WO 2013/022959 PCT/US2012/049979 DEVICES AND METHODS FOR MINIMALLY INVASiVE SUTURING CROSS-REFERENCE TO RELATED APPLICATIONS [00011 This application is a continuationn-part of and claims the benefit of prority of U.S. Patent Apphcation Serial No. 12/909,606, filed October 21, 2010 and issued as U.S. Patent No. 7993,354 August 9, 2011, witch in turn claims the benefit of priority of U.S. Patent Application Serial No. 61/388648, filed October 1,2010, This application is also related to International Application No. PCTUS2O09/006212 filed November 20.2009. which in turn claims priority to US. Provisional Application Serial No. 61/200280 filed November 25, 2008. This application is also related to S Patent Application Srial No. 1 i/231,135, filed September 20. 2005, which in turn claims the benefit of priority to US. Provisional Application Serial No. 60/611.362, filed September 20 2004. This patent application is also related to International Application No. PCUS200S06674 filed May 23, 2008 which in turn claimspriority to U.S, Provisional Application Serial No. 60/9397887. filed May 24, 200 This patent application is also related to U.S Patent Applicaion Serial No. 12175442, filed ly 17, 2008. Each of the aforementioned appleatons is incorporated by reference herein in is entirety. FIELD 100021 The embodiments disclosed herein relate to a medical device for suturing tissue, and more particularly to a device for the manipulation and control of a suturing needle during minimally invasive suturing, methods for making such a device and methods for using such a device for suturing tissue. BACKGROUND [0003] Minimally invasive surgery (MIS) has allowed physician 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, enablhng the surgeon to easily visualize and manipulate both tissue and instruments, MIS requires the surgeon to operate remotely by inserting and manipulating instruments through WO 2013/022959 PCT/US2012/049979 all punctures (keyholeurgery" or though natural orifices, including for example the vagina, the esophagus or the anus. [0004] In MIS, a small puncture is typically made in the body. Medical instruments are then inserted through a eanla, A cannila has a small inside diameter, typically 5-10 millimeters (imm, and sometimes up to 20 millimeters (mmll) or more. A number of such cannulas may be inserted into the body for any given operation. 1 inimally invasive surgical instruments are necessarily smaller, and are also generally longer and therefore are more difficult to manipulate with precision. [0005] 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 saturing by hand an extremely difficuh, often virtually impossible surgical task. [0006] In the preferred method of suturing by hand, a grasping forceps ("needle driver) is held by the surgeon and is used to gip a cuved needle near the needles tail, Pronation of the surgeon's wrist drives the needle into the issue. When the poir of the mcued 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's curvature to follow the most atraumatie path through the tissue, until the entire length of the needle has exited the tissue. Each time a stitch is placed, the crved 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 are repeatedly until the desired length of suture and number of stitches has been placed. n order to place additional interrupted or continuous stitches, the surgeon must let 23 WO 2013/022959 PCT/US2012/049979 go of the point of the needle and e-grasp the needle near theneedles tail. [0007] In the manual suturing technique described above, the direct handling of the needle can result in accidental needle pricks through a surgeon or nurses gloves posing a potential risk of infection for the surgeon, nurse staff and patient, or cause the needle to becorne contaminated wth 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, [0008] Various devices for suturing for MIS are descihed in S. Pat, No, 5 3295 entitled "Methods and Apparatus for Suturing Tissue; 11. Pat. No. 5,665,096 entitled "Needle Driving Apparatus and Methods of Suturing issue" .S. Pat No. 566109 entited "Methods and Apparatus for Suturing Tissue"; IS. Pat No. 55988 entitled "Suturing Instrument with Rotatably Mounted Needle Driver and Catcher"; U.S. Pat No. 516092 entitled "Endoscopic Suturing Devices and Methods"; UKS. Pat. No. 954,733 entied "Suturing Instrument with Rotatably Mounted Needle Driver and catcher UK. Pat No. 6.719,6 entitled "Endoscopic Suturing Device and U.S Pat No. 6,55,43 entitled "Endoscopic SutLuring Deviceall of which are incorporated by reference in their entreties for the teachings therein. 100091 Assignees' US Pat No, 5,437,68 1, US Pat No. 5,540,705 and U.S. Pat, No. 6 923,819 dispose a suturing device with thread management comprising a protective Lcartridge, 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 compose 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. [00010] 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 I3 WO 2013/022959 PCT/US2012/049979 with controlled tension; places continuous stitches; and protects users from accidental needle sticks during needle handling, as wcll as internal organs and vessels from inadvertent needle prcks. SUMM~ARY [00011] Devices and tnethods for minimally invastve suturing of tissue internal to a body are disclosed herein. [000121 According to aspects illrated herein, there is provided a medical device for closing openings internal to a patients body, which closely emulates or replicates the manual suturing actions carried out by a surgeon. The device offersseveral advantages over conventional methods used bysurgeons for suaring tssue 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. [000131 According to aspects illustrated herein, a suture head assembly may be removable attached to an actuator mechanism of the suturing device. The diameter of the device is small enough to fit into a 5mm eannula 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 desirableto 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 articuliated to the left of centeto the right of center, up, and down, once inside he 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 4 WO 2013/022959 PCT/US2012/049979 [00014] Devices of the present disclosed embodimients 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 rc. 