Laparoscopic suturing system

Abstract

A laparoscopic suturing instrument is provided.SOLUTION: The laparoscopic suturing device 10 allows a suturing needle to be passed back and forth between the jaws of the jaw assembly 100 to suture tissue at a surgical site in a minimally invasive procedure. The jaw assembly may include a pivotable jaw member in each jaw for positioning the jaw assembly and needle in a low-profile storage configuration for insertion through a small-diameter surgical port. The jaw members can be actuated by the handle assembly 300, which can simultaneously pass the needle from the driving jaw to the receiving jaw and latch the needle in the receiving jaw in a single trigger cycle.SELECTED DRAWING: Figure 41

Description

[Technical Field]

[0001] This application relates to surgical instruments, and more particularly to laparoscopic surgical instruments for suturing tissue.

[0002] Description of Related Applications This application claims the benefit of pending U.S. Provisional Patent Application No. 62 / 217,502, entitled "LAPAROSCOPIC SUTURING SYSTEM," filed September 11, 2015, which is incorporated herein by reference in its entirety. [Background technology]

[0003] In surgical procedures in which the surgical site is accessed through a port, e.g., minimally invasive surgical procedures, it may be desirable to suture tissue using a suturing tool that can be advanced to the surgical site through a relatively small diameter port. The suturing tool may be configured to advance a needle and attached suture through tissue at the surgical site, allowing the operator to create a running stitch that approximates the tissue. Suturing instruments have been fabricated to descend along a trocar with the needle's longitudinal axis perpendicular to the trocar's axis, thereby limiting the needle length that can be used within the instrument to the inner diameter of the trocar. Furthermore, current suturing instruments typically have actuation mechanisms that are complex and cumbersome to operate, requiring multiple operating steps to complete a single stitch. Desirably, an improved suturing instrument would provide high efficiency, simplicity, and ease of use. Summary of the Invention

[0004] In certain embodiments, a laparoscopic suturing instrument is provided herein. The laparoscopic suturing instrument has a handle assembly, an elongated shaft, a jaw assembly, and a needle. The handle assembly has a proximal end and a distal end. The elongated shaft extends distally from the distal end of the handle assembly and defines a central longitudinal axis. The jaw assembly extends distally from the elongated shaft. The jaw assembly includes a first jaw and a second jaw, each having a proximal end pivotally coupled to the elongated shaft and a distal end. The jaw assembly and needle are selectively positionable between a retracted configuration in which the first jaw, the second jaw, and the needle are generally aligned with the central longitudinal axis, with the needle positioned within one of the first jaw and the second jaw, and an open position in which the first jaw, the second jaw, and the needle extend transversely to the central longitudinal axis.

[0005] In certain embodiments, a laparoscopic suturing instrument is provided herein. The laparoscopic suturing instrument has a handle assembly, an elongated shaft, a jaw assembly, and a needle. The handle assembly has a proximal end and a distal end. The handle assembly includes a trigger mechanism, a closure mechanism, and a toggle mechanism. The elongated shaft extends distally from the distal end of the handle assembly and defines a longitudinal central axis. The jaw assembly extends distally from the elongated shaft. The jaw assembly includes first and second jaws, each having a proximal end pivotally coupled to the elongated shaft and a distal end. The trigger mechanism is operably coupled to the closure mechanism and the toggle mechanism such that an actuation cycle of the trigger mechanism sequentially actuates the closure mechanism to close the first and second jaws of the jaw assembly, actuates the toggle mechanism to transfer the needle from one of the first and second jaws to the other of the first and second jaws, and actuates the closure mechanism to open the first and second jaws.

[0006] In certain embodiments, a laparoscopic suturing system is provided herein. The laparoscopic suturing system includes a laparoscopic suturing instrument and a suture needle. The laparoscopic suturing instrument has a handle assembly, an elongated shaft, and a jaw assembly. The elongated shaft has a proximal end coupled to the handle assembly and a distal end. The elongated shaft defines a longitudinal central axis extending between the proximal end and the distal end. The jaw assembly is coupled to the distal end of the elongated shaft. The jaw assembly includes a first jaw and a second jaw, each pivotally coupled to the elongated shaft, the first jaw and the second jaw being pivotable between an open configuration and a closed configuration. The suture needle is positionable within the jaw assembly. The suture needle has a needle and a suture coupled to the needle. The needle has a generally curved profile and extends from a first penetrating tip to a second penetrating tip. The needle has a first shim notch located adjacent to the first penetrating tip, a second shim notch located adjacent to the second penetrating tip, a first recess located adjacent to the first penetrating tip, and a second recess located adjacent to the second penetrating tip.

[0007] In certain embodiments, a laparoscopic suturing instrument is provided herein. The laparoscopic suturing instrument has a handle assembly, an elongated shaft, and a jaw assembly. The handle assembly includes a proximal end and a distal end. The elongated shaft extends distally from the distal end of the handle assembly and defines a longitudinal central axis. The jaw assembly includes a proximal end pivotally coupled to the elongated shaft and a distal end. The jaw assembly includes a first jaw and a second jaw. The first jaw includes a first base jaw located at the proximal end of the jaw assembly and a first flip jaw located at the distal end of the jaw assembly. The first flip jaw is pivotally coupled to the first base jaw. The first flip jaw has a first needle channel. The first flip jaw is rotatable between a retracted or stowed position in which it is oriented generally longitudinally relative to the first base jaw and a suturing position in which the first needle channel is oriented transversely relative to the first base jaw. The second jaw includes a second base jaw located at a proximal end of the jaw assembly and a second flip jaw located at a distal end of the jaw assembly. The second base jaw is rotatably coupled to the first base jaw and the elongated shaft. The second flip jaw is rotatably coupled to the second base jaw. The second flip jaw has a second needle channel. The second flip jaw is rotatable between a retracted or stowed position in which it is oriented generally longitudinally relative to the second base jaw and a suturing position in which the second needle channel is oriented transversely relative to the second base jaw.

[0008] In certain embodiments, a laparoscopic suturing instrument is provided herein. The laparoscopic suturing instrument has a handle assembly, an elongated shaft, and a jaw assembly. The handle assembly includes a proximal end and a distal end. The handle assembly includes a handle body, a trigger, and a toggle mechanism. The trigger is pivotally coupled to the handle body. The toggle mechanism is actuable by pivotal movement of the trigger relative to the handle body. The toggle mechanism includes a toggle tube, a first shim, and a second shim. The toggle tube is rotatable within the handle body in response to pivotal movement of the trigger. The toggle tube has a shim guide. The first shim has a proximal end with a first follower positioned within the shim guide. The first shim is longitudinally movable by rotation of the toggle tube. The second shim has a proximal end with a second follower positioned within the shim guide. The second shim is longitudinally movable by rotation of the toggle tube. The elongated shaft extends distally from the distal end of the handle assembly and defines a central longitudinal axis. The jaw assembly extends distally from the elongated shaft. The jaw assembly includes a proximal end pivotally coupled to the elongated shaft and a distal end. The jaw assembly includes a first jaw and a second jaw. The first jaw has a proximal end pivotally coupled to the elongated shaft and a distal end with a first needle retaining slot. The second jaw has a proximal end pivotally coupled to the elongated shaft and a distal end with a second needle retaining slot. The first shim extends distally to a distal end positioned within the first jaw, and the second shim extends distally to a distal end positioned within the second jaw. The toggle mechanism is operable in a toggle cycle to alternately longitudinally advance the distal end of a first shim located adjacent the first needle retention slot and longitudinally advance the distal end of a second shim located adjacent the second needle retention slot.

