Patent Publication Number: US-2021161522-A1

Title: Devices and methods for minimally invasive suturing

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 16/236,966, filed Dec. 31, 2018, which in turn is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 15/942,509, filed Mar. 13, 2018, now U.S. Pat. No. 10,792,031, which in turn is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 15/610,277, filed May 31, 2017, now U.S. Pat. No. 9,962,151, which in turn is a is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 15/377,562, filed Dec. 13, 2016, now U.S. Pat. No. 9,675,339, which in turn is a is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 13/204,820, filed Aug. 8, 2011, now U.S. Pat. No. 9,775,600, which in turn is a continuation-in-part of and claims the benefit of priority to U.S. patent application Ser. No. 12/909,606, filed Oct. 21, 2010 and issued as U.S. Pat. No. 7,993,354 on Aug. 9, 2011, which in turn claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61/388,648, filed Oct. 1, 2010. This application is also related to International Application No. PCT/US2009/006212 filed Nov. 20, 2009, which in turn claims priority to U.S. Provisional Application Ser. No. 61/200,180, filed Nov. 25, 2008. This application is also related to U.S. patent application Ser. No. 11/231,135, filed Sep. 20, 2005, which in turn claims the benefit of priority to U.S. Provisional Application Ser. No. 60/611,362, filed Sep. 20, 2004. This patent application is also related to International Application No. PCT/US2008/06674 filed May 23, 2008, which in turn claims priority to U.S. Provisional Application Ser. No. 60/939,887, filed May 24, 2007. This patent application is also related to U.S. patent application Ser. No. 12/175,442, filed Jul. 17, 2008. Each of the aforementioned applications is incorporated by reference herein in its entirety for any purpose whatsoever. 
    
    
     FIELD 
     The embodiments disclosed herein relate to medical devices for suturing tissue using curved suturing needles during minimally invasive suturing, methods for making such a device and methods for using such a device for suturing tissue. 
     BACKGROUND 
     Minimally invasive surgery (MIS) has allowed physicians to carry out many surgical procedures with less pain and disability than conventional, open surgery. Unlike conventional open surgery, where the surgical site is readily accessible through a large incision, enabling the surgeon to easily visualize and manipulate both tissue and instruments, MIS requires the surgeon to operate remotely by inserting and manipulating instruments through small punctures (“keyhole surgery”) or through natural orifices, including for example the vagina, the esophagus, or the anus. 
     In MIS, a small puncture is typically made in the body. Medical instruments are then inserted through a cannula. A cannula has a small inside diameter, typically 5-10 millimeters (mm), and sometimes up to 20 millimeters (mm) or more. A number of such cannulas may be inserted into the body for any given operation. Minimally invasive surgical instruments are necessarily smaller, and are also generally longer and therefore are more difficult to manipulate with precision. 
     Perhaps the most problematic surgical task in MIS is suturing. Suturing requires coordinated manipulation with both hands of small needles and sutures that are difficult to visualize (particularly when only indirect, two-dimensional video imaging is available) as well as the several instruments (including needle-drivers and pick-up forceps) ordinarily used to suture by hand. In an environment characterized by limited space, limited visualization, and limited mobility, many surgeons find minimally invasive suturing by hand an extremely difficult, often virtually impossible, surgical task. 
     In the preferred method of suturing by hand, a grasping forceps (“needle driver”) is held by the surgeon and is used to grip a curved needle near the needle&#39;s tail. Pronation of the surgeon&#39;s wrist drives the needle into the tissue. When the point of the curved needle emerges from the tissue, the surgeon releases the needle from the grip of the needle driver and grasps the point with another forceps (“pick-ups”). The surgeon then pulls the curved needle by the needle point, preferably in a circular path following the arc of the needle&#39;s curvature to follow the most atraumatic path through the tissue, until the entire length of the needle has exited the tissue. Each time a stitch is placed, the curved needle is thus driven around in a complete circular arc. Individual (interrupted) stitches are placed by tying off the suture following placement of each stitch. Running (continuous) stitches are placed by repeatedly driving the curved needle in a complete circular arc repeatedly until the desired length of suture and number of stitches has been placed. In order to place additional interrupted or continuous stitches, the surgeon must let go of the point of the needle and re-grasp the needle near the needle&#39;s tail. 
     In the manual suturing technique described above, the direct handling of the needle can result in accidental needle pricks through a surgeon or nurse&#39;s gloves, posing a potential risk of infection for the surgeon, nurse, staff, and patient, or cause the needle to become contaminated with pathogenic bacteria that can cause onset of infection at the site of the sutures. There is also a risk of the needle penetrating internal organs or vessels and causing a serious, and often fatal infection. 
     Various devices for suturing for MIS are described in U.S. Pat. No. 5,643,295 entitled “Methods and Apparatus for Suturing Tissue”; U.S. Pat. No. 5,665,096 entitled “Needle Driving Apparatus and Methods of Suturing Tissue”; U.S. Pat. No. 5,665,109 entitled “Methods and Apparatus for Suturing Tissue”; U.S. Pat. No. 5,759,188 entitled “Suturing Instrument with Rotatably Mounted Needle Driver and Catcher”; U.S. Pat. No. 5,860,992 entitled “Endoscopic Suturing Devices and Methods”; U.S. Pat. No. 5,954,733 entitled “Suturing Instrument with Rotatably Mounted Needle Driver and Catcher”; U.S. Pat. No. 6,719,763 entitled “Endoscopic Suturing Device”; and U.S. Pat. No. 6,755,843 entitled “Endoscopic Suturing Device”, all of which are incorporated by reference in their entireties for the teachings therein. 
     Assignees&#39; U.S. Pat. Nos. 5,437,681, 5,540,705 and 6,923,819 disclose a suturing device with thread management comprising a protective cartridge, suturing needle and needle rotation drive, the disclosures of which are hereby incorporated by reference. The devices described in the above-mentioned patents and patent application comprise a mechanism for driving a protected needle however, the needle is rotated about an axis that is parallel to the axis of the device. In addition, the orientation and size of the suturing device makes it difficult to visualize and cumbersome to use for MIS. 
     Therefore, there remains a need in the art for a minimally invasive suturing device that is easily manipulated within the small diameter of the cannula; functions in an environment characterized by limited space, limited visualization, and limited mobility; mimics the preferred method of suturing used by surgeons; permits the surgeon to secure and tie knots quickly and with controlled tension; places continuous stitches; and protects users from accidental needle sticks during needle handling, as well as internal organs and vessels from inadvertent needle-pricks. 
     SUMMARY 
     Devices and methods for minimally invasive suturing of tissue internal to a body are disclosed herein. 
     According to aspects illustrated herein, there is provided a medical device for closing openings internal to a patient&#39;s body, which closely emulates or replicates the manual suturing actions carried out by a surgeon. The device offers several advantages over conventional methods used by surgeons for suturing tissue during minimally invasive surgery in that the device provides a hand-held suturing instrument that requires no external motive source. The presently disclosed embodiments provide relative ease of operation for the surgeon with only one hand. 
     According to aspects illustrated herein, a suture head assembly may be removably attached to an actuator mechanism of the suturing device. The diameter of the device is small enough to fit into a 5 mm cannula in some embodiments, thus making the device extremely easy to maneuver, as well as suture, during endoscopic or other MIS procedures. In surgical procedures, it is desirable to make as few incisions as possible, and for those incisions to be as small as possible. As such, devices with reduced profile are highly advantageous. Also, the suture head assembly of the device can be laterally articulated to the left of center, to the right of center, up, and down, once inside the cannula, which is ideal for use in the course of endoscopic surgery, including laparoscopy, thoracoscopy and arthroscopy, as well as other less-invasive surgical procedures. 
