Suturing devices and related systems and methods

Abstract

Implementations of a suturing device related methods are provided. The suturing device (100) includes a housing (110) that defines an arcuate needle track (120) having a first end (122) and a second end (124) and a gap (112) 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 (200) about the arcuate needle track and across the gap along a first direction. The device can further include a needle tip delivery passageway (180) intersecting the arcuate needle track. The needle tip delivery passageway can be configured to direct a distal portion of a needle tip delivery mechanism into the arcuate needle track.

Description

SUTURING DEVICES AND RELATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 583,903 filed September 20, 2023. The foregoing patent application 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 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 hasan 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 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 including a drive member to advance an arcuate needle 360 degrees about the arcuate needle track and across the gap along a first direction in a plurality of drive strokes. The device can further include a needle tip delivery passageway intersecting the arcuate needle track. Theneedle tip delivery passageway can be configured to direct a distal portion of a needle tip delivery mechanism into the arcuate needle track.

[0007] In accordance with some implementations, the needle tip delivery passageway can tangentially intersect the arcuate needle track along a lateral side portion of the housing.

[0008] In accordance with further aspects of the disclosure, the suturing device can further include a needle tip delivery mechanism configured to direct a needle tip along the needle tip delivery passageway into the arcuate needle track. The drive system can be configured to direct a main body of the arcuate needle into engagement with the needle tip after the needle tip delivery mechanism has delivered the needle tip to the arcuate needle track.

[0009] In some implementations, the needle tip delivery mechanism can include a needle tip delivery catheter configured to be advanced along the needle tip delivery passageway. The needle tip delivery catheter can include a proximal end, a distal end an elongate body connecting the proximal end to the distal end. The distal end of the needle tip delivery catheter can include a housing defining a distally facing cavity to receive a needle tip therein. The housing can include a magnet to help hold the needle tip in place within the distally facing cavity. The elongate body of the needle tip delivery catheter can include at least one guide thereon to maintain alignment of the elongate body within the needle tip delivery passageway. The at least one guide can have a lateral dimension that is larger than the elongate body. The guide can define at least one opening therethrough for receiving a length of suturing material therethrough. If desired, the housing can define at least one opening therethrough for receiving a length of suturing material coupled to the needle tip disposed in the distally facing cavity.

[0010] In some implementations, the needle tip delivery mechanism can be further configured to engage a main body of the arcuate needle. The drive system can be configured toremove the needle tip from the main body of the arcuate needle when the needle tip delivery mechanism engages the main body of the arcuate needle. The drive system can mechanically engage the needle tip while the needle tip delivery mechanism is engaged with the main body of the arcuate needle. The drive system can be further configured to pull the needle tip away from the main body of the arcuate needle to separate the needle tip from the main body of the arcuate needle. The drive member of the drive system can be prevented from moving past a location along the arcuate needle track where the needle tip delivery mechanism is engaged with the main body of the arcuate needle.

[0011] In accordance with further aspects, the housing of the suturing device can be configured to eject the needle tip from the arcuate needle track of the suturing device after the drive system separates the needle tip from the main body of the arcuate needle. In some implementations, the needle tip delivery passageway can include a lower portion that passes underneath the needle track. The lower portion of the needle tip delivery passageway can be configured to receive a distal protrusion of the needle tip delivery mechanism, wherein the suturing device is configured to direct the distal portion of the needle tip delivery mechanism underneath the arcuate needle. In accordance with further aspects, the needle tip delivery passageway can define a channel to slidably receive a distal protrusion of the needle tip delivery mechanism.

[0012] In accordance with further aspects of the disclosure, the needle tip delivery mechanism can include a needle tip delivery catheter that is slidably received in the needle tip delivery passageway. The needle tip delivery mechanism can include an elongate movable body coupled to a distal housing. The distal housing can define a compartment to removably receive the needle tip therein. The compartment can be configured to receive a sharp distal end of theneedle tip therein. A proximal end of the needle tip can protrude distally from the needle tip delivery mechanism. The distal housing of the needle tip delivery mechanism can include a distally extending protrusion extending distally of the compartment, wherein the distally extending protrusion can be configured to extend adjacent to a proximal region of the needle tip. The distal housing can define a passageway therethrough to receive a length of suturing material therethrough that is attached to the needle tip.

[0013] In some implementations, the drive member can be operably coupled to an elongate flexible member to advance the arcuate needle about the arcuate needle track and across the gap along the 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. The first path and second path overlap when viewed along a direction normal to the first plane.

[0014] 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.

[0015] In accordance with further aspects of the disclosure, the elongate flexible member can include a cable or a band, for example. 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.

[0016] 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.

[0017] 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.

[0018] In accordance with further aspects of the disclosure, the elongate flexible member can traverse an 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, the device can further include a first conduit that can in turn 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 tubularmember 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.

[0019] 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.

[0020] In accordance with still further aspects, the suturing device can further include a tool that includes an instrumentality to engage tissue. 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 arcuate needle passes across the gap.

[0021] 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.

[0022] 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 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 arcuateneedle 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.

[0023] 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 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.

[0024] The disclosure further provides needles having particular aspects. In some implementations, an arcuate needle is provided having a main body that in turn has a leading end defining a coupling and a trailing end. The main body is arcuately shaped, and defines at least one indentation therein. The at least one indentation can be located proximate the coupling at the leading end of the main body.

[0025] The needle can further include a needle tip having a sharpened leading end and a trailing end. The trailing end of the needle tip defines a complementary coupling to connect to the coupling of the main body. In some implementations, the needle tip can have an arcuately shaped body, and a coupling at the proximal end of the needle tip to engage a main body of the arcuate needle. At least one passageway can be defined through at least one surface of the needle tip. A distal end of a length of suturing material can traverse the at least one passageway defined through the needle tip. The length of suturing material can be coupled to the needle tip. If desired, the needle tip can define at least one surface therein to removably engage the drive member of the drive system of the suturing device. The main body of the arcuate needle can include a leading end and a trailing end, wherein the leading end defines a coupling to engage the needle tip.

[0026] In accordance with further aspects, at least one indentation can be formed into a radially outer surface of the main body of the arcuate needle. If desired, the arcuate needle can further include at least one indentation formed into a surface of the needle tip that can be configured to engage a drive member of a drive system of a suturing device. If desired, the arcuate needle can further include at least one indentation formed into a radially inner surface of the main body of the arcuate needle, and / or an upper arcuately shaped face of the needle and / or a lower arcuately shaped face of the arcuate needle. The needle tip can be arcuately shaped. Ifdesired, the arcuate needle can have a “D” shaped cross section along its length, among different or additional shapes.

[0027] 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.

[0028] 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 including a drive member to advance an arcuate needle 360 degrees about the arcuate needle track and across the gap along a first direction in a plurality of drive strokes, 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. The suturing device can further include a needle tip delivery mechanism configured to direct a needle tip into the arcuate needle track.

[0029] The disclosure further provides implementations of methods of performing a suturing procedure. An illustrative method includes providing a suturing device as set forth herein, deploying an elongate body 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.

[0030] In accordance with further aspects, the illustrative method can further include advancing the needle tip delivery mechanism to the needle track to engage a surface of the arcuate needle. The drive system can then be actuated to mechanically separate a needle tip of the arcuate needle from a main body of the arcuate needle. The method can still further include ejecting the needle tip of the arcuate needle from the suturing device. The method can still further include introducing a new needle tip into the arcuate needle track using the needle tip delivery mechanism, and actuating the drive system to mechanically engage the new needle tip with the main body of the arcuate needle. In some implementations, the suturing procedure can be repeated multiple times to perform a Endoscopic Sleeve Gastroplasty (“ESG”). It will be appreciated that the disclosed devices and methods can be applied to various laparoscopic, thoracic, gastrointestinal, pulmonary and cardiovascular procedures. The ejected needle tip can remain attached to a length of suturing material that has been routed through the target region of tissue and function as a suture anchor in the target region of tissue to prevent the length of suturing material from being pulled through the tissue.