'The design of the suturing devices of the present disclosed embodiments allows for a lack of obstructon in the center of the are of the needle during suturing. In other words, there is no hub at the center of the circular ar of the string needle. The entire area within the circular arc of the needle is unobstructed. This allows for the user to have better visualization during opeationunlike the present mechanical suturing methods while maintaining control over needle movement. [000 15 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 dives the point of the needle through the tissue. The device then picksupthe 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 sutring needle thus consistency follows the arc of the needless own curve, which is the preferred method of suturing in the most atrauratic way of passing a needle through tissue. A benefit provided by the suturing device of the presently disclosed embodiments isthe ability of the suturing needle to pill the suturing thread entirely though the tissue segments being closed, following each stitch, Wherusing 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 he used to tighten the knots. (00016] 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 WO 2013/022959 PCT/US2012/049979 as a shield between the organs and the needle. [000171 In one embodiment, a suturing device is provided having a sturing head. The suturing head includes a housing defining at leas 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 'herein the needle track is essentially disposed within the housing to an expandedor 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 deposed 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 vhen 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 360rotation. 1000181 In accordance vith further aspects, he housing of the suturing device can be generally cylindrical, and have an outer diameter of about 51J mm. The circular path of the needle track can have a dineter of about 10 mm. If desiredthe needle can have a non-circular crosssection, Preferably the device further includes means for deploying the needle track from the stored condition to the deployed condition. The needle rack can occupy about 2700 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 2700, such as in increments of one degree. For example a needle track can be provided that expands from about 180' to about 1900, about 2000, about 2100, about 2200, about 230' abo, abou0, about 2500, about 2600, about 270, about 2800, about 2900, about 3000, about 3100, about 3200, or about 300 among others. For example, depending on the diameter of the device and the dinensions 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 200, about 30, about 40, about 500. about 600, about 70, about 80, about 6 WO 2013/022959 PCT/US2012/049979 90 , about 1000. about 1100, about l20, about 130, about 1400 about 5 or about I 60 from the undeployed unexpendedd) configuration to the deployed (xpanded)onfiguration. The drie 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 number is advanced proximally with respect to the housing The needle canincilde first and second notches along an inner face of the needle for engaging an antirotate e mchanism 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 he notch on the top ace of the needle intersects one of the notches disposed on the inner face of the needle, [000191 In accodance with a preferred enbodiment, the deployable needle track includes ateast one arcuate guide that is adapted to be deployed from the housing along an arcuate pat. Preferablyhe 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 wir 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 pul 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 guidesand at a proximal end to a pair of handles, wherein movement of the handles resuhs in movement of the guides. [00020] The disclosure also provides a sutuing 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 irst 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 wih a generally square cross section. The needle can further define a third notch in the needle proximate its trailing end for receiving a 7 WO 2013/022959 PCT/US2012/049979 portion of a dive pawl Moreover, the needle can define an arcuate keel along its length to stabilize its movement in the suturing device. [00021] According to aspects illustrated herein, there is provided a method for suturing tissue during minimally invasive surgery that indudes 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 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 ofseparated tissue segments to form a stitch. [00022] In accordance with a further aspect, a sutuing 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 sde joining the proximal and distal ends. The head further includes a deployable needle track disposed at least partially within the ousing, 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 conditon wherein the needle track has an angular extent in excess of 1800 and extends outwardly from the pedpheral 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 arenate 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 drve 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. [00023] 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. 