     Devices of the present disclosed embodiments closely emulate or replicate the manual suturing actions carried out by a surgeon. For example, during manual suturing by hand, the needle is held in forceps and travels in a circular arc with no obstructions anywhere in the interior of the arc. The design of the suturing devices of the present disclosed embodiments allows for a lack of obstruction in the center of the arc of the needle during suturing. In other words, there is no hub at the center of the circular arc of the suturing needle. The entire area within the circular arc of the needle is unobstructed. This allows for the user to have better visualization during operation, unlike the present mechanical suturing methods, while maintaining control over needle movement. 
     A benefit provided by suturing devices of the presently disclosed embodiments is that the devices enable maneuvering a suturing material through a tissue incision in a manner substantially similar to the way a surgeon would do so by hand. In particular, some embodiments of the suturing device first push a suturing needle from the tail of the needle and drives the point of the needle through the tissue. The device then picks up the point of the needle that passed through the tissue, and pulls the remainder of the suturing needle and the suture attached to the suturing needle through the tissue. The suturing needle thus consistently follows the arc of the needle&#39;s own curve, which is the preferred method of suturing, in the most atraumatic way of passing a needle through tissue. A benefit provided by the suturing device of the presently disclosed embodiments is the ability of the suturing needle to pull the suturing thread entirely through the tissue segments being closed, following each stitch. When using the suturing device of the presently disclosed embodiments, no ancillary instruments or tools such as needle holders, pick-up forceps or the like are needed to complete the stitch. A forceps or grasping instrument can be used to tighten the knots. 
     According to aspects illustrated herein, there is provided an embodiment of a suturing device that includes a suturing needle that is protected by a housing, the suturing needle is not exposed to or handled directly by the user, thereby preventing inadvertent needle sticks. The configuration of the suturing device of the presently disclosed embodiments also protects against inadvertent penetration of internal organs or vessels by the needle, since the housing acts as a shield between the organs and the needle. 
     In one embodiment, a suturing device is provided having a suturing head. The suturing head includes a housing defining at least one passage therein and a deployable needle track. The deployable needle track is disposed in the housing, and the needle track is adapted and configured to be deployed, or expanded from a stored or contracted condition wherein the needle track is essentially disposed within the housing to an expanded, or deployed condition wherein the needle track extends outwardly from the housing to form an arcuate needle track. The device further includes an arcuate or circular needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body. The device further includes a drive for advancing the needle about a 360° path about the needle track when the deployable needle track is in a deployed condition. The drive is adapted and configured to advance the needle in multiple 360° revolutions about the needle track when the deployable or expandable needle track is in a deployed or expanded condition without removing the needle from the needle track. The drive selectively engages with and disengages from the needle to advance the needle about a 360° rotation. 
     In accordance with further aspects, the housing of the suturing device can be generally cylindrical, and have an outer diameter of about 5.0 mm. The circular path of the needle track can have a diameter of about 10 mm. If desired, the needle can have a non-circular cross-section. Preferably, the device further includes means for deploying the needle track from the stored condition to the deployed condition. The needle track can occupy about 270° of the 360° needle path when the needle track is deployed. It will be appreciated however that the present disclosure is directed to a device having a deployable, or, angularly expandable, needle track that can expand to a final extent that is greater or less than 270°, such as in increments of one degree. For example, a needle track can be provided that expands from about 180° to about 190°, about 200°, about 210°, about 220°, about 230°, about 240°, about 250°, about 260°, about 270°, about 280°, about 290°, about 300°, about 310°, about 320°, or about 300°, among others. For example, depending on the diameter of the device and the dimensions of the needle track, it may only be necessary to have guides that increase the angular extent of the needle track by about 10°, about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, about 90°, about 100°, about 110°, about 120°, about 130°, about 140°, about 150°, or about 160° from the undeployed (unexpanded) configuration to the deployed (expanded) configuration. The drive can include an elongate flexible member that reciprocates along a longitudinal axis of the device. The drive can engage with and advance the needle along the needle track when the elongate flexible member is advanced proximally with respect to the housing. The needle can include first and second notches along an inner face of the needle for engaging an antirotate mechanism disposed on at least one of the housing and the deployable needle track. The needle can further include a notch on a top face of the needle for engaging a portion of the drive, wherein the notch on the top face of the needle intersects one of the notches disposed on the inner face of the needle. 
     In accordance with a preferred embodiment, the deployable needle track includes at least one arcuate guide that is adapted to be deployed from the housing along an arcuate path. Preferably, the deployable needle track includes a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path. The pair of arcuate guides are preferably deployed from the housing along the arcuate path by pulling in a first pair of pull wires, wherein one pull wire is attached to each guide. The pair of guides are further preferably adapted and configured to be retracted into the housing by pulling in a second pair of pull wires, wherein one pull wire in the second pair of pull wires is attached to each guide. The first pair of pull wires is preferably connected to the second pair of pull wires to make a pair of continuous mechanical loops, wherein the loops are connected at a distal end to the guides, and at a proximal end to a pair of handles, wherein movement of the handles results in movement of the guides. 
     The disclosure also provides a suturing needle having an arcuate body with a leading tip and a trailing end, wherein the arcuate body defines a first notch along an inner radial region needle and a second notch having a projection that lies within a plane that is defined by a central curved axis of the needle, and further wherein the first notch and second notch intersect. If desired, the needle can further includes a generally square cross-section. The needle body can include a portion with a round cross section that separates a main portion of the needle with a generally square cross section from a tail portion with a generally square cross section. The needle can further define a third notch in the needle proximate its trailing end for receiving a portion of a drive pawl. Moreover, the needle can define an arcuate keel along its length to stabilize its movement in the suturing device. 
     According to aspects illustrated herein, there is provided a method for suturing tissue during minimally invasive surgery that includes inserting a distal end of a suturing device having a suturing needle with a pointed end into a body; positioning the suturing needle to span a plurality of separated tissue segments; activating an actuator a first time causing the pointed end of the suturing needle to extend beyond a protective housing of a cartridge to engage the plurality of separated tissue segments; and activating the actuator a second time to cause the suturing needle to complete a revolution and pull a suture extending from the suturing needle through the plurality of separated tissue segments to form a stitch. 
     In accordance with a further aspect, a suturing device having a suturing head is provided. The suturing head includes a housing defining at least one passage therein, the housing having a proximal end, a distal end and a peripheral side joining the proximal and distal ends. The head further includes a deployable needle track disposed at least partially within the housing, the needle track being adapted and configured to be deployed from a stored condition wherein the needle track is essentially disposed within the housing and has an angular extent of about 180° to a deployed condition wherein the needle track has an angular extent in excess of 180° and extends outwardly from the peripheral side of the housing to form an arcuate needle track that lies in a plane that is parallel to a longitudinal axis of the housing. Preferably, the needle track is angularly expandable along a circular path that defines the path of travel of the needle such that the track expands angularly about the circular path from a contracted condition to an expanded condition. The suturing head further includes an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body. The suturing head further includes a drive for advancing the needle in multiple 360° revolutions about the needle track when the deployable needle track is in a deployed condition, wherein the drive selectively engages with and disengages from the needle to advance the needle about a 360° rotation. 
     In accordance with a further aspect, housing is generally cylindrical, and has a diameter of about 5.0 mm and the path of the needle track has a diameter of about 10 mm. However, it will be appreciated that the diameter can be larger or smaller as desired. The needle can have a substantially circular cross section, a circular cross section, a non-circular cross-section, a square or triangular cross section, or may have a cross section that varies along its length that transitions from one shape to another, such as from a square to a circle to a square. The device preferably further includes means for deploying the needle track from the stored condition to the deployed condition. The needle track preferably occupies about 270° of a 360° needle path when the needle track is deployed, but the angular extent of the track can be more or less than 270°, as desired, in one degree increments, for example. 