[0031] Additional objects, features, and / or advantages will be set forth in part in the description which follows, and in part will be apparent from the description, or may be learned by practice of the present disclosure and / or claims. At least some of these objects and advantagesmay be realized and attained by the elements and combinations particularly pointed out in the appended claims.

[0032] 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

[0033] 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,

[0034] FIG. 1 depicts an isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0035] FIG. 2 depicts a transparent isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0036] FIG. 3 depicts an exploded isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0037] FIG. 4A depicts a lower isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof. FIG. 4B depicts an upper isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof. FIG. 4C depicts a lower plan view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0038] FIG. 5 A depicts an isometric view of a housing component of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof. FIGS. 5B-5C depict lower isometric views of the housing of FIG. 5 A, whereas FIG. 5D depicts an upper isometric view of the housing of FIG. 5 A.

[0039] FIG. 6A depicts an enlarged lower isometric view of the housing of FIG. 5 A, whereas FIG. 6B depicts a further enlarged view of a cavity configured to receive an anti -rotate pawl, or brake, that protrudes through a lower surface of an arcuate needle track of the housing of FIG. 5 A.

[0040] FIG. 7 depicts a further enlarged lower isometric view of the housing of FIG. 5 A.

[0041] FIG. 8 is an upper isometric section view of the housing of FIG. 5 A, illustrating relative placement of the arcuate needle track and the needle tip delivery passageway.

[0042] FIG. 9 is an upper isometric section view of the housing of FIG. 5 A, illustrating relative placement of a plate defining a channel that joins the arcuate needle track to a shuttle track of the housing, and relative placement of the needle tip delivery passageway.

[0043] FIGS. 10A-10C depict various longitudinal isometric section views of the suturing device of FIG. 1.

[0044] FIGS. 11-12 are lower isometric views of the suturing device of FIG. 1. illustrating relative placement of components of the drive system of the suturing device.

[0045] FIGS. 13A-13B are upper and lower isometric views of a lower housing cover component in accordance with the present disclosure.

[0046] FIGS. 14-18 depict isometric views of a removable cover portion for a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0047] FIG. 19 depicts an isometric top view of a suturing device in accordance with some embodiments of the present disclosure and illustrative brakes, or aspects thereof.

[0048] FIGS. 20-21 depict an isometric lower front view and an isometric upper rear view of an elongate flexible member pathway and shuttle of the drive system of the suturing device of FIG. 1, or aspects thereof.

[0049] FIGS. 22-25B depict isometric views of a shuttle of the drive system of the suturing device of FIG. 1, or aspects thereof.

[0050] FIG. 26 depicts aspects of routing an elongate flexible member in accordance with the present disclosure.

[0051] FIGS. 27-38 depict isometric views of an arcuate needle for a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0052] FIGS. 39-490 depict views of a needle delivery mechanism in accordance with some embodiments of the present disclosure, or aspects thereof.

[0053] FIGS. 50A-63 depict views of steps for operation of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0054] FIGS. 64-79 depict views of further steps for operation of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0055] FIG. 80 depicts a distal isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0056] FIG. 81 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.

[0057] FIG. 82 is a schematic diagram for a robotically -assisted manipulator system, according to some examples.

[0058] FIG. 83 A is a schematic diagram of an instrument system according to examples described herein.

[0059] FIG. 83B illustrates a distal portion of the instrument system of FIG. 97A with an extended example of an instrument according to examples described herein.DETAILED DESCRIPTION

[0060] 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 and gastrointestinal procedures.

[0061] 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.

[0062] For purposes of illustration, and not limitation, a representative implementation of a suturing device is presented in FIGS. 1-4, 10A-12 and 50A-80. 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.

[0063] The suturing device 100 of FIGS. 1-4 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 (FIGS. 53-58). The suturing device 100 furtherincludes a drive system 130 utilizing an elongate flexible member 150 coupled to a shuttle 140 containing a drive member 132 to advance an arcuate needle 200 about the arcuate needle track 120 and across the gap 112 along a first direction A as indicated. Not pictured but forming a part of the suturing device 100 include cable sheaths to route tension cables to one or more proximally located actuators, such as hand actuated devices or an automated or robotic surgical system (FIGS. 82-83B), discussed below. The return side of the elongate flexible 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.

[0064] With reference to FIGS. 4A-4B, in some implementations, the segment(s) of the elongate flexible member (e.g., 152A, 154A, 156A) that pull the shuttle 140 along the drive direction to advance the needle can be routed round a pulley 134A as depicted. However, the segment(s) of the elongate flexible member (e.g., 152B, 154B, 156B) that pull the shuttle 140 back to its starting position may be under less tension, and may not use a pulley 134B as depicted. For example, a guide tube or channel (not shown) may be used instead that defines a channel for the elongate flexible member to traverse, such as one that follows a spline-shaped pathway through the housing 110 of the suturing device 100. Additionally or alternatively, in some implementations, the pulley 134A that the segment(s) of the elongate flexible member (e.g., 152A, 154A, 156A) ride over to pull the shuttle 140 along the drive direction to advance the needle can be eliminated, and be replaced with a low friction cable / surface interface instead, such as a low friction synthetic cable that passes through or along a channel of any desired shape, such as a spline or other shaped channel or pathway.

[0065] FIG. 1 further depicts a needle tip delivery passageway 180 incorporated into the housing 110 of the suturing device 100 that extends from a proximal location, such as proximate an actuator (FIGS. 82-83B) to the needle track 120, wherein the needle tip delivery passageway180 intersects with and passes beneath the needle track in order to accommodate a needle tip delivery mechanism (280, 290) discussed in further detail below. Suturing device 100 includes a removable cover 160 that covers the needle track. The cover 160 is discussed in further detail below with reference to FIGS. 14-18.

[0066] As depicted in FIG. 80, the suturing device 100 can be operably coupled to an endoscope 300, such as 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 housing 110 of the suturing device 100. 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 arcuate needle 200 when it is situated in the needle track 120.

[0067] A needle drive system 130, discussed in further detail below, provides functionality to effect movement of the arcuate needle 200 about the needle track 120 to advance the arcuate needle 200 through tissue to be sutured that is present within the gap 112. FIG. 4A depicts a lower view of the suturing device 100 illustrating the location of different system including pulleys, elongate flexible members / cables and the like. FIG. 2 presents a transparent view of the suturing device 100, illustrating relative placement of the arcuate needle 200 within a needle track 120 of the device, but omitting components of the drive system 130 to better illustrate interior components of the housing 110. FIG. 3 depicts an exploded view of the portionof the suturing device depicted in FIGS. 1-2, but also omitting the components of the drive system 130 omitted in FIG. 2.

[0068] FIGS. 4A-4C depict the routing of inner elongate flexible member or cable 150 that includes cable portions 152A, 152B, which in turn traverse a path that 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 portions 152A, 152B begin at a center point or apex of the arch of the needle track 120 and continue distally to a locations where they are directed around respective pulleys 134A, 134B, after which proximally directed portions 154A, 154B are directed through sheath portions 172A, 172B and then proximally as proximal cable portions 156A, 156B. As depicted, shuttle 140 is situated in arcuate shuttle track 120A, which is coupled to elongate flexible member or cable 150 at a center portion thereof.

[0069] Each pulley 134A, 134B comprises a bearing surface that contacts the elongate flexible member 150. Other mechanical components 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 or sheathing 172A, 172B is 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.

[0070] 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 154 A, 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. As depicted in FIG. 4C, the first path (e.g., of cable section 152A, 152B) and second path (e.g., of cable section 154A, 154B) overlap when viewed along a direction normal to the first plane.

[0071] 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.

[0072] For purposes of illustration, and not limitation, with continuing reference to FIGS. 4A-4C, pulley 134A rotates about an axle portion 104 that has a centerline, forming an axis of rotation XIA. Pulley 134B rotates about an axle portion 104 that also has a centerline, forming an axis of rotation X1B. As can be seen, axes of rotation XIA, X1B are neither normal to, nor parallel to a plane defined by the travel of tip of arcuate needle 200 or wall 120C. Axes XIA, 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, elongate flexible member portion 152A extends distally along a first parallel arm 110A of the housing, around the first pulley 134A, andback along a proximal direction. Second elongate flexible member portion 152B extends distally along the second parallel arm HOB of housing 110, around the second pulley 134B, and back along a proximal direction.