8 WO 2013/022959 PCT/US2012/049979 However, it will be appredated that the diameter can be larger or smaller as desired, The needle can havI substantially circular cross section, a circular cross section, a non-circular cros secion a square or tiangular 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 occupiebout 27O 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 desed in one degree increment,. for examn ple. [00024] In accordance with a further aspect. the drive preferably includes an elongate flexible rnember that reciprocates along a longitudinal ax is 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 he deployed from the housing alongan 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., [00025] In another embodiment. a suturing device is provided having a suturing head. The suturing head includes an ekmgae housing having a proxmal 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 9 WO 2013/022959 PCT/US2012/049979 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 endand a generally toroidal body. The sutuing head also includes a drive for advancing the needle in multiple 360" revolutions about the needle track when the deployable nedl track is in a deployed condition, wherein the drive selectely engages with and disengages frm the needle to advance the needle about a 360 rotation. [00026] In accordance with a further aspect the housing can be generally cylindrical or rectilinear, as desred 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 he deployed from the housing along the arcuate pat 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 3600 needle path whenthe needIe track is in the expanded condition. but the angular extent of the track can be more or less than 70 a desired, in one degree increments for example. [000271 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 consruction, combination of elements and arrangement of parts that will be exemplified in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [00024] 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 presendy disclosed embodiments, wherein: [00025] Figs. 1-3 generally depict a suturing device made in accordance with the present disclosure. [00026] Figs. 432 and 47A)-47(D) illustrate aspects of a first embodiment of a sutunIng head of a suturing device made in accordance with the present disclosure 10 WO 2013/022959 PCT/US2012/049979 [00027] Figs. 33-37 illustrate aspects of an embodiment of a needle loader made inl accordance with the present disclosure. [00028 Figs. 3840 illustrate aspects of a first embodiment of a suturing needle made in accordance with the present disclosure. [000291 Figs. 41-44 illustrate aspects of a second embodiment of a suturing needle made in accordance with the present disclosure. [00030] Fig. 45 illustrates aspects of a third embodiment of a sAturing needle made in accordance with the present disclosure. [00031] Fig. 46 illustrates aspects of a fourth embodiment of a suturing needle made in accordance with the present disclosure. [00032] Figs.47(F)55 illustrate aspects of a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. [00033] Figs 56-59 illustrate aspects of an intermediate region of the suturing device illustrated in Figs 1-3, [000341 Figs. 60-122 illustrate aspects of a handle portion of the suturing device illustrated in Figs. 1-3. [000351 Figs. 123- 31 illustrate oratation of the sutuing head of Figs. 4-32 and 47(Ab 47(D). [000361 While the drawings set forth presently disclosed embodimentsother 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 scopeand spirt of the principles of the presently disclosed embodiments. DETAILED DESCRIPTION [00037] 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.
WO 2013/022959 PCT/US2012/049979 [00038] Broadly speaking, the disclosure providesembodiments of suturing devices having features that permtA 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 am adapted and configured to fit through a 5mm trocar dvantageously the disclosed embodiments still use a corparativelylarge suturing needle, thereby permitting substanal tOsue capture during operation, resulting in effective maturing [00039] For purposes of illustration and not limitation, as embodied heroin, 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 illustatesdevice 1000 with certain portions of[the handle housing removed. [000401 For purposes of illustraton, and not linitation, suture head 100, separated from the remainder of device 1000. 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 fonn a series of sutures through tissue to be sutured. [00041] Prior to advancing needle across gap 110, suture head 100 must be converted from a delivery configuration to a deployed configuration. A s illustrated in Fig. 4 and Fig. 5, suture head 100 is initially pro-vided in a compact form having a predetermined transverse dimension, or diameter. This transverse dimension p, can be any desired dimension, and is preferably about 5 millimeters. In particular, the dimension g is preferably selected so that suture head 100 can pass through a standard 5mm trocar into a patient's abdomen, for example, during a laparoscopic surgical procedure. Fig. 5 shows suture head 100 from the opposite angle 12 WO 2013/022959 PCT/US2012/049979 as compared to Fig, 4, including pIot boss 114, which mates with intermediate portion 500 of device 1000. [000421 Suture bead 100 is illustrate 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 cirtlar 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 oft 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 iii detail below [00043] After guides 120, 130 are in a deployed condition aid needle track 140 is defined, needle 300 can then he advanced through track by advancing pawl 160 to a distal extremity along its path of reciprocaton Fig. 7 illustrates needle 300 spanni ng the gap i10, wherein needle 300 being about 180 n arcuate extend s essentially located outside of the enclosure defined by house ing segments06, 108. 