AU2015238863B2 - Devices and methods for minimally invasive suturing - Google Patents

Abstract

A suturing needle disposed in a deployable needle track. The needle has an arcuate body with leading tip and trailing end, a notch along an inner radial region needle and another notch having a projection that lies on a plane of a central curved axis of the needle, with the notches intersecting. The main and tail portions have round and square cross sections, respectively. A drive pawl is connected to a third notch at a trailing end. An arcuate keel along the needle's length stabilizes its movement in the suturing device.

Description

DEVICES AND METHODS FOR MI N IMALLY INVASIVE SUTURING

GROSS-REtERENGETO RELATED APPLICATIONS

[000:1] This appl icalion is a: eo nt i rtuation^i n - part af and claims theUenefi t Of 'priority of U.S, Patent; Applkarion Serial No, 12/909,606, ixlecl October 21, 2010 and issued as U.S. Patent Nd:. 7^993:,354 August 9. 2011, videh in turn claims the benefits! prioritytsf U.S. Patent Application ..Serial No, 61/38 8,648:, filed October 1, 2010, This application related to International Application No. PCT/US2009/006212 tiled November 20. 2009, which in turn claims priority to U.S. 'Pioylsional: Application Serial No, 61/200. I SO, filed November 25, 2008, This application is d:so rela^ditoiUAi Patent:Application Serial No. i 1/231,135, filed September 20. 2005, which in turn cJaimsthe /benefit of priority to U.S. Pr ovisional Application SmiaiNb-: 60/61! .162, filed September 20, 2004. This patent application is also: related to hitematiottal Application No PGT/US2008/06674 filed May 23. 2008, which.in turn claims priority to U Proyisional Application Serial No. 60/939,887, filed May/24, 2007, This patent application is also related to U.S. Patent Application Serial No. 12/175,4^2, tiled July 17, 2008. Each of the alprementioned ^applications is incorporated by reference herein in its entirety,

TIEED

[0002] 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 (MTS] has allowed: physicians to carry out many surgical procedures with less pain and disability than conventional, open surgery. Unlike conventionalopen surgery, where the surgical siteis readily accessible through a large incision, enabling the surgeons to easily vi sualize and manipulate both tissue and instruments, MIS requires the surgeon to operate remotely by inserting and xnanipulating instruments through small punctures: f,,ReyhqIie::.s:u^ orifices, including for example the

Vagina, the esophagus;,; or the anus.

[0004] In MIS, a smalt 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 s uch ©annhlasmay be inserted into the body for any given operation. Minimally invasive surgical, /instruments are necessarily smaller, and are also generally longer and therefore are mOreiifficult tomanipuiate^ wift precision, [00011 Perhaps the most problematic surgical task in MIS is sutufing. Suturing requires

Cpordinateti manipulation with both hands of small needles and sutures that are difficult to visualize:(particularly when only indirect, two-dimensional video imagihgis available) as? well/as ;thip needle-drivers and pick-up forceps);ordinarily used to suture by hand, Inpncn^vliipnmeiii: charae Leri zed by limited space, limitetliyiisuali/atiQnj and limited mobility , many surgeons find minimally invasive suturing by hand an extremely difficult, often virtually impossible, surgical task. P006] In the .preferred method; of suturing by hand, a grasping forces (rneedle driver11) is held by the surgeon and is used to grip a curved needle near the needle's tail. Pronation of the surgeon's wrist drives the needle into the tissue. When the point of the curved needle emcrges from the tissue, the surgeon releases the needle from the grip of the t»sc^ciAiyerand:-^3asps;:iiiic point with another forceps ('picR-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 atraumatic path through the tissue, until the entire length of the needfc lms 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 sti tches has been placed. In order to place additional interrupted or continuous stitches, the ;surgeon must let go of thepoint of the needle and re-grasp the needle near the needle's tai I.

[0007] In the manual suturing technique described above, the direct handling of the needle eail result in accidental needle pricks through a surgeon or nurse'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 causconsetofiniection 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 htection, [0008] 'Bafiousdevices:;forsutriringfor MIS are described in U.S, Pat. No. 5,643,295 entiied ''Methods and Apparatus:fbr Suturing Tissue"; U.S. Pat. No. 5,665,096 entitled "Needle Driving Apparatus and Methqds of Suturing Tissue"; U.S. Pat. No. 5,665,109 entitled "Methods: and Apparatus for Sutui^giTfSiid!?11'? Pat- No. 5.759,188 entitled "Suturing Instrurnent with Rotatably Mounted Needle t^V’eri'aftdii^her";· U.S. Pat. No. 5.860,992 entitled "Endoscopic Suturing Devices and Methods"; U S. Pat, No. 5,954,733 entided "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 v hidi ore incorporated-bydeference:ih theirguiretfes for the teachings therein.

[0OQ9] Assignees- U.S, Pat, No, 5,437,681, U.APat.No. 5,540,705 and U.S. Pat, No. :6;923,81§idise]ose: a suturing device with thread management comprising a protective cartridge, suturing: needle and needle rotation drive, the disclosures of which arc hereby incorporated by reference; The devices described in the abovemotentioned 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 ske of the suturing device makes ifedifficulfeto visualize and cumbersome to use for MIS.

[00010] Therefore, there remains a need in the art for a minanally 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 de knots quickly and with coritMlled. tension; places continuous stitches; and protects users from accidental needle: sticks during needle handling, as well as internal organs and vessels fern inadvertent needle-pricks.

SUMMARY

[00011] Devices and; methods for minimally invasive suturing of tissue internal to a body are disclosed herein. I0OQI2J ffecording to aspects illustrated herein;: there is provided a medical device for closing opningS;::infornal to a patient's body, which closely emulates or replicates the manual SUfofeg aclohS carried out by a surgeon. Iheidevice offers several adyantages over conventional methods used by surgeons: for suturing tissue during minimalIv inv as ive surgery in foatfoe-deviee provides a hand-held suturing instrument that requires no external moti ve source. The pmsendy disclosfidembodiments prpyidejfolatiye esse!of operation for the surgeon with only one hand.