[0073] As further depicted in FIGS. 4A-4C, elongate flexible member portions 154A, 154B can extend proximally to a point where they each enter a first conduit 172A, 172B where the flexible member portions 154A, 154B are redirected into proximal elongate member portions 156A, 156B that extend proximally through the conduits 172A, 172B to an actuator of the suturing device 100 (FIGS. 82-83B). The proximal portions 156A, 156B of elongate flexible member 150 are depicted with the conduits 172A, 172B removed. It will be appreciated that both proximal portions 156A, 156B of elongate flexible member 150 can be directed through a single suitably configured conduit rather than individual conduits, as desired.

[0074] As further illustrated in FIG. 4B, the drive 130 includes a drive member 132 operably coupled to elongate flexible member 150 via a shuttle 140. The drive 130 via the shuttle 140 is configured to reciprocate the drive member 132 along an arcuate pathway from a starting position to an ending position during a drive stroke. Depicted in FIGS. 4A-4C 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 and 134B. Shuttle 140 is held in place on elongate flexible member 150 through any suitable means such as a crimp 150A (FIG. 25 A), and follows the elongate flexible member 150 as the elongate flexible member 150 reciprocates back and forth over the pulleys 134A, 134B. As the elongate flexible member 150 reciprocates, the shuttle 140 and drive member 132 follow an arcuate path that follows the path of the arcuate needle 200 in the arcuate needle track 120. Also depicted in FIGS. 4A-4C are brake members in the form of pawls or clips 113.

[0075] FIG. 4C is a bottom plan view of the device 100 presented in a plane that is parallel to the path of travel of the centerline of the arcuate needle 200 with the lower housing covers 117A, 117B removed, illustrating the pathway of the elongate flexible member 150, and the direction each elongate flexible member segment (152A, 152B, 154A, 154B) follows during operation of the suturing device 100 when moving the shuttle 140 from a starting position to an ending position along the shuttle track or raceway 120A. When shuttle 140 moves counterclockwise along the raceway or shuttle track 120A, elongate flexible member 154A moves distally and elongate flexible member 154B moves proximally. When returning shuttle 140 to its starting point when moving in a clockwise direction around gap 112, the direction of rotation of the pulleys 134A, 134B reverses as does the direction of travel of the elongate flexible member 150.

[0076] FIGS. 10A-10C and FIGS. 25A-25B are various longitudinal cross sections of suturing device 100. In FIGS 25A-25B, the longitudinal cross section is taken along a centerline of drive member 132 to illustrate how the drive member 132 moves downward into the shuttle and upward to engage a notch in arcuate needle 200 so that the drive member 132 and shuttle 140 carry the arcuate needle 200 along the needle track 120 when the shuttle 140 is moving from the shuttle starting position to the shuttle ending position. The cross sections in FIGS. 10A-10C are taken to better illustrate the pathway followed by the needle tip delivery passageway 180.

[0077] The manner in which the elongate flexible member or cable 150 is routed about pulleys 134A, 134B helps reduce the profile of the suturing device 100 to provide a correspondingly larger tissue gap 112 and needle track 120 to capture and suture tissue. The depicted suturing device 100 is configured so that a significant portion of suturing device 100 aligns with the axial “shadow” or projection of the endoscope, reducing the effective insertiondiameter 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. FIG. 20 presents a distal end plan view of the elongate flexible member 150 and shuttle 140, particularly illustrating segments 152A, 152B, 154A, 154B of elongate flexible member 150. The relative angulation of the axes about which the pulleys 134A, 134B rotate (FIGS. 4A-4C) facilitate creating a suturing device 100 of a smaller relative width profde than if pulleys 134A, 134B reciprocated about axes that were vertical as depicted in FIG. 20. FIG. 21 is an opposing view of the shuttle 140 and cable sections of FIG. 20 when viewed along a distal direction.

[0078] 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 150 is intended 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 150 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 150 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.

[0079] For purposes of further illustration, and not limitation, as embodied herein, FIGS.4A-4C, 11, and 12 present lower isometric views 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 arm HOB that cooperate to at least partially define the gap 112. Furtherillustrated is the raceway 120A that is disposed parallel to the needle track 120 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., 108), 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, 172B).

[0080] FIGS. 5A-FIG. 9 and FIG. 19 illustrate the housing 110 of the suturing device 100 from various angles. As illustrated, the housing 110 of the suturing device also defines a plurality of bores 102 formed therein to receive a respective end of each of two axles 104 (FIGS. 4A-4C, FIG. 11, FIG. 12) that correspondingly support pulleys or wheels 134A, 134B (FIGS.4A-4C). Housing 110 further defines a plurality of passageways 106 therethrough for receiving a threaded fastener (e.g., 108) to hold the cover 160 in place on the housing (FIG. 1), or holding the lower housing covers 117A, 117B in place (FIGS. 11-13B).

[0081] As further depicted in FIG. 5A, the housing 110 defines a needle tip delivery passageway 180 that extends from beyond a proximal end of the housing 110 parallel to the direction of the sleeve 119 into the distal portion of the housing where the needle tip delivery passageway 180 intersects the needle track 120, raceway or shuttle track 120A, as well as the wall 120C that separates the needle track 120 and raceway 120A in the location of channel 120D, which intersects with arcuate channel 120B. FIGS. 5B-5D depict the housing 110 in combination with an arcuate needle 200 and a needle track cover 160 to illustrate relative placement of these components. 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 ofadditive 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.

[0082] FIG. 19 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. For purposes of illustration only, FIG. 19 illustrates housing 110 of device 100 with the cover 160 removed from the housing 110 to fully expose the needle track 120. FIG. 19 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. 7). The needle track 120 and shuttle track 120A are both arcuate and are separated by a separation 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 leading point 214 of the arcuate needle 200 as the arcuate needle 200 traverses the needle track 120 when the device 100 is operated.The separation 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. Groove 120B intersects with enlarged groove 120D formed into wall 120C as a part of the needle tip delivery passageway 180 to receive a distal projection 284 of the housing 280 of the needle tip delivery mechanism. As illustrated in FIGS. 25A-25B, 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 a drive surface, such as an indentation, drive notch (e.g., 221, 225, 231 in FIG. 28), or trailing surface 222 of the arcuate needle 200, discussed in further detail below.

[0083] FIG. 19 also depicts the positions of brakes, such as brake pawls or brake clips113, 115. As depicted, brake pawl 113 is presented as “U” or “V” shaped member made from a resilient and spring-like material such as a metal or a stiff polymer. Brake 115 is instead depicted as a protrusion extending upwardly from a floor of the needle track 120. Brake 115 is substantially the same as drive member 132 disposed within shuttle 140, and may be disposed in any desired location along the needle track 120 that pushes up or down into the needle 120 or radially inwardly or outwardly into the arcuate needle 200. Brake 113 is received by a corresponding “V”-shaped cavity formed into the housing 110 as depicted in FIG. 19, whereas brake 115 is received by a complementary cavity 115A formed into the housing 110. The cavity into which clip 113 is disposed is configured to orient one tip of clip 113 into the needle track 120 along a direction that is oblique to the direction of travel of the needle such that brake clip 113 can engage a surface of an indentation formed into the arcuate needle 200, or a trailing edge 222 of the arcuate needle 200. 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.

[0084] FIGS. 14-18 illustrate various views of a representative implementation of a needle track cover 160 in accordance with the present disclosure. As depicted, the cover 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 is installed in the housing 110. Optional tabs 165 A, 165B are illustrated for providing a location for boreholes to accommodate a threaded fastener 108. It will be appreciated that suchtabs and fasteners 108 are optional and that the cover 160 can be configured to snap fit into place over the housing 110, if desired.

[0085] 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. It can be observed 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 is actually defined in the angled surface 163D that is either slightly oblique or orthogonal to the direction of travel of the needle.

[0086] The boss 163C and angled surface 163D can help to keep tissue stable during the period when the arcuate 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. As depicted, surface 163D 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.

[0087] 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, one or more chamfered surfaces 163E are 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 aroundthe 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.