112. [00044] Figs. 840 Mustrate 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 receivesthe 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. [00045] Figs. il{ANii(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 13 WO 2013/022959 PCT/US2012/049979 between a movable pin 168 and cap portion 162. Cap 162 is preferably attached to housing166 such as be welding. [000461 Fig. 12 ilustates suture head 100 with cover portion 106 removed, revealing the reciprocating guide path followed by drie member 150 and pawi 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 series of bosses in housing portion 106, discussed below, In parcular. each guide 120, 130 includes Crimps 102a. 120h, 130a. 130b that integrally forn a end of each of the guides 120. 130 Each crimp includes passages fonned therein for receiving an end of wires 172-178 Wires 172178 can take any suitable form nost preferably mUi-strand 300 series StainlessSteel cables .009" in diameter. These ends are then crimpedadhered or otherwise attached to the crimps. Then by applying tension to one w ir in each pair attached to each guide. the guides 120. 130 are pulled into or out of the sture head 100. [000471 Flg. 13 illustrates the guides 120, 130 in a deployed condition and does not display wires 172 178 simply for purposes of clarity Fig. 1 ltrates drive member 150 with pawi 160 at the full distal extent of its travel, riding within groove 135 in the side of guide 130. The elevation 130e of walt 130d can be increased and can be thickened to coincide with groove 135 to provide an enhanced bearing surface for pawI 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, [00048] As is alsoevident, 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 whh respect to needle with other device components removed. Fig. 16 illustrates the relative positions of needle 300 with respect to antirotate springs 115 and drve pin 168 housed within pawl 160. Fig. 17 illustrates drive pin 168 in detail, wherein pin 168 includes a distal face 168a that contacts a body of the needle, a circumferential generallycylindrical face 168b, the distal extremhy of which also contacts a surface of a notch in 14 WO 2013/022959 PCT/US2012/049979 needle 100, or the distal end 304 of needle, a proximal face I68d that contacts pawi spring 164, an enlarged head portion 168c, and a circumferential distal face 168C that contacts with a narrowed portion of the housing 166 of pawl 160 that prevents pin 168 from falling out of housing 166. [00049] Figs. 18-21 are additional views of suture head 100 shoing a progressive removal components. Fig, 18 shows the suture head 100 in tact while igs. 19420 shows the positioning of bosses I 06a 06b H6c on housing portion 106 that define bearing points for guide cables 172. 174, 176. 178 (not shown). Spacers 106d may also be provided to maintain a desired distance between housing components 106, 108 to permit the movement ofcomponents within suture head 100, and can also act as bearing surfaces or wires 176, 178 ig. 29) Fgs. 202 1 illstrate removal of guard 109 which provides inner support for guides 120, 130 to hear against Guides 120, 130 ride in arcuate channels defined by the cooperation of components 106, 108 and 109. [00050] Flg. 22 illustrates proximal and distal guides 120, 130 inl the same spatial relationship asin Fig. 21. Views of the proximalguide 120 are depictedin 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 assenibled, Guides can be thought of as having a "top" facethat faces the drive member 150, and a bottom "faces" 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 124b defined therein an inner face 126 hat bears against the inner surface of guard 109 and an outer face 128 that hears against housing components 106 l. A 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 134b 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. [00051] Figs 2532 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 WO 2013/022959 PCT/US2012/049979 bosses 1 06a, 106b, 106c and the other components of suture head 100 to permit guides 120, 130 to be sectivly advanced and reacted. Wire 178 terminates in rinmp 130b of guide 130. Applying tension to wire 178 which wraps around boss 10a (Fig 28) results in guide 120 being advanced out of the suture head 100. Conversely applying tension to wire 176 which terminates in crimp 130a of guide 10 Fig 30) causes guide 130 to be retracted into suture head 100. Similar, applying tension tov ire 172, which wraps around boss 106c and is attached to guide 120 at crimp 120b causes guide 120 to be advanced out of suture head, while applying tension to wire 174, which wraps around boss 106c in a direction opposite to wire 172, pulls at the attachment point at crimp 120a. causing the guide 120 to be withdrawn back into the housing. [00052] Figs. 33- 37 illustrate an embodiment of a needle loader 180 that is configured for loading a suturing needle 300350. 