[0009] In certain embodiments, a laparoscopic suturing instrument is provided herein. The laparoscopic suturing instrument has a handle assembly, an elongated shaft, and a jaw assembly. The handle assembly includes a proximal end and a distal end. The handle assembly includes a latch mechanism having a latching configuration and an unlatching configuration. The elongated shaft extends distally from the distal end of the handle assembly and defines a longitudinal central axis. The jaw assembly extends distally from the elongated shaft. The jaw assembly includes a proximal end pivotally coupled to the elongated shaft and a distal end. The jaw assembly includes a first jaw and a second jaw. The first jaw includes a first base jaw and a first flip jaw. The first base jaw is located at the proximal end of the jaw assembly. The first flip jaw is located at the distal end of the jaw assembly and pivotally coupled to the first base jaw. The first flip jaw is pivotable between a retracted position defining a small diameter profile for the jaw assembly and a suturing position. The second jaw includes a second base jaw and a second flip jaw. The second base jaw is located at a proximal end of the jaw assembly and pivotally coupled to the first base jaw and the elongated shaft. The second flip jaw is located at a distal end of the jaw assembly and pivotally coupled to the second base jaw. The second flip jaw is pivotable between a retracted position defining a small diameter profile for the jaw assembly and a suturing position. The latch mechanism is operably coupled to the first flip jaw and the second flip jaw such that when the latch mechanism is in the latched position, the first flip jaw and the second flip jaw are retained in the retracted position, and when the latch mechanism is in the unlatched position, the first flip jaw and the second flip jaw are pivotable to the suturing position. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is an isometric view of an embodiment of a jaw assembly for a laparoscopic suturing instrument in a retracted or stowed configuration. [Figure 2]FIG. 2 is a side view of the jaw assembly of FIG. 1. [Figure 3] FIG. 2 is a plan view of the jaw assembly of FIG. 1. [Figure 4] FIG. 2 is a side view of the jaw assembly of FIG. 1 showing the base jaws in an open position and the flip jaws in a retracted configuration. [Figure 5] FIG. 2 is a side view of the jaw assembly of FIG. 1 showing the base jaws in an open position and the flip jaws partially rotated to a suturing configuration. [Figure 6] FIG. 2 is a side view of the jaw assembly of FIG. 1 showing the base jaws in an open position and the flip jaws rotated to a suture configuration. [Figure 7] FIG. 2 is a side view of one jaw of the jaw assembly of FIG. 1, showing a suture needle positioned therein. [Figure 8] FIG. 8 is a plan view of the jaw of FIG. 7. [Figure 9] FIG. 8 is an isometric view of the jaw of FIG. 7, showing a suture needle positioned therein. [Figure 10] FIG. 8 is a cross-sectional view of the flip jaw and suture needle of the jaw of FIG. 7. [Figure 11] FIG. 8 is a bottom view of a flip jaw for the jaw of FIG. 7. [Figure 12] FIG. 8 is an exploded view of the jaw of FIG. 7. [Figure 13] FIG. 8 is a plan view of the jaw of FIG. 7 showing the state in which section lines are applied. [Figure 14] 8 is a cross-sectional view of the jaw of FIG. 7 in a suturing configuration, taken about a cross-sectional line. [Figure 15] 8 is a cross-sectional view of the jaw of FIG. 7 partially rotated in a retracted configuration about a cross-sectional line. [Figure 16] 8 is a cross-sectional view of the jaw of FIG. 7 partially rotated to a retracted configuration about a cross-sectional line. [Figure 17] 8 is a cross-sectional view of the jaw of FIG. 7 rotated to a retracted configuration about a cross-sectional line. [Figure 18]8 is a cross-sectional view of the jaw of FIG. 7 in a suturing configuration, taken about a cross-sectional line. [Figure 19] FIG. 8 is a cross-sectional view of the jaws of FIG. 7 in a suturing configuration, taken about the section line, with the shim partially advanced to lock the flip jaws. [Figure 20] FIG. 8 is a cross-sectional view of the jaws of FIG. 7 in a suturing configuration, taken about the section line, with the shim advanced to latch the flip jaws and retain the suturing needle. [Figure 21] FIG. 8 is a perspective view of the flip jaw and needle of the jaw of FIG. 7, with the cross-sectional plane indicated by the dashed line. [Figure 22] 22 is a cross-sectional view of the flip jaw and needle of FIG. 21 about the cross-sectional plane. [Figure 23] FIG. 22 is a side view of the flip jaw and needle of FIG. 21. [Figure 24] FIG. 22 is a perspective view of the flip jaw and needle of FIG. 21 with an actuation cable attached thereto. [Figure 25] FIG. 1 is an exploded view of an embodiment of a jaw assembly and actuation assembly for a laparoscopic suturing instrument. [Figure 26] FIG. 26 is a perspective view of the base jaw of the jaw assembly of FIG. 25 in an open configuration. [Figure 27] FIG. 26 is a perspective view of the base jaw of the jaw assembly of FIG. 25 in a closed configuration. [Figure 28] 1 is an end view of an embodiment of a suturing needle for use in a laparoscopic suturing instrument. [Figure 29] FIG. 29 is a side view of the suture needle of FIG. 28. [Figure 30] FIG. 8 is an isometric view of the base jaw of the jaw of FIG. [Figure 31] FIG. 26 is a perspective view of a clevis of the actuation assembly of FIG. 25. [Figure 32] FIG. 32 is a perspective view of the clevis of FIG. 31, with the cross-sectional plane indicated by the dashed line. [Figure 33] FIG. 32 is a cross-sectional view of the clevis of FIG. 31 about the cross-sectional plane. [Figure 34]FIG. 26 is a perspective view of the jaw assembly and actuation assembly of FIG. 25, showing the clevis removed. [Figure 35] FIG. 35 is a cross-sectional perspective view of the jaw assembly and actuation assembly of FIG. 34; [Figure 36] FIG. 35 is a side cross-sectional view of the jaw assembly and actuation assembly of FIG. 34. [Figure 37] FIG. 2 is a side cross-sectional view of the distal end of the jaw assembly of FIG. 1 in a retracted configuration. [Figure 38] FIG. 26 is an isometric view of an embodiment of a slotted actuator of the actuation assembly of FIG. [Figure 39] FIG. 39 is a plan view of the slotted actuator of FIG. 38. [Figure 40] FIG. 39 is a side view of the slotted actuator of FIG. 38. [Figure 41] 2 is an isometric view of an embodiment of a suturing instrument having the jaw assembly of FIG. 1. [Figure 42] FIG. 42 is a partially exploded view of an embodiment of a handle assembly of the suturing instrument of FIG. 41. [Figure 43] FIG. 43 is an exploded view of the handle assembly of FIG. 42. [Figure 44] FIG. 43 is a cross-sectional plan view of the handle assembly of FIG. 42. [Figure 45] FIG. 43 is a side cross-sectional view of the handle assembly of FIG. 42. [Figure 46] 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in an open configuration, with the handle assembly shown in plan cross-section. [Figure 47] FIG. 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in a partially closed configuration, with the handle assembly shown in plan cross-section. [Figure 48] FIG. 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in a closed configuration, with the handle assembly shown in plan cross-section. [Figure 49] FIG. 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in a closed configuration, with the handle assembly shown in plan cross-section. [Figure 50]FIG. 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in a partially closed configuration, with the handle assembly shown in plan cross-section. [Figure 51] 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in an open configuration, with the handle assembly shown in plan cross-section. [Figure 52] FIG. 42 is an isometric view of an embodiment of a toggle and latch mechanism of the handle assembly of FIG. 41. [Figure 53] FIG. 53 is a side view of the toggle and latch mechanism of FIG. 52. [Figure 54] FIG. 53 is a top view of the toggle and latch mechanism of FIG. 52. [Figure 55] FIG. 53 is a cross-sectional view of the toggle mechanism of FIG. 52 showing the follower in a first position during a toggle cycle. [Figure 56] FIG. 53 is a cross-sectional view of the toggle mechanism of FIG. 52 showing the follower in a second position during a toggle cycle. [Figure 57] FIG. 53 is a cross-sectional view of the toggle mechanism of FIG. 52 showing the follower in a third position during a toggle cycle. [Figure 58] FIG. 53 is a cross-sectional view of the toggle mechanism of FIG. 52 with the follower in a fourth position during a toggle cycle. [Figure 59] FIG. 53 is a cross-sectional view of the toggle mechanism of FIG. 52 with the follower in a fifth position during a toggle cycle. [Figure 60] FIG. 53 is a cross-sectional view of the toggle mechanism of FIG. 52 showing the follower in a first position after completing a toggle cycle. [Figure 61] 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 in an open configuration, with the handle assembly shown in cross-sectional side view. [Figure 62] 42 is a partial cross-sectional view of the suturing instrument of FIG. 41 with the flip jaws rotated by the latch mechanism to a partially retracted configuration and the handle assembly shown in cross-sectional side view. [Figure 63]42 is a partial cross-sectional view of the suturing instrument of FIG. 41 with the flip jaws rotated to a stored configuration by the latch mechanism and the handle assembly shown in cross-sectional side view. [Figure 64] 42 is a cross-sectional view of an embodiment of an elongate shaft of the suturing instrument of FIG. 41. [Figure 65] FIG. 1 is a side view of an embodiment of a jaw assembly of a suturing instrument having a barbed suture and a needle with a braided anchor. [Figure 66] FIG. 1 is a side view of an embodiment of a jaw assembly of a suturing instrument having a barbed suture, a braided leader, and a needle with a braided anchor. DETAILED DESCRIPTION OF THE INVENTION