[000133 According to aspects illustratedfoeroin, 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 3mm: cannula in some embodiments, thus making the device extremely easy to maneuver, as well as suture, during endoseopic 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 arehighly advantageous. Also, the suture head assembly of the device can be lateral ly articulated to the left of center, to the right of center, up, and down, once in side: the cannula, which is ideal for use in thecourse of endoscopic surgery, including laparoscopy, thoracoscopy and arthroscopy, as well as other less-invasive surgical procedures. P014] Devices of the present disclosederifoodime^ 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 obstiucLions anywhere in the interior of the are. The design of the suturing devices of the present disclosed embodiments allows for a lack of obstruction in the center of the arc ol the needle during -suturing. In other words, there is no hub at the center of the circular arc of the suturing needle. The entire iitrea within ;:the;::eimular arc of the needle is unobstrocted. This allows for the user to hayerietter yisualixatioh during operation, unlike the present mechanical suturing methods, while malntafoih$iddntrol over needle movement.

[00015] A benefit pro vided by suturing devices of the presently di selosed embodiments: :is that the deviees 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 suturmg?tfevice first push a suturing needle from the tail of the needld and, dri ves die point of die rieedle thioiigli the tissue. The device then picks up the point of the needle that passed through die tissue* and pulIS; the remainder of the suturing needle and die suture attached to the suturing needle through the tissue. The suturing needle thus consistently follows the arc pf the needle's own eurye, which is the preferred method of suturing, in the most atraumatic way of passing a; needle through tissue. A benefit provided by the sumring 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 discfosed embodiments, no ancillary instruments or tools such as needle-holders,: piefc-up forceps or the like are needed to complete the stitch. A forcep s or grasping xnstmrnent cari be used: to tighten the knots. JPD016] According to aspects illusirated herein, there is provided an embodiment of a suturing;device foat inefodes 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 eif 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.

[00017] Tn 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 (rack is disposed in the housing, and the needle track is adapted and be deployed, or expanded from a stoned or contracted condition wherein die needle track isMsentiallg disposed within the housing to an expanded; dr deployed condition wherein the neecUe track extends outwardlyfrom the housing to form an arcuate needle track. The device further ineludes ;:anarcuate or circular needle disposed in the deployable needle track, the needle having a first Chet, 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 adyMc.e;;fhe:h^0tild in multiple 360'·' revolutions about the needle track when the deployable or expandablemeedie hack/is in a deployed or expandedcondition without removing the needle from the needle track. The drive selectively engages with and disengages from the needle to advance'toneedio about a 360°' rotation.

[0001:8] 111 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 canTiave a diameter of about 10 ram. If desired, the needle can have a non-circular eross-seefion, Preferably, the device further includes means for deploying the needle track from the stored condltiou to the deployed condition. The needle track can. occupy about 270° of the 360° needle path when the needle ( rack 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 2Θ0”, about 210°, about 220®, about 230°, about240% 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 neces sary to have guides thaf 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 lO0°,:about ll:0o,^but:l:2{i):0, about 130\ about 140°, about 1;S0°, or about 160° from fh© Undeployed (unexpanded^eQn0^radbbtbtbe deployed (expanded) Configuration. The drive can; include an; elongate flexible member that reciproeates along a longitudinal axis of the device. The drive can engage with and 3ΐνΐ^^·::0ϊ9···ή:!0«^6 along the needle frack:When the elongate flexible member is advanced proximallv with respect to; the housing. Themeedle can include first and second notches along an inner face of the needle for engaging;rijiedifc^in.rsm disposed on at least one of the housing and the deployable needle track, Theheedle can further include a notch on a top face of the needle for engaging a portion of the drih^:fS;;.;wil:ei^iii';tlm^'-,'rifP^tl on the top face of the needle intersects one of the notches disposed on the inner face ©fithS: needle, [00019] In, aCeOrdanee Wftha preferred embodiment, the deployable needle track includes at leastoMefacuafe guide ibatls adapted to be deployed from the housing along an arcuate path. Preferably, the deplopbi© needlehack includes a pair of arcuate guides that are adapted to be deployed 'from: thehousitig/along; aunropate path. The pair of arcuate guides are preferably deployed from toehpusing: along: fte arpuate ;pafh 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 palr of pull wires to rnakea 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.

[00020] 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 fhatlies within a plane that is defined by a central cauved axis of the needle, and frn ther wherein the first notch and second notch intersect.

If desired, the needle camfurtherincludes 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 h.dfive· pawl. Moreover, the needle can defmean arcuate keel along; itSilength; to stabilizes; itsmovement in the: suturing device.

[00021] According^ aspects illustrated herein, there is pro\ idea ^method fariSUturing tiSiSUesduring minimally· Invasive surgery that includes inserting a distal ehdpf a; suturing device having· a suturing needle with a pointed end into a body; positioning thessutiMnglneedle tp span a: plurality of separated tissue segments;; activating an actuator a first time: causing thepointed end Of theiSUturing needledoiestendlbejpnd a protective housing of a cartridge to engage the plurality pfseparated tissue segments;,und activating the actuator a second time to cause the suturing needle to complete aueyolutitiri and pull a suture extending from the suturing needle through the plurality of separated tissue segments to form a stitch.

[00022] In acct^dance with,;a further aspect, a suturing device having a suturing head is; provided. The suturing headTncludeaa housing defining at least one passage therein, the housing having a pend arid; a peripheral side joining the proximal and distal ends. The heap furtheriincludes a deployable needle track disposed at least partially within the housing, the needle track being adapted and configured to bedeployedTrom a stored condition \yherein; 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 fromThe: peripheral side of thehousingto 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 kom a contracted condition to an expanded condition , The sutoring head further includes an arenate need Ie disposed in the deploy able needle track, the needle having a first end. a second endpand a generally toroidal body . The suturing head farther includes a drivefhr advancing the needle in multiple 360° revolutions about the needle track when the deployable needle traek is in a deployed condition, wherein the drive selectively engages with and to advance the needle about a 3603 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 hasa dlameterof about 10 mm.