[0088] As further depicted in FIGS. 14-18, cover 160 further includes a lower lip or flange 168 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. In some implementations, the housing 110 suturing device can define a compartment or bore 109 (FIG. 9) containing an axially compressible member (not shown) such as a compressive coil spring, leaf spring or an elastomer spring that tends to urge the needle track cover 160 distally 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 a proximal side of wall portion 164 of the cover 160, if desired. Moreover, the suturing device 100 can 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 an 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 actuator can rupture the frangible coupling to permit the compressed member to eject the needle track cover 160 from the housing in a distal direction off of the housing 110 to expose the arcuate needle track 120. It can be desirable to remotely remove the needle track cover 160 during a medical procedure while the suturing device 100 is still inside the patient. For example, if the arcuate needle 200 should become jammed inside the device, the cover 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 to dangle from the housing 110 if it is ejected to facilitate removal of the arcuateneedle 200 from the needle track 120, but still permit the cover 160 to be withdrawn with the device 110. In a further implementation, the cover 160 can be formed from bioresorbable material so that it need not be removed from the patient if ejected from the suturing device 100.

[0089] FIGS. 13A-13B depict a first view of component 117B depicted with its lower face showing as depicted in FIGS. 11-12. Also depicted is the upper face 117B5 of component 117B that faces and mates to a lower surface of the housing 110. As depicted, the upper face 117B5 of component 117B includes distal and proximal bores 117B1, 117B3 for receiving a fastener 108 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 component 117B that is not parallel to upper face 117B5 of component 117B, but is instead orthogonal with respect to a central axis of an axle 104 that is received by the bore in cooperation with bore 102 of housing 110 of suturing device 100. A channel 117B6 is further defined in the upper face 117B5 of component 117B to receive elongate flexible member or cable segment 154B.

[0090] FIGS. 22-25B relate to the construction and configuration of shuttle 140. As depicted in FIG. 22, 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 1206 that is defined through wall 120C to help guide the shuttle 140 and drive member 132 along an arcuate path to drive the arcuate needle 200.

[0091] As illustrated shuttle 140 defines a first central window 143B in a front face of the shuttle 140, and side windows 143 A, 143C in the side walls of the main body portion 141 of the shuttle 140. 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 140, between the guides 141 A through arcuate groove 120B into the needle track 120 where it can engage the arcuate needle 200. When the bottom plate 142 of the shuttle is removed, grooves 143 A 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 1 0.

[0092] The shuttle 140 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 arcuate needle 200. Also illustrated is relative placement of crimp 150A within compartment 144A of housing portion 141. FIGS. 25A-25B present a cross section of some of the components of shuttle 140 along a vertical centerline of drive member 132.

[0093] With reference to FIG. 26, the suturing device 100 can use various techniques to guide the elongate flexible member 150 to an actuator of the suturing device 100, such as a manual actuator or an automated actuator (FIG. 82-83B). In some implementations, the sheathing or conduits 172A-172 B can be configured as indicated in FIG. 26. Such conduits can include an inner tubular member 174 that directly contacts the proximal section 156 of theelongate flexible member 150, and an outer tubular member 172 that surrounds the inner tubular member 174. The outer tubular member 172 can be a coil with flattened windings that define a hollow passage therethrough (similar to the flexible proximal portion 290 of the needle tip delivery mechanism) to maintain tension in the elongate flexible member 150 during operation of the suturing device 100. As illustrated in FIG. 4A, for example, segment 156B passes into conduit 172 travels in a proximal direction. A corresponding cavity or cavities 171, 173, 175 can be formed into the housing 110 of the suturing device 100 including, for example, a first channel 171 configured to permit elongate flexible member 150 / 156 to pass through, preferably without touching the housing 110 of the suturing device. Channel 171 widens into a channel 173 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 174. Inner tubular member 174 is preferably formed from a polymeric tubular material that is lubricious material, such as PTFE, or includes a lubricious coating such that any relative sliding contact between cable or elongate flexible member 150 / 156B and the inner wall of tubular member 174 does not cause significant frictional resistance. Channel 173 widens further into a larger channel 175 that includes a proximally facing distal wall and circumferential wall to receive a distal end therein of outer tubular member 172.

[0094] In a complete assembly, conduits 172, 174 can be located along both sides of the suturing device 100 to accommodate a respective end of the elongate flexible member 150. These ends of the elongate flexible member 150 and inner 174 and outer 172 sleeves are then operably coupled with one or more actuators, including but not limited to an actuator of a robotic surgical system depicted in FIGS. 82-83B, described in detail further below. In use, the suturingdevice 100 receives a distal end of an endoscope 300, and the conduits 172A, 172B can be clipped or otherwise attached to the endoscope at discrete locations along its length.

[0095] The disclosure further provides suturing needles having particular aspects.

[0096] For purposes of illustration, and not limitation, as illustrated in FIGS. 27-30, an arcuate needle 200 is provided having a main body portion 220 and a removable needle tip 210, which may each in turn have arcuately shaped bodies. The arcuate needle 200 can have a “D” shaped cross section along its length (see, e.g., FIGS. 29 and 34), wherein a flat side (e.g., 210A, 220A) 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). An arcuate needle 200 with rectangular (or square) cross section, potentially with sharp, chamfered, or radiused comers may be used, as well as a circular cross section needle, and the like.

[0097] With reference to FIGS. 27-31 a main body 220 of the arcuate needle 200 is illustrated. Main body 220 has a leading end 224 defining a coupling 230 and a trailing end 222. The main body 220 is arcuately shaped, and defines at least one indentation, or notch (221, 223, 225, 231, 233) therein. As illustrated, one of indentation 223 is located proximate the coupling 230 at the leading end of the main body, immediately behind the coupling 230.

[0098] As illustrated, an indentation, or notch, 221 is formed into a radially inner surface 220B of the main body of the arcuate needle. Notch 223 is formed into a radially outer surface 220C of the main body 220 of the arcuate needle 200. Notches 231, 233, 225 are formed into a lower arcuately shaped face of the main body 220 of the arcuate needle 200. A ramped portion 223A can also be formed into a leading, lower surface of the main body 220 of the needle.

[0099] With reference to FIG, 31, the coupling 230 of the main body 220 of the arcuate needle 200 is formed from a leading tapered or conical surface 230A of a body of a first diameterfollowed by a reduced diameter section 230B, that is followed by a further enlarged section 230D having a cross-sectional shape (such as a “D” shape) that complements the shape of the cavity 213 defined in a trailing end 212 of the needle tip 210.

[0100] With reference to FIGS. 32-38, the arcuate needle 200 can further include a needle tip 210 having a sharpened leading end 24 and a trailing end 212. The trailing end 212 of the needle tip 210, as illustrated, defines a complementary coupling to connect to the coupling of the main body in the form of an opening 218 leading to a cavity 213 A defined within the body of the needle tip 210 that is configured and arranged to receive the coupling 230 of the main body 220. As illustrated, a plurality of passageways 211, 213, 215, 217 are defined through the needle tip 210 both to receive the coupling 230 of the main body 220, as well as for purposes of holding a distal end of a length of suturing material in place, attached to the needle tip 210. A distal end of a length of suturing material (not shown) can traverse the at least one passageway 211 defined through the needle tip 210, bend over surface 211 A, and exit the needle tip 210 out through passageway 217. As illustrated, all openings through the surface of the needle tip 210 are interconnected through internal passageways defined through the needle tip 210. The opening 218 in the trailing end 212 of the needle tip progresses into passageway 213 that receives the coupling 230 of the main body 220. This passageway 213 is in fluid communication with a passageway 217 that itself is connected to passageway 211 and 215. As further illustrated in FIG. 32, the needle tip 210 further defines an indentation, notch or surface 219 therein to removably engage the drive system 130 of the suturing device 100. More specifically, the indentation or engagement surface 219 can engage drive member 132 of the drive system 130 of the suturing device 100. As depicted in FIG. 36B, a variation 210’ of needle tip 210 is depicted wherein opening 213 is teardrop-shaped rather than rectangularly-shaped. Also depicted is aleading end of a length of suturing material 10, or suture, showing a pathway, such as a serpentine pathway, that the suture 10 may traverse through the passageways of the needle tip to hold the suture 10 in place. The end of the length of suture 10 can be held in place within the passageways of tip 210, 210’, for example, by adhesive, melting the suture, and the like.