[0011] In various embodiments, a suturing system is disclosed herein that can improve a surgeon's efficiency in applying sutures to tissue within a patient's body during minimally invasive surgery, such as laparoscopic surgery. The suturing instrument passes a needle having an attached suture back and forth across the tissue margin between the jaws of a jaw assembly by inserting the needle into the tissue and grasping the needle with a receiving jaw while a driving jaw grasps the needle.

[0012] During clinical use, an access device, such as a trocar, is first placed through the body wall into a body cavity, with the trocar cannula remaining positioned within and across the body wall. The suturing instruments described herein may utilize a suture attached to the center of a needle with sharpened ends, thereby allowing the needle to be passed back and forth across the tissue margins. To allow the instrument to fit down a relatively small diameter trocar, e.g., a 5 mm trocar, the needle may be retracted during insertion and removal through the trocar, thereby lowering the diametric profile of the suturing instrument. When the needle is retracted, the suturing instrument is considered to be in its non-operational or retracted state. When positioned within a body cavity or during needle loading outside the body, the suturing instrument can be deployed to its operational or suturing state. While in its operational state, the suturing instrument may insert the suture needle into tissue and pass the needle and its attached suture from the driving jaw to the receiving jaw.

[0013] Advantageously, the retracted needle configuration of the suturing instruments described herein allows for the use of needles with lengths that would otherwise not be able to fit down a 5 mm trocar. The ability for surgeons to use smaller diameter trocars provides significant advantages, such as reduced postoperative healing time and scarring for patients. Larger, conventional trocar sizes, e.g., 10 mm, 12 mm, and 15 mm, require significantly larger incisions than 5 mm trocars. The retracted configuration of the suturing instruments described herein eliminates the needle length limitations of conventional suturing instruments. Thus, the suturing instruments described herein can be used to suture using longer needles than conventional 10 mm trocar diameter suturing instruments while still being able to fit through a 5 mm trocar. This use of longer needles advantageously allows for penetration of more tissue or thicker tissue, thereby enabling surgeons to perform sutures that are possible with suturing instruments larger than 10 mm.

[0014] 1-6, various views of an embodiment of the distal end of a laparoscopic suturing instrument 10 having an elongate shaft 50 and a jaw assembly 100 are shown. FIGS. 1-3 are isometric, side, and top views, respectively, of the jaw assembly 100 in a retracted or stowed configuration holding a needle 200 and a suture 220. In the retracted configuration, the jaw assembly 100 has a relatively small profile that allows it to be inserted into a laparoscopic surgical port, such as a trocar or nula. As shown, with the jaw assembly in the retracted configuration, the needle 200 is held by one of the jaws 110, 160, and the suture 220 extends proximally from the needle along the elongate shaft 50.

[0015] In certain embodiments, jaw assembly 100 is sized for insertion through one of multiple sizes of trocar cannulas, for example, trocar cannulas that accept 5 mm instruments, 10 mm instruments, 12 mm instruments, or 15 mm instruments. Advantageously, the suturing instruments described herein with a low-profile retraction jaw assembly configuration allow for the deployment of relatively large diameter needles through instruments sized for relatively small trocars.

[0016] 1-3 , in the illustrated embodiment, the jaw assembly 100 includes a first jaw 110 and a second jaw 160, each having a proximal end pivotally coupled to each other and to the distal end 52 of the elongate shaft 50. The first jaw 110 can include a first base jaw 120 having a proximal end pivotally coupled to the elongate shaft 50 and a distal end. The first jaw 110 can also include a first flip jaw 140 pivotally coupled to the distal end of the first base jaw 120. Similarly, in the illustrated embodiment, the second jaw 160 can include a second base jaw 170 having a proximal end pivotally coupled to the elongate shaft 50 and a distal end to which a second flip jaw 190 is pivotally coupled.

[0017] Referring to Figures 4-6, another view of an embodiment of the jaw assembly 100 of the laparoscopic suturing instrument 10 is shown. Figures 4-6 show side views of the sequence of operation of the jaw assembly from the stored configuration to the suturing configuration. Figure 4 shows the jaw assembly 100 with the jaws 110, 160 having their base jaws 120, 170 in an open position with their distal ends rotated apart and their flip jaws 140, 190 rotated to the stored configuration. As further described herein with reference to Figures 61-63, a user can actuate a latch mechanism to rotate the flip jaws 140, 190 from the stored configuration (Figure 4) through a partially rotated position (Figure 5) to the suturing configuration (Figure 6).

[0018] 7-12, various views of the first jaw 110 and needle 200 of an embodiment of the jaw assembly 100 are shown. FIGS. 7-9 are side, top, and isometric views, respectively, of the first jaw 110 with the first flip jaw 140 in a suturing configuration with the needle 200 positioned within the first flip jaw 140. A pivot 124, or bore, can be provided through the proximal end of the first base jaw 120 to receive a rivet or pinned connection with the second jaw 160 and the distal end 52 of the elongate shaft 50. The proximal end of the first base jaw 120 can further include an actuation post 126 such that the first base jaw 120 can be rotated about the pivot 124 by actuation of the post 126 by the jaw actuation assembly. The first base jaw has a jaw body extending distally from the pivot 124 to its distal end. The first flip jaw 140 is pivotally coupled to the distal end of the first base jaw 120 .

[0019] 10, a cross-sectional view of the distal end of the first jaw 110 is shown. The first flip jaw 140 can have a needle-receiving channel 142 formed therein. With the first flip jaw 140 rotated to the suturing position, the needle-receiving channel 142 is positioned generally transverse to the longitudinal axis of the first base jaw 120 to align with the curvature of the needle. Additionally, with reference to FIG. 11, the needle-receiving channel 142 can have an oval or eccentric cross-sectional profile to maintain the rotational orientation of the needle 200 relative to the needle-receiving channel 142.

[0020] Continuing with reference to FIG. 10 , in some embodiments, to improve manufacturability, the needle-receiving channel of the flip jaw can be a straight hole to allow for the use of a non-rotating core pin during injection molding. This straight hole can be angled to be tangent to a circle drawn about the base jaw pivot centerline. The core pin can be inserted at an angle to account for the curvature of the needle. The core pin hole can be elliptical or elongated oval to minimize the ability of a curved needle to rotate once seated within the hole. The major axis of the elliptical cross-section can be oriented in the direction of the needle bend to account for the needle curvature. In a cross-section through the flip jaw needle hole in the direction of the needle curvature, the needle can have three contact points to prevent movement. The width of the minor axis of the cross-sectional ellipse is the needle diameter plus clearance to prevent the needle from twisting around its longitudinal axis once seated within the hole.