     In accordance with a further aspect, the drive preferably includes an elongate flexible member that reciprocates along a longitudinal axis of the device. The drive preferably engages with and advances the needle along the needle track when the elongate flexible member is advanced proximally with respect to the housing. The deployable needle track preferably includes at least one arcuate guide that is adapted to be deployed from the housing along an arcuate path. The deployable needle track preferably includes a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path. The pair of arcuate guides are preferably deployed from the housing along the arcuate path by pulling in a first pair of pull wires, wherein one pull wire is attached to each guide. The pair of arcuate guides is preferably adapted and configured to be retracted into the housing by pulling in a second pair of pull wires, wherein one pull wire in the second pair of pull wires is attached to each guide. The first pair of pull wires is preferably connected to the second pair of pull wires to make a pair of continuous mechanical loops, wherein the loops are connected at a distal end to the guides, and at a proximal end to a pair of handles, wherein movement of the handles results in movement of the guides. 
     In another embodiment, a suturing device is provided having a suturing head. The suturing head includes an elongate housing having a proximal end, a distal end and a peripheral side joining the proximal and distal ends, wherein the housing defines a longitudinal axis from its proximal end to its distal end. The suturing head further includes a deployable needle track disposed at least partially within the housing, at least a portion of the needle track being adapted and configured to be deployed along an arcuate path from a undeployed condition wherein the needle track has an arcuate extent of about 180 degrees and is essentially disposed within the housing to a deployed condition wherein the needle track has an arcuate extent in excess of 180 degrees, and wherein the needle track lies in a plane that is parallel to a longitudinal axis of the housing. The suturing head further includes an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body. The suturing head also includes a drive for advancing the needle in multiple 360° revolutions about the needle track when the deployable needle track is in a deployed condition, wherein the drive selectively engages with and disengages from the needle to advance the needle about a 360° rotation. 
     In accordance with a further aspect, the housing can be generally cylindrical or rectilinear, as desired. The deployable or expandable needle track can include one or more arcuate guides that are adapted to be deployed from the housing along an arcuate path. The deployable or expandable needle track can include a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path. Accordingly, a pair of arcuate guides can be deployed from the housing along the arcuate path by pulling on a first pair of pull wires, wherein one pull wire is attached to each guide. In one embodiment, the deployable or expandable needle track occupies about 270° of a 360° needle path when the needle track is in the expanded condition, but the angular extent of the track can be more or less than 270°, as desired, in one degree increments, for example. 
     These and other advantages of the presently disclosed embodiments are illustrated through the embodiments described hereinafter. The presently disclosed embodiments accordingly comprise the features of construction, combination of elements and arrangement of parts that will be exemplified in the following detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments, wherein: 
         FIGS. 1-3  generally depict a suturing device made in accordance with the present disclosure. 
         FIGS. 4-32 and 47 (A)- 47 (D) illustrate aspects of a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 
         FIGS. 33-37  illustrate aspects of an embodiment of a needle loader made in accordance with the present disclosure. 
         FIGS. 38-40  illustrate aspects of a first embodiment of a suturing needle made in accordance with the present disclosure. 
         FIGS. 41-44  illustrate aspects of a second embodiment of a suturing needle made in accordance with the present disclosure. 
         FIG. 45  illustrates aspects of a third embodiment of a suturing needle made in accordance with the present disclosure. 
         FIG. 46  illustrates aspects of a fourth embodiment of a suturing needle made in accordance with the present disclosure. 
         FIGS. 47(E) - 55  illustrate aspects of a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 
         FIGS. 56-59  illustrate aspects of an intermediate region of the suturing device illustrated in  FIGS. 1-3 . 
         FIGS. 60-122  illustrate aspects of a handle portion of the suturing device illustrated in  FIGS. 1-3 . 
         FIGS. 123-131  illustrate operation of the suturing head of  FIGS. 4-32 and 47 (A)- 47 (D). 
     
    
    
     While the drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments. 
     DETAILED DESCRIPTION 
     Reference will now be made in detail to the present preferred embodiments of the disclosure, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the disclosed embodiments will be described in conjunction with the detailed description of the system. 
     Broadly speaking, the disclosure provides embodiments of suturing devices having features that permit the device to be constructed on a smaller scale and having a smaller profile than embodiments discussed in the prior art and in patent applications incorporated herein by reference. In particular, embodiments made in accordance with the present disclosure have been constructed that are adapted and configured to fit through a 5 mm trocar. Advantageously, the disclosed embodiments still use a comparatively large suturing needle, thereby permitting substantial tissue capture during operation, resulting in effective suturing. 
     For purposes of illustration and not limitation, as embodied herein, an exemplary embodiment of a suturing device  1000  is illustrated in  FIG. 1 . Device  1000  includes three regions, including a suture head  100 , an intermediate region  500 , and a handle  600 . Each of these regions is discussed in detail below.  FIGS. 2-3  illustrate device  1000  with certain portions removed. In particular,  FIG. 2  illustrates device  1000  with a needle loader removed (discussed in further detail below), while  FIG. 3  illustrates device  1000  with certain portions of the handle housing removed. 
     For purposes of illustration, and not limitation, suture head  100 , separated from the remainder of device  1000 , is illustrated in  FIG. 4 . Suture head  100  includes a proximal end  102 , a distal end  104 , and is formed by the cooperation of three main housing components ( 106 ,  108 ,  112 ) that define a gap  110  for receiving tissue of a patient to be sutured together. Suture head  100  is adapted and configured to direct a semi-circular needle ( 300 ,  350 ,  400 ) about a semicircular track and across gap  110  to form a series of sutures through tissue to be sutured. 
     Prior to advancing needle across gap  110 , suture head  100  must be converted from a delivery configuration to a deployed configuration. As illustrated in  FIG. 4  and  FIG. 5 , suture head  100  is initially provided in a compact form having a predetermined transverse dimension, or diameter, φ. This transverse dimension, φ, can be any desired dimension, and is preferably about 5 millimeters. In particular, the dimension φ is preferably selected so that suture head  100  can pass through a standard 5 mm trocar into a patient&#39;s abdomen, for example, during a laparoscopic surgical procedure.  FIG. 5  shows suture head  100  from the opposite angle as compared to  FIG. 4 , including pivot boss  114 , which mates with intermediate portion  500  of device  1000 . 
     Suture head  100  is illustrated in deployed configuration in  FIG. 6 . As illustrated in  FIG. 6 , in a deployed configuration, proximal guide  120  and distal guide  130  are moved outwardly from their nested position defined by housing components  106 ,  108 , discussed in further detail below. When deployed as in  FIG. 6 , guides  120 ,  130  define a circular needle path or track  140  that lies in a plane P that is parallel to a longitudinal axis X of device  1000 . In addition, as illustrated, leading tip  302  of needle  300  is advanced slightly by virtue of being dragged along by virtue of a pawl  125  in proximal guide  120  engaging a notch  306  disposed along an interior surface of needle  300 , discussed in detail below. 
     After guides  120 ,  130  are in a deployed condition and needle track  140  is defined, needle  300  can then be advanced through track by advancing pawl  160  to a distal extremity along its path of reciprocation.  FIG. 7  illustrates needle  300  spanning the gap  110 , wherein needle  300 , being about 180° in arcuate extent, is essentially located outside of the enclosure defined by housing segments  106 ,  108 ,  112 . 
       FIGS. 8-10  illustrate the functionality of suture head  110  from the opposite side of the head.  FIG. 8  illustrates suture head  100  in a delivery configuration with the guides  120 ,  130  retracted. As can be seen, engagement pawl  160  is withdrawn to a position proximal to the needle  300 , and the trailing end  304  of needle  300  is visible.  FIG. 9  illustrates suture head in a deployed configuration wherein guides  120 ,  130  are deployed. As seen in  FIG. 9 , distal guide  130  defines an arcuate recess  135  that receives the pawl  160  at the distal extremity of its reciprocating movement, best observed in  FIG. 10 . As is evident from  FIG. 10 , notch  158  in drive member  150  is advanced in a distal direction as is pawl  160 . 