[0101] One or more of the notches or indentations formed into the arcuate needle 200 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., 221A) that is perpendicular (or approximately perpendicular) to an arcuate centerline 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., 221C). Alternatively, a second flat wall (e.g., 22 IB) can be provided at a bottom of the notch or indentation that is perpendicular, or approximately perpendicular to the first wall (e.g., 221 A). For example, notch or indentation 221 is comprised of a first “vertical” wall (e.g., 221A), a second “horizontal” surface (e.g., 221B) that is parallel to an arcuate centerline of the needle, and a third “ramped” surface (e g., 221 C) that traverses toward the radially inner surface 220B of the main body 220 of the arcuate needle 200. The components of arcuate needle 200 can be formed in a coining process, or can be formed by way of metal injection molding, or by additive manufacturing techniques, among others.

[0102] In accordance with further aspects of the disclosure, the suturing device can further include a needle tip delivery mechanism configured to direct a needle tip into the arcuate needle track. For purposes of illustration, and not limitation, FIGS. 39-490 illustrate a needle tip delivery mechanism that includes a distal housing 280 operably coupled to an elongate member 290. As discussed below with reference to FIGS. 50A-79, the drive system 130 of the suturing device 100 can be configured to direct a main body 220 of the arcuate needle 200 intoengagement with the needle tip 210 after the needle tip delivery mechanism 280, 290 has delivered the needle tip 210 to the arcuate needle track 120. The needle tip delivery mechanism 280, 290 can include a needle tip delivery catheter configured to be advanced along the needle tip delivery passageway 180, or may be an end effector for a robotic assisted surgical system as described below.

[0103] FIGS. 39-43 illustrate aspects of the needle tip delivery mechanism, which includes a distal housing 280 operably coupled to a proximal elongate flexible member 290, illustrated in the form of a coiled member with flattened windings and defining an internal passageway 292 along its length. A distal end of elongate flexible member 290 is received at and attached to a surface 282A of distal housing 280. Distal housing 280 is formed from a body that defines a cavity 286 therein that is configured to receive needle tip 210 therein. A distally extending projection 284 of distal housing 280 cooperates with an interior curved wall 286A of cavity 286 to support and hold needle tip 210 in place while it is being delivered. While not illustrated, a length of suture extending from a passageway of the needle tip 210 is received through lumen 288, wherein the length of suturing material extends from the needle tip 210 into distal port 288D of passageway 288 and exits from proximal port 288P of passageway 288. The length of suturing material then extends proximally alongside elongate flexible member 290, and out of the suturing device 100. Distal housing 280 defines a shoulder 223 A at a distal end thereof to engage with engagement surface 223 of the main body portion 220 of arcuate needle 200 to prevent the main body portion 220 of the arcuate needle 200 from moving along the needle track to permit the drive member 132 to engage engagement surface or notch 219 of the needle tip to permit the drive system 130 of the suturing device 100 to separate the needle tip 210 from the main body 220 of the arcuate needle 200. During removal of the needle tip 210 fromthe main body portion 220 of the arcuate needle 200, the distal housing 280 engages and / or pushes up against a radially outer curved surface of the needle tip 210. This engagement then prevents the drive member 132 from moving past the drive notch 219 in the needle tip 210. As the needle tip 210 is pulled forward the main body portion 220 of the arcuate needle 200 is pulled along with the needle tip 210 until the distal housing 280 engages with the notch 223, facilitating separation of the needle tip 210 from the main body 220 of the arcuate needle 200.

[0104] As further depicted in FIGS. 44-47B, the distal housing 280 includes an outer circumferential surface 282B that is configured to be slidably received along needle tip delivery passageway 180 of the suturing device 100. The protrusion 284 of the housing is located to pass underneath the needle tip 210 of the arcuate needle 200 and coincide with the raceway or shuttle track 120A as well as the gap 120D defined in plate 120C of the housing 110 of the suturing device. Specifically, the needle tip delivery mechanism is advanced distally until protrusion 284 contacts the periphery of gap 120D, which acts as a distal stop for the distal housing 280, wherein a portion of the protrusion extends downward into the shuttle track 120A. This alignment, combined with the geometry of the distal housing 280 provides alignment and support to receive the leading end 224 of the main body portion of the needle to engage the needle tip 210. Further details of the operation of the suturing device 100, including delivery and attachment of the needle tip 210, suturing, and detachment and ejection of the needle tip 210 are described below with reference to FIGS. 50A-79.

[0105] As further illustrated in FIGS. 48A-48D, a variation 280’ of a distal housing is depicted with a depiction of a distal end portion 80 of a needle delivery catheter 50 described in further detail below with respect to Figs. 49A-49O.

[0106] Distal housing 280’ is generally similar to embodiment 280 described above with two notable differences. First, rather than using a closed passageway for routing suturing material as discussed above with respect to distal housing 280, distal housing 280’ utilizes a suture management slot 288’ that is fully open, permitting a suture to be slid into the slot 288’ laterally rather than requiring introduction along a proximal direction through a distal port, as with distal port 288D of distal housing 280. This permits a length of suturing material (e.g., 10 in FIG. 36B) attached to a needle tip (e.g., 210’) to be inserted through slot 288’at any desired time. Second, distal housing 280’ includes a proximally extending sleeve 281 ’ that is configured to receive therein a magnet 294’ and tubular member 296’, discussed in further detail below.

[0107] As mentioned above, FIG. 48D depicts a partial distal end portion 80 of a shaft of an illustrative needle delivery catheter 50 in accordance with the present disclosure. A full view of the needle delivery catheter 50 is depicted in FIG. 49A, and portions of the needle delivery catheter 50 are depicted in FIGS. 49B-49O. As depicted, needle delivery catheter 50 includes a proximal end 52 including a handle assembly 60, 70, an elongate central portion 90 and a distal end portion 80. With continuing reference to FIG. 48D, the distal end portion 80 of needle delivery catheter 50 is depicted with distal housing 280’ removed from the shaft 290’. This reveals a shortened distal hypotube portion 296’ or sleeve that is adhered or welded over tubular member 290’. Tubular member 290’ may be a torqueable tube such as a hypotube or other suitable tubular member that is configured to transmit applied torque along its length.

[0108] With continuing reference to FIG. 48D, a magnet 294’, such as a neodymium magnet, can be located at the distal end of tube 290’ and be located within compartment 282’ of housing 280’. Magnet 294’ can be held in place in compartment 282’ by adhesive or the like. Hypotube section 296’ can be adhered or welded to housing 280’, also helping to hold magnet294’ in place. Magnet 294’ can be used to help hold needle tip (e.g., 210, 210’) in place within housing 280’ when the needle tip 210 / 210’ is made from or otherwise contains ferromagnetic material.

[0109] FIGS. 49B and 49C depict two variations of a distal end portion 80 of needle delivery catheter 50. Each of these embodiments includes a different guide (82, 84) to help maintain relative angulation of the distal housing when the needle delivery catheter 50 is traversing passageway 180 of suturing device 100. As depicted, the distal end portion 80 of the needle delivery catheter 50 includes torqueable tube 290’ described above that is attached to distal housing 280’. Tube 290’ may be continuous through the proximal end of the device that is captured within the distal clamping arrangement of housing 60’ (FIG. 491). Alternatively, tube 290’, or may transition to a proximal tubular portion (or rod) 293’ made from another material, such as a shape memory material, including a nickel -titanium alloy, for example. If made from shape memory material, tubular portion (or rod) 293’ may be imparted with a shape memory in the form of a bend that helps to align distal housing 280 with the needle track of the suturing device.