[0021] 12, an exploded view of an embodiment of the first jaw 110 is shown. In the illustrated embodiment, the first flip jaw 140 is pivotally coupled to the first base jaw 120 by a pinned connection. In some embodiments, the first flip jaw 140 can be biased into a suturing position by a biasing member, such as a torsion spring 144, positioned between the flip jaw 140 and the base jaw 120 about the axis of rotation of the flip jaw 140. A first cable 390 and a first shim 360 extend to the first flip jaw 140 through slots in the first base jaw 120 and are selectively actuable in an actuating sequence by the operation of latching and toggle mechanisms, as described further below.

[0022] 14-17, cross-sectional views of an embodiment of the first jaw 110 are shown about the cross-sectional line indicated in FIG. 13. FIGS. 14-17 illustrate the actuation sequence of the first flip jaw 140 upon actuation of the latching mechanism to rotate the first flip jaw from a suturing configuration (FIG. 14), through a partially retracted configuration (FIGS. 15 and 16), to a retracted configuration (FIG. 17). Actuation of the latching mechanism increases tension on a first cable 390 that extends through a longitudinal slot or channel formed in the first base jaw 120, causing the first flip jaw 140 to rotate relative to the first base jaw. Although a first torsion spring 144 (FIG. 12) can be used to bias the first flip jaw 140 into the suturing configuration once the suturing instrument is introduced into the surgical field, the cable under tension can advantageously provide reliable and robust rotation of the flip jaw 140 to the retracted position, even when bodily fluids or tissue buildup would otherwise resist or prevent rotation of the flip jaw. In other embodiments, an additional cable can be used in place of the torsion spring 144, such that the latching mechanism utilizes the first cable to rotate the flip jaw to the suturing configuration in an unlatching operation and the illustrated cable to rotate the flip jaw to the retracted configuration in a latching operation.

[0023] 18-20 are cross-sectional views of the first jaw 110 during an actuation sequence of the toggle mechanism to distally advance the distal end of the first shim 360 into a slot or shim channel 141 in the first flip jaw 140. Distal advancement of the first shim 360 into the shim channel 141 extending through the first flip jaw 140 (FIG. 19) locks the first flip jaw 140 into a suturing configuration. The shim channel 141 may intersect the needle-receiving channel. With the needle 200 positioned within the needle-receiving channel 142, the shim notch 210 on the needle is generally aligned with the shim channel 141 on the first flip jaw 140. Thus, further advancement of the first shim 360 causes the shim to extend distally and engage an interference feature, such as a first slot or shim notch 210 ( FIGS. 28 and 29 ), on the needle 200 to latch the needle 200 into the first flip jaw ( FIG. 20 ). The shim channel 141 of the first flip jaw 140 can extend distally beyond the needle receiving channel 142 to allow the first shim to engage and retract the first flip jaw 140 proximal and distal to the needle receiving channel 142. In some embodiments, the distal surface of the first flip jaw 140 can be formed with a protrusion having a slot therein to allow additional distal movement of the first shim 360. While the illustrated embodiment has a single shim that locks both the flip jaw and the needle, it is envisioned that in other embodiments, locking of the needle and flip jaw can be achieved using two separate mechanisms, in which the needle can be locked using a shim and the flip jaw can be locked by another mechanism, such as a second shim, a sliding bolt, or a pin.

[0024] 21-24, various views of the first flip jaw 140, needle 200, and first shim 360 (FIGS. 21 and 22) are shown. FIG. 22 shows a cross-sectional view of the first flip jaw about the cross-sectional plane indicated by the dashed line in FIG. 21, with the shim 360 partially advanced into the shim channel 141 of the first flip jaw 140. The first flip jaw may be provided with a retention feature, such as a generally spherical detent 146, which fits into a corresponding matching recess 214 on the needle 200. This detent fit advantageously maintains the position of the needle 200 within the flip jaw when the first flip jaw 140 is in the stored configuration and before the toggle mechanism fully advances the first shim 360 into engagement with the first shim notch 210 on the needle. In some embodiments, the detent may include a leaf spring wrapped around the flip jaw and applying a force to the ball. The ball may be located in a cylindrical channel in the flip jaw that intersects with the needle eye. The channel narrows near the needle eye to prevent the ball from falling out when the needle is not present. When the needle is in the flip jaw, the ball is pressed into a corresponding recess in the needle, thereby retaining the ball while the shim does not lock the needle in place. In other embodiments, instead of the ball in the illustrated embodiment, the needle detent in the flip jaw may be an elastomeric protrusion, a profiled leaf spring tab, or a magnet.

[0025] 23 shows a first torsion spring 144 positioned about the pivot axis of the first flip jaw 140. The illustrated embodiment of the first flip jaw 140 further includes a distal protrusion located beyond the needle-retaining channel. As shown, a portion of the distal surface of the first flip jaw 140 protrudes from the otherwise generally flat face and has a shim slot extending therethrough. An adjacent portion of the distal surface of the first flip jaw is recessed to allow the first flip jaw 140 to fit within the second flip jaw when the jaw assembly is in the retracted configuration and the second flip jaw is in a low-profile configuration having a relatively small outer diameter.

[0026] 24 shows a first cable 390 of the latch mechanism coupled to the first flip jaw. The first cable 390 is coupled to the first flip jaw at a location offset from the pivot axis so that tension in the cable tends to rotate the first flip jaw toward the stored configuration. The first flip jaw 140 can have a cable slot on its outer surface that receives the first cable 390 when the first flip jaw 140 is rotated to the suturing configuration.

[0027] Referring to FIG. 25 , an exploded view of the distal end of the laparoscopic suturing instrument 10 is shown. As shown, the distal end includes a jaw assembly 100, a jaw actuation mechanism 150, and the distal end 52 of the elongate shaft 50. In the illustrated embodiment, the jaw assembly includes a first jaw 110 and a second jaw 160 that are pivotally coupled to one another and are substantially similar. Other embodiments of jaw assemblies usable with the suturing instruments described herein contemplate that the suturing instruments may have jaws with different configurations. For example, the jaw assembly may include a single pivotable jaw and a single stationary jaw or only one jaw with a pivotable flip jaw. Thus, in some embodiments, the jaw assembly may include a first jaw having a first base jaw and a first flip jaw pivotally coupled to the first base jaw, and a second jaw having a needle recess pivotally coupled to the distal end of the elongate shaft but without a corresponding second flip jaw. In other embodiments, the second jaw may extend longitudinally distally from the elongate shaft and may be pivotally fixed relative to the elongate shaft.

[0028] 25 , the jaw actuation mechanism 150 may include a clevis 152 and an actuator 154. The clevis 152 may have guide slots for the shim and cable to prevent buckling. A slotted head of the actuator 154 may support the shim and cable from below to prevent buckling within the clevis. The clevis may be formed at or positioned on the distal end 52 of the elongate shaft 50. The first and second jaws may be pivotally coupled to the clevis 152. The slotted head of the actuator 154 may have an actuation slot 156 formed therein. In the illustrated embodiment, a drive rod 158 is slidable within the elongate shaft 50 and is coupled to the actuator 154 to advance the actuator 154 proximally and distally relative to the elongate shaft 50. The actuation posts 126 of the first and second base jaws 120, 170 may be positioned within the actuation slots 156 such that longitudinal translation of the actuator 154 opens and closes the base jaws 120, 170.

[0029] 26 and 27 show the actuator 154, the first base jaw 120, and the second base jaw 170. As shown, the actuator 154 can be translated longitudinally to rotate the base jaws 120, 170 relative to one another, such that the base jaws 120, 170 can be selectively positioned in an open configuration (FIG. 26) or a closed configuration (FIG. 27).

