Patent Description:
Minimally invasive surgery (MIS) has allowed physicians to carry out many surgical procedures with less pain and disability than conventional, open surgery. Unlike conventional open surgery, where the surgical site is readily accessible through a large incision, enabling the surgeon to easily visualize and manipulate both tissue and instruments, MIS requires the surgeon to operate remotely by inserting and manipulating instruments through small punctures ("keyhole surgery") or through natural orifices, including for example the vagina, the esophagus, or the anus.

In MIS, a small puncture is typically made in the body. Medical instruments are then inserted through a cannula. A cannula has a small inside diameter, typically <NUM>-<NUM> millimeters (mm), and sometimes up to <NUM> millimeters (mm) or more. A number of such cannulas may be inserted into the body for any given operation. Minimally invasive surgical instruments are necessarily smaller, and are also generally longer and therefore are more difficult to manipulate with precision.

Perhaps the most problematic surgical task in MIS is suturing. Suturing requires coordinated manipulation with both hands of small needles and sutures that are difficult to visualize (particularly when only indirect, two-dimensional video imaging is available) as well as the several instruments (including needle-drivers and pick-up forceps) ordinarily used to suture by hand. In an environment characterized by limited space, limited visualization, and limited mobility, many surgeons find minimally invasive suturing by hand an extremely difficult, often virtually impossible, surgical task.

In the preferred method of suturing by hand, a grasping forceps ("needle driver") is held by the surgeon and is used to grip a curved needle near the needle's tail. Pronation of the surgeon's wrist drives the needle into the tissue. When the point of the curved needle emerges from the tissue, the surgeon releases the needle from the grip of the needle driver and grasps the point with another forceps ("pickups"). 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 needle has exited the tissue. Each time a stitch is placed, the curved needle is thus driven around in a complete circular arc, Individual (interrupted) stitches are placed by tying off the suture following placement of each stitch. Running (continuous) stitches are placed by repeatedly driving the curved needle in a complete circular arc repeatedly until the desired length of suture and number of stitches has been placed. In order to place additional interrupted or continuous stitches, the surgeon must let go of the point of the needle and re-grasp the needle near the needle's tail.

In the manual suturing technique described above, the direct handling of the needle can result in accidental needle pricks through a surgeon or nurse's gloves, posing a potential risk of infection for the surgeon, nurse, staff, and patient, or cause the needle to become contaminated with pathogenic bacteria that can cause onset of infection at the site of the sutures. There is also a risk of the needle penetrating internal organs or vessels and causing a serious, and often fatal infection.

Various devices for suturing for MIS are described in <CIT> entitled "Methods and Apparatus for Suturing Tissue"; <CIT> entitled "Needle Driving Apparatus and Methods of Suturing Tissue"; <CIT> entitled "Methods and Apparatus for Suturing Tissue"; <CIT> entitled "Suturing Instrument with Rotatably Mounted Needle Driver and Catcher"; <CIT> entitled "Endoscopic Suturing Devices and Methods"; <CIT> entitled "Suturing Instrument with Rotatably Mounted Needle Driver and Catcher"; <CIT> entitled "Endoscopic Suturing Device"; and <CIT> entitled "Endoscopic Suturing Device".

Assignees' <CIT>, <CIT> and <CIT> disclose a suturing device with thread management comprising a protective cartridge, suturing needle and needle rotation drive. The devices described in the above-mentioned patents and patent application comprise a mechanism for driving a protected needle however, the needle is rotated about an axis that is parallel to the axis of the device. In addition, the orientation and size of the suturing device makes it difficult to visualize and cumbersome to use for MIS.

Therefore, there remains a need in the art for a minimally invasive suturing device that is easily manipulated within the small diameter of the cannula; functions in an environment characterized by limited space, limited visualization, and limited mobility; mimics the preferred method of suturing used by surgeons; permits the surgeon to secure and tie knots quickly and with controlled tension; places continuous stitches; and protects users from accidental needle sticks during needle handling, as well as internal organs and vessels from inadvertent needle-pricks.