400) into suture head 100. Needle loader 180 has two main componentsncluding a main body portion 182 and an advancement portion 184. Pin 184a of advancement portion is received in opening 182a of main body portion 182, Main body portion 182 deines a groove 182f for receiving a suturing needle (300, 350, 400), Main body portion 182 includes a central portion 182 d and clip portions 182c. 182e that lit over suture head 100. If desired, clip potions 182c, 182e may be adapted to snap it over suture head 100. A distal stop plate 182b is provided to facilitate axial alignment between loader 180 and suture head 100 Advancement portion 184 rotates within opening 182a of main body portion 182, and further includes a needle pushing arm 186 In operation, a needle is situated within track 184f with suturing materia 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 he advanced back into the needle loader 180, by virtue of the fact that arm 186 is dimensioned to pass through the grooves 124b, 134b of proximal guide 120 and diNtal guide 130, respectively, [00053] 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 312a. 16 WO 2013/022959 PCT/US2012/049979 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 axisV of the needle. Notch 310 includes a first poron 310a th generally perpendiclar to the plane P and a portion 31b that generally lies in plane P and a sloped portion 310c. The notches 306, 308 have projections that are generally perpendicular to the plane PU Notches 308, 306 have first portions 306a, 308a that are generally parallel to a cross section the needle in thatlocation, and sloped portions 306h. 308b that are angled (such as by an angle of 60 degree) with respect to portions 306a. 308a Notches 308, 310 interset to facilitate the function of the particular embodiments of suturing head 100 100' described herein [00054] figs 41-44 illustrate a second embodiment f 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 indudes 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 projecton that lies within a plane P that is defined by the central curved axis X' of the needle. Notch 360 includes a fist portion 360a that is generally perpendicular to the plane ' and a poron 360b that generally lies in plane PU and a sloped portion 360c. The notches 356. 358 have projections that are generally perpendicular to the plane Pt Notches 358 356 hav first portions 356n, 358a that are generally parallel to a cross section of the needle in that location, and sloped portions 356b, 358b that are angled (such as by an angle of 60 degrees) with respect to portions 356a, 358a. 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 generallysqare 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, 17 WO 2013/022959 PCT/US2012/049979 [00055] Fig. 45 illustrates a third embodiment of a suturing needle 400. Needle 400 include an arcuate body defined bya ading end 402. a talking end 404 and a generallytoroidal surface 405. Needle 400 includes a phrality of notches 406, 408. 410 formed therein s wel 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 centralcurved x of the needle The notches 406, 408, 410 aregenerallysimilar to thosedescribed with respect to needle 30The 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 hoping 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 aCcompared to needle 300. [000561 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 75, or raised surface, along its length Keel 475 is adapted and configured to ride in grooves 124b. 134b of guides I 20 130 to stabilize the needle 450 asn it cosses the gap 110 of suture head and re-enters suture head with superior alignment as compared to needle 300. [000571 Figs 47(f)-55 ilrstrate 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. [00058] 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 106W, 108W Fig 4A47(D,) when pawl 1 60 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 proxirnal guide 120 (Fig. 14). However as soon as tension is then applied to bring pawl 160 (and needle 300) proximally along the needle track, thenarrowed region 158 of drive member 150 slips past bosses 106W, 108W, so that pawi 160 will travel up lower leg of passage 106T when moving proximally until 18 WO 2013/022959 PCT/US2012/049979 it passes boss 106W and emerge afrom the passage, rady to begin another cycle. Stated another way, bosses I06W. 108W reult in a passageway between them that peimits narrowed region 158 to slip through, but not the rest ofnmember 150 or pawl 160. Thus, narrowed region 158 permits the drive member 150 to travel along an upper path above bosses 106W 108V when advancing dismally, and slip past bosses 106W, 108W when region 158 aligns with the bosses ths pemitting drive member 150 and pawl 160 to move proximall along a lower path below bosses 106W, 108W Housing portion 112 is illustrated in Fig.4(E) Accordingly, it can be appreciated that drivermember 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/Arnoloy® of Illinois, 118 Simonds Avenue, DeKalb, IL 60115, (815) 758669. Preferably, member 150 is 17-7 PH Stainless steel, condition "C' that is then hardened to condition 04900. and then coated with a ME 92® coating. Preferably, the ME-92® coating is applied after 900 1-eat Treatment. The sequence of operations in manufacturing member 150 includes providingM.17-7 PH strip stock material that is machined to size by any number of known methods (e.g., electrical discharge machining ("EDM") shearingmilling etc) The drive ribbon is heat treated, and then cleaned to remove heat treatment srface oxidation, and the ME 92 ® coating is then applied. By way of father example, 17PH condition "A" material can be heat treated to RH950. In other mbodimentthe drve member 150 can be made, for example, from shape memory material such as nickel-titanium alloys sold under the tiade name of NITINOL@ and the like. In another embodiment member 150 is made from a polymeric material I one aspect, member 150 can iclde 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. [00059] The other components of suture head 100 including the needle (300, etc. are preferably formed by metal injection molding ("MIN") techniquesas are known in the art from various materials, preferably stainless steel I accordance smith a preferred embodientA, 17-4 1~9 WO 2013/022959 PCT/US2012/049979 