[0030] 28 and 29, an embodiment of a suture needle is shown. As shown, needle 200 has a first shim notch 210 located adjacent to the first penetrating tip, a second shim notch 212 located adjacent to the second penetrating tip, a first recess 214 located adjacent to the first penetrating tip, and a second recess 216 located adjacent to the second penetrating tip. Alternating selection of which shim locks the needle allows the needle to be threaded between the two jaws of the instrument. Advantageously, the needle also includes a detent feature provided by the first and second recesses 214, 216, which allows the jaws to grasp the needle without the presence of a shim to lock the needle in place (i.e., in the retracted configuration). The needle may also include a bore 218 for receiving a suture therethrough. As envisioned, in some embodiments, the suture may have a leader segment, e.g., a braided metal or polymer segment, coupled to the needle 200 at the hole 218, and a suture segment coupled to the leader, e.g., at a crimp joint. In various embodiments, the leader segment may be knotted, attached with adhesive, thermoformed, or tied around the needle. In various embodiments, the leader and suture segment may be secured by tying a knot in the suture and leader, by thermoforming the suture and leader internally, or by adhesively attaching them together. The suture segment may be a monofilament polymer suture.

[0031] This suture structure, with its braided leader and monofilament suture segment, can desirably be flexible and increase usability. Inserting the needle into tissue can cause repeated bending of the leader at the needle / leader interface. A more flexible material can reduce the risk of breakage due to repeated bending of the material at this interface. This flexibility also reduces the amount of force required to insert the needle into tissue because the material bends easily, thus reducing its profile. In some embodiments, the leader can be inserted into the needle bore and then crimped within the bore. The leader can be connected to the suture by a stainless steel crimp tube. The suture can also be braided to increase flexibility. In some embodiments, the leader can be braided stainless steel, which desirably increases strength and allows for welding to the needle.

[0032] In some embodiments, the suture segment may comprise a monofilament or braided suture that is barbed in one direction to prevent it from retracting through the tissue and causing wound tearing. This retention feature eliminates the need for the surgeon to tie a knot after each stitch, thereby improving the efficiency and ease of the procedure. The end of the suture opposite the needle may have an anchor to prevent further movement into the tissue and wound tearing. In some embodiments, the anchor may have a fixed or variable diameter loop through which the suture is threaded after the first pass through the tissue, resulting in a knotless anchor. Suturing may then proceed without the need to tie any knots. In other embodiments, the suture anchor may comprise a T-shaped anchor. Desirably, the T-shaped anchor may eliminate the need to thread the suture through the anchor loop after the first pass through the tissue.

[0033] Continuing with reference to FIG. 29, in the illustrated embodiment, the needle may be of a dual-headed configuration with penetrating tips located at opposite ends. The central body of the needle may be generally curved. In some embodiments, the needle is curved to have a bend radius equal to the distance from the needle to the pivot centerline of the base jaw. This bend radius can help guide the needle through tissue and minimize the amount of torque that may bend the needle during tissue penetration. In other embodiments, the needle may be of a single-headed configuration with a single penetrating tip at one end.

[0034] 30-33, there is shown an embodiment of the first base jaw 120 (FIG. 30) and an embodiment of the clevis 152. As shown, both the base jaw 120, 170 and the clevis 152 can have passages, such as longitudinal slots or channels, to facilitate manipulation of shims and cables.

[0035] 34-37, jaw assembly 100 and jaw actuation mechanism 150 are shown with the jaw assembly in a retracted configuration with needle 200 positioned within one of the jaws. Figure 37 shows needle 200 having attached thereto suture 220 having leader 222, crimp 224, and suture segment 226.

[0036] 38-40, one embodiment of an actuator 154 for the jaw actuation mechanism is shown. As shown, the actuator has a slotted actuation member with actuation slots 156 on opposing surfaces. The slotted portions of the actuation member can be positioned proximal to the pivot and between the first and second base jaws such that the actuation posts of the base jaws are each received in the actuation slots 156.

[0037] Referring to FIG. 41 , an embodiment of a laparoscopic suturing instrument 10 is shown. The suturing instrument 10 can include a handle assembly 300, an elongated shaft 50, and a jaw assembly 100. The handle assembly can extend generally longitudinally from a proximal end to a distal end. The handle assembly 300 can include a trigger mechanism 310 including a pivotable lever projecting from the handle assembly. In other embodiments, it is contemplated that other handle and trigger configurations can be used with various aspects of the jaw assembly mechanisms described herein. The elongated shaft 50 extends distally from the distal end of the handle assembly and defines a central longitudinal axis of the suturing instrument 10. The jaw assembly 100 can include a pair of opposing jaws pivotally coupled to each other and to the distal end 52 of the elongated shaft 50.

[0038] 42 and 43, an embodiment of a handle assembly is shown in partially and fully exploded views. In FIG. 42, the handle housing has been removed to show the trigger mechanism 310, closure mechanism 340, toggle mechanism 350, and latch mechanism 380 located within the handle housing. In FIG. 43, the trigger mechanism 310, closure mechanism 340, toggle mechanism 350, and latch mechanism 380 are shown in exploded form.

[0039] 44 and 45, cross-sectional views of an embodiment of a handle assembly are shown: Fig. 44 is a cross-sectional top view; and Fig. 45 is a cross-sectional side view.

[0040] 46-51, partial cross-sectional views of the handle assembly are shown along with the corresponding positions of the jaw assembly 100 and needle 200. FIG. 46 shows the handle assembly in an initial position with the needle 200 positioned within the first jaw 110. FIGS. 47 and 48 show the actuation sequence when the first and second levers 312, 322 of the trigger mechanism are squeezed toward the handle body of the handle assembly 300. FIGS. 49-51 show the actuation sequence when the first and second levers 312, 322 of the trigger mechanism 310 are released from the handle body of the handle assembly 300.

[0041] 46-48, the trigger mechanism can include a pair of opposed levers 312, 322, each pivotable relative to the handle body. As shown, the levers can be pivotally coupled to the handle body adjacent the distal end of the handle assembly. Each of the levers 312, 322 can have a drive slot 314, 324 formed therein. As shown, the drive slots 314, 324 can have a profile configured to initially close the jaws when the levers are squeezed and then maintain the closed state upon further movement of the levers 312, 322 while the toggle mechanism is actuated. For example, the drive slots 314, 324 can include drive segments 316, 326 and dwell segments 318, 328. The closure mechanism 340 may include posts guided by the drive slots 314, 324 and coupled to the proximal ends of drive rods 342, which extend distally through the elongate shaft 50 to the jaw actuation assembly 150. Thus, upon initial movement of the levers 312, 322 toward the handle body (FIGS. 46 and 47), the posts 344 are guided through the drive segments 316, 326 of the drive slots 314, 324 to longitudinally translate the drive rods 342 and close the base jaws 120, 170 (FIG. 47).

[0042] 47 and 48, further compression of the levers 312, 322 toward the handle body results in the closure mechanism post 344 moving within the retention segments 318, 328 of the drive slots 314, 324, thereby minimizing further displacement of the drive rod 342. However, the trigger mechanism levers 312, 322 are each pivotally coupled to a first end of an actuation link 320, 330 that extends generally proximally within the handle assembly. A second end of the actuation link 320, 330, opposite the first end, is coupled to a drive pusher 352 that is longitudinally translatable within the handle body. Longitudinal translation of the drive pusher 352 within the handle body can actuate a toggle mechanism 350, thereby selectively rotating a toggle tube 354 within the handle body, as further described with reference to FIGS. 52-60.

[0043] 46-48, initial compression of levers 312, 322 of the trigger mechanism (FIGS. 46 and 47) actuates actuation links 320, 330 to translate drive pusher 352 proximally along toggle tube 354 of toggle mechanism 350. Further compression of levers 312, 322 of the trigger mechanism actuates actuation links 320, 330 to translate drive pusher proximally along toggle tube 354 and rotate the toggle tube about the longitudinal axis of the handle body. As further described herein with reference to FIGS. 52-60, rotation of toggle tube 354 alternately longitudinally advances one of first shim 360 and second shim 370 to alternately retain needle 200 in one of the first and second jaws. Thus, when a user squeezes the levers 312, 322 of the trigger mechanism, the jaws of the jaw assembly close, passing the needle 200 from one jaw to the other.