BoWever, it wil) -idiitHigiiCer can be larger or sm all er as desired. The needle bah have a substaBrtiiaiji^··CsilCiiajaf Ι«ΐί^^.ίίί·::::!!ίί^1^:0ΐΐ, a circular cross section, a non-circular cross-iseetlon. a square or triangular erpsysection, of may have a cross section that varies along; its length that transitions from,one shape tOianother, such as from a square to m circle to a square. The device preferably further includes meahsTbr deploying the needle track from the stored condition to the deployed condition, The needle buck preferably occupies about 27t)'; ol a 360° needle path when the needle track is deployed, but the angular extent of the traekean be more or less than 2'hh- as desired^ in one degree increments, for example, 100024] In acccrrcfahce witho further1 aspect, the drive preferably includes an elongate fexlble member that reciprocates along a longitudinal axis of the device. The-drive preferably engages with and advances the needleiateg4the 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;;:guid& to be deployed from the housing along an arcuate path. The deployable needle traek preferably includes a pair Of arcuate guidesthat are adapted to be deployed liom;dtelipusing:along an arcuate path. The pair of arcuate guides are peferably deployed from the;housing :alptig:the arcuate path by pulling in a first pair of pull wires, wherein one pull wireis attached to. each :guide> The pal r ef arcuate guides is preferably adapted and configmed to be retracted into (he housing by pulling in a second pair of pull wires, wherein one pull wire in the second pair of pul l wires is attached to each guide. The first pair of pull wires is preferablyconnected 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] It another embodiment, a suturing device is provided having a suturing head.

The suturing head includes an elongate housing having a proximal end, adistal 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 bousing, 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 arenate extent of about ISO degrees and is essentially disposed within the housing to a deployed condition wherein the needle track has an arcuate extent in excess of 1:80 degrees, and wherein the needle track lies in a plane that is parallel to a longitudinal axisOf 1¾¾¾ Ί he suturing head further includes an arcuateneedle disposed in the deployable needle track, tbeneedle 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 truck is in a deployed condition, wherein the drive selectively engages: Vdth and disengagesirom the needle to advance the needle about, a 3S0'a';rotation,. 100026] In accordance with a ihdhef aspect, the housing canbe generaliycylindncal or rectiliheaj^jas desired,: The deployable:or expandable needle track-can include one or more arcuate ghidekthatarcad to be deployed from the housing along an arctiate path. The deployable or expandable needletrack can i nclude 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, me deployable pr expandable needle track occupies about 270° of a 360° needle path when the needle track isTtl the expanded condition, but the angular extent of the track can be more prieKS-dranJlQ®,: as desired, in one degree increnients, for example.

[00027] These and other "advantages: -pf the presently disclosed embodi ments are Illustmted 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

[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 presently disetosed embodiments, wherein: [00025] Tigs,T-3' generally depict a suturing cievice made in accordance with the present disclosure, [00026] Tigs-,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^ [β®Η0@7] Figs. 33-37 illustrate aspects ol an embodiment of a needle loader made in accordance with the present disclosure.

[()0028] Figsf: 38-4() illustrate aspects of a first embodiment of a suturing needle made in accordance with the: pnesent disclosure. $0020] Figs. 41-44 illustrate aspects of a secondembodimentof a suturing needle made in iaccordanee with the present disclosure. $0030] Fig. 45 illustrates aspects of a third embodiment of a suturing needle made in accondance with the present disclosure. $0031] Fig. 46 illustrates aspects of a fourth embodiment of a suturing needle made: in accoidance widi the present disclosure. $0032] Figs. 47(E)-55 ill ustrate aspects of a second embodiment of a suturing head of a smuring device made in accordance with the present disclosure, $0033] F igs 56-59 illustrate aspects of an intermediate region of the suturing device illustrated in Figsr 1-3.

[00034] Figs,:.:6p-|22 illustrate aspeCLs of a handle portion ofthe suturing device illustrated in Figs. 1-3:.

[00035] Figs. 123-131 illustrate pger&fion ofthe suturing head of Figs. 4-32 and 47( A)- 41%.

[00036] 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 ofrepresentation and not limitation, Numerous other modifications and embodiments can be: devised by those skilled in the art which fall within the scope,and spirTof the principles ofthe presently disclosed embodiments.

DETAILED DESCRIPTION

[00037] Reference will now be made in detail to the present preferred embodiments: of the disclosure, examples oTwhieh are illustrated hi:the: accompanying drawings. The method and corresponding steps of the disclosed embodiments? will be described in conjunction with the: detailed description of the system:, [00038] Broad!y speaking, the disclosure provides embodiments of suturing devices having features that peOTjt the dewee to be constructed on a smaller scale and having a smaller profile than embodiments discussed in the pripr art and in patent applications incorporated herein by reference. In particular, embodiments made in accordance with the present disclosure have been constructed thatareadapted and configured to fit through a 5mm trocar. Advantageously, the disclosed embodiments still use id^ cbmparative^f^large suturing needle, thereby permitting substantial tissue capture dbring opemtioUi resulting in effective suturing. 100039] For purposes of illustration and not limitation, as embodied helBin, an exemplaiy embodiinenfibf a suturing device 1000 is illustrated in Fig. 1. Device lOOO incIudes three regipnSs including a suture head 100, an intermediate region 500. and a handle 600. Each of theseriigiOhs :is discussed in detail he low. bigs. 2-3 illustrate device 1000 with certain porti on s removed:? In particular. Fig. 2 illustratesdevice 1000 with a needle loader removed (discussed in 'further'detail belpw). while Fig. 3 illustrates device 1000 with certain portions of thc handle housing rempyed.

[00040] Forputposppf inuskutipnimnd nos Ihnitation, suture head 100, separated from the remainder of device 1000,: is illustimed in Fig. 4, Suture head 100 includes a proximal end 102, a distal end 104, and isformed by the cooperation of three main housing components (106, 108, ί 12 J that define a gap 110 for recei ving tissue of a patient to be sutured together. Suture head 100 is adapted: and configured to direct a scmi-circularncedlchSOOi 350, 400) about a semicircular track and ::across: gap 110 to :form a series: of sutures through tissue to be sutured.

[00041] Prior to advancing :needle across gap: 110, suturehead 100 must be converted from a deli very 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 predetemi i ued Irans verse 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 Smm trocar into a patient'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 intermeibate portion 500 of device 1000.