       FIGS. 11(A)-11(D)  illustrate the structure of the engagement pawl  160 . Pawl  160  includes a housing  166  attached (e.g., welded) to the distal end  154  of drive member  150 . Housing  166  is preferably a metallic tubular structure, and houses a pawl spring  164  biased between a movable pin  168  and cap portion  162 . Cap  162  is preferably attached to housing  166 , such as be welding. 
       FIG. 12  illustrates suture head  100  with cover portion  106  removed, revealing the reciprocating guide path followed by drive member  150  and pawl  160 , as well as guides  120 ,  130 . Guides  120 ,  130  are advanced from the delivery configuration to the deployed configuration by four advancement wires, cables or filaments,  172 ,  174 ,  176 ,  178  that are directed around a series of bosses in housing portion  106 , discussed below. In particular, each guide  120 ,  130  includes crimps  102   a ,  120   b ,  130   a ,  130   b  that integrally form an end of each of the guides  120 ,  130 . Each crimp includes passages formed therein for receiving an end of wires  172 - 178 . Wires  172 - 178  can take any suitable form, most preferably multi-strand  300  series Stainless Steel cables 0.009″ in diameter. These ends are then crimped, adhered or otherwise attached to the crimps. Then by applying tension to one wire in each pair attached to each guide, the guides  120 ,  130  are pulled into or out of the suture head  100 . 
       FIG. 13  illustrates the guides  120 ,  130  in a deployed condition and does not display wires  172 - 178  simply for purposes of clarity.  FIG. 14  illustrates drive member  150  with pawl  160  at the full distal extent of its travel, riding within groove  135  in the side of guide  130 . The elevation  130   e  of wall  130   d  can be increased and can be thickened to coincide with groove  135  to provide an enhanced bearing surface for pawl  160 . Stops (not shown) are preferably provided in the form of raised surfaces on guides  120 ,  130  and the housing components to help prevent guides  120 ,  130  from falling out of suture head. 
     As is also evident, groove  125  in the side of guide  120  becomes accessible for the passage of pawl when the guides are in a deployed condition. As illustrated in  FIG. 14 , guide  150  traverses an arcuate path along guides and follows the path of the needle.  FIG. 15  illustrates the spatial relationship of drive member  150  with respect to needle with other device components removed.  FIG. 16  illustrates the relative positions of needle  300  with respect to antirotate springs  115  and drive pin  168  housed within pawl  160 .  FIG. 17  illustrates drive pin  168  in detail, wherein pin  168  includes a distal face  168   a  that contacts a body of the needle, a circumferential generally cylindrical face  168   b , the distal extremity of which also contacts a surface of a notch in needle  100 , or the distal end  304  of needle, a proximal face  168   d  that contacts pawl spring  164 , an enlarged head portion  168   c , and a circumferential distal face  168   e  that contacts with a narrowed portion of the housing  166  of pawl  160  that prevents pin  168  from falling out of housing  166 . 
       FIGS. 18-21  are additional views of suture head  100  showing a progressive removal of components.  FIG. 18  shows the suture head  100  intact, while  FIGS. 19-20  shows the positioning of bosses  106   a ,  106   b ,  106   c  on housing portion  106  that define bearing points for guide cables  172 ,  174 ,  176 ,  178  (not shown). Spacers  106   d  may also be provided to maintain a desired distance between housing components  106 ,  108  to permit the movement of components within suture head  100 , and can also act as bearing surfaces for wires  176 ,  178  ( FIG. 29 ).  FIGS. 20-21  illustrate removal of guard  109  which provides inner support for guides  120 ,  130  to bear against. Guides  120 ,  130  ride in arcuate channels defined by the cooperation of components  106 ,  108  and  109 . 
       FIG. 22  illustrates proximal and distal guides  120 ,  130  in the same spatial relationship as in  FIG. 21 . Views of the proximal guide  120  are depicted in  FIGS. 23(A)-23(B) . Guides  120 ,  130  are preferably made from a metallic material by assembling a series of metallic subcomponents, such as by laser welding, and are unitary and integral once assembled. Guides can be thought of as having a “top” face that faces the drive member  150 , and a bottom “face” that faces housing portion  108 . Proximal guide  120  defines a curved channel  125  in the top face  122  thereof. Proximal guide  120  further defines a lower face  124 , having a groove  124   b  defined therein, an inner face  126  that bears against the inner surface of guard  109  and an outer face  128  that bears against housing components  106 ,  108 . As illustrated in  FIGS. 24(A)-24(B) , distal guide  130  defines a curved channel  135  in the top face  132  thereof for guiding the pawl  160 . Distal guide  130  further defines a lower face  134 , having a groove  134   b  defined therein, an inner face  136  that bears against the inner surface of guard  109  and an outer face  138  that bears against housing components  106 ,  108 . 
       FIGS. 25-32  illustrate the cooperation between wires/filaments  172 - 178  and guides  120 ,  130 . As shown in these figures, wires/filaments  172 ,  174 ,  176  and  178  cooperate with bosses  106   a ,  106   b ,  106   c  and the other components of suture head  100  to permit guides  120 ,  130  to be selectively advanced and retracted. Wire  178  terminates in crimp  130   b  of guide  130 . Applying tension to wire  178 , which wraps around boss  106   a  ( FIG. 28 ) results in guide  120  being advanced out of the suture head  100 . Conversely, applying tension to wire  176 , which terminates in crimp  130   a  of guide  130  ( FIG. 30 ) causes guide  130  to be retracted into suture head  100 . Similarly, applying tension to wire  172 , which wraps around boss  106   c  and is attached to guide  120  at crimp  120   b , causes guide  120  to be advanced out of suture head, while applying tension to wire  174 , which wraps around boss  106   c  in a direction opposite to wire  172 , pulls at the attachment point at crimp  120   a , causing the guide  120  to be withdrawn back into the housing. 
       FIGS. 33-37  illustrate an embodiment of a needle loader  180  that is configured for loading a suturing needle ( 300 ,  350 ,  400 ) into suture head  100 . Needle loader  180  has two main components, including a main body portion  182  and an advancement portion  184 . Pin  184   a  of advancement portion is received in opening  182   a  of main body portion  182 . Main body portion  182  defines a groove  182   f  for receiving a suturing needle ( 300 ,  350 ,  400 ). Main body portion  182  includes a central portion  182   d  and clip portions  182   c ,  182   e  that fit over suture head  100 . If desired, clip portions  182   c ,  182   e  may be adapted to snap fit over suture head  100 . A distal stop plate  182   b  is provided to facilitate axial alignment between loader  180  and suture head  100 . Advancement portion  184  rotates within opening  182   a  of main body portion  182 , and further includes a needle pushing arm  186 . In operation, a needle is situated within track  184   f  with suturing material attached to the trailing end, as discussed herein. The loader  180  is then snapped onto suture head. Arm  186  is preferably situated at this time proximate the trailing end of the needle. Arm  186  is then rotated such that needle ( 300 ,  350 ,  400 ) is advanced into the needle track  140 . If needed, needle ( 300 ,  350 ,  400 ) can be advanced back into the needle loader  180 , by virtue of the fact that arm  186  is dimensioned to pass through the grooves  124   b ,  134   b  of proximal guide  120  and distal guide  130 , respectively. 
       FIGS. 38-40  illustrate a first embodiment of a suturing needle  300 . Needle  300  includes an arcuate body defined by a leading end  302 , a trailing end  304  and a generally toroidal surface  305 . Needle  300  includes a plurality of notches  306 ,  308 ,  310  formed therein, as well as an opening  312  in trailing end  304  for receiving an end of a length of suturing material  312   a . Notches  306 ,  308  are located on an inner radial region  322  of needle, while notch  310  has a projection that lies within a plane P′ that is defined by the central curved axis X′ of the needle. Notch  310  includes a first portion  310   a  that is generally perpendicular to the plane P′ and a portion  310   b  that generally lies in plane P′, and a sloped portion  310   c . The notches  306 ,  308  have projections that are generally perpendicular to the plane P′. Notches  308 ,  306  have first portions  306   a ,  308   a  that are generally parallel to a cross section of the needle in that location, and sloped portions  306   b ,  308   b  that are angled (such as by an angle of 60 degrees) with respect to portions  306   a ,  308   a . Notches  308 ,  310  intersect to facilitate the function of the particular embodiments of suturing head  100 ,  100 ′ described herein. 