[0044] 49-51, releasing the levers 312, 322 guides the post 344 of the closure mechanism 340 along the dwell segments 318, 328 of the slots 314, 324 (FIGS. 49 and 50). During this initial opening motion, the toggle tube 354 continues to rotate, completing the advancement of one of the shims. As the levers continue to spread apart, the post 344 of the closure mechanism 340 moves along the drive segments 316, 326 of the slots 314, 324 (FIGS. 50 and 51), thereby longitudinally translating the drive rod 342 and returning the jaw assembly to the open configuration. This further motion causes the drive pusher 352 to translate distally along the toggle tube 354 of the toggle mechanism 350.

[0045] 52-54, various views of the toggle mechanism are shown in isometric, top, and side views, respectively. As shown, the toggle mechanism 350 includes a drive pusher 352 that is longitudinally slidable within the handle body upon actuation of the trigger mechanism 310. The drive pusher 352 can have a bifurcated proximal end with a follower 353, e.g., a post, protruding from each prong of the drive pusher 352. While the drive pusher 352 is shown as an integrally formed component, in other embodiments, the pusher's fork arms can be separate pieces that function in a similar manner. In some embodiments, the pusher's fork arms can be rigid and include a translating pin and spring element that maintains the pin in contact with the toggle tube. The toggle mechanism 350 can further include a toggle tube 354 that is rotatable within the handle body. As shown, the toggle tube 354 has a cam drive slot 356 and a shim guide 358. The drive pusher follower 353 may be positioned within the cam drive slot 356. The cam drive slot 356 may have a pair of generally longitudinally extending lead segments and a rotation segment extending between the lead segments at an angle transverse to the longitudinal axis of the handle body.

[0046] Continuing with reference to FIGS. 52-54, the toggle mechanism 350 may further include a first shim 360 with a first follower 362 at its proximal end and a second shim 370 with a second follower 372 at its proximal end. The followers 362, 372 may comprise protruding posts extending radially inward from the shims 360, 370. Each of the followers 362, 372 may be positioned within a shim guide 358 of the toggle tube 354. In other embodiments, the shims may have a radially inward-extending flange positioned within the shim guide to move the shims without a follower. The shim guide 358 may have a shim advancement profile such that rotation of the toggle tube 354 within the handle body alternately longitudinally advances or retracts the followers 362, 372 of the shims 360, 370. Thus, rotation of toggle tube 354 through a toggle cycle alternately advances and retracts shims 360, 370, thereby alternately retaining the needle in one or the other of the flip jaws as will be described with reference to Figures 18-20.

[0047] 55-60, the actuation sequence of the toggle mechanism is shown in cross-sectional views. In FIG. 55, follower 353 of drive pusher 352 is positioned within the longitudinal lead segment of cam drive slot 356, with first shim 360 in a distally advanced position and second shim 370 in a retracted position. During an initial squeezing of the trigger mechanism, corresponding to closing of the jaw assembly as described above with reference to FIGS. 46 and 47, follower 353 is advanced longitudinally proximally along the lead segment of cam drive slot 356, as shown in FIGS. 55 and 56. Toggle tube 354 is not rotated during this operation, and first and second shims 350, 370 remain in their initial positions.

[0048] 56-58, during the actuation sequence of toggle mechanism 350, once the trigger mechanism is squeezed past the jaw closure (FIGS. 47 and 48), follower 353 of drive pusher 352 reaches a rotational segment of cam drive slot 356. The rotational segment may be configured to rotate toggle tube 354 in a predetermined direction upon actuation by drive pusher 352. For example, the rotational segment may have a variable depth profile at the intersection of the rotational segment and the lead segment, such that as follower 353 is advanced through the rotational segment, cam follower 353 tends to follow a desired segment of the rotational segment and rotate the toggle tube in a predetermined direction. The rotational segment extends along toggle tube 354 transverse to the longitudinal axis of the handle body, such that further proximal advancement of drive pusher 352 and follower 353 relative to the toggle tube causes toggle tube 354 to rotate within the handle body ( FIGS. 56-58 ). This rotation of toggle tube 354 in turn rotates shim guide 358, thereby retracting first shim follower 362 and first shim 360 proximally and advancing second shim follower 372 and second shim 370 distally. Thus, during successive squeezing of the closed trigger mechanism of the jaw assembly as described above with reference to FIGS. 47 and 48 , follower 353 advances along the rotational segment of cam drive slot 356, as shown in FIGS. 56-58 . The toggle tube 354 is rotated during this operation, causing the first and second shims 360, 370 to move longitudinally.

[0049] 58-60, during the actuation sequence of toggle mechanism 350, once the trigger mechanism is released from the fully squeezed orientation (FIGS. 49-51), follower 353 of drive pusher 352 reaches the proximal-most peak of the rotation segment of cam drive slot 356 (FIG. 58). The rotation segment can be configured to continue to rotate toggle tube 354 in a predetermined direction upon release of the trigger mechanism and distal movement of drive pusher 352. For example, the rotation segment can have a variable depth profile at the proximal-most peak of the rotation segment such that as follower 353 is advanced along the rotation segment, follower 353 tends to track a desired segment of the rotation segment, thereby rotating the toggle tube in a predetermined direction. Additionally, follower 353 may be located at the end of a flexible arm on the drive pusher, which acts as a leaf spring that allows follower 353 to advance through the depth step. The rotational segment extends along toggle tube 354 transverse to the longitudinal axis of the handle body, such that initial distal retraction of drive pusher 352 and follower 353 relative to the toggle tube causes toggle tube 354 to continue rotating within the handle body (FIGS. 58 and 59). Advantageously, this continued rotation is achieved by a "double-action" stroke of the toggle tube (i.e., rotation between both squeezing and releasing the trigger mechanism). This double-action stroke desirably halves the stroke length of the trigger mechanism otherwise required to rotate the toggle tube, thereby enabling a small pressure angle of the follower 353 and cam drive slot 356 system. This rotation of toggle tube 354 in turn rotates shim guide 358, which in turn retracts first shim follower 362 and first shim 360 proximally and advances second shim follower 372 and second shim 370 distally.Thus, during the initial release operation of the trigger mechanism, corresponding to the initial dwell portion as described above with reference to Figures 49 and 50, the follower 353 is advanced along the rotational segment of the cam drive slot 356 as shown in Figures 58 and 59. As the toggle tube 354 rotates during this operation, the first and second shims 360, 370 continue to move distally until the second shim 370 reaches its distal advanced position and the first shim reaches its proximal retracted position.

[0050] Referring to FIG. 60, as the trigger mechanism continues to move to the fully released position (FIGS. 50 and 51) during the actuation sequence of the toggle mechanism 350, the follower 353 of the drive pusher 352 reaches the longitudinal lead segment of the cam drive slot 356 (FIG. 60). The rotation segment may have a variable depth profile at the intersection of the rotation segment and the lead segment, such that as the follower 353 is being retracted proximally, it tends to enter the lead segment. Thus, continued distal retraction of the drive pusher 352 and follower 353 relative to the toggle tube along the longitudinally extending lead segment maintains the rotational orientation of the toggle tube 354 within the handle body (FIG. 60). Thus, during a fully released actuation of the trigger mechanism corresponding to the jaw opening described above with reference to FIGS. 50 and 51, the follower 353 advances along the lead segment of the cam drive slot 356 as shown in FIG. 60. During this actuation, the second shim 370 remains in the distally advanced position and the first shim 360 remains in the proximal retracted position.

[0051] Thus, in the illustrated embodiment, a single compression and release cycle of the trigger mechanism cycles the toggle mechanism 350 to rotate the toggle tube 354 180 degrees. This 180 degree rotation of the toggle tube 354 repositions one shim 360 from a distally advanced position to a proximal retracted position and repositions the other shim 370 from a proximal retracted position to a distally advanced position. Thus, the illustrated toggle mechanism advantageously allows a single trigger mechanism to actuate the open / close / open cycle of the jaws and alternately advance the shim to retain the needle within one of the jaws. In other embodiments, other toggle mechanisms may be used to alternately advance and retract the shim in response to the cycling of the trigger mechanism.