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. [000601 A further embodiment of a suture head 100' is set forth in Figs. 47(F)-55. IT principal difference between suture head 100' and suture head 100 isi hat 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. Gides 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 disoncued 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 alernate path 1001 that can be traversed by drive member 150' by modifying Components 106, 112' by removing material 12a' that acts as a pawi stop and adding material 106b in component 106' to act as a new pawl stop. The end result is a different angle of incidence for the drive member 150. [000611 Flg. 49 illustrates the "left housing component 108' fror various angles, while Figs 50(-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 wil be appreciated that drive member 150' and pawi 160' can be substantially identical to embodiments 150, 160, but need not have the notched region 153, 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-I (B and illustrates he location of pawl 1 15' 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 1 68a' 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 117T, which help guides 120', 130' stop in a predetennined location when in an undeployed condition.
WO 2013/022959 PCT/US2012/049979 [000621 Fgs 569 illustrate aspects of the intermediate region 500 of devie 1000. intermediate region 500 includes an elongate, preferably metallic tube 510 hang 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 pilot 1 14 to suture head 10 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 Stainles Steel cables that are .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 524a 524b for receiving suture head 100) separated by an intermediate region 526. Intermediate rgion 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 crossectional 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 or controlling the movement of guides 120, 130. The proximal end of tubular member 510 is attached to a articulation mechanism that rotates the tube 510 and suture head 100 with respect to a handle 600 of the device, discussed below. The distal end 514a of tube 510 may be extended slightly to provide for tighter control of drive element 150 as it passes into intermediate region 500. [00063] For purposes of illustration, and not limitation, handle 600 of device 1000 is illustrated from Figs. 60122. Handle 600 includes many components nd systems for operating suture head 100, 100' Fig. 61 illustrates head-on view of handle with tube 510 removed. illutrating 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 res pect 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 5 10, which can be, for example and not limitation, a 5mm nominal outside diameter staindessteel hypotube Ao 21 WO 2013/022959 PCT/US2012/049979 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 hal e including a right side 612 and a left side 614. fig. 63 lustrates handle 600 with tube collars 632, 634 removed. Proximal cable guide 606 is anchored within hypotube, such as byinterference fit The longitudinal distance along tube 510 between the distal disc 606b of proximal cable guide 606 and cae disc 648 (Figs. 712) 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 prefeied embodiment. suture head has a total angular range of motion of about 270 degrees with respect to handle 600 desirablyabout 135 degrees in either direction fromthe home position illustrated in the Figures. Detents in roticulation handle 620 (Fig. 64) are adapted and configured to engage with a pawl 614g housed in an opening in left handle portion 614 (Fig. 79(A ). [000641 Tube collars (Figs. 66-67) are essentially mirror images of each other (across a verical centerplane ofthe device 10) and cooperate to define a hollow ,generally cylindrical interior for receiving proximal end 512 of tbe 5 1A In particular lugs 632a. 634a are provided to mate with openings 518 near the proximal end 51 of tube 510 (ig. 69) Tube collars also define radially oriented detents 632. 634b along their proximal faces to mate with raised portions 644b on the distal face of roticulator plate 644 Fig. 68) Roiculator plate 644 further includes a proximal portion 644c having a square cross section for being received by the left and right housing side portions 612, 614. (00065] Roticulator plate 644 is received in housing 614 between adjacent ribs 614r(Fig. 70) as is cable disc 648 Cable disc 648 (Figs. 71-72) defines a circumferential groove 648b about its periphery for mating with a rib 614r aswell as an annularly-shaped channel 648a in its distal facefor receiving a roticulator spring 646 Spring 646 is adapted and configured to urge roticulator plate into contact with detents 632b, 634b to facilitate stepwise rotational movement. cable disc 648 further defines a plurality of openings 648c therethrough to permit passage of cables/wires 172 174, 176, 178, 532, 534 and 551. 