       FIGS. 41-44  illustrate a second embodiment of a suturing needle  350 . Needle  350  includes an arcuate body defined by a leading end  352 , a trailing end  354  and a generally toroidal surface  355 . Needle  350  includes a plurality of notches  356 ,  358 ,  360  formed therein, as well as an opening  362  in trailing end  354  for receiving an end of a length of suturing material. Notches  356 ,  358  are located on an inner radial region  372  of needle, while notch  360  has a projection that lies within a plane P′ that is defined by the central curved axis X′ of the needle. Notch  360  includes a first portion  360   a  that is generally perpendicular to the plane P′ and a portion  360   b  that generally lies in plane P′, and a sloped portion  360   c . The notches  356 ,  358  have projections that are generally perpendicular to the plane P′. Notches  358 ,  356  have first portions  356   a ,  358   a  that are generally parallel to a cross section of the needle in that location, and sloped portions  356   b ,  358   b  that are angled (such as by an angle of 60 degrees) with respect to portions  356   a ,  358   a . Notches  358 ,  360  intersect to facilitate the function of the particular embodiments of suturing head  100 ,  100 ′ described herein. Needle  350  further includes a generally square cross-section having a rounded portion  366  and a tail portion  364 , also having a round cross section. Stated another way, the needle body includes a portion with a round cross section  366  that separates a main portion of the needle with a generally square cross section from a tail portion  364  with a generally square cross section. It is believed that using a needle with a square cross section helps the needle  350  cross the gap  110  of suture head and re-enter suture head with superior alignment as compared to needle  300 . 
       FIG. 45  illustrates a third embodiment of a suturing needle  400 . Needle  400  includes an arcuate body defined by a leading end  402 , a trailing end  404  and a generally toroidal surface  405 . Needle  400  includes a plurality of notches  406 ,  408 ,  410  formed therein, as well as an opening  412  in trailing end  404  for receiving an end of a length of suturing material. Notches  406 ,  408  are located on an inner radial region  422  of needle, while notch  410  has a projection that lies within a plane P′ that is defined by the central curved axis X′ of the needle. The notches  406 ,  408 ,  410  are generally similar to those described with respect to needle  300 . The principal difference between needles  300 ,  400  are the addition of an additional notch  415  cut into the needle proximate its trailing end  404 . Notch  415  has a projection in the plane P′ and is shaped to receive the housing  166  of the pawl  160 . It is believed that using a needle with notch  415  helps the needle  400  cross the gap  110  of suture head and re-enter suture head with superior alignment as compared to needle  300 . 
       FIG. 46  illustrates a fourth embodiment of a suturing needle  450 . Needle  450  is essentially the same as needle  300 , except that it further includes an arcuate keel  475 , or raised surface, along its length. Keel  475  is adapted and configured to ride in grooves  124   b ,  134   b  of guides  120 ,  130  to stabilize the needle  450  as it crosses the gap  110  of suture head and re-enters suture head with superior alignment as compared to needle  300 . 
       FIGS. 47(F) - 55  illustrate aspects of an alternative embodiment of a suture head  100 ′ made in accordance with the disclosure. The principal difference between suture head  100  and suture head  100 ′ lies in the path of travel of the drive element  150 . 
     Embodiment  100  of suture head includes a drive member  150  that defines a narrowed, or notched region  158 , as illustrated in  FIG. 12 , for example. In operation, notched region  158  is located to coincide with bosses  106 W,  108 W ( FIGS. 47(A)-47(D) ) when pawl  160  is located at the distal extremity of its range of motion within groove  135  of distal guide  130 . When in this position, drive member  150  extends into groove  125  of proximal guide  120  ( FIG. 14 ). However, as soon as tension is then applied to bring pawl  160  (and needle  300 ) proximally along the needle track, the narrowed region  158  of drive member  150  slips past bosses  106 W,  108 W, so that pawl  160  will travel up lower leg of passage  106 T when moving proximally until it passes boss  106 W and emerges from the passage, ready to begin another cycle. Stated another way, bosses  106 W,  108 W result in a passageway between them that permits narrowed region  158  to slip through, but not the rest of member  150  or pawl  160 . Thus, narrowed region  158  permits the drive member  150  to travel along an upper path above bosses  106 W,  108 W when advancing distally, and slip past bosses  106 W,  108 W when region  158  aligns with the bosses, thus permitting drive member  150  and pawl  160  to move proximally along a lower path below bosses  106 W,  108 W. Housing portion  112  is illustrated in  FIG. 47(E) . 
     Accordingly, it can be appreciated that drive member  150  should ideally be metallic. Preferably, member  150  is made from hardened stainless steel that has been heat treated to HR  900 , and may have a chromium coating, such as an Armoloy ME 92® coating commercially available from ME-92® West/Armoloy® of Illinois, 118 Simonds Avenue, DeKalb, Ill. 60115, (815) 758-6691. Preferably, member  150  is 17-7 PH Stainless steel, condition “C” that is then hardened to condition CH900, and then coated with a ME 92® coating. Preferably, the ME-92® coating is applied after 900 Heat Treatment. The sequence of operations in manufacturing member  150  includes providing 17-7 PH strip stock material that is machined to size by any number of known methods (e.g., electrical discharge machining (“EDM”), shearing, milling, etc.). The drive ribbon is heat treated, and then cleaned to remove heat treatment surface oxidation, and the ME-92® coating is then applied. By way of further example, 17-7PH condition “A” material can be heat treated to RH950. In other embodiments, the drive member  150  can be made, for example, from shape memory material such as nickel-titanium alloys sold under the trade name of NITINOL® and the like. In another embodiment, member  150  is made from a polymeric material. In one aspect, member  150  can include polyethylene terephthalate material or nylon material of high strength. If desired, a laminate of plastic and metal materials or multiple materials can be used. By way of further example, member  150  can be comprised of a bundle of wires or filaments, a single wire or filament, or any material in any configuration that permits driving the needle around the needle track. 
     The other components of suture head  100  including the needle ( 300 , etc.) are preferably formed by metal injection molding (“MIM”) techniques, as are known in the art from various materials, preferably stainless steel. In accordance with a preferred embodiment, 17-4 PH stainless steel alloy is preferably used. Device  1000  is preferably a disposable device, and handle components are preferably made from injection molded plastic wherever desirable. 
     A further embodiment of a suture head  100 ′ is set forth in  FIGS. 47(F) - 55 . The principal difference between suture head  100 ′ and suture head  100  is that the drive member  150  in suture head  100 ′ follows a single path during reciprocation, in contrast with the alternating path of embodiment  100 .  FIG. 47(F)  illustrates suture head  100 ′ including a needle  300  with guides  120 ′,  130 ′ in a deployed configuration. Guides  120 ′  130 ′ are only partially represented and are not depicted including crimps at their extremities for mating with deployment or retraction cables as with embodiment  100  discussed earlier. Suture head  100 ′ defines a guide path  153 ′ between housing components  106 ′,  112 ′ ( FIG. 48 ), similar to the manner in which suture head  100  defines a guide path between housing components  106  and  112  ( FIG. 21 ).  FIG. 48  further illustrates an alternate path  1001  that can be traversed by drive member  150 ′ by modifying components  106 ′,  112 ′ by removing material  112   a ′ that acts as a pawl stop and adding material  106 ′ b  in component  106 ′ to act as a new pawl stop. The end result is a different angle of incidence for the drive member  150 . 