<CIT> describes a suture insertion device that includes a shaft, which is adapted to be inserted into a body cavity. First and second needles hold respective first and second ends of a suture thread. First and second needle guides are attached to the shaft and respectively hold the first and second needles. The needle guides have a first operative configuration in which the needle guides are held parallel to the axis of the shaft for insertion of the shaft into the body cavity and a second operative configuration in which the needle guides are deployed outward from the shaft within the body cavity so as to point the needles in a proximal direction. An ejector is operative to eject the needles from the needle guides in the second operative configuration so as to cause the needles to penetrate tissue adjoining the body cavity.

<CIT> describes an apparatus and method for minimally invasive suturing i. A suturing device for minimally invasive suturing includes proximal section having a proximal end, a distal end, and a longitudinal axis therebetween; a suture head assembly extending from the distal end of the proximal section; a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis approximately perpendicular to a longitudinal axis of the proximal section, wherein the pointed end of the suturing needle is positioned within the suture head assembly prior to and after rotation of the suturing needle; and an actuator extending from the proximal end of the proximal section to actuate a drive mechanism having a needle driver for engaging and rotating the suturing needle.

<CIT> describes a cycling, suturing and knot-tying device characterized by an arcuate fixed, grooved or recessed way provided in a correspondingly shaped support frame for accommodating a curved needle fitted with thread, and frictional needle-engaging devices provided in the way for selectively engaging the needle and driving the needle in one or both rotational directions to suture a wound with the thread. Selective articulation of the frame and the way and driving of the needle in the way by positioning the frictional needle-engaging devices with respect to the needle are typically effected by manipulation of a pistol-grip operating apparatus having a transmission tube that mounts the frame and the way in articulating relationship and rotates and articulates with respect to the pistol grip and carries various operating elements that interface with the frictional needle-engaging devices in the way. In at least one embodiment needle, direction-adjusting elements are provided in the frame in cooperation with selected devices in the way for determining the direction of needle rotation responsive to manipulation of an interfacing operating element located on the operating apparatus. Auxiliary thread-handling or incrementing and knot-tying devices are also disclosed.

Further embodiments are provided by the dependent claims.

According to aspects illustrated herein, there is provided a medical device for closing openings internal to a patient's body, which closely emulates or replicates the manual suturing actions carried out by a surgeon. The device offers several advantages over conventional methods used by surgeons for suturing tissue during minimally invasive surgery in that the device provides a hand-held suturing instrument that requires no external motive source. The presently disclosed embodiments provide relative ease of operation for the surgeon with only one hand.

According to aspects illustrated herein, a suture head assembly may be removably attached to an actuator mechanism of the suturing device. The diameter of the device is small enough to fit into a <NUM> cannula in some embodiments, thus making the device extremely easy to maneuver, as well as suture, during endoscopic or other MIS procedures. In surgical procedures, it is desirable to make as few incisions as possible, and for those incisions to be as small as possible. As such, devices with reduced profile are highly advantageous. Also, the suture head assembly of the device can be laterally articulated to the left of center, to the right of center, up, and down, once inside the cannula, which is ideal for use in the course of endoscopic surgery, including laparoscopy, thoracoscopy and arthroscopy, as well as other less-invasive surgical procedures.

Devices of the present disclosed embodiments closely emulate or replicate the manual suturing actions carried out by a surgeon. For example, during manual suturing by hand, the needle is held in forceps and travels in a circular arc with no obstructions anywhere in the interior of the arc. The design of the suturing devices of the present disclosed embodiments allows for a lack of obstruction in the center of the arc of the needle during suturing. In other words, there is no hub at the center of the circular arc of the suturing needle. The entire area within the circular arc of the needle is unobstructed. This allows for the user to have better visualization during operation, unlike the present mechanical suturing methods, while maintaining control over needle movement.

A benefit provided by suturing devices of the presently disclosed embodiments is that the devices enable maneuvering a suturing material through a tissue incision in a manner substantially similar to the way a surgeon would do so by hand. In particular, some embodiments of the suturing device first push a suturing needle from the tail of the needle and drives the point of the needle through the tissue. The device then picks up the point of the needle that passed through the tissue, and pulls the remainder of the suturing needle and the suture attached to the suturing needle through the tissue. The suturing needle thus consistently follows the arc of the needle's own curve, which is the preferred method of suturing, in the most atraumatic way of passing a needle through tissue. A benefit provided by the suturing device of the presently disclosed embodiments is the ability of the suturing needle to pull the suturing thread entirely through the tissue segments being closed, following each stitch. When using the suturing device of the presently disclosed embodiments, no ancillary instruments or tools such as needle holders, pick-up forceps or the like are needed to complete the stitch. A forceps or grasping instrument can be used to tighten the knots.