[00042] 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 housiii® eomponents 106,108, discussed ία further detail, belom When deployed: as in Fig, 6, guides 12(¾.! 1iriey-a or traclc MO that lies in a plane P that is parallel to a longitudinal asis:'X;pf device 1000;. In addition,::18 illustrated, leading tip 302;ρ£ needle 3001s -a<hy:dirujeijd. l^:iirfiyj:e of being: dragged'aldnghy virtue of a pawl 123 in proximal guide 1:20: engaglugiavnotch hObdisposed along an interior surface of needle 300, discussed in detail below. 100043] After guides 120, 130 are in a depioyedicpndition and needle track 140 is defined, needle 300 can thenbe advanced throughfraeh byadvancing 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°¾ arcuate exteat,: is essentially located outside of the enclosure defined by housing^egments· '106,: 108:, 112. P0044] ;iigs:,8^ 1(1: 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 fieedle:3001s 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 af the distal extremity of its reciprocating movement, best observed in Fig. 10. As is evident from fng. 10, notch 158 in drive member 150 is advanced in a distal -direction’ as is pawl 160.

[Q0G45] Figs. 11( A)-11(D) illustrate the structure of the engagement pawl 16Qi Pawl 160 includes a housing166 attached (e.g., welded) to the distal end 154 of drive member 150. I lousing 166 is preferably a metallic tubular structure, and houses a pawl spring 164 biased 168: anrfcap portion ] 62. Cap 162 is preferably KUChlas be wblding, [00046] 'Fig, II illustrates: suture head IDO with 'cover portion IOCremoye|vrevealing reeiprocaiing guide:;patfefelldwed fey drivemeniber I SO and pawl 160, as «Ml as guiies: 110, 130. Guides 120,130 are adyaneedfroni the delivery configuration to thbideplbyed, configuration by four advancement wires, cables or ft Laments. 172. 174. 176, 178 that are directed around:a iSeriesiof bosses;'!n housing·portion 106,discussed belong In particular-each guide 120, llOdnciudes erilnps 102a, 120b, 110¾ l30b that irnegrally foxlniaiend of each of the guides 120, 130;, fiach crimp:Includes passages formed therein for receiving an end :of wires: 172-J 78. Wires;: 172-178 eanfake any suifabletem, rrmstiprefbfilbly multi-strand 300 series Stainless Steel Cables; ,0:0:0’:'in diameter, fihese ends are then Crimped, adhered or otherwise1 attached to the cnmpS - Then by applying fensiOn to one wire in each pair attached to each guide;, the guides 120.130 are, pulled into or out of the suture head. 100.

[00047] Fig. 13 illustrates the guides 120,130 in a deployed condition and does not display wires 172-178 simply for purposes of elatity, Fig. 14 illustrates drive member 150 with pawl 160 at die fulldisfd extent of its travel, groove 135 in the side of guide 130.

The elevation 130e of yyall 1-3(¾ can be i ncreased an d can be thickened to coineide 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 ofsuture head.

[00048] 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 andfMlows the path of the needle. Fig. 15 illustrates the spatial relationship of drive member 150 with respect to needle wi th other device components removed. Fig. 16 illustrates therelative 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 168a that contacts: a body of the needle, a circumferential generally cylindrical face 168b,the distal extremity of which also contacts a surface of a notch in needle 10(), of the distal end 304 of needle, a proximal Idee I68d that con tacts pawl spring 164, an enlarged head portion 168c, and a circumferential distal face 168c that contacts with a nattowed portion of the housing 166 of pawl 160 that prevents pin 168 from falling out of housing 100. 100049] Figs. 18-21 are additional views of suture head 100 showing a progressive removal of component Fig. 18 shows the suture head 100 in tact, while Figs. 19-20 shows the posjfioningof bosses406a, 1060. 106c on housing portion 106 that define bearing points for guide cables 172, VJM176.178 (not shown). Spacers 106d may also be provided to maintain a desired distance between housing com 106. JOB lei permit the movement of components within suturchead 100. and eaualso act as hearing surfaces for wires 176, 178 (Fig. 29). Figs. 20421 illustrate removal of guard 109 which provides inner support for guides 120, 130 to bear against Guides 120, 130 ride;in arcuate phip^ of components 106, 108 and 109.

[00050] Fig. 22 illustrates proximal and distal guides· 120, 130 in the same spatial relationshi p as in Fig. 21. ¥iews of the proximal guide 120 are depicted in Figs. 23(A)-r23(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''‘1op^-ifac6.:fltahfat»s;:the:'dr!ve member 150, and a bottom ^face** thatfaces 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 that bears against teinner surface of guard 109 and an outer face 128 that bears against housing components 106,108. ,4s 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. 25-32 illustrate the cooperation between wires/filaments 172-17:8 and guides 120, 130, As shown i n these figures, wires/filaments 172, 174,176 and 178 cooperate with busses i 06a, 106b, !06c aiid the other components of suture head 100 to permit guides 120, 130 selectively advanced- and retracted. Wire 178 terminates in crimp 130b of guide 130, Applying tension to wire 178, whiter waps around boss 106 a (Fig. 28) results in: guide 120 being advanced owt of the suture head 100. Conversely, applying tension to wire 176, which terminates in crimp 130a 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 106c and is attached to guide 120 at chimp 120b. causes guide 120 to be advanced out of suture head, while applying tension to wire: 17¾ 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, [Q0QS2] Figs. 33- 37 illustrate an embodiment of a needle loader 180 that is 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 184a of advancement portion is received in opening 182a of main body portion 182, Main body portion 182: defilies a groove 182Γ i'or receiving a suLuring needle (300, 350, 400). Main body portion 182 includes a cerhral poitioii 182:darid clip portrons 182c, I82e that fit over suture head 1(K). If desiredj clip portions 182e, 18le may be adapted to snap (it over suture head KM). A distal slop plate 1826 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 material attached tothe h-ailing end, as discussed herein. The loader 180 is then snapped onto suturc 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, 40G) can be 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 distal 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 trai Iing end 304 and a generally toroidal surface 305, Needle300 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. :Notches:;:3i6',: 3:08 axe located oil aii.inneriradia] region 32¾ o| needle, while notch 3;10 has a projection; that: lies within a plane P? that is defined by the central curved axis X’pf the needle, Notch li'Oiineludes afifst poid'an: dldathat is generally perpendicular to the plattOP* and a portion lldb that generally lies in plane P\ and a sloped portion 310c, The-notches 3P6, 308 have projections that are generally perpendicularto the plane P\ Notches 308. 306 haye; first; portions 306a, 3Q8a:that:are generally paralMtoi'alcrpsis section of the needle in that location, and sloped portions 306b, 308b that are angled fsuchas by an angledf'6#degrees) with respect: to: portions. 306a,: 308a, Notches308,.330 intersect to facilitate the function of the particular embodiments of suturing. head IGOrlW describedlherem:,. I000S4] 'Bigs. 41-44 illustrate a Second embodiment of a miiaing needle 330. Needle 330 includes: an arcuate body defined by a leading end 332. a trailing end 354 and a generally toroidal surface 355. Needle 350 includes aplurality 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 an an itiner radialupgipn: 3:72 of needle, while notch 360 has a pitgeettpu: that lies within a plane P’ ithaf is derinedhythecentralxurved-axis W· of the needle. Notch 360 includes a first portion 360a that is generally perpendicular to the plane P’ and a portion360b that generally lies in plane Ph and a sloped portion 360c. The notches 356. 358 have projections that are generally perpendicular to the plane P*. Notches 35X: 356 have first portions 356a. 358a that ai^ generally parallel to a eross section of the needle in that location, and sloped portions 356b, 358b that are angled fsueh ashy 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 Ml 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 needle1 with: a: generally square cross section from a fail portion: 364 with· a;generally square cross section, Ifcls believed that using a needle with a square cross section -helps the needle 3:50 cross the gap H O of suture head and-re-enter suture head: with superior-alignment as compared to needle 300.