       FIG. 49  illustrates the “left” housing component  108 ′ from various angles, while  FIGS. 50(A)-50(E)  illustrate the “right” housing component from various angles. Apparent from the figures is the path  153 ′ followed by the drive member  150 ′ and pawl  160 ′ (not shown). It will be appreciated that drive member  150 ′ and pawl  160 ′ can be substantially identical to embodiments  150 ,  160 , but need not have the notched region  158 , as a single path for traversal of pawl  160 ′ is defined by cooperation of housing components  106 ′,  108 ′. Guard  109 ′ is illustrated in  FIGS. 51(A)-51(B) , and illustrates the location of pawl  115 ′ that helps prevent needle (e.g.,  300 ) from moving against the direction of desired travel.  FIG. 52  illustrates the spatial relationship of guides  120 ′,  130 ′ with respect to pin face  168   a ′ and pawl  160 ′ in their two respective locations, for purposes of illustration only.  FIGS. 53(A)-53(D)  illustrate various views of housing portion  112 ′.  FIGS. 54-55  illustrate the spatial orientation of guides  120 ′,  130 ′ (which are substantially identical to guides  120 ,  130 ) with respect to pawl  115 ′ and further illustrates guide stops  117 ′, which help guides  120 ′,  130 ′ stop in a predetermined location when in an undeployed condition. 
       FIGS. 56-59  illustrate aspects of the intermediate region  500  of device  1000 . Intermediate region  500  includes an elongate, preferably metallic tube  510  having a proximal end and a distal end  514 . Distal end  514  of tube  510  is attached to a knuckle assembly  520 , which in turn is pivotally attached at pivot  114  to suture head  110 . A pulley  515  is located at pivot  114  to serve as a bearing surface for adjoined articulation cables  532 ,  534  and cables  532 ,  534  are preferably affixed to pulley  515  to provide leverage for accomplishing articulation. Articulation cables  532 ,  534  can take any suitable form, most preferably multi-strand  300  series Stainless Steel cables that are 0.020″ in diameter. By pulling on one of the articulation cables, the suture head  100  will articulate with respect to intermediate region  500  about the pivot  114 . Knuckle  520  includes a proximal end  522  and a distal end  524  (in the form of a yoke  524   a ,  524   b  for receiving suture head  100 ) separated by an intermediate region  526 . Intermediate region  526  defines a longitudinal channel  528  therethrough for receiving drive member  150 . Preferably, member  150  is attached to a pull rod  151  in this region, and the cross-sectional profile of channel  528  is adapted to accommodate such a geometry, as depicted in the Figures. Openings  523  are also defined for receiving members  532 ,  534 . Moreover, openings  525 ,  527  are also provided to permit passage of pull wires/cables  172 ,  174 ,  176 ,  178  for controlling the movement of guides  120 ,  130 . The proximal end of tubular member  510  is attached to a roticulation mechanism that rotates the tube  510  and suture head  100  with respect to a handle  600  of the device, discussed below. The distal end  514   a  of tube  510  may be extended slightly to provide for tighter control of drive element  150  as it passes into intermediate region  500 . 
     For purposes of illustration, and not limitation, handle  600  of device  1000  is illustrated from  FIGS. 60-122 . Handle  600  includes many components and systems for operating suture head  100 ,  100 ′.  FIG. 61  illustrates a head-on view of handle with tube  510  removed, illustrating roticulation handle  620 , wherein relative rotational motion of handle  620  with respect to handle  600  will cause the suture head  100 ,  100 ′ to rotate with respect to handle  600 .  FIG. 60  depicts a rear view of handle  600 .  FIG. 62  depicts handle with roticulation handle  620  removed, and depicting proximal cable guide  606 , left tube collar  634  and right tube collar  632 . Tube collar portions  632 ,  634  cooperate to capture the proximal end  512  of tube  510 , which can be, for example and not limitation, a 5 mm nominal outside diameter stainless steel hypotube. Also illustrated is articulation handle  630  that can be used to articulate suture head  100  about its pivot point as discussed above. Housing  600  includes two main housing halves including a right side  612  and a left side  614 .  FIG. 63  illustrates handle  600  with tube collars  632 ,  634  removed. Proximal cable guide  606  is anchored within hypotube, such as by interference fit. The longitudinal distance along tube  510  between the distal disc  606   b  of proximal cable guide  606  and cable disc  648  ( FIGS. 71-72 ) represents a twist region over which all cables routed through tube  510  can rotate and twist about each other when the suture head is roticulated, or rotated with respect to the handle  600 . The twist region is preferably between about three and six inches long, most preferably about four inches long. In a preferred embodiment, suture head has a total angular range of motion of about 270 degrees with respect to handle  600 , desirably about 135 degrees in either direction from the home position illustrated in the Figures. Detents in roticulation handle  620  ( FIG. 64 ) are adapted and configured to engage with a pawl  614   g  housed in an opening in left handle portion  614  ( FIG. 79(A) ). 
     Tube collars ( FIGS. 66-67 ) are essentially mirror images of each other (across a vertical centerplane of the device  1000 ) and cooperate to define a hollow, generally cylindrical interior for receiving proximal end  512  of tube  510 . In particular, lugs  632   a ,  634   a  are provided to mate with openings  518  near the proximal end  512  of tube  510  ( FIG. 69 ). Tube collars also define radially oriented detents  632   b ,  634   b  along their proximal faces to mate with raised portions  644   b  on the distal face of roticulator plate  644  ( FIG. 68 ). Roticulator plate  644  further includes a proximal portion  644   c  having a square cross section for being received by the left and right housing side portions  612 ,  614 . 
     Roticulator plate  644  is received in housing  614  between adjacent ribs  614   r  ( FIG. 70 ) as is cable disc  648 . Cable disc  648  ( FIGS. 71-72 ) defines a circumferential groove  648   b  about its periphery for mating with a rib  614   r  as well as an annularly-shaped channel  648   a  in its distal face for receiving a roticulator spring  646 . Spring  646  is adapted and configured to urge roticulator plate into contact with detents  632   b ,  634   b  to facilitate stepwise rotational movement. cable disc  648  further defines a plurality of openings  648   c  therethrough to permit passage of cables/wires  172 ,  174 ,  176 ,  178 ,  532 ,  534  and  551 . 
     As illustrated in  FIGS. 73-74 , a cable path guide  650  is provided for directing cables  172 ,  174 ,  176 ,  178 ,  532 ,  534  through the handle  600 . In particular, guide  650  provides a first set of guides  654  for guiding cables  172 ,  174 ,  176 ,  178 , and a second set of guides, or bosses,  652 ,  654  for directing cables  532 ,  534  through the handle  600 . Grooves  658  are provided in guide  650  for receiving ribs  612   r  of right housing portion  612  ( FIG. 79(D) ). 