According to aspects illustrated herein, there is provided an embodiment of a suturing device that includes a suturing needle that is protected by a housing, the suturing needle is not exposed to or handled directly by the user, thereby preventing inadvertent needle sticks. The configuration of the suturing device of the presently disclosed embodiments also protects against inadvertent penetration of internal organs or vessels by the needle, since the housing acts as a shield between the organs and the needle.

A suturing device is provided having a suturing head. The suturing head includes a housing defining at least one passage therein and a deployable needle track. The deployable needle track is disposed in the housing, and the needle track is adapted and configured to be deployed, or expanded from a stored or contracted condition wherein the needle track is essentially disposed within the housing to an expanded, or deployed condition wherein the needle track extends outwardly from the housing to form an arcuate needle track. The device further includes an arcuate or circular needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body. The device further includes a drive for advancing the needle about a <NUM>° 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 <NUM>° revolutions about the needle track when the deployable or expandable needle track is in a deployed or expanded condition without removing the needle from the needle track. The drive selectively engages with and disengages from the needle to advance the needle about a <NUM>° rotation.

In accordance with further aspects, the housing of the suturing device can be generally cylindrical, and have an outer diameter of about <NUM>. The circular path of the needle track can have a diameter of about <NUM>. If desired, the needle can have a non-circular cross-section. Preferably, the device further includes means for deploying the needle track from the stored condition to the deployed condition. The needle track can occupy about <NUM>° of the <NUM>° 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 <NUM>°, such as in increments of one degree. For example, a needle track can be provided that expands from about <NUM>° to about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, or about <NUM>°, among others. For example, depending on the diameter of the device and the dimensions of the needle track, it may only be necessary to have guides that increase the angular extent of the needle track by about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, about <NUM>°, or about <NUM>° from the undeployed (unexpanded) configuration to the deployed (expanded) configuration. The drive can include an elongate flexible member that reciprocates along a longitudinal axis of the device. The drive can engage with and advance the needle along the needle track when the elongate flexible member is advanced proximally with respect to the housing. The needle can include first and second notches along an inner face of the needle for engaging an antirotate mechanism disposed on at least one of the housing and the deployable needle track. The needle can further include a notch on a top face of the needle for engaging a portion of the drive, wherein the notch on the top face of the needle intersects one of the notches disposed on the inner face of the needle.

In accordance with a preferred embodiment, the deployable needle track includes at least one arcuate guide that is adapted to be deployed from the housing along an arcuate path. Preferably, the deployable needle track includes a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path. The pair of arcuate guides are preferably deployed from the housing along the arcuate path by pulling in a first pair of pull wires, wherein one pull wire is attached to each guide. The pair of guides are further preferably adapted and configured to be retracted into the housing by pulling in a second pair of pull wires, wherein one pull wire in the second pair of pull wires is attached to each guide. The first pair of pull wires is preferably connected to the second pair of pull wires to make a pair of continuous mechanical loops, wherein the loops are connected at a distal end to the guides, and at a proximal end to a pair of handles, wherein movement of the handles results in movement of the guides.

The disclosure also provides a suturing needle having an arcuate body with a leading tip and a trailing end, wherein the arcuate body defines a first notch along an inner radial region needle and a second notch having a projection that lies within a plane that is defined by a central curved axis of the needle, and further wherein the first notch and second notch intersect. If desired, the needle can further includes a generally square cross-section. The needle body can include a portion with a round cross section that separates a main portion of the needle with a generally square cross section from a tail portion with a generally square cross section. The needle can further define a third notch in the needle proximate its trailing end for receiving a portion of a drive pawl. Moreover, the needle can define an arcuate keel along its length to stabilize its movement in the suturing device.