[0110] As depicted in FIGS. 49B and 49C, portions 290’, 293’ may be joined by a tubular sleeve 291’ by way of adhesive or the like. As mentioned above, a sleeve guide (82, 84) is joined to distal end portion 80 at the location of sleeve 291’. Sleeve guide 82, 84 is configured to slightly clear the inner diameter of the needle tip delivery passageway 180 (e.g., FIG. 1) so that the sleeve guide may slide without interference within needle tip delivery passageway 180. With reference to FIG. 49D-49G, the sleeve guides 82, 84 may provide one or more openings or peripheral slots (e.g., 82A, 82B, 84A) to accommodate a length of suturing material (e.g., 10 in FIG. 36B) therein (or simply to reduce the circumferential contact area of the sleeve guide) toprevent the suturing material from interfering with movement of the needle delivery catheter 50 along the needle tip delivery passageway 180. Each guide 82, 84 also includes a main notch or indentation 82C, 84C to accommodate sleeve 291’, such as by way of adhesive connection.

[0111] FIGS. 49H-49O depict a proximal portion of the needle delivery catheter 50, which is composed of two interlocking components including a housing 60 that is configured to clamp to a proximal end of tubular member 295 (FIG. 49B, 49C) and a torqueing handle 70 that is configured to clamp to inner rod or tube 2937297’ (or torque tube 290’ if so configured). Specifically, torqueing handle 70 includes an offset lateral portion 73 coupled to a proximally extending boss 74 and a distally extending boss 75. Distally extending boss 75 terminates in a clamping arrangement configured to clamp down on a proximal region of inner rod or tube 293’ that in turn is defined by two distally extending tabs defining a slot 72 therebetween, wherein the slot can be narrowed by tightening threaded fasteners in holes 78, thereby clamping down on inner rod (or tube) 293 ’ . Inner rod or tube 293 ’ extends proximally through tubular member 295 and proximally with respect to tubular member 295, terminating in a 90 degree bent portion 297. Portion 297 is received within a slot 76 through a proximal face of offset lateral plate 73, which in turn is located proximally with respect to tubular member 295. Bent portion 297 permits torque to be transmitted from handle 70 to the distal housing 280. Tubular member 295 in turn is held in place within a clamping arrangement defined in a distally extending boss of housing 60. This clamping arrangement includes a slot 68 that can be collapsed by tightening threaded fasteners received in openings 66. The distal boss 75 is received within cavity 64 of housing and held in place by tightening fasteners disposed in cavities / holes 67.

[0112] FIGS. 50A-52 depict certain aspects of loading a needle tip 210 on a main body220 of an arcuate needle 200 using the drive system 130 of the suturing device, and FIGS. 64-71illustrate the same process, showing the movement of internal components of the suturing device100.

[0113] With reference to FIG. 50A and FIGS. 64-67, in a first step of loading a needle tip 210, the main needle body 220 is rotated along the arcuate needle track 120 to a needle tip insertion position, wherein the position of the main body 220 of the arcuate needle 200 is advanced to a location wherein it will not mechanically interfere with delivery of the needle tip 210 via the distal housing 280 of the needle tip delivery mechanism. In this position, an antirotate pawl 115 is visible that extends upwardly through a floor of the needle track 120. Also visible is the needle tip delivery passageway 180 that intersects the needle track 120 in a tangential geometric relationship. FIG. 64 illustrates the drive member 132, which contacts and drives the trailing end of the main body 220 of the arcuate needle 200.

[0114] With reference to FIG. 50 and FIG. 66, the needle tip delivery mechanism, in the form of a delivery catheter with a distal housing 280 operably coupled to an elongate flexible proximal portion 290 in the form of a flattened coil, is delivered down the needle tip delivery passageway 180 until the distal housing 280 enters and intersects the needle track 120. As illustrated, the distal housing 280 includes the needle tip 210 disposed within the cavity 286 of the housing 280, and the needle tip is delivered with the leading end 214 of the needle tip 210 facing proximally, such that the trailing end 212 of the needle tip faces distally and the opening 218 of the needle top 210 can receive the coupling 230 therein that is located at the leading end of the main body 220 of the needle. The relative location of an outer notch 223 is indicated, which will be discussed in detail below with regard to removing the needle tip 210. The needle tip delivery passageway 180 includes a lower portion that passes underneath the needle track 120. The lower portion of the needle tip delivery passageway 180 is configured to receive aportion of the distal protrusion 284 of the needle tip delivery mechanism. In this manner, the distal portion of the needle tip delivery mechanism is located underneath the needle tip 210 of the arcuate needle 200. The plate 120C in the housing opens into a channel 120D to receive and physically contact, and act as a stop, for the distal protrusion 284 of the needle tip delivery mechanism. FIGS. 67 further indicates that, as the distal housing 280 is advanced along the needle tip delivery passageway, the main body 220 of the needle is pushed backwards along the needle track 120 until it stops at anti-rotate spring, pawl, or clip, 113. Since the main body 220 of the needle cannot move backward at this time, the distal housing can then align and at least partially force the needle tip 210 onto the main needle body, as indicated in FIG. 67.

[0115] With reference to FIG. 51 and FIGS. 68-69, the drive mechanism 130 of the suturing device 100 is actuated to advance the main needle body 220 along the needle track into contact with the needle tip 210, wherein the coupling 230 of the main body 220 of the needle 200 is received through the opening 218 of the needle tip and into the cavity 213 where the coupling attaches to the inner wall of the cavity 213 in an interference fit sufficiently strong to permit the device to suture tissue, but sufficiently weak to permit the drive system 130 of the suturing device to separate the needle tip 210 from the main body 220 of the arcuate needle 200. FIG. 51 further illustrates the relative locations of channel 120B, and anti-rotate spring or clip 113. With reference to FIG. 52, and FIGS 70-71, the needle tip delivery mechanism 280, 290 is withdrawn proximally from the needle track 120 to permit the suturing device 100 to perform a suturing function. The present figures omit a length of suturing material, but it will be appreciated that a length of suturing material extends from needle tip 210 through passageway 288 of distal housing 280 and up needle tip delivery passageway 180.

[0116] FIGS. 53-58 illustrate operation of the suturing device 100 to suture a plication of tissue. As illustrated in FIG. 53, the arcuate needle 200, consisting of the needle tip 210 fitted over the main body 220, is driven to a “home” position wherein the tissue gap 112 of the suturing device 100 is unobstructed. In this position, the arcuate needle 200 is preferably wholly contained within the needle track 120. With reference to FIG. 54, an elongate tool 350 terminating in a tissue helix is advanced distally outwardly of passageway 303E of endoscope 300, through gap 112 in device 100, and into tissue, where the tool 350 is pressed into tissue and rotated so that the helix penetrates the tissue. Once tissue is captured, the tool is withdrawn proximally, forming a tissue plication 600. With reference to FIGS. 55-57, the tool 350 is withdrawn proximally so that the plication 600 is pulled into the tissue gap 112 of the suturing device 100. FIGS. 56-57 illustrate an issue of “throwing” a suture through the tissue plication by actuating the drive system 130 to advance the arcuate needle 200 through the tissue plication 600 with a length of suturing material (not shown) trailing behind the arcuate needle 200 from the needle tip 210. In so doing, the drive member 132 of the drive system 130 either pushes on the trailing end 222 of the arcuate needle 200 or engages one of the notches (e.g., 231, 233, 225) formed into the arcuate surface of the arcuate needle 200 (FIG. 29). With reference to FIG. 58, as the arcuate needle 200 has been returned to the home position and is not in contact with the tissue plication, the tool 350 is released from the tissue plication by unscrewing it from the tissue, and withdrawing the tool 350 proximally back into the endoscope 300.

[0117] With reference to FIGS. 59-62 and FIGS. 72-79, the needle tip delivery mechanism 280, 290 can be further configured to engage main body 220 of the arcuate needle 200 to remove the needle tip 210 in cooperation with the drive system 130 of the suturing device 100.