       FIGS. 75-76  illustrate a cutaway view of handle  600  wherein right housing portion  612  has been removed to permit view of interior components of handle  600 .  FIG. 75  illustrates trigger  700 , or actuator, in a locked position, whereas  FIG. 76  illustrates trigger  700  in a released position wherein the trigger can be depressed, thus advancing needle (e.g.,  300 ) about needle track  140 . As illustrated in  FIGS. 75-76 , handle includes trigger  700 , pull cable/ribbon  710 , trigger spring capsule  720 , trigger return spring  730 , pull cable  727 , pulley  750  and brake handle  800  for preventing articulation knob  810  from being rotated. As stop surface  614   s  is defined in left housing  614  to define a stop point for trigger  700  when trigger  700  is locked. Right housing  612  includes a similar stop feature  612   s  ( FIG. 79(D) ). Articulation knob  810  ( FIG. 77(E) ) includes a handle portion  812 , an elongate shaft  814  for engaging with brake rotate fitting  830  ( FIG. 83 ), and a distal portion  816  that is preferably threaded for receiving a hex nut  886  ( FIG. 90 ). Right and left handle cap portions  616 ,  618  ( FIGS. 77(A)-77(D) ) are provided with bosses  616   a ,  618   a  for receiving and supporting the edges  835   b  of brake springs  835  ( FIG. 84 ). Bearing portion  835   a  of brake springs  835  bear against brake rotate fittings  830 , which in turn urges brake rotate fittings  830  against shaft  814  of knob  810 . Portion  814  of knob  810  preferably includes a resilient layer or coating that can grip serrated portion  834  of fittings  830 , wherein rotation of the knob  810  causes the fittings  830 , and hence cables  532 ,  534  to advance along a proximal-distal direction with respect to device  1000 , resulting in articulation of suture head  100 ,  100 ′.  FIG. 78  illustrates handle  600  with components  810 ,  616 ,  618  removed.  FIGS. 79(A)-79(D)  illustrate inner and outer views of left and right handle portions  612 ,  614 .  FIGS. 80-81  illustrate the inner workings of handle  600  with both handle portions  612 ,  614  removed with the trigger  700  locked, and released, respectively.  FIG. 82  illustrates a close up view of the inner workings of handle  600 , showing the upper brake pad  820  removed, fully revealing the positioning of fittings  830  and springs  835  with the trigger  700  released. Also illustrated is knuckle pulley  842 , which is rotationally supported by knuckle pulley holder  840 , which in turn is biased by a guide spring  845  against bracket  870  to maintain tension on cables  532 ,  534 .  FIGS. 83-85  further illustrate fittings  830 , spring  835  and spring  845 . 
       FIGS. 86(A)-86(B)  illustrate the movement of shuttle  888  ( FIGS. 99(A)-99(B) ), which moves proximally upon the release of trigger  700 . Proximal movement of shuttle  888  prevents handle  892   r  from being articulated, which, in turn, prevents guides  120 ,  130  from being withdrawn into suture head  100 ,  100 ′ while trigger  700  is actuated, advancing the needle (e.g.,  300 ) about circular needle track  140 ,  140 ′. Components  830 ,  835  have been removed in  FIG. 86  to better illustrate lower brake pad  850 . Brake pads  820 ,  850  are preferably made from resilient and somewhat compressible material, such as silicone.  FIG. 87(A)  further illustrates lower brake pad  850 , while  FIGS. 87(B)-87(D)  illustrate brake bracket  860 . Bracket  860  defines a circular boss  862  thereon for receiving lower brake pad  850 , as well as brake handle components  882 ,  884 ,  884   a  ( FIG. 91(B) ).  FIGS. 88-89 (A) illustrate remaining inner workings of handle with brake pad removed ( FIG. 88 ) and further with pulley holder  840  and brake bracket  860  removed.  FIGS. 89(A)-89(B)  further illustrates coupling knuckle  872 , which includes longitudinal openings  872   a  having narrowed portions  872   c  that are wide enough to permit passage of a cable  532 ,  534 , but not wide enough to permit passage of cable terminations  874  ( FIG. 91 ). Opening  872   b , in contrast, is large enough to permit terminations  874  to pass into knuckle  872 , thus joining cable  532  to cable  534 , and providing a closed loop to facilitate articulation by way of articulation and brake control  800 . Brake trigger  884  can be pulled, causing a camming effect of by moving an upper portion of handle component  882  (and its counterpart on the left side of the device) into contact with lower brake pad  850 , causing the brake pad  850  to compress components  830  between the upper and lower brake pads  820 ,  850 . 
       FIGS. 92-102  illustrate aspects of the operation and control for the guides  120 ,  130  as well as the locking mechanism for trigger  700 . Guides  120 ,  130  are deployed or withdrawn by rotating handles  892 . Cables  172 - 178  are routed over guide  885 , which is held in place by housing components  612 ,  614  and are split up into two pairs of wires, wherein one set of wires is directed downwardly around spring loaded pulleys  894   a ,  896   a  and routed up to handles  192  where all four cables,  172 ,  174 ,  176 ,  178  are held in place in openings  892   b  in handles  892  by tapered pins  893 . The other pair of cables is routed about guide  887  directly into handles  892 . Guide  885  ( FIG. 93(B) ) is a generally curved planar member having a plurality of cable guides  885   a , wherein the cables  172 - 178  bear over its upper surface on their route to handles  892 .  FIG. 93(A)  illustrates guides  887  and  885  in situ in relation to other internal components of handle  600 . Guide  887  ( FIGS. 93(C)-93(D) ) include bosses  887   a  to be received by housing portions  612 ,  614 , and grooves  887   b  defined by fins  887   c  for routing cables/wires. Handles  892  include grips  892   a  and grooves  892   c  and channels  892   d  for directing cables/wires into openings  892   b  ( FIGS. 94(A) - 94 E). Both handles  892  can be essentially identical in form. 
     Guide handles  892  also play a role in releasing trigger lock  780 , thereby permitting trigger  700  to actuate the movement of needle (e.g.,  300 ). As illustrated in  FIGS. 95(A)-95(B) , trigger lock  780  is attached to a cable at ferrule  781 , which is disposed in opening  783  at bifurcation  782  of trigger lock ( FIGS. 95(C)-95(D) ). Trigger lock  780  is slidably disposed on a cylindrical rail  786 , and is biased toward a locked position by spring  787 . A bifurcation  784  at the opposite end of trigger lock  780  is adapted and configured to interlock with trigger  700 . When the cable to which ferrule  781  is attached is advanced upwardly ( FIG. 95(B) ) by rotating handle  892 L, bifurcation  784  of trigger lock  780  disengages from trigger  700 , permitting free movement of trigger. Handles  892 L,  892 R are pivotally disposed on axle  891  ( FIGS. 96, 122 ).  FIGS. 97-101  further illustrate additional features of the actuation system for guides  120 ,  130  with progressively additional components removed to better illustrate other components, and their relative positions.  FIG. 102  further illustrates additional aspects and views of components  840 ,  894 ,  896 . 
       FIGS. 103-113  illustrate aspects of the operation of reciprocating trigger mechanism  700 .  FIG. 103  illustrates the relative positions of trigger  700 , pull cable/ribbon  710 , trigger spring capsule  720 , trigger return spring  730 , pull cable  727  and pulley  750 .  FIG. 103  removes components  786 ,  787  and handle  700  to reveal ferrule  752 , which is fixed to a terminal end of pull cable  727  and resides within an opening  701  within handle  700  ( FIG. 105 ). Trigger  700  is further illustrated in  FIGS. 106(A)-106(B)  from two additional angles, showing bifurcated yoke  702  proximate the top end of trigger  700 . Yoke cap  704  is received in trigger handle  700  by securing studs  704   a  into holes  700   a  by interference fit and/or ultrasonic welding, adhesive or the like. Yoke  702  and yoke cap  704  define openings  702   a ,  704   a  therein for receiving bosses  888   a  of shuttle link  888  ( FIG. 99(B) ).  FIG. 107(A)  illustrates the interior of capsule  720 , revealing clutch spring  724 .  FIGS. 107(B)-107(C)  illustrate housing portion  720   a , which mates with housing portion  720   b . Housing portion  720   b  is an identical minor image of portion  720   a , so only  720   a  is illustrated. Clutch spring  724  is removed in  FIG. 108 , clearly illustrating pull cable  727 , clutch spring ferrule  723  and clutch washer  726 .  FIG. 109  illustrates the assembly with spring  730  and housing portion  720   b  removed.  FIG. 110  illustrates a close-up of the connection of drive member  710  to assembly  720 , showing the manner in which tabs  711 ,  712  at proximal end of drive member  710  are bent and inserted through the slot  721   a  in washer plate  721 . O-rings  720 , which may be silicone or other suitable material, are illustrated in  FIGS. 104 and 109 . O-rings  729  provide a seal against housing segments  612 ,  614 . Ferrule  723  is secured to cable  727 .  FIGS. 111-113  provide closer views of ferrule  723 , washer plate  721  and proximal end of member  710 , respectively. 