According to aspects illustrated herein, there is provided a method for suturing tissue during minimally invasive surgery that includes inserting a distal end of a suturing device having a suturing needle with a pointed end into a body; positioning the suturing needle to span a plurality of separated tissue segments; activating an actuator a first time causing the pointed end of the suturing needle to extend beyond a protective housing of a cartridge to engage the plurality of separated tissue segments; and activating the actuator a second time to cause the suturing needle to complete a revolution and pull a suture extending from the suturing needle through the plurality of separated tissue segments to form a stitch.

In accordance with a further aspect, a suturing device having a suturing head is provided. The suturing head includes a housing defining at least one passage therein, the housing having a proximal end, a distal end and a peripheral side joining the proximal and distal ends. The head further includes a deployable needle track disposed at least partially within the housing, the needle track being adapted and configured to be deployed from a stored condition wherein the needle track is essentially disposed within the housing and has an angular extent of about <NUM>° to a deployed condition wherein the needle track has an angular extent in excess of <NUM>° and extends outwardly from the peripheral side of the housing to form an arcuate needle track that lies in a plane that is parallel to a longitudinal axis of the housing. Preferably, the needle track is angularly expandable along a circular path that defines the path of travel of the needle such that the track expands angularly about the circular path from a contracted condition to an expanded condition. The suturing head further includes an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body. The suturing head further includes a drive for advancing the needle in multiple <NUM>° 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 <NUM>° rotation.

In accordance with a further aspect, housing is generally cylindrical, and has a diameter of about <NUM> and the path of the needle track has a diameter of about <NUM>. However, it will be appreciated that the diameter can be larger or smaller as desired. The needle can have a substantially circular cross section, a circular cross section, a non-circular cross-section, a square or triangular cross section, or may have a cross section that varies along its length that transitions from one shape to another, such as from a square to a circle to a square. The device preferably further includes means for deploying the needle track from the stored condition to the deployed condition. The needle track preferably occupies about <NUM>° of a <NUM>° needle path when the needle track is deployed, but the angular extent of the track can be more or less than <NUM>°, as desired, in one degree increments, for example.

In accordance with a further aspect, the drive preferably includes an elongate flexible member that reciprocates along a longitudinal axis of the device. The drive preferably engages with and advances the needle along the needle track when the elongate flexible member is advanced proximally with respect to the housing. The deployable needle track preferably includes at least one arcuate guide that is adapted to be deployed from the housing along an arcuate path. The deployable needle track preferably includes a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path. The pair of arcuate guides are preferably deployed from the housing along the arcuate path by pulling in a first pair of pull wires, wherein one pull wire is attached to each guide. The pair of arcuate guides is preferably adapted and configured to be retracted into the housing by pulling in a second pair of pull wires, wherein one pull wire in the second pair of pull wires is attached to each guide. The first pair of pull wires is preferably connected to the second pair of pull wires to make a pair of continuous mechanical loops, wherein the loops are connected at a distal end to the guides, and at a proximal end to a pair of handles, wherein movement of the handles results in movement of the guides.

In another embodiment, a suturing device is provided having a suturing head. The suturing head includes an elongate housing having a proximal end, a distal end and a peripheral side joining the proximal and distal ends, wherein the housing defines a longitudinal axis from its proximal end to its distal end. The suturing head further includes a deployable needle track disposed at least partially within the housing, at least a portion of the needle track being adapted and configured to be deployed along an arcuate path from a undeployed condition wherein the needle track has an arcuate extent of about <NUM> degrees and is essentially disposed within the housing to a deployed condition wherein the needle track has an arcuate extent in excess of <NUM> degrees, and wherein the needle track lies in a plane that is parallel to a longitudinal axis of the housing. The suturing head further includes an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally toroidal body. The suturing head also includes a drive for advancing the needle in multiple <NUM>° 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 <NUM>° rotation.

In accordance with a further aspect, the housing can be generally cylindrical or rectilinear, as desired. The deployable or expandable needle track can include one or more arcuate guides that are adapted to be deployed from the housing along an arcuate path. The deployable or expandable needle track can include a pair of arcuate guides that are adapted to be deployed from the housing along an arcuate path. Accordingly, a pair of arcuate guides can be deployed from the housing along the arcuate path by pulling on a first pair of pull wires, wherein one pull wire is attached to each guide. In one embodiment, the deployable or expandable needle track occupies about <NUM>° of a <NUM>° needle path when the needle track is in the expanded condition, but the angular extent of the track can be more or less than <NUM>°, as desired, in one degree increments, for example.

