuate needle is advanced from a first location to a second location along the arcuate needle track along the first direction as the drive member is advanced from the starting position to the ending position.

40. The suturing device of Claim 39, wherein the arcuate needle is advanced along the first direction 360 degrees around the arcuate needle track after the drive member is advanced through a plurality of drive strokes.

41. The suturing device of Claim 40, wherein, in a needle starting position, the arcuate needle resides within the arcuate needle track and does not extend into the gap in the housing, and further wherein the at least one brake engages a first needle surface when the arcuate needle is in the needle starting position to prevent the arcuate needle from traveling in the second direction.

42. The suturing device of Claim 41, wherein after a first drive stroke by the drive member, the arcuate needle is advanced from the needle starting position to a second position wherein the at least one brake engages a second needle surface different from the first needle surface to prevent the arcuate needle from traveling in the second direction, and further wherein the drive member engages the arcuate needle at a first needle location during the first drive stroke.

43. The suturing device of Claim 42, wherein the second needle surface includes a trailing end of the arcuate needle.

44. The suturing device of Claim 42, wherein the first needle location includes a surface of an indentation formed into the arcuate needle.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 44. The suturing device of Claim 42, wherein, during a second drive stroke, the drive member engages a second needle location different from the first needle location, and the drive member advances the arcuate needle along the arcuate needle track to a location wherein a second brake engages the arcuate needle to prevent the arcuate needle from traveling in the second direction.

45. The suturing device of Claim 44, wherein the second needle location includes a trailing end of the arcuate needle.

46. The suturing device of Claim 44, wherein, during a third drive stroke, the drive member engages a third needle location different from the first needle location and second needle location, and the drive member advances the arcuate needle along the arcuate needle track to the needle starting location.

47. An arcuate needle having a leading end, a trailing end, and an arcuately shaped body, the arcuately shaped body defining a plurality of indentations therein, wherein first, second and third radial inward indentations are formed into a radially inward face of the arcuate needle, wherein two of said first, second and third indentations are antipodal, and the third of said first, second, and third indentations is located proximate one of the antipodal indentations.

48. An arcuate needle having a leading end, a trailing end, and an arcuately shaped body, the arcuately shaped body having a “D” shaped cross section along its length, wherein a flat side of said cross section is located on an upper face of the arcuate needle, wherein said upper face is parallel to a plane defined by a centerline of the arcuate needle along the length of the arcuate needle.

49. The arcuate needle of Claim 48, further comprising at least one indentation formed into a lower arcuately shaped face of said arcuate needle that is opposite the flat side of said cross section.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 50. The suturing device of Claim 1, further comprising a movable shuttle operably coupled to the drive member and the elongate flexible member.

51. The suturing device of Claim 50, wherein the shuttle includes a compressible body therein that urges the drive member into contact with the arcuate needle.

52. The suturing device of Claim 1, wherein the housing comprises a proximal portion to be coupled to a distal end of an endoscope or catheter body, and a distal portion that comprises the arcuate needle track.

53. The suturing device of Claim 52, wherein the proximal portion of the housing and the distal portion of the housing are configured to align a centerline of the endoscope or catheter body toward the gap in the housing.

54. The suturing device of Claim 52, wherein the proximal portion of the housing and the distal portion of the housing are pivotally coupled.

55. A suturing device comprising: a housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction; and an elongate body having a tissue anchor at a distal end thereof, wherein the elongate body can be advanced toward and beyond the gap to grasp tissue and retract tissue into the gap to be sutured by the suturing device.

56. A method of performing a suturing procedure, comprising: providing a suturing device according to Claim 55;U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 deploying the elongate body distally to a target region of tissue; anchoring the anchor into the target region of tissue; retracting the elongate body to pull tissue into the gap into a path of travel of the arcuate needle; and actuating the drive system to advance the arcuate needle through the tissue.

57. The method of Claim 56, wherein the suturing procedure is repeated multiple times to perform an Endoscopic Sleeve Gastroplasty (“ESG”).

58. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, the drive system comprising a drive member operably coupled to an elongate flexible member, the drive system being configured to reciprocate the drive member along an arcuate pathway, the drive system further including at least one pulley rotatably disposed in the housing, wherein the at least one pulley rotates about an axis that is oriented obliquely with respect to a plane defined by a centerline of the arcuate needle.

59. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured;U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 a drive system to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, the drive system comprising a drive member operably coupled to an elongate flexible member, the drive being configured to reciprocate the drive member along an arcuate pathway; a conduit that extends proximally along the suturing device, wherein the elongate flexible member passes through the conduit toward a proximal end of the suturing device, wherein the conduit is configured to absorb an axial load to maintain tension in the elongate flexible member during operation of the suturing device.

60. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; a drive to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, the drive comprising a drive member operably coupled to an elongate flexible member, the drive being configured to reciprocate the drive member along an arcuate pathway; and a needle track cover that traverses and covers at least a portion of the arcuate needle track, wherein the needle track cover is configured to be ejected from the suturing device to permit the needle to be removed from the needle track.

61. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured;U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 a drive to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, the drive comprising a drive member operably coupled to an elongate flexible member, the drive being configured to reciprocate the drive member along an arcuate pathway; a deployable instrument configured to be deployed in a distal direction beyond a distal end of the housing; and a deflection surface to alter a trajectory of the deployable instrument as the deployable instrument is being deployed distally.

62. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; a drive to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, the drive comprising a drive member operably coupled to an elongate flexible member, the drive being configured to reciprocate the drive member along an arcuate pathway; and a plurality of brakes extending into the arcuate needle track to prevent the needle from moving in a second direction opposite to the first direction; wherein the arcuate needle is advanced along the first direction 360 degrees around the arcuate needle track after the drive member is advanced through a plurality of drive strokes.

63. The suturing device of Claim 62 wherein the arcuate needle is advanced along the first direction 360 degrees around the arcuate needle track after the drive member is advanced through two drive strokes.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 64. The suturing device of Claim 62 wherein the arcuate needle is advanced along the first direction 360 degrees around the arcuate needle track after the drive member is advanced through three drive strokes.

65. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; a drive system comprising an actuator having a first trigger, and a drive member operably coupled to an elongate flexible member to advance an arcuate needle about the arcuate needle track and across the gap along a first direction; wherein the first trigger is operably coupled to a first end of the elongate flexible member; wherein the elongate flexible member reciprocates over at least one bearing surface proximate a distal end of the housing; wherein the at least one bearing surface directs the elongate flexible member from a first path laying in a first plane to a second path laying in a second plane different from the first plane, wherein the first path and second path overlap when viewed along a direction normal to the first plane; and wherein applying tension to the first trigger applies tension to the elongate flexible member in a first direction.

66. The suturing device of Claim 65, wherein the actuator is configured to be manually operated.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 67. The suturing device of Claim 65, wherein the actuator is configured to be coupled to an automated surgical device.

68. The suturing device of Claim 65, wherein the actuator is configured to be coupled to an automated surgical device and to be manually operated.

68. The suturing device of Claim 65, further comprising a needle track cover removably disposed on the housing.

69. The suturing device of Claim 68, further comprising a compressed member that urges the needle track cover off of the housing when in an unconstrained condition.

70. The suturing device of Claim 69, further comprising: a frangible coupling that counteracts force applied by the compressed member to hold the needle track cover in place; and an actuator operably coupled to the frangible coupling, wherein actuating the actuator ruptures the frangible coupling to permit the compressed member to eject the needle track cover from the housing.

71. The suturing device of Claim 70, further comprising a pull cable operably coupling the frangible coupling actuator to the frangible coupling.

72. The suturing device of Claim 65, further comprising: a second trigger operably coupled to a second end of the elongate flexible member, wherein applying tension to the second actuator applies tension to the elongate flexible member in a second direction.

73. The suturing device of Claim 65, further comprising an inner tubular member directly contacting the elongate flexible member, and an outer tubular member that surrounds the inner tubular member.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 74. The suturing device of Claim 73, further comprising: a proximal clamping assembly receiving the first end of the elongate flexible member, a first end of the inner tubular member, and a first end of the outer tubular member, wherein the first end of the elongate flexible member extends through the proximal clamping assembly.

75. The suturing device of Claim 65, further comprising a trigger spool received into a lateral opening in the first trigger.

76. The suturing device of Claim 75, further comprising at least one groove in the trigger spool holding the first end of the elongate flexible member therein.

77. The suturing device of Claim 75, further comprising a retainer extending over the trigger spool to hold the first end of the elongate flexible member thereon.

78. The suturing device of Claim 65, wherein the first trigger is spring biased.

79. The suturing device of Claim 65, wherein the first trigger is slidably coupled to the housing.

80. The suturing device of Claim 65, wherein the first trigger is rotatably coupled to the housing.

81. The suturing device of Claim 65, wherein the first trigger is rotatably coupled to at least one force- or movement-multiplying gearing between the first trigger and the first end of the elongate flexible member.

82. The suturing device of Claim 65, further comprising at least one ratchet-and-pawl or a detent mechanism extending between the housing and the first trigger to hold the first trigger in place.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 83. The suturing device of Claim 65, further comprising at least one tactile, colored, symbolic, or alphanumeric indicator on the housing or connected to the housing indicating needle position or stroke count.

84. The suturing device of Claim 65, further comprising at least one electronic or mechanical stroke counter on the housing.