       FIGS. 114-120  further illustrate the connections between drive member  710  and drive members  150 / 551 . As illustrated in  FIG. 114 , proximal drive member, which can include ribbon-element  150  described above attached to intermediate cable section  551  in intermediate region  500 , is received by a ferrule  910  which is affixed in place after termination  930  is attached, and positioned into cavity  922  in coupling by passing cable/rod  551  through slot  924  in coupling  920 . Rounded portion  932  of termination faces distally, permitting movement between member  551  and coupling  920 . As illustrated in  FIGS. 115-117 , termination  930  defines a passage  936  therethrough for receiving cable  551 , and defines a generally cylindrical proximal section  934 . Ferrule  910  defines a passage  912  therethrough for receiving cable  551 , and a transverse opening  914  therethrough, such as for receiving brazing or soldering material or other material for holding ferrule in place on cable  551 . Coupling  920  includes a proximal face  922   a , a distal face  928  and a bore  922  therethrough. As illustrated in  FIG. 114  in cooperation with  FIGS. 118-120 , threaded male fitting  940  is received within threaded opening  922  of coupling, and receives a retaining hex nut  950  thereon. Proximal end  943  of fitting  940  faces proximally, and defines a cavity  946  therein for receiving distal tip  717  of drive ribbon/cable  710 . Tip  717  is inserted into cavity  946  until stop  719  contacts proximal face  943 . Threads  942 ,  952  are defined on fitting  940  and nut  950 . Components  940 ,  710  may be coupled by any suitable means, including but not limited to interference fit and/or welding, soldering, brazing, adhesive and the like.  FIGS. 121-122  illustrate torsion spring  960  and guide spring  970  and their positioning with respect to the other components within handle  600 . Springs  960 ,  970  are a part of the control mechanism for deploying and retracting guides  120 ,  130 . Return spring  895 ,  897  is illustrated in  FIG. 121(C) . 
     An exemplary method of operation of suture head  100  is set forth in  FIGS. 123-131 .  FIG. 123  illustrates a cutaway view of suture head  100  with needle  300  disposed therein in a delivery configuration with guides  120 ,  130  retracted. Needle  300  is wholly contained within device  1000 , and pawl spring  115   b  prevents needle  300  from moving in a counterclockwise direction. Similarly, pawl spring  115   a  is biased against the inner circumferential surface  322  of needle, tending to prevent needle from moving in a clockwise direction. As set forth in  FIGS. 123-131 , it is apparent from the instant disclosure that the drive system of the device  1000  is adapted and configured to advance the needle  300  in multiple 360° revolutions about the needle track when the needle track is in a deployed condition. It is further evident that the needle track is about 180° in extent prior to deployment, and greater than 180° in angular extent after deployment. 
       FIG. 124  illustrates the initial deployment of guides. Pawl  115   a  is dragged along surface  322  of needle  300  until it engages with notch  308  and pawl  115   b  engages with notch  306 . Guides are then fully retracted in  FIG. 125 , and pawl  115   a  situated in guide  120  drags needle  300  in a clockwise direction to present it for suturing. Pawl  160  meanwhile is advanced along its arcuate track along guides  120 ,  130  to its distalmost extent, causing notch  158  in the drive member  150  to align with boss  108   a , and pawl  115   b  bears against surface  122  of needle  300 . When drive member  150  is then pulled proximally, notched region  158  of member  150  slips past bosses  106   a ,  108   a  and drive member  150  drops into lower passage defined in part by passage  108 T. Further proximal movement of drive member  150  causes the distally located wider portion of ribbon  150  to bear against the underside of bosses  106   a ,  108   a , and pawl  160  makes contact with the trailing end of the needle  300 , and needle is advanced about 180°, as illustrated in  FIG. 126 . The distal movement of pawl  160  is then repeated, such that pawl  160  engages with notch  310  in needle  300 . Region  158  slips past bosses  106   a ,  108   a  as before, and pawl  160  and the leading tip  302  of needle are pulled along the arcuate needle track  140 , resulting in the needle being returned to its starting point, as illustrated in  FIG. 128 .  FIG. 129  illustrates guides  120 ,  130  in partial retraction such that needle is moved counterclockwise until notch  306  meets with pawl  115   b .  FIG. 130  illustrates guides  120 ,  130  retracted even further, illustrating how pawl  115   a  is pulled out of notch  308  and is dragged along surface  322  of needle. Further counterclockwise movement of needle  300  is prevented by pawl  115   b  being locked into notch  306 .  FIG. 131  illustrates suture head  110  once again in delivery or removal configuration with guides  120 ,  130  fully withdrawn. Thus, a device is provided herein that can rotate the disclosed needle through 180°, 360°, or any further multiple of 180° as desired. If desired, the angular increments of advancement could be increments of more or less than 180° as desired. 
     The suturing devices of the presently disclosed embodiments can be used for laparoscopic procedures, including but not limited to laparoscopic colostomy, colectomy, adrenalectomy, splenectomy, repair of paraesophageal hernia, inguinal hernia repair, ventral hernia repair, Nissen fundoplication, liver lobectomy, gastrectomy, small bowel resection, treatment of small bowel obstruction, distal pancreatectomy, nephrectomy and gastric bypass. Those skilled in the art will recognize that the presently disclosed embodiments can be used in other laparoscopic procedures. 
     In using the devices of the presently disclosed embodiments, the abdomen is insufflated with gas to create a working space for the user. Any gas known to those skilled in the art including, but not limited to, nitrogen or carbon dioxide, can be used. Access portals are established using trocars in locations to suit the particular surgical procedure. A variety of surgical instruments may then be inserted into the body through these access ports/cannulas. The user then introduces the distal end portion of the suturing device into a cannula, and then articulates the suture head assembly (e.g.,  100 ,  100 ′). The suture head assembly is then positioned relative to the tissue/vessel to be sutured together, and the user preferably locks the suture head assembly in place. The user then, through manipulation of the suturing device, positions a plurality of separated tissue segments into the opening defined at the distal end portion of the suture head assembly. The user, using only one hand, may manipulate the device while actuating the handle to close an incision with a continuous suture whose stitches may be individually tensioned precisely and uniformly along the length of the suture similar to suturing done by hand in the conventional way. The user may employ a single suture which would extend the entire length of the incision or multiple sutures. Thus, by placement of the device spanning the incised tissue segments and actuating the handle, the suturing device enables the user to lay down a running stitch or interrupted stitch to close the tissue incision in a time efficient manner. Those skilled in the art will recognize that any conventional procedure for conducting laparoscopic surgery can be used with the device. 
     The minimalized structural design of the suture head assembly enables the user to have a clear, unobstructed view of the suturing needle during advancement through the tissue segments during the course of a suturing operation, thereby enabling precise placement of the suturing device to provide uniform sutures and precluding the risk of tearing tissue by placement too close to the edge of the incision. The suturing device is then advanced a short distance along the incision and the aforementioned operation is repeated to produce another stitch comprising the suturing material or thread. 
     The user may continue to manipulate the suturing device, alternately advancing and actuating rotation of the needle about an axis that is generally parallel to the direction of advancement to create a continuous suture which may extend through the entire length of the incision or a series of interrupted stitches. After each individual stitch is laid down, the stitch is tightened by exerting a pull on the suturing material or thread so that the resultant suture is tensioned uniformly along the length of the incised tissue segments. Therefore, a tight closure of the segments is accomplished and bleeding and tearing of tissue are minimized. Once the appropriate amount of suture material or thread  246  has been placed, the user can use a needle grasper to tighten and knot the formed stitches. 
     All patents, patent applications, and published references cited herein are hereby incorporated by reference in their entirety. It will be appreciated that variations of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the present disclosure.