These and other advantages of the presently disclosed embodiments are illustrated through the embodiments described hereinafter. The presently disclosed embodiments accordingly comprise the features of construction, combination of elements and arrangement of parts that will be exemplified in the following detailed description.

The presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments, wherein:.

While the drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope of the principles of the presently disclosed embodiments.

Reference will now be made in detail to the present preferred embodiments of the disclosure, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the disclosed embodiments will be described in conjunction with the detailed description of the system.

Broadly speaking, the disclosure provides embodiments of suturing devices having features that permit the device to be constructed on a smaller scale and having a smaller profile than embodiments discussed in the prior art and in patent applications referenced herein. In particular, embodiments made in accordance with the present disclosure have been constructed that are adapted and configured to fit through a <NUM> trocar. Advantageously, the disclosed embodiments still use a comparatively large suturing needle, thereby permitting substantial tissue capture during operation, resulting in effective suturing.

For purposes of illustration and not limitation, as embodied herein, an exemplary embodiment of a suturing device <NUM> is illustrated in <FIG>. Device <NUM> includes three regions, including a suture head <NUM>, an intermediate region <NUM>, and a handle <NUM>. Each of these regions is discussed in detail below. <FIG> illustrate device <NUM> with certain portions removed. In particular, <FIG> illustrates device <NUM> with a needle loader removed (discussed in further detail below), while <FIG> illustrates device <NUM> with certain portions of the handle housing removed.

For purposes of illustration, and not limitation, suture head <NUM>, separated from the remainder of device <NUM>, is illustrated in <FIG>. Suture head <NUM> includes a proximal end <NUM>, a distal end <NUM>, and is formed by the cooperation of three main housing components (<NUM>, <NUM>, <NUM>) that define a gap <NUM> for receiving tissue of a patient to be sutured together. Suture head <NUM> is adapted and configured to direct a semi-circular needle (<NUM>, <NUM>, <NUM>) about a semicircular track and across gap <NUM> to form a series of sutures through tissue to be sutured.

Prior to advancing needle across gap <NUM>, suture head <NUM> must be converted from a delivery configuration to a deployed configuration. As illustrated in <FIG> and <FIG>, suture head <NUM> is initially provided in a compact form having a predetermined transverse dimension, or diameter, ϕ. This transverse dimension, ϕ, can be any desired dimension, and is preferably about <NUM> millimeters. In particular, the dimension ϕ is preferably selected so that suture head <NUM> can pass through a standard <NUM> trocar into a patient's abdomen, for example, during a laparoscopic surgical procedure. <FIG> shows suture head <NUM> from the opposite angle as compared to <FIG>, including pivot boss <NUM>, which mates with intermediate portion <NUM> of device <NUM>.

Suture head <NUM> is illustrated in deployed configuration in <FIG>. As illustrated in <FIG>, in a deployed configuration, proximal guide <NUM> and distal guide <NUM> are moved outwardly from their nested position defined by housing components <NUM>, <NUM>, discussed in further detail below. When deployed as in <FIG>, guides <NUM>, <NUM> define a circular needle path or track <NUM> that lies in a plane P that is parallel to a longitudinal axis X of device <NUM>. In addition, as illustrated, leading tip <NUM> of needle <NUM> is advanced slightly by virtue of being dragged along by virtue of a pawl <NUM> in proximal guide <NUM> engaging a notch <NUM> disposed along an interior surface of needle <NUM>, discussed in detail below.

After guides <NUM>, <NUM> are in a deployed condition and needle track <NUM> is defined, needle <NUM> can then be advanced through track by advancing pawl <NUM> to a distal extremity along its path of reciprocation. <FIG> illustrates needle <NUM> spanning the gap <NUM>, wherein needle <NUM>, being about <NUM>° in arcuate extent, is essentially located outside of the enclosure defined by housing segments <NUM>, <NUM>, <NUM>.