[00055] Fig, 4-5 iliustratessatli&amp;M needle 400, Needle 400 includes an arcuate body defined leading end 401, ;a irailing end 404 and a generally toroidal surface 405, Needle 400 includes a plurality of notcbes:406. 408. dtOformed therein, as well as an opening 412 in txadHiig end 404 ^receiving an enddf a length of suturing material, Notches; 406,408 are located on an innei': radial region 422 of needle, while notch 410 has a projection that lies within a plane P’ thatvis defmed by die eciitraleurved axis X* of the needle. The·notches: 406. 408,410 me(g:eneraiIy:;K^ those described with respect to; needle :300. The principal difference between needles 30014004® the .addition of an additional notch: 415 cut intothe needle proximate its trailing; end 404.: 'Notch 415 has ft..JP.C0jectiori: andlis shappri to receive the housing Ifiri pf the pawl ,160:. It is bel ieved that using 5' ipei-tjpis the needle 400 cross the gap 110 ofisutUre head and:;re^enter sutureihead withiSuperiOrvalignment as compared to needle 300.

[00056] Fig. 41 iilu^thhjtes:: avfGnjjriti^&amp;ihib suturing needle 450.: Needle 450 is essentially the samens needle :300,: exeeptfliat iiifuidieirineludes an arcuarokcel 475, or raised surface, along itsdength. Keel475 is· adapted and configured to ride in grooves; 124b, 134b of gpides 120, 130 to stabilize the needle 450 as it crosses the gap 110 of suture head and le-enters suture head with superior afignmedtas: compared to needle JOO.

[00057] Figs, 47(F)-JS: 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' licsin the path of travel of the drive clement 150.

[00058] F.rnhodi merit 100 of suture head includes a drive member 150 that: defines a narrowed, or notched region 158, as illustrated in Fig. 12, for example, to operation, notched region 158 is located to coincide with bosses 106W, 108W (Figs. 47(Λ)-47(Γ))) when pawl 160 i s 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) proximal !y along the needle tracFy the narrowed region 158;of drive member; 150 slips past bosses 106W, 1Q8W, so that pawl 160 will travel updower leg of passage 106T when movingproximally until iTpasses boss 106W and emerges from the passage, ready to begin another cycle. Stated another way, bosses 106W. 108W result itt a passageway between them that permits nano wed region lS8 ;toi slip through, but not the rest of member I S® or pawl 160. Thus, narrowed region 158 permits the drive member 150 to travel along an upper paid above bosses; 106W, 108W when advancing distally, and slip past bosses 106W, 108¾ when region 158 aligns with the bosses, thus permitting^drive member 150 and pawl 160 to move proximally along a lower path below bosses 10:6¾^. 108¾.: Housing:portion 112 is illustrated in big. 47(E).

Aceordinglyy 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 achromiam coating, such as art Armoloy ME;:92® coating commercially avai (able from ME-92®: West/Armoloy® of Illinois, 118 Simonds Avenue, DeKalb, IL 60 i 15. (815) 7:58-6691,: Preferably, member 150 is .17-7 PH Stainless steely condition ”C" that i s then hardened to eondition:01900, 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 fe,g,, electrical discharge machining (“EDM” !, shearing, millingyete,):. The drive ribbon is heat treated,: and then cleahedfOTemove heat treatment: surface oxidation, and the ME-:92::® edatihg:ls tiled applied. By way of fuithef exainple, 17-7PH condition "Λ" material can be heat treated to RH950. In other embodiments, the drive member 150 can be: made, for example, item shape: memory material such as nickel-titanium alloys sold under the trade name of NITIHQL® and the like. In another embodiment, member 150 is made from a polymeric material, In Ode: aspect, member 150 can include polyethyleneterephthalate material or nylon Material Of high strength. If desired . a laminate of plastic and metal materials oi multiple materials can beused. By way of further example, member 150 can be comprised Of a bundle of wires or filarrtemsVa smgle wire or fi lament, or any material in any eonfigutotiun that permits driving the neMle around thehoeedte track.

[00059] The othcr componcnts of suture head KX) including the needlcTBOO, etc.) are ptoterably foimed'by rnetal iipeMion molding (“MIM’") techniques, as are known in the art from various materials, preferably stainless steel, In accordance with a preferred embodiment, 17-4

Ml stainless steel alloy is preferably used. Device 1 DUO is preferably a disposable device, and handle component,!are preferably made from injection molded plastic wherever desirable, [00060] Afurlher embodiment of a suture head iOO’ is set forth in Figs. 47(F's-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. lug. 47(1·’) iliustnites suture head 100’ including a needle 300 with guides 1201 130’ in a depioyed confi guration. Guides 120' 130' are only partially represented and are not depicted including comps at then extremities for mating with deployment or retraction cables as with embodiment 100 discussed earlier. Suture head 100’ defines a guide path l?)' 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 100! that can be traversed by drive member 150’ by modifying components 106’. 112’ by removing material 112a’ 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, [00061] Fig. 49 illustrates the “left” housing component 108’ from various angles, while Figs. 50(A)-50(F) 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 deSnedby cooperation of housing components 106’, H)8\ 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 tra vel. Fig, 52 illustrates the spatial relationship of guides 120), 130’ with respect to pin face 168a’ and pawl 1 GO’ in their two respective locations, for purposes of illustration only. Figs. 53{Α)-53{15) illustrate:1 various views: of housing portion 112’. EigS;54-55 illustrate the spatial orientation .·, of guides 120’*: 130’ (which are substantially identical to guides 120, 130) with respect: to pawl I IS’ andfurther illmstrates guide stops 'Ll?’* which help guides 120.’, 130’ stop in a predetermined location when in an undep loved condi t i on.