85. An actuator handle for a cable-driven tool comprising: a first trigger operably coupled to a housing and to a first end of an elongate flexible member, wherein applying tension to the first trigger applies tension to the elongate flexible member in a first direction; and a second trigger operably coupled to a second end of the elongate flexible member, wherein applying tension to the second actuator applies tension to the elongate flexible member in a second direction.

86. The actuator handle of Claim 85, wherein the actuator is configured to be manually operated.

87. The actuator handle of Claim 85, wherein the actuator is configured to be coupled to an automated actuation device.

88. The actuator handle of Claim 85, wherein the actuator is configured to be coupled to an automated actuation device and to be manually operated.

89. The actuator handle of Claim 85, further comprising an inner tubular member directly contacting the elongate flexible member, and an outer tubular member that surrounds the inner tubular member.

90. The actuator handle of Claim 89, further comprising:U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 a proximal clamping assembly receiving the first end of the elongate flexible member, a first end of the inner tubular member, and a first end of the outer tubular member, wherein the first end of the elongate flexible member extends through the proximal clamping assembly.

91. The actuator handle of Claim 85, further comprising a trigger spool received into a lateral opening in the first trigger.

92. The actuator handle of Claim 91, further comprising at least one groove in the trigger spool holding the first end of the elongate flexible member therein.

93. The actuator handle of Claim 91, further comprising a retainer extending over the trigger spool to hold the first end of the elongate flexible member thereon.

94. The actuator handle of Claim 85, wherein the first trigger is spring biased.

95. The actuator handle of Claim 85, wherein the first trigger is slidably coupled to the housing.

96. The actuator handle of Claim 85, wherein the first trigger is rotatably coupled to the housing.

97. The actuator handle of Claim 85, wherein the first trigger is rotatably coupled to at least one force- or movement-multiplying gearing between the first trigger and the first end of the elongate flexible member.

98. The actuator handle of Claim 85, further comprising at least one ratchet-and-pawl or a detent mechanism extending between the housing and the first trigger to hold the first trigger in place.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 99. The actuator handle of Claim 85, further comprising at least one tactile, colored, symbolic, or alphanumeric indicator on the housing or connected to the housing indicating needle position or stroke count.

100. The actuator handle of Claim 85, further comprising at least one electronic or mechanical stroke counter on the housing.

101. A suturing device comprising: a housing, the housing defining an arcuate needle track, the arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive a tissue sample therein to be sutured; drive to advance an arcuate needle about the arcuate needle track and across the gap along a first direction, the drive comprising a drive member operably coupled to an elongate flexible member, the drive being configured to reciprocate the drive member along an arcuate pathway; and a retainer extending in a proximal direction from the housing, the retainer being configured to receive a distal end portion of an endoscope therein, the retainer being configured to hold the housing in place on the endoscope in a predetermined axial and rotational orientation.

102. The suturing device of Claim 101, wherein the retainer includes a deformable clip configured to grip the distal end portion of the endoscope.

103. The suturing device of Claim 101, wherein the retainer includes a guide sleeve configured to be received by an axial passage of the endoscope.

104. The suturing device of Claim 103, wherein the guide sleeve is eccentrically exposed within a passageway defined by the retainer.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 105. The suturing device of Claim 103, wherein the guide sleeve is axially aligned with and laterally offset with respect to a central axis of a passageway defined by the retainer.

106. The suturing device of Claim 105, wherein the guide sleeve includes an axial slit along a length thereof to permit the sleeve to be deflected laterally inwardly.

107. The suturing device of Claim 103, wherein the guide sleeve extends proximally from a radially inwardly extending boss.

108. The suturing device of Claim 103, wherein the guide sleeve is operably coupled to a proximally facing surface configured to contact a distal face of the endoscope.

109. The suturing device of Claim 101, wherein the retainer is defined by a deformable sleeve configured to slidably receive the distal end portion of the endoscope therein.

110. The suturing device of Claim 109, wherein the deformable sleeve defines an axial slit along its length configured to be deformed radially outwardly to receive the distal end portion of the endoscope therein.

111. The suturing device of Claim 109, wherein the deformable sleeve includes a proximal band configured to be clamped around the distal end portion of the endoscope by tightening a fastener coupling the proximal band to the housing of the suturing device.

112. The suturing device of Claim 111, wherein the deformable sleeve includes a distal portion including an alignment boss for engaging with a passageway defined in the distal end portion of the endoscope.

113. The suturing device of Claim 112, wherein the proximal band is separated from the distal portion by a transverse lateral gap.U.S. PROVISIONAL PATENT APPLICATION P06735-PCT FILE NO.: 106931.0047 114. The suturing device of Claim 113, wherein the transverse lateral gap has a circumferential extent in excess of ninety degrees.

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