<FIG> illustrate the functionality of suture head <NUM> from the opposite side of the head. <FIG> illustrates suture head <NUM> in a delivery configuration with the guides <NUM>, <NUM> retracted. As can be seen, engagement pawl <NUM> is withdrawn to a position proximal to the needle <NUM>, and the trailing end <NUM> of needle <NUM> is visible. <FIG> illustrates suture head in a deployed configuration wherein guides <NUM>, <NUM> are deployed. As seen in <FIG>, distal guide <NUM> defines an arcuate recess <NUM> that receives the pawl <NUM> at the distal extremity of its reciprocating movement, best observed in <FIG>. As is evident from <FIG>, notch <NUM> in drive member <NUM> is advanced in a distal direction as is pawl <NUM>.

<FIG> illustrate the structure of the engagement pawl <NUM>. Pawl <NUM> includes a housing <NUM> attached (e.g., welded) to the distal end <NUM> of drive member <NUM>. Housing <NUM> is preferably a metallic tubular structure, and houses a pawl spring <NUM> biased between a movable pin <NUM> and cap portion <NUM>. Cap <NUM> is preferably attached to housing <NUM>, such as be welding.

<FIG> illustrates suture head <NUM> with cover portion <NUM> removed, revealing the reciprocating guide path followed by drive member <NUM> and pawl <NUM>, as well as guides <NUM>, <NUM>. Guides <NUM>, <NUM> are advanced from the delivery configuration to the deployed configuration by four advancement wires, cables or filaments, <NUM>, <NUM>, <NUM>, <NUM> that are directed around a series of bosses in housing portion <NUM>, discussed below. In particular, each guide <NUM>, <NUM> includes crimps 102a, 120b, 130a, 130b that integrally form a end of each of the guides <NUM>, <NUM>. Each crimp includes passages formed therein for receiving an end of wires <NUM>-<NUM>. Wires <NUM>-<NUM> can take any suitable form, most preferably multi-strand <NUM> series Stainless Steel cables <NUM> (<NUM>") in diameter. These ends are then crimped, adhered or otherwise attached to the crimps. Then by applying tension to one wire in each pair attached to each guide, the guides <NUM>, <NUM> are pulled into or out of the suture head <NUM>.

<FIG> illustrates the guides <NUM>, <NUM> in a deployed condition and does not display wires <NUM>-<NUM> simply for purposes of clarity. <FIG> illustrates drive member <NUM> with pawl <NUM> at the full distal extent of its travel, riding within groove <NUM> in the side of guide <NUM>. The elevation 130e of wall 130d can be increased and can be thickened to coincide with groove <NUM> to provide an enhanced beating surface for pawl <NUM>. Stops (not shown) are preferably provided in the form of raised surfaces on guides <NUM>, <NUM> and the housing components to help prevent guides <NUM>, <NUM> from falling out of suture head.

As is also evident, groove <NUM> in the side of guide <NUM> becomes accessible for the passage of pawl when the guides are in a deployed condition. As illustrated in <FIG>, guide <NUM> traverses an arcuate path along guides and follows the path of the needle. <FIG> illustrates the spatial relationship of drive member <NUM> with respect to needle with other device components removed. <FIG> illustrates the relative positions of needle <NUM> with respect to antirotate springs <NUM> and drive pin <NUM> housed within pawl <NUM>. <FIG> illustrates drive pin <NUM> in detail, wherein pin <NUM> 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 <NUM>, or the distal end <NUM> of needle, a proximal face 168d that contacts pawl spring <NUM>, an enlarged head portion 168c, and a circumferential distal face 168e that contacts with a narrowed portion of the housing <NUM> of pawl <NUM> that prevents pin <NUM> from falling out of housing <NUM>.

<FIG> are additional views of suture head <NUM> showing a progressive removal of components. <FIG> shows the suture head <NUM> in tact, while <FIG> shows the positioning of bosses 106a, 106b, 106c on housing portion <NUM> that define bearing points for guide cables <NUM>, <NUM>, <NUM>, <NUM> (not shown). Spacers 106d may also be provided to maintain a desired distance between housing components <NUM>, <NUM> to permit the movement of components within suture head <NUM>, and can also act as bearing surfaces for wires <NUM>, <NUM> (<FIG>). <FIG> illustrate removal of guard <NUM> which provides inner support for guides <NUM>, <NUM> to bear against. Guides <NUM>, <NUM> ride in arcuate channels defined by the cooperation of components <NUM>, <NUM> and <NUM>.