[00062] Figs, '56-59 ilhustilte aspects of 'the intermediate; region 500 of’device 1000,

Intermediate region 500 ineludekdh elongate, preferably metallic tube 510 having a proximal end and a distal end,:514. liistal end 514 of tube 510 is attached to a knuckle assembly 520, which in turn is pivotally attached Mipivot 114 to suture head 110, A pulley 515 is located at pivot; 114 to serve asm bearingiStifface for adjoined articulation cables 532, 534 and cables 532,. 534 are preferably affixed to;puileyllSTo: provide leverage fbr:;accompIishing mtieuiation. Articulation cables 532, 534 Cap take any suitable form, most ptmferably multi-stimnd30|} series Stainless Steel cables that are; ,020,:,':m diameter. By pulfingfoapne Of the articulation cables:, the suture head 100 will articulate with respect to intermediate 50Q'tf'4r

Knuckle 520 includes a proximal end 522 and a distal end 524 fin thefbrm of a yo&amp;e 524a, 524b for receiving suture head 100) separated by an intermediate region; 516, Intermediate region 526 defines a longitudinal channel 528 therethrough for receivingidliyeimembcr 150. Preferably, member 150 is attached to a; pull rod 151 in this region, and profile of channel :528 P adapted to accommodate sueh^ngeomefry, as depicted in the Figures., Openings 523 are also defined for receiving members;532,: 334· Moreover, openings 525, 527 are also provided to permit pasdageof pull wtres/cables 172, 174, 176. l78fci controlling the movement of guides 120, 130. Tfie pre^mal end oi 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, dismissed below?, The distal end 314a of tube 510 may be extended slightly to provide for tighter control of diiveelement. 150:;as if passes into intermediate region SOO.

[00063] For purposes, of ill ustration, and not limitation, handle 600 of dev ice 1000 is illustrated from Figs, :60-122., Handle 600 includes many components and systems For operating: suture head: 10¾ 100s. Fig; :ό 1 illustrates a: head-on view of handle with tube 510 removed, illustrating rotieulation handle 620. wherein:relative rotational motion of handle 620 with respect: to handle 600 will cause the suture head 100, 100s to rotate with respect to handle 600, Fig. 60 depicts a rear·: view of handle 600. Fig. 62 depicts: handle: with roticuiation 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 capt ure the proximal end 512 oftube S l O, which can be, for example and not limitation, a 5mm nominal outside::diameter stainless steel hypotube, Also illustrated is be used to: articular pivot point/as discussed above;, Housing: 600 ineiudes two main; housing':BH:veslneluding a right.aide 612 and a leftiside 614. Fug- 63 illustrates haridi© 600 with tube do liars 632. 634 removed,. Hfoximal cable:|ύί|©606ΐ§: anchoiM withib such as by intedemheefit. The longitudinal distance along tube 510 between the distal disc 606b of proximal cable guide 606 and cable disc 648 (Figs, 71-72) repru^htsibM which all cables muted through tube 510 ©an rotate and twist about each Other: when:thei:;suture:head isroticulated, or rotated With; respect m the handle16Q0v The twist region is preferahlyhetween: about three and six inches long;imost preferably about four inches Jong, lh:a:;peferred:embodim^ hasu total angular range of motion of about 270 :cteg fees with respect to handle: 600:,; des i rablv about 135: degrees in either direction from the home position illustrated in the Figures. Detents in reticulation handle 620 (Fig. 64) are adapted and configured to engage with a pawl 614g housed in an Opening ill left handle portion 614 (Fig. 79(A)). 1000641 lube coll ars (Figs. 66-67) are: essentially mirror images of each other (across a vertical eenterplane of die device 1000) and cooperate to define a hollow, generally cylindrical interior for receiving proximal end 512 of tube 510. In particular, lugs 632a,634aare provided to mate with 518 near the proximal end 512 of tube 510 (Fig. 60). Tup collars also define radially oriented detents632b, 634b along their proximal faces to mate with raised portions 644b on the distal face of rodeulatorp late 644 (Fig. 68), Roticulator plate 644 further includes a proximal portion 644e having a square emss section for being received by the: left and right housing: side portions 612, 614.

[00065] Ttoticulator plate 644 is received in housing 614 between adjacent ribs 61 drill g. 70) as is cable disc 648. Cable disc 648 (Figs. 71-72) defines a circumferential :gnoove;64Sb about its periphery for mating with a rib 614r as well as an anmilarly-shaped channel 648a in i fe distal face fbr receiving a rotieulator spring 6461 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.

[00066] 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 522,534 through the handle 600. Grooves 658 are provided in guide 65Q:for receiving ribs 612r ofright housing portion 612 (Fig. 79(D)).

[00067] Figs. 75-76 illustrate a cutaway view of handle 600 wherein right housing portion :612 has been re moved to permit view of interior components of handle 600. Fig, 75 illustrates trigger 700, or actuatdrr hnua loe^d position, where 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 614s is defined in left housing ji 4 to define a stop point for trigger 700 when trigger 700 is locked. Right housing 612 Inciyides a.similar stop feature 612s (Fig. 79(D)). Articulation knob 810 (Fig, 77(E)) includes: a handle portion 812, anelongate shaft 814 for engaging with brake rotate fitting: 830 (Fig. 83), and a distal portion/816 that is preferably threaded lor receiving a hex nut 886 (Fig. 90). Right, and lep handledSp portions 616,618 (Figs. 77( A)-77(D)) are provided with bosses 616a, 618a for-receiving, and/supporting the edges 835b of brake springs 835 (Fig. 84), Bearing portion 835a of brake.springs 835 bear against brakeiOtatc 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 hothhandle 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 rotational ly supported by knuckle pulley holder 840, which in turn: :is biased by a guide :sprihg::845 against bracket 870 to maintain, tension on cables 532, 534, Pigs, 83-85::further illustrate: fittings 830, spring 835 and spring’MS.