22 WO 2013/022959 PCT/US2012/049979 [00066] As illustrated in Figs 73-4, 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, 1 74, 1 76 178 and a second set ofguides, or bosses, 652, 654 for directing cables 53, 534 through the handle 600, Grooves 658 are provided in guide 650 for receiving ibs 612r of right housing portion 612 ig. 79(D). [00067] Figs. 75-76 illustrate a cutaway view of handle 600 herein 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 positiondwherea Fig, illustrates trigger 700 in a released position wherein the trigger can be depressed thus advancing needle(e.gi 300) about needle track 140. As illustrated in Figs.75-76, handle includes trigger 700. puil cable/ribbon 7i0 trigger spring capsule 720,rigger return spring 730, pull cable 727. pulley 750 and brake handle 800 for preventing articulation knob 810 from being rotated. As stop surface 614s is defined in left housing 614 to define a stop point for trigger 700 when trigger 700 is locked. Right housing 612 includes a siNilar sop feature 612s (Fig. 79(D Articulation knob 810 (ig 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 hat is preferably threaded for receiving a hex nut 886 (Fig. 90n Right and left handle cap portions 616, 618 (Figs. 77(Ai-77(D)) are provided with bosses 616a. 618 a for receiving and supporting the edges 835b of brake sprngs 835(Fig 84. Bearing portion 835a 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 porion 834 of fittings 830, wherein rotation of the knob 810 causes the fitings 830, and hence cables 532, 534 to advance along a proximaldistal direction with respect to device 1000, resuming 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 ofthe 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 23 WO 2013/022959 PCT/US2012/049979 spring 845 against bracket 870 to maintain tension on cables 532, 534, Figs. 83-85 further illustrate fittings 830. spring 835 and spring 845. [00068] Figs, 86(A) B) illustrate the movement of shuttle88 (Figs 99(A-99B)), which moves proximally upon the release of trigger 700. Irimal movement of shuttle 888 prevents handle 892r from being articulated, which, in tun prevents guides 120, 130 fromn being withdrawn into sure head 100, 100 while trigger 700 is actuated, advancing the needle (eg. 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 silione. Ig. 87A) further illustrates lower brake pad 850, while Figs. 87(B)-87D) 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, 884a (Fig. 91(B)) Figs. 88-89(A) illustrate remaining inner workings of handle with brake pad removed(Fig. 8) and further with pulley holder 840 and brake bracket 860 removed. Figs. 89(A)19(B) fuher ilustrates couplhng knuckle 872, which includes longitudinal openings 872a having narrowed portions 872c that are wide enough to permit passage of a cable 532, 534, but not wide enough to permit passage of cable terminations 874 (Fig91). Opening 872b, in contrast, is large enough to permit Ierminations 874 to pass into knuckle 871 thus joining cable 532 to cable 534, and providing a closed loop to facilitateartielation by way of articuladon and brake control800, Bake trigger 884 can be pulled, causing a camming effect of by moving an upper portion of handle component 882 (and it 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. [00069] 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 894a, 896a and routed up to handles 192 where all four cables, 172, 174, 176, 178 are held in place in openings 892b in handles 892 by tapered pins 893. The other pair of cables is routed about guide 887 directly into handles 892. 24 WO 2013/022959 PCT/US2012/049979 Guide 885 (Fig. 93(B)) i a generally curved planar member having a plurality of cable guides 885a 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 intemal components of handle 600. Guide 87 (Figs. 93C)-93(D) include bosses 887a to be received by using portions 612 614, and grooves 88T defined by fins 887c for routing cablewAres. candles 892 include grips 892a and grooves 892c and channels 892d for directing cableswires into openings 892b Wigs. 94(A)94 Both handles 892 can be essentially identical in foam. [00070] Guide handles 892 also play a role in releasing trigger lock 780. thereby permitting bigger 700 to actuate the movement of needle (eg 300) As illustrated in Figs. 95(A95(B triggerock 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 86 and is biased ward a locked position by spring 787. A bifurcation 7S4 at the opposite end of trigger lock 780 is adapted and configured to interlock with trigger 700. When the cable to whicb ferrule 781 is attached is advanced upwardly (Fig 95(B)) byrotatng handle 892L, bifurcation 784 of trigger lock 780 disengages from trigger 700, permitting free movement of triggen Handles 892L 892R are pivotally disposed on ax le 89 (Figs. 96, 122). figs 97-101 uther illustrate additional features of the actuation system for guides 120 130 with progressively addiional components removed to better illustrate other components, and their relative posidins. Fig. 102 further illustrates additional aspets and views of components 840, 894, 896, [00071] Figs 10113 ilhstrate aspects of the operation of reciprocating trigger mechanism 700, Fig 103 lustrates the relative position 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)-106B) from two additional angles showing bifurcated yoke 702 proximate the top end of trigger 700 Yoke cap 704 i received in trigger handle 700 by securing studs 704a into holes 700a by interference fit and/or ultrasonic welding, adhesive or the like, Yoke 702 and yoke cap 704 define openings 702a, 704a therein for receiving bosses 25 WO 2013/022959 PCT/US2012/049979 888a o shuttle link 888 (Fig. 9(B))0 Fig. 107(A) illustrates the interior of capsule 720. revealingcutch spring 724. Figs 107(B- 107(C) illustrate housing portion 720a which mates with housing portion 720b. lAusing portion 72Gb is an identical miror image of portion 720a, so only 720a is illustrated, Clutch spring724 is removed in Fig. IO8 clearlillustrating pull cable 727, clutch spring femle 723 and cutch washer 726. Fig 109 illustrates the assembly with spring 730 and housing portion 72b removed. Fig. 110 illustrates a closeup of the connection of drive number 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 slot721a in washer plate 721. 0-rings 720, vhich ray be silicone or other suitable material, are illustrated in Ngs 104 and 109, 0-rings 729 provide a seal against housing segments 612. 