[0118] As illustrated in FIG. 59, the arcuate needle 200 is advanced along the needle track 120, or “rotated” about a center point of the needle track, to a position where the needle tip 210 can be removed from the main body 220 of the arcuate needle 200. FIGS. 72-74 illustrate the shuttle 140 beginning its movement from its ending position, and moving backwards along the shuttle track 120 to the shuttle 140 starting position as illustrated in FIG. 74. The drive member 132 within the shuttle slides across the rounded bottom surface of the arcuate needle 200 until the drive member 132 drops into notch 225 of arcuate needle 200. The shuttle 140 and drive member 132 then move forward, pulling the needle along by notch 225 until the needle tip 210 is in the position indicated in FIG. 75. In this position, and as illustrated in FIG. 60 and FIGS. 76-77, the distal housing 280 of the needle tip delivery mechanism is again advanced down needle tip delivery passageway 180 and into the needle track 120 such that the distal protrusion 284 of the housing 280 passes into channel 120D underneath the needle tip 210. As depicted in FIGS. 77-78, the outer radial notch 223 of the arcuate needle 200 is engaged by a complementary surface, or shoulder, 223A of the distal housing 280 of the needle tip delivery mechanism. The engagement between the notch 223 and shoulder 223A act to hold the main body 220 of the arcuate needle 200 in place with respect to the housing 110 of the suturing device 100. When the distal housing 280 is in this position within the needle track 120 and the shuttle track 120A, the distal protrusion 284 interferes and prevents the shuttle 140 from moving fully back to its starting position along the shuttle track or raceway 120A. Instead, the shuttle 140 and drive member 132 only move back as far as the protrusion 284. In this position, the drive member 132 engages the surface or notch 219 of the needle tip 210. Once drive member 132 is engaged with surface 219 of needle tip 210, the drive system 130 of the suturing device130 can then be actuated to pull the needle tip 210 off of the coupling portion 230 of the main body 220 of the arcuate needle 200 as depicted in FIG. 79.

[0119] With continuing reference to FIGS. 59-62, the housing 110 of the suturing device 100 can then eject the needle tip 210 from the arcuate needle track 120 of the suturing device 100 after the drive system 130 separates the needle tip from the main body of the arcuate needle 200. Specifically, after the needle tip 210 is separated from the main body 220, the drive member 132 continues to advance the needle tip 210 along the needle track until it passes to an exit window 162X from the needle track, which is formed by not having the upper surface 162 of the cover 160 extend over the needle track 120. Since the needle tip 210 is no longer attached to the main body 220 of the arcuate needle 200, the drive member 132, which is biased upwards, pushes the needle tip 210 upwardly and out through the exit window 162X. With reference to FIG. 76, the distal housing 280 of the needle tip delivery mechanism is then withdrawn proximally. The ejected needle tip 210 can remain attached to a length of suturing material and function as a suture anchor in the target region of tissue.

[0120] 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. For purposes of illustration, and not limitation, as depicted in FIG. 80, 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 furtherimplementation, 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.

[0121] As depicted in FIG. 80, a central longitudinal axis of the endoscope 300 is oriented obliquely with respect to a plane defined by a centerline of the arcuate 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 350) prior to suturing with arcuate 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. 81. Endoscope 300 may be a conventional endoscope, or an endoscope that is specially configured for use with suturing device 100.

[0122] The disclosed suturing devices (e.g., 100) can be used to perform various suturing procedures, such as laparoscopic, robotically-assisted minimally invasive procedures, 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 afold, or plication of such a tissue structure to be pulled into gap 112. As discussed above, implementations of devices in accordance with the present disclosure can be used to perform an Endoscopic Sleeve Gastroplasty (“ESG”) procedure, wherein a device 100 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 can then be held in place by passing arcuate 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. The needle tip 210 can be ejected from the suturing device 100, still attached to the length of suturing material, and function as a suture anchor in the target region of tissue to prevent the length of suturing material from being pulled through the tissue, thereby maintaining tension on the length of suturing material. The other end of the length of suturing material can have a stop or an anchor to prevent pull through from the other end, or a knot can be formed by way of stitching when the suturing process is started.

[0123] Aspects of the suturing devices described 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.

[0124] FIG. 82 illustrates an embodiment of a robotically-assisted manipulator system for use with the suturing devices 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 operatingone 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, nonteleoperated, 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 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. The suturing devices 100 described herein are an example of the medical instrument system 1104, and the suturing devices 100 may have a substantially rigid shaft or may have a shaft that is a substantially flexible member.

[0125] Robotically-assisted manipulator system 1100 also includes a display system1110 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 display able on the display system 1110 and / or a display system of an independent planning workstation.

[0126] 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 integrated endoscopic device or a separate endoscope can serve as an endoscope that supports the suturing device (e.g., 100) set forth herein.

[0127] 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.

[0128] 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.

[0129] 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-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.

[0130] 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.

[0131] 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 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) can be coupled to elongate flexible device 1202 as desired in lieu of endoscope 300.

[0132] 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.

[0133] 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.

[0134] 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 suturing, 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, suturing devices, 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, suturing devices, forceps, graspers, balloons, needles, scissors, clip appliers, and / or the like. Other end effectors can further include electrically activated end effectors such as electrosurgicalelectrodes, 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 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. In some embodiments, the suturing device 100 described herein is an example of the medical instrument 1226. For example, the suturing device 100 may have a flexible shaft configured to be extended through the channel 1221 of the flexible body 1216 or extended outside and along a length of the flexible body 1216. In some embodiments, the suturing device 100 can be formed as an attachment configured to be attached to a distal end portion of the flexible body 1216, with the housing 110 extending distally from the flexible body 1216. In such embodiments, the drive 130 may be extended through a channel 1221, while in other embodiments, the drive 130 may extend outside and along a length of the flexible body 1216.

[0135] 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 medicalinstrument 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.

[0136] 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 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.

[0137] 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, unlessindicated 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.

[0138] 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 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.

[0139] 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.

[0140] 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 methodsmay 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. 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.

[0141] 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.

[0142] 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

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 to advance an arcuate needle 360 degrees about the arcuate needle track and across the gap along a first direction in a plurality of drive strokes; a needle tip delivery passageway intersecting the arcuate needle track, wherein the needle tip delivery passageway is configured to direct a distal portion of a needle tip delivery mechanism into the arcuate needle track.

2. The suturing device of Claim 1, wherein the needle tip delivery passageway tangentially intersects the arcuate needle track along a lateral side portion of the housing.

3. The suturing device of Claim 1, further comprising a needle tip delivery mechanism configured to direct a needle tip along the needle tip delivery passageway into the arcuate needle track.

4. The suturing device of Claim 3, wherein the drive system is configured to direct a main body of the arcuate needle into engagement with the needle tip after the needle tip delivery mechanism has delivered the needle tip to the arcuate needle track.

5. The suturing device of Claim 3, wherein the needle tip delivery mechanism includes a needle tip delivery catheter configured to be advanced along the needle tip delivery passageway.

6. The suturing device of Claim 3, wherein the needle tip delivery mechanism is further configured to engage a main body of the arcuate needle, and further wherein the drive system isconfigured to remove the needle tip from the main body of the arcuate needle when the needle tip delivery mechanism engages the main body of the arcuate needle.

7. The suturing device of Claim 6, wherein the drive system mechanically engages the needle tip while the needle tip delivery mechanism is engaged with the main body of the arcuate needle.

8. The suturing device of Claim 7, wherein the drive system pulls the needle tip away from the main body of the arcuate needle to separate the needle tip from the main body of the arcuate needle.

9. The suturing device of Claim 8, wherein the housing is configured to eject the needle tip from the arcuate needle track of the suturing device after the drive system separates the needle tip from the main body of the arcuate needle.

10. The suturing device of Claim 1, wherein the needle tip delivery passageway includes a lower portion that passes underneath the needle track.

11. The suturing device of Claim 1, wherein the lower portion of the needle tip delivery passageway is configured to receive a distal protrusion of the needle tip delivery mechanism, wherein the suturing device is configured to direct the distal portion of the needle tip delivery mechanism underneath the arcuate needle.

12. The suturing device of Claim 1, wherein the needle tip delivery passageway defines a channel to slidably receive a distal protrusion of the needle tip delivery mechanism.

13. The suturing device of Claim 3, wherein the needle tip delivery mechanism includes a needle tip delivery catheter that is slidably received in the needle tip delivery passageway.

14. The suturing device of Claim 3, wherein the needle tip delivery mechanism includes an elongate movable body coupled to a distal housing, wherein the distal housing defines a compartment to removably receive the needle tip therein.