[00068] Figs, 86t A j-86(B) illustrate the movement of shuttle 888 (Pigs: 99(A)-99(B)), whieh moves piOxiinall> upon the release of trigger 7(10. Proximal movement of shuttle 888 prevents handle 892r from being articulated, which, in turn, prevents guides 120,130 from being withdrawn info suture head 100 100' while trigger;700is: actuated:, advancing the needle (e.g., 300) about circular needle track 140¾ 140’, Components 830, 835 have been removed in Pig. 86 to better illustrate lower brake pad 830, Brake pads 820,850 are preferably made nom msiBent and somewhat compressible materials Such as silicone. Pig. 87(A) further illustrates lower brake pad 850, While Figs. 8?(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, 884a (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. S:9(A)-:89(B) further illustrates coupling knuckle 872,wliichincludes longitudinal openings 872a having: narrowed portions: 872c that are wide enough to permit passage of a cable 532, 534, but not v, ide enough to permit passage of cable term 874 (Fig. 91). Opening 872b, in comrast. 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, [00069] Figs,92-102 illustrate aspects of the operation and control for the guides 12(¼ 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 arou^ 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 iST direetly into bandies 892,

Guide 885 (Hg. 93(B)) is 4 generalI y curved planar member having a plurality of cable guides 885a. yriierem the cables 172-178 bear dyer 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 887a to be received byhousing portions 612. :614, and girddyes 887b defined by fins 887c ibi muring cables/wires. Handles 872 include grips 892aand grooves 892c andiehahhels: 892d for directing cables/wires into openings 892b (Figs. 94(A)-94E), Both handles:892:::cah be essentially identical in form.

[000701 Guide handles1892 alsoplaydrole-in releasing Itriggeriock 780, thereby1 permitting trigger 700 to aetuatefbemo^ needle (e.g,, 300):. ;A;S: illustrated in Figs, 95( A)-95(B), trigger lock 780 is arfachedlO' a: cable at ferrule 781. which is disposed in opening 783 at bifurcation 782 of trigger lot:Ji:(Figs<i95{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 892L. bifurcation 784of triggerlock 780disengages from trigger 700,pejanitting free movement of trigger. Handles 892L, 892R are pivotally disposedonaxle 891 (Figs. 96, 122). Figs. 97-101 fiff|her illusd^ additional features of the actuation system lor guides 120,130 with progressively additional components removed to better illustrate other components^ and their relative positions. Figii02ifurther illustrates additional aspects and views of components 840, 894, 896, [00071] Figs. 103:-1:13 illustrateaspects 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'.andhandle 700 to reveal ferrule 752, which is 6xed:fo:afenuinat end of pull cable 727 and: resides within an opening 701 within handle 700 (Fig:. 105) . Trigger 700:1s further illustrated in Figs, ,106(A)-:1O6(B); from two additional angles,:showing bifurcated yoke 702 proximate the fop: end of trigger700. Yoke:cap 704 is reeeivedln 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 :888a of shuttle link 888: (Eig. 99(B)), Fig, 107(A) illustrates the interior of capsule 720, reveahng:;ciuteh spring;:72#, Figs. ll:£)j^;©!.)-iD?portion 720a, which mates with;h;ousrng portion 720b, Honsing portion. 720bi is an identieal mirror image of portion 720a. so: only 720a istillustrateh. Clut0h;s|3qing 724 is removed In Fig. 108,.clearly:illustrating pull cable 727, clutch spring tenuis 72:3' andelutcb W:asher226. Fig. 109 illustrates ihe assembly withhousing portion 320b remo ved. Big:, iiOhllwsrtate&amp;a eloseup of the connection of drive member 710 to assembly 720;.. shoeing the manner in which, tabs 71.1., 712 at proximal end of drive member 710 are bent and inserted through the slot 721a in -washer plate 721,. brings 720. which may he: Silicone or other suitable material.areilliistrated in Figs, 104 and .109, O-rings 729 provide a seal is.^g;aj:n.st Tici;Kl'iisii:lri-gFerrule7i3ri-s secured.' tpieable 327.. Figs. 1 i i-113 provide closerviews of ferrule .723:,.washer^^ end of member 710, respectively.

[00072] Kgs, 114-120 further illustrate the connections between drive member 710 and drive membei-s 150Μ5Ί. As illusttatediin Fig, 114, proximal drive member, which can include rtbbon-element ISO described above attached tointermediate cable section 551 in intermediate region 500, is received by a ferrule 910 which is affixed in place aftcr termination 930 is attached, and positioned into cavity 922 in coupling by passing eable/rod 551 through slot 924 in coupling 920 Rounded portion 952 of termination faces distal ly. permitting movement between member 551 and coupling 920, As illustrated in Kgs. 115-117, ternrination 930 defines a passage 936 therethrough for receiving cable 551, and defines a generally cylindrical proximal section 934, Ferrule 010 defines a passage 912 thenrthroughfor receiving cable 551, and a trans verse opening 914 therethrough, such as for receiving brazing or soldering material or other material for hQlding:,fertuledin:p.laee on cable-551. Coupling 920 includes a proximal face 922a, a distal face 928 and a bore-:922:therethrough. As illustrated in Fig, 114 in cooperation with Figs. illS-120. threaded male::fitting: 940 is received within threaded opening 922 of coupling, and receives a retmningjhexinut^SQ thereon. ProximaFend: 943 of fitting 940 faces: proximally; and defines: a cavity 946 thereinsfonrecei ving. distal,tip 717 of drive ribbon/cable 710. Tip:? 17 -is inserted into cavity 946: until stop 719 contacts proximal face 943. Threads :942,. 952: aredefined-on: fitting-940-and nut 950, Components 940, 710 may be coupled by any suitable means, including1 but not limited to interference fit and/or welding, soldering, brazing, adhesive:and:the like. Figs. :12f 422 illustrate torsion spring 960 and guide spring 970;arid their positioning with respect to the other components within handle 600. Springs 960. 970 are a part of the control mechanism fetfe guides 120. 130. Return spring 893,897 is-illustrated In

Fig. 12 i [000731 An exemplarytnetho^df operation of suture head lGO is set forth in Figures 123-131, Fig. 123 illustrates:¾cutaway 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 115b prevents needle 300 from moving ifta c<mhterelbe^ difectiori, Similarly,: pawl Spring 1 15a is biased against the iηnercircumferentia! surface 3¾¾ of fleedle, tending to prevent needle fhSin 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 HKK) is adapted and configured to advance the needle 300 in multiple 360Q 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 18()f in angular extent alter deployment.