614, Ferrule7is secured to cable 727. Figs. 111-113 provide closer views of ferrule 723,asher plate 721 and proximal end of member 710 respectively. [000721 Figs. 114-120 further illustrate the connections between drive member 710 and dive members 150551. As illustrated in Fig. 114, proxmal drive member which can include ribbon-element 150 described above attached to intennediate cable section 551 in intermediate region 500,iseceived by a ferriue 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, permittig movement between member 551 and coupling 920. As illustrated in Figs. 115-117, terminaton 930 defines a passage 936 therethrough for receiving cable 551, and defines a generally cylindrical proximal sectiuan 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 feiile in place on cable 551. Coupling 920 includes a proximal face 922 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. Proxinal end 943 of fitting 940 faces proximally, and defines a cavity 946 therein for receiving distal tip 717 of drive ribbonicable 710. Tip 717 is inserted into cavity 946 undi stop 719 contacts proximal face 943. Threads 942, 952 are defined on fitting 940 and nut 950. Components 940, 110 may be coupled by any suIable means, including but not limited to interference fit andlor welding, soldering, blazing, adhesive and the 26 WO 2013/022959 PCT/US2012/049979 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. 11(C). [00073] An exemplary method of operation of suture head 100 is set forth in Figures 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 paw pring 115b prevents needle 300 front moving in acounterclockwise direction. Similarly, pawl spring I Isa 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 ist i 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 ement prior to deployment and greater than 180 in angular extent after deployment. [000741 Flg. 124 illustrates the initial deployment of guides. Pawl 1ia is dragged along surface 322 of needle 300 until it engages wit notch 308 and paw! 1 15b engages with notch 306, Guides are then fully retracted in Fig, 125, and pawlI H 5a situated in guide 120 drags needle 300 in a clockwise direction to present it for sutring 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 10a and pawil 115b bears against surface 122 of needle 300 When drive member 150 is then pulled proximally notched region 158 of member 150 slips past bosses 106a, 108a and drive member 150 drops into lower passage defined in part by passage 108T Frther proximal movement of drive member 150 causesthe distally located wider portion of ribbon 150 to bear against the underside of bosses 106a, tO1a, and pawi 160 makes contact with die trailing end of the needle 300, and needle is advanced about 180 as illustrated in Fig. 126. The distal movement of pawl 160 is hen repeated, such that pawi 160 engages with notch 310 in needle 300. Region 158 slips past bosses 106a, I 0Sa as before, and pawl 160 and the leading tip 302 of needle are pulled along he arcuate needle track 140 27 WO 2013/022959 PCT/US2012/049979 resulting in the inedle beig returned to its tarting point, as illustrated in Fig. 128. Fig. 129 lustrates guides 120. 130 in partial retraction such that needle is med counterclockwise until notch 306 meets with pawl 11b. Fig. 130 ilhistrates guide i 20, 130 retracted even Irther, illustrating how pawi 115a is pulled out of notch 308 and is dragged along surface 322 of needle. further counterclockwise movement of needle 300 is prevented by pawl 115b being locked into notch 306. Fig. 131 illustratessuture head 110 once again in deivery or removal configuration with guides 120 130 fully withdrawn. Thus. a device is provided herein that can rotate the disclosed needle through I 80 %3600, or any further multiple of 180 as desired, If desired the angular increments of advancement could be increments of more or less than 180O as desired. [00075] 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 fundoplicationliver lobectony gastectomysmall bowel rejection, treatment of small bowel obstruction, distal pancreatectomy, nephretomy and gastic bypass. Those skilled in the art will recognize that the presetly disclosed embodiments can be used in other laparoscopic procedures. [00076] 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. nirogen 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 assembly1(eg, 100, 1007) The suture head assembly is then positioned relative to the issue/vessl o 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, ushig 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 suturesnilar to suturing individual cnrn! l luS21 WO 2013/022959 PCT/US2012/049979 done by hand in the conventional way The user may employ a single suture which would extend the entie length of the incisionlor nmtiple stares Thus, by placennt of the device spanning the incised tissue segmentsand actuating the handle, the suturing device enables the user to lay down a running stitch or interrupted stitc to close thetissue incision in a time efficient manner. Those skilled in the art wil recognize that any conventional procedure for conducting laparoscopic surgery can be used ith the device. [00077] The mininalized structural design of the stature head assenmy 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 enabing 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. [000781 The user may continue to manipulate the suturing deve, alternately advancing and actuating rotation of the needle about an axis that is generally paralleI 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 dght 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 sitche. [00079] All patents, patent applications, and published references cited herein air hereby incorporated by reference in their entirety Will be appreciated that various 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. 29