<FIG> illustrates proximal and distal guides <NUM>, <NUM> in the same spatial relationship as in <FIG>. Views of the proximal guide <NUM> are depicted in <FIG>, Guides <NUM>,<NUM> are preferably made from a metallic material by assembling a series of metallic subcomponents, such as by laser welding, and are unitary and integral once assembled. Guides can be thought of as having a "top" face that faces the drive member <NUM>, and a bottom "face" that faces housing portion <NUM>. Proximal guide <NUM> defines a curved channel <NUM> in the top face <NUM> thereof. Proximal guide <NUM> further defines a lower face <NUM>, having a groove 124b defined therein, an inner face <NUM> that bears against the inner surface of guard <NUM> and an outer face <NUM> that bears against housing components <NUM>, <NUM>. As illustrated in <FIG>, distal guide <NUM> defines a curved channel <NUM> in the top face <NUM> thereof for guiding the pawl <NUM>. Distal guide <NUM> further defines a lower face <NUM>, having a groove 134b defined therein, an inner face <NUM> that bears against the inner surface of guard <NUM> and an outer face <NUM> that bears against housing components <NUM>, <NUM>.

<FIG> illustrate the cooperation between wires/filaments <NUM>-<NUM> and guides <NUM>, <NUM>. As shown in these figures, wires/filaments <NUM>, <NUM>, <NUM> and <NUM> cooperate with bosses 106a, 106b, 106c and the other components of suture head <NUM> to permit guides <NUM>, <NUM> to be selectively advanced and retracted. Wire <NUM> terminates in crimp 130b of guide <NUM>. Applying tension to wire <NUM>, which wraps around boss 106a (<FIG>) results in guide <NUM> being advanced out of the suture head <NUM>. Conversely, applying tension to wire <NUM>, which terminates in crimp 130a of guide <NUM> (<FIG>) causes guide <NUM> to be retracted into suture head <NUM>. Similarly, applying tension to wire <NUM>, which wraps around boss 106c and is attached to guide <NUM> at crimp 120b, causes guide <NUM> to be advanced out of suture head, while applying tension to wire <NUM>, which wraps around boss 106c in a direction opposite to wire <NUM>, pulls at the attachment point at crimp 120a, causing the guide <NUM> to be withdrawn back into the housing.

<FIG> illustrate an embodiment of a needle loader <NUM> that is configured for loading a suturing needle (<NUM>, <NUM>, <NUM>) into suture head <NUM>. Needle loader <NUM> has two main components, including a main body portion <NUM> and an advancement portion <NUM>. Pin 184a of advancement portion is received in opening 182a of main body portion <NUM>. Main body portion <NUM> defines a groove 182f for receiving a suturing needle (<NUM>, <NUM>, <NUM>). Main body portion <NUM> includes a central portion <NUM> d and clip portions 182c, 182e that fit over suture head <NUM>. If desired, clip portions 182c, 182e may be adapted to snap fit over suture head <NUM>. A distal stop plate 182b is provided to facilitate axial alignment between loader <NUM> and suture head <NUM>. Advancement portion <NUM> rotates within opening 182a of main body portion <NUM>, and further includes a needle pushing arm <NUM>. In operation, a needle is situated within track 184f with suturing material attached to the trailing end, as discussed herein. The loader <NUM> is then snapped onto suture head. Arm <NUM> is preferably situated at this time proximate the trailing end of the needle. Arm <NUM> is then rotated such that needle (<NUM>, <NUM>, <NUM>) is advanced into the needle track <NUM>. If needed, needle (<NUM>, <NUM>, <NUM>) can be advanced back into the needle loader <NUM>, by virtue of the fact that arm <NUM> is dimensioned to pass through the grooves 124b, 134b of proximal guide <NUM> and distal guide <NUM>, respectively.