15. The suturing device of Claim 14, further comprising a needle tip, wherein the compartment is configured to receive a sharp distal end of the needle tip therein, and furtherwherein a proximal end of the needle tip protrudes distally from the needle tip delivery mechanism.

16. The suturing device of Claim 15, wherein the distal housing of the needle tip delivery mechanism includes a distally extending protrusion extending distally of the compartment, wherein the distally extending protrusion is configured to extend adjacent to a proximal region of the needle tip.

17. The suturing device of Claim 14, wherein the distal housing defines a passageway therethrough to receive a length of suturing material therethrough that is attached to the needle tip.

18. The suturing device of Claim 15, wherein the needle tip includes an arcuately shaped body, and a coupling at the proximal end of the needle tip to engage a main body of the arcuate needle.

19. The suturing device of Claim 18, further comprising at least one passageway defined through at least one surface of the needle tip, and further wherein a distal end of a length of suturing material traverses the at least one passageway defined through the needle tip, and further wherein the length of suturing material is coupled to the needle tip.

20. The suturing device of Claim 15, wherein the needle tip defines at least one surface therein to removably engage the drive system of the suturing device.

21. The suturing device of Claim 1, further comprising a main body of the arcuate needle slidably disposed in the arcuate needle track.

22. The suturing device of Claim 21, wherein the main body of the arcuate needle includes a leading end and a trailing end, wherein the leading end defines a coupling to engage the needle tip.

23. The suturing device of Claim 1, wherein the drive system further comprises an elongate flexible member operably coupled to the drive member.

24. The suturing device of Claim 23, wherein the elongate flexible member reciprocates over at least one bearing surface proximate a distal end of the housing.

25. The suturing device of Claim 23, wherein the elongate flexible member includes at least one of a cable and a band.

26. The suturing device of Claim 24, 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.

27. The suturing device of Claim 26, wherein the first plane and second plane are parallel.

28. The suturing device of Claim 26, wherein the first plane and second plane are not parallel.

29. The suturing device of Claim 26, wherein the first path and second path cross in at least one location when viewed along a direction normal to the first plane.

30. The suturing device of Claim 24, 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.

31. The suturing device of Claim 24, 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.

32. The suturing device of Claim 31, 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 elongate flexible member from the first plane into the second plane.

33. The suturing device of Claim 32, 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.

34. The suturing device of Claim 33, wherein the first rotational axis and second rotational axis are each oriented obliquely with respect to the first plane and the second plane.

35. The suturing device of Claim 32, 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.

36. The suturing device of Claim 36, further comprising: a first conduit that comprises an inner tubular member that contacts the first elongate flexible member portion and an outer tubular member that surrounds the inner tubular member; and wherein the outer tubular member is under a compressive axial load to maintain tension in the first elongate flexible member portion during operation of the suturing device.

37. The suturing device of Claim 36, 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.

38. The suturing device of Claim 37, wherein the first actuator is configured to be manually operated.

39. The suturing device of Claim 37, wherein the first actuator is configured to be coupled to an automated surgical device.

40. The suturing device of Claim 37, wherein the first actuator is configured to be coupled to a robotically-assisted manipulator system.

41. The suturing device of Claim 1, further comprising a tool that 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 arcuate needle passes across the gap.

42. The suturing device of Claim 41, wherein the instrumentality is helically shaped to permit the instrumentality to be screwed into tissue by rotating the instrumentality into the tissue.

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

44. The suturing device of Claim 43, wherein the needle track cover can be removed from the housing by advancing the needle track cover distally off the housing.

45. 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.

46. The suturing device of Claim 45, wherein the at least one brake is disposed at least partially inside of a circular pathway defined by travel of the arcuate needle along the arcuate needle track.

47. The suturing device of Claim 45, wherein the at least one brake extends upwardly into the arcuate needle track.

48. The suturing device of Claim 45, wherein the at least one brake prevents movement of the arcuate needle along the second direction while the drive system moves along the second direction to engage the arcuate needle.

49. The suturing device of Claim 48, 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 a starting position to an ending position.

50. The suturing device of Claim 49, 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.

51. The suturing device of Claim 45, wherein the at least one brake is configured to engage a trailing end of the arcuate needle.

52. The suturing device of Claim 45, wherein the at least one brake is configured to engage an indentation formed into the arcuate needle.

53. An arcuate needle comprising: a main body, the main body having a leading end defining a coupling and a trailing end, wherein the main body is arcuately shaped, the main body defining at least one indentation therein, said at least one indentation being located proximate the coupling at the leading end of the main body; and a needle tip, the needle tip having a sharpened leading end and a trailing end, the trailing end of the needle tip defining a complementary coupling to connect to the coupling of the main body.

54. The arcuate needle of Claim 53, wherein the at least one indentation is formed into a radially outer surface of the main body of the arcuate needle.

55. The arcuate needle of Claim 53, further including at least one indentation formed into a surface of the needle tip, the at least one indentation being configured to engage a drive member of a drive system of a suturing device.

56. The arcuate needle of Claim 53, further including at least one indentation formed into a radially inner surface of the main body of the arcuate needle.

57. The arcuate needle of Claim 53, further including at least one indentation formed into an upper arcuately shaped face of the arcuate needle or a lower arcuately shaped face of the arcuate needle.

58. The arcuate needle of Claim 54, wherein the needle tip is arcuately shaped.

59. The arcuate needle of Claim 53, wherein the arcuate needle has a “D” shaped cross section along its length.

60. The suturing device of Claim 28, further comprising a movable shuttle operably coupled to the elongate flexible member, wherein the drive member protrudes outwardly from the movable shuttle.

61. The suturing device of Claim 60, wherein the shuttle includes a compressible body therein that urges the drive member into contact with the arcuate needle.

62. The suturing device of Claim 1, further comprising a coupling to receive a distal end of an endoscope or catheter.

63. 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.

64. The suturing device of Claim 63, 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.

65. The suturing device of Claim 63, wherein the proximal portion of the housing and the distal portion of the housing are pivotally coupled.

66. 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 comprising a drive member to advance an arcuate needle 360 degrees about the arcuate needle track and across the gap along a first direction in a plurality of drive strokes; 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; and a needle tip delivery mechanism configured to direct a needle tip into the arcuate needle track.

67. A method of performing a suturing procedure, comprising: providing a suturing device according to Claim 66; 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; actuating the drive system to advance the arcuate needle through the tissue; advancing the needle tip delivery mechanism to the needle track to engage a surface of the arcuate needle; and actuating the drive system to mechanically separate a needle tip of the arcuate needle from a main body of the arcuate needle.

68. The method of Claim 67, further comprising ejecting the needle tip of the arcuate needle from the suturing device.

69. The method of Claim 68, further comprising introducing a new needle tip into the arcuate needle track using the needle tip delivery mechanism, and actuating the drive system to mechanically engage the new needle tip with the main body of the arcuate needle.

70. The method of Claim 67, wherein the suturing procedure is repeated multiple times to perform a Endoscopic Sleeve Gastroplasty (“ESG”).

71. The method of Claim 68, wherein the ejected needle tip remains attached to a length of suturing material and functions as a suture anchor in the target region of tissue.

72. The suturing device of Claim 5, wherein the needle tip delivery catheter includes a proximal end, a distal end an elongate body connecting the proximal end to the distal end.

73. The suturing device of Claim 72, wherein the distal end of the needle tip delivery catheter includes a housing defining a distally facing cavity to receive a needle tip therein.

74. The suturing device of Claim 73, wherein the housing includes a magnet to help hold the needle tip in place within the distally facing cavity.

75. The suturing device of Claim 74, wherein the elongate body includes at least one guide thereon to maintain alignment of the elongate body within the needle tip delivery passageway.

76. The suturing device of Claim 75, wherein the at least one guide has a lateral dimension that is larger than the elongate body, and further wherein the guide defines at least one opening therethrough for receiving a length of suturing material therethrough.

77. The suturing device of Claim 73, wherein the housing defines at least one opening therethrough for receiving a length of suturing material coupled to the needle tip disposed in the distally facing cavity.

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