[0052] As described above, the flip jaws utilize a torsion spring and cable mechanism to rotate between the retracted and suturing configurations. The flip jaws rotate around a dowel pin held on either end of the flip jaw by the base jaw. In some embodiments, the distal end of a cable is welded to the bottom of the corresponding flip jaw, and the distal end of the cable is controlled by a latch mechanism located within the handle. In other embodiments, the cables may be attached to the corresponding flip jaw by crimping each cable into a slot located in the corresponding flip jaw or by providing a fitting at the end of each cable attached to the corresponding flip jaw. In other embodiments, the flip jaw cables may also be secured to the flip jaw by soldering or brazing. A torsion spring is located on the axis of rotation of the flip jaw between the flip jaw and the base jaw. The spring is biased to rotate the flip jaw into the operative suturing configuration. To rotate the flip jaw to the operative state, tension is released from the cable, allowing the torsion spring to rotate the jaw. Tension is applied to the cable to rotate the flip jaw to its inoperative state.

[0053] Referring to Figures 61-63, the actuation sequence of the latch mechanism 380 is shown. Figure 61 shows the latch mechanism in an unlatched configuration corresponding to the sewn-up configuration of the flip jaws. The latch mechanism 380 may include a latch knob 381 at the proximal end of the handle assembly. In the illustrated embodiment, the latch knob 381 is coupled to a latch tube 382 having first and second guide slots 384, 386 formed therein. The latch mechanism further includes first and second cables 390, 394 that extend distally through the handle assembly and elongate shaft and are coupled to the flip jaws of the jaw assembly, as described above with reference to Figures 14-17. The proximal ends of the cables 390, 394 are coupled to posts 392, 396 positioned within the guide slots 384, 386 of the latch tube 382. Posts 392, 396 may be dowel pins protruding from bearing tubes that are coupled to toggle tube 354 of the toggle mechanism such that proximal movement of posts 392, 396 causes the toggle tube and shims 360, 370 to retract proximally.

[0054] 61-63, upon rotation of the latch knob 381, the latch tube 382 correspondingly rotates. Thus, the posts 392, 396 are retracted proximally due to their interaction with the guide slots 384, 386 of the guide tubes. This proximal movement of the posts 392, 396 applies tension to the cables 390, 394, rotating the flip jaws from the suturing configuration (FIG. 61) to the retracted configuration (FIG. 63). This proximal movement of the posts 392, 396 also proximally retracts the toggle tube 354 and shims 360, 370. With the latch mechanism 380 partially rotated, the shims 360, 370 can be retracted from both jaws so that the jaw assembly can be reloaded with a new needle, if desired. Further rotation of the latch knob 381 positions the posts 392, 396 at the ends of guide slots 384, 386, which may be configured, for example, by flat segments or detents, to maintain the latch mechanism 380 in a latched configuration with the flip jaws in the retracted configuration.

[0055] When it is desired to unlatch the suturing instrument and position the flip jaws in the suturing configuration, the sequence of Figures 61-63 can be reversed. In the unlatch sequence, the latch mechanism in the handle releases cable tension and slides the needle locking shim forward in one motion. After the cable tension is released and the spring stops rotation of the activated flip jaws, the shim slides forward into the flip jaws to prevent them from rotating back to the unactivated state. One shim slides further to lock the needle within its jaws. In some embodiments, the latch mechanism can further include a tension spring to maintain tension on the cable in both the latched and unlatched configurations of the suturing instrument.

[0056] Although torsion spring-biased unlatching and cable-driven latching of the latching mechanism are illustrated, in other embodiments, other latching mechanisms can be used with the suturing instruments described herein. For example, in some embodiments, each jaw can have a first cable for rotating the flip jaw to the suturing configuration and a second cable for rotating the flip jaw to the retracted configuration. In other embodiments, the flip jaw can be rotated or pushed to the suturing or retracted configuration using a stiffer cable or rod that can push or pull the flip jaw, eliminating the need for a torsion spring or two counteracting cables. In yet other embodiments, the flip jaw can be rotated relative to the base jaw by a worm gear and sector, a nitinol actuator, or a lead screw and nut arrangement.

[0057] Referring to FIG. 64, a cross section of the elongate shaft adjacent the distal end is shown. In the illustrated embodiment, the elongate shaft 50 can include a cover tube and spacer member 56 through which the drive rod, cable, and shim pass. In some embodiments, the spacer member can be an extruded member. The spacer member can prevent buckling of the shim, cable, and drive rod within the cover tube. When a user squeezes the lever of the trigger mechanism, the lever transmits force to the drive rod down the length of the suturing instrument shaft.

[0058] 65 and 66, in some embodiments, the needle 200 and suture 420 can include a braided polymer tube anchor 430. The braided polymer tube 430 can be positioned at the end of the suture opposite the needle to serve as an anchor for the suture. The braided polymer tube 430 anchor can be attached to the end of the suture by welding, adhesive, or another bonding method. Advantageously, the braided polymer tube 430 can provide a relatively easy target for the surgeon to thread the needle, with multiple insertion regions provided by voids between adjacent regions of overlapping polymer strands.

[0059] 66, in certain embodiments, the needle 200 and suture 420 may have a leader segment 440 with a braided polymer tube between the needle 200 and the suture 420. The braided polymer tube may provide increased flexibility of the suture at the needle interface.

[0060] 65 and 66, in certain embodiments, the needle and suture 420 may comprise a unidirectional barbed suture to facilitate tissue retention by the suture. In other embodiments, a smooth monofilament suture may be used in conjunction with a braided polymer tube anchor and / or braided polymer tube leader.

[0061] The suturing instruments described herein can have a variety of materials and combinations of materials in their construction. For example, in some embodiments, the flip jaws, base jaws, clevises, slotted heads, drive rods, cables, torsion springs, shims, dowel pins, needles, detent springs, detent balls, cover tubes, suture crimps, toggle tubes, and rivets can be made of metals such as stainless steel, aluminum, titanium, tungsten, brass, bronze, or alloys thereof. In some embodiments, the shims and / or cables can be made of nickel-titanium (nitinol) to provide high flexibility and long fatigue life. In some embodiments, the monofilament or braided suture and flexible multifilament leader can be made of a non-bioabsorbable polymer, such as polypropylene, nylon, polyester, or silk, or a bioabsorbable polymer, such as polydioxanone, polylactic acid, polyglycolide, polylactic-co-glycolic acid, polycaprolactone, or catgut. In some embodiments, some or all of the trigger lever, linkage, latch, knob, shim follower, and drive rod adapter may be made from plastic, such as polycarbonate, ABS, polyethylene, polypropylene, PEEK, polyurethane, PVC, acrylic, nylon, polystyrene, acetal, carbon fiber, polyimide, or polyester.

[0062] While the illustrated embodiment of the suturing instrument has a latching mechanism for configuring the jaws to a retracted, small-diameter profile configuration that allows for insertion of a relatively large-diameter needle through a relatively small-diameter surgical port, it is envisioned that other configurations of the suturing instrument can achieve the small-diameter profile that allows for insertion. For example, in some embodiments, the suturing instrument can have a telescopically collapsible needle. A compression element, e.g., a spring, can be housed within the needle, allowing the two halves of the needle to collapse concentrically upon receiving a force greater than that required for tissue penetration. Jaw closure can be selectively controlled with one setting for passage of the needle from jaw to jaw and another setting for allowing further closure of the jaws, thereby collapsing the needle to a low-profile state to allow retraction through a 5mm trocar.