[00074] Fig. 124 illustrates the initial deployment of guides. Bawl 11-5a is dragged along surface 322 of needle 300 until if engages with notch 308 and pawl 113b engages with notch 306, Guides arc then fully retracted in Fig. 125, and pawl 115a simafed in guide 120 drags needle 300- in a clockwise direetion to present it for suturing. Pawl 160 meanwhile is advanced along its arcuate track along guides :120¾ 130 to its distalmost extent, causing; notch 158 in the drive member 150 to ahgn withiboss 108a, and pawl 115 b bears against: surface 122 of needle 300. When drive member ISO isthenpnlled proximally. notched region 158 of member 150 slips past bosses 106a, F08a:and drive member 150 drops into lower passage defiiied in part by passage 108T. Further proximal movement of drive member 150 causesfhedistallyloeated wider: portion of ribbon 150 to bear against tbe underside of bosses 106 a, 108a, and pawl 160 makes contact with the trailing end of the needle 300, and needle is advanced aboutl80°, as illustrated in Fig. 126. The distal movement of pawl 160 is then repeated, such that pawl 1 60 engages with notch 310:in needle -300. Region 158 slips past bosses 106a, 108a as before, and pawl 160 and the leading tip 302 of needle are pulled along the arcuate needle track 140. resiiltiiig in the needle being returned to its starting point, asSlustratodln Fig, 128, Fig. 129 iltostrates guides 120.130 in partial r enaction such 'that needle ikmoved until notch '306 meets with pawl 115b. Fig. 130 illustrates guides: 110,, 130 iet)heted.et?en· ihrther, illustrating how pawl 115a is pulled out ol notch 3US and is dragged further counterclockwise movement of needle 300 is prevented by pawl 115b being lockcd into notch 306. Fig. 131 illustrates suture head 110 once again in delivery or removal conliguratioin withguides 120, 130 fuily withdrawn. Thus, a device isprovided herein that can rotate the disclosed needle through 180°, 360°, or any further multiple of 180° as desired. If desired,, the anplaf increments QTadvahcemerit could be increments of more or less than 180° as desired.

[000751 The suturing devices of the presently disclosed embodiments can be used for laparoscopic procedures, including but not limitedto laparoscopic colostomy, colectomy, adrenalectomy, splenectomy, repair paraesophageal hernia, htgumal hernia ventral hefnia repair, Nissen;fundoplication,: hy^ 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 dtherlaparoseppic procedures:..

[00076] to using the devices of the presently di sclosed embodiments,: the abdomen is insufflated with gas to create a working space for the user,,· Any :gas known tothose skilled in the: aid including, but not limited: to, nitrogen or carbon dioxide,; can bo 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 throughifhese access ports/cannulas. The user then introduces the di stal end portion of the suturing, device Into: a, cannula, and then: articulates the suture head assembly :fe.:g,,; 100,1005). The suturediead assembly is then positioned relative to the tissue/vessel to: be sutured together, and theurser preferably locks the suture head assembly in place ,: The riser 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 ™ture :sinnlar to suturing done by band in the ephyehtiohal way. The user may employ a single suture which would extend the entire ler^gth.«ί'tii.e:::iii.e:isiOii-Or multiple sutures, Thus, by placement of the device spanning the incised tissuesegments,'and.a^aiing^-ban'idle, the suturing device enables the userto lay down a runiinig stitch or interrupted stitch to close the tissue incision in a time efficient manner. Those shilled in the art will recognize that any conventional procedure for epoduetmg: laparoscopic: surgery can be used with the device. wmm I he mitiimalized structural design ofthe suture head assembly enables the user to have a ciearznnbbstoictedyiew of thsrsuthring needle:during advancement through the tissue segments during the course of a suturing operation. thereby enabling precise placement of the Suturing deviee to provide uniform sutures and precluding the risk of tearing tissue by placement ;too;elqse: 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:materialof thread.

[OO07S] Thu user may eontinue to manipulate the suturing devicer 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 tbrpugh the entire lengthof the incision or a series of interrupted stitches. After each individual stitch is laid down,: the stifrihis tightened by exerti ng 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: arc 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, [00079] All patents, patent applications, and publishedireferencesoited· herein are hereby incorporated by reference in their entirety. It will be:appreciated that various offfieiabove^: disclosed and other:features and functions, or alternatives thereof,; may he desirably combined: into many other different systems or applications. Various presently unforeseen or unantieipated alternatives, modifications, variations* orimprovements therein may he: subsequently madei.hy: those skilled in the art which are also intended to be encompassed by the present: disclosure.

Claims (12)

1. A suturing device having a suturing head, the suturing head comprising: a) 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; b) 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 degrees to a deployed condition wherein the needle track has an angular extent of about 270 degrees 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; c) an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body; and d) a drive for advancing the needle in multiple 360 degree 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 degree rotation.

2. The suturing device of claim 1, wherein the housing is generally cylindrical, and has a diameter of about 5.0 mm.

3. The suturing device of claim 2, wherein the path of the needle track has a diameter of about 10 mm.

4. The suturing device of claim 1, wherein the needle has a non-circular crosssection.

5. The suturing device of claim 1, further comprising means for deploying the needle track from the stored condition to the deployed condition.

6. The suturing device of claim 1, wherein the drive includes an elongate flexible member that reciprocates along a longitudinal axis of the device.

7. The suturing device of claim 6, wherein the drive engages with and advances the needle along the needle track when the elongate flexible member is advanced proximally with respect to the housing.

8. The suturing device of claim 1, wherein the deployable needle track includes at least one arcuate guide that is adapted to be deployed from the housing along an arcuate path.

9. The suturing device of claim 8, wherein the deployable needle track includes a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path.

10. The suturing device of claim 9, wherein the pair of arcuate guides are 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.

11. The suturing device of claim 10, wherein the pair of arcuate guides are 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.

12. The suturing device of claim 11, wherein the first pair of pull wires is 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.