[0063] In the illustrated embodiment, the suture is positioned along the elongate shaft with the jaw assembly in a low-profile stored configuration insertable through a surgical port. Other embodiments contemplate further reducing the profile of the suturing instrument for insertion. For example, in some embodiments, the clevis and outer tube of the elongate shaft can be formed with axial grooves into which the suture aligns during insertion into the trocar, thereby reducing the cross-sectional profile of the suturing instrument. In other embodiments, the suture can be coiled or folded within the two base jaws during insertion into the trocar, thereby reducing the cross-sectional profile of the suturing instrument. The jaw assembly can be retracted and the base jaws can close around the coiled or folded suture. The base jaws can then be opened while positioned within the body cavity to release the suture. In other embodiments, the suturing instrument can further include an introducer tube within which the suture can be coiled or folded for insertion through the trocar. The introducer tube desirably reduces the cross-sectional profile of the suturing instrument during insertion through the trocar, yet allows for the use of a larger profile suture anchor. The introducer tube can cover the base jaws while they are fully closed in the retracted configuration. Once another instrument, such as a surgical grasper, has been inserted into the body cavity, the introducer tube can be withdrawn from the jaws, thereby releasing the suture into the body cavity. The introducer tube can then be quickly removed from the body cavity through the other instrument's trocar.

[0064] While the present application discloses certain preferred embodiments and examples, those skilled in the art will recognize that the present invention extends to other variations and / or uses of the invention beyond the specifically disclosed embodiments, as well as obvious modifications and equivalents thereof. Moreover, various features of the present invention can be used alone or in combination with other features of the invention other than those expressly described above. Thus, it is intended that the scope of the invention disclosed herein not be limited by the particularly disclosed embodiments described above, but should be determined only by a fair interpretation of the following claims.

Claims

1. A laparoscopic suturing instrument, a handle assembly having a proximal end and a distal end; an elongated shaft extending distally from the distal end of the handle assembly and defining a central longitudinal axis; a jaw assembly extending distally from the elongate shaft, the jaw assembly including a first jaw and a second jaw, each having a proximal end pivotally coupled to the elongate shaft and a distal end; having a needle, the jaw assembly and the needle are selectively positionable between a stored configuration in which the needle is positioned within one of the first jaw and the second jaw and the first jaw, the second jaw, and the needle are generally aligned with the central longitudinal axis, and an open position in which the first jaw, the second jaw, and the needle extend transversely to the central longitudinal axis.

2. The laparoscopic suturing instrument of claim 1 , wherein the handle assembly includes a latch mechanism operably coupled to the jaw assembly for selectively positioning the first jaw and the second jaw in the stored configuration.

3. The first jaw comprises: a first base jaw located at the proximal end of the first jaw; 2. The laparoscopic suturing instrument of claim 1, further comprising: a first flip jaw located at the distal end of the first jaw and pivotally coupled to the first base jaw, the first flip jaw being pivotable relative to the first base jaw between a retracted position when the jaw assembly is in the retracted configuration and a suturing position.

4. 4. The laparoscopic suturing instrument of claim 3, wherein the first flip jaw defines a needle receiving channel, the needle receiving channel being positioned generally transverse to an axis extending from the proximal end of the first jaw to the distal end of the first jaw.

5. The laparoscopic suturing instrument of claim 4, wherein said first flip jaw includes a detent that engages said needle when a portion of said needle is positioned within said needle receiving channel.

6. The laparoscopic suturing instrument of claim 4 , wherein a shim channel extends through said first flip jaw, said shim channel intersecting said needle-receiving channel.

7. 7. The laparoscopic suturing instrument of claim 6, further comprising a shim extendable partially into the shim channel to lock the first flip jaw in the suturing configuration and further extendable into the needle receiving channel to engage the needle when the needle is positioned within the needle receiving channel.

8. The laparoscopic suturing instrument of claim 7 , wherein the needle has a shim notch alignable with the shim channel of the first flip jaw when the needle is positioned within the needle receiving channel of the first flip jaw.

9. The second jaw comprises: a second base jaw located at the proximal end of the second jaw; 4. The laparoscopic suturing instrument of claim 3, further comprising: a second flip jaw located at the distal end of the second jaw and pivotally coupled to the second base jaw, the second flip jaw being pivotable relative to the first base jaw between a retracted position when the jaw assembly is in the retracted configuration and a suturing position.

10. The laparoscopic suturing instrument of claim 1 , wherein the needle has the first penetrating tip and a second penetrating tip opposite the first penetrating tip.

11. A laparoscopic suturing instrument, a handle assembly having a proximal end and a distal end, the handle assembly including a trigger mechanism, a closure mechanism, and a toggle mechanism; an elongated shaft extending distally from the distal end of the handle assembly and defining a central longitudinal axis; a jaw assembly extending distally from the elongate shaft, the jaw assembly including a first jaw and a second jaw, each having a proximal end pivotally coupled to the elongate shaft and a distal end; having a needle, the trigger mechanism is operably coupled to the closure mechanism and the toggle mechanism such that an actuation cycle of the trigger mechanism sequentially actuates the closure mechanism to close the first and second jaws of the jaw assembly, actuates the toggle mechanism to transfer the needle from one of the first and second jaws to the other of the first and second jaws, and actuates the closure mechanism to open the first and second jaws.

12. The laparoscopic suturing instrument of claim 11 , wherein the closure mechanism includes a drive rod extending longitudinally through the elongate shaft, the drive rod having a proximal end coupled to the trigger mechanism.

13. 13. The laparoscopic suturing instrument of claim 12, wherein the trigger mechanism defines a drive slot, the drive rod having a post positioned within the drive slot to couple the closure mechanism to the trigger mechanism.

14. 13. The laparoscopic suturing instrument of claim 12, wherein the drive slot comprises a profile having a drive segment positioned to translate the drive rod upon actuation of the trigger mechanism and a retention segment positioned to maintain the position of the drive rod upon further actuation of the trigger mechanism.

15. The laparoscopic suturing instrument of claim 11, wherein the trigger mechanism includes an actuation link having an end coupled to a longitudinally translatable drive pusher within the handle assembly.

16. 16. The laparoscopic suturing instrument of claim 15, wherein the toggle mechanism includes a toggle tube rotatable about the central longitudinal axis relative to the handle assembly, the toggle tube having a cam drive slot and a shim guide formed within the cam drive slot.

17. 17. The laparoscopic suturing instrument of claim 16, wherein the drive pusher is coupled to the cam drive slot such that translation of the drive pusher within the handle assembly rotates the toggle tube relative to the handle assembly.

18. 17. The laparoscopic suturing instrument of claim 16, wherein the toggle mechanism further includes a first shim and a second shim each coupled to the shim guide of the toggle tube such that rotation of the toggle tube alternately advances and retracts the first shim and the second shim longitudinally relative to the handle assembly.

19. 1. A laparoscopic suturing system, comprising: a laparoscopic suturing instrument, the laparoscopic suturing instrument comprising: A handle assembly; an elongate shaft having a proximal end coupled to the handle assembly and a distal end, the elongate shaft defining a central longitudinal axis extending between the proximal and distal ends; a jaw assembly coupled to the distal end of the elongate shaft, the jaw assembly including a first jaw and a second jaw each pivotally coupled to the elongate shaft, the first jaw and the second jaw pivotable between an open configuration and a closed configuration; a suture needle positionable within the jaw assembly, the suture needle comprising: a needle having a generally curved profile and extending from a first penetrating tip to a second penetrating tip, said needle comprising: a first shim notch located adjacent the first penetrating tip; a second shim notch located adjacent the second penetrating tip; a first recess located adjacent to the first penetrating tip; a second recess located adjacent to the second penetrating tip; A laparoscopic suturing system including a suture coupled to the needle.

20. The laparoscopic suturing system of claim 19, further comprising a leader segment connecting the suture to the needle.

21. The laparoscopic suturing system of claim 19, further comprising an anchor segment coupled to the suture.

22. The laparoscopic suturing system of claim 19, wherein the anchor segments are comprised of a polymeric braided mesh.

23. 20. The laparoscopic suturing system of claim 19, wherein the suture comprises a barbed monofilament suture.

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