<FIG> illustrate a first embodiment of a suturing needle <NUM>. Needle <NUM> includes an arcuate body defined by a leading end <NUM>, a trailing end <NUM> and a generally toroidal surface <NUM>. Needle <NUM> includes a plurality of notches <NUM>, <NUM>, <NUM> formed therein, as well as an opening <NUM> in trailing end <NUM> for receiving an end of a length of suturing material 312a. Notches <NUM>, <NUM> are located on an inner radial region <NUM> of needle, while notch <NUM> has a projection that lies within a plane P' that is defined by the central curved axis X' of the needle. Notch <NUM> includes a first portion 310a that is generally perpendicular to the plane P' and a portion 310b that generally lies in plane P', and a sloped portion 310c. The notches <NUM>, <NUM> have projections that are generally perpendicular to the plane P'. Notches <NUM>, <NUM> have first portions 306a, 308a that are generally parallel to a cross section of the needle in that location, and sloped portions 306b, 308b that are angled (such as by an angle of <NUM> degrees) with respect to portions 306a, 308a. Notches <NUM>, <NUM> intersect to facilitate the function of the particular embodiments of suturing head <NUM>, <NUM>' described herein.

<FIG> illustrate a second embodiment of a suturing needle <NUM>. Needle <NUM> includes an arcuate body defined by a leading end <NUM>, a trailing end <NUM> and a generally toroidal surface <NUM>. Needle <NUM> includes a plurality of notches <NUM>, <NUM>, <NUM> formed therein, as well as an opening <NUM> in trailing end <NUM> for receiving an end of a length of suturing material. Notches <NUM>, <NUM> are located on an inner radial region <NUM> of needle, while notch <NUM> has a projection that lies within a plane P' that is defined by the central curved axis X' of the needle. Notch <NUM> includes a first portion 360a that is generally perpendicular to the plane P' and a portion 360b that generally lies in plane P', and a sloped portion 360c. The notches <NUM>, <NUM> have projections that are generally perpendicular to the plane P'. Notches <NUM>, <NUM> have first portions 356a, 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 <NUM> degrees) with respect to portions 356a, 358a. Notches <NUM>, <NUM> intersect to facilitate the function of the particular embodiments of suturing head <NUM>, <NUM>' described herein. Needle <NUM> further includes a generally square cross-section having a rounded portion <NUM> and a tail portion <NUM>, also having a round cross section. Stated another way, the needle body includes a portion with a round cross section <NUM> that separates a main portion of the needle with a generally square cross section from a tail portion <NUM> with a generally square cross section. It is believed that using a needle with a square cross section helps the needle <NUM> cross the gap <NUM> of suture head and re-enter suture head with superior alignment as compared to needle <NUM>.

<FIG> illustrates a third embodiment of a suturing needle <NUM>. Needle <NUM> includes an arcuate body defined by a leading end <NUM>, a trailing end <NUM> and a generally toroidal surface <NUM>. Needle <NUM> includes a plurality of notches <NUM>, <NUM>, <NUM> formed therein, as well as an opening <NUM> in trailing end <NUM> for receiving an end of a length of suturing material. Notches <NUM>, <NUM> are located on an inner radial region <NUM> of needle, while notch <NUM> has a projection that lies within a plane P' that is defined by the central curved axis X' of the needle. The notches <NUM>, <NUM>, <NUM> are generally similar to those described with respect to needle <NUM>. The principal difference between needles <NUM>, <NUM> are the addition of an additional notch <NUM> cut into the needle proximate its trailing end <NUM>. Notch <NUM> has a projection in the plane P' and is shaped to receive the housing <NUM> of the pawl <NUM>. It is believed that using a needle with notch <NUM> helps the needle <NUM> cross the gap <NUM> of suture head and re-enter suture head with superior alignment as compared to needle <NUM>.

<FIG> illustrates a fourth embodiment of a suturing needle <NUM>. Needle <NUM> is essentially the same as needle <NUM>, except that it further includes an arcuate keel <NUM>, or raised surface, along its length. Keel <NUM> is adapted and configured to ride in grooves 124b, 134b of guides <NUM>, <NUM> to stabilize the needle <NUM> as it crosses the gap <NUM> of suture head and re-enters suture head with superior alignment as compared to needle <NUM>.

<FIG> illustrate aspects of an alternative embodiment of a suture head <NUM>' made in accordance with the disclosure. The principal difference between suture head <NUM> and suture head <NUM>' lies in the path of travel of the drive element <NUM>.

Embodiment <NUM> of suture head includes a drive member <NUM> that defines a narrowed, or notched region <NUM>, as illustrated in <FIG>, for example. In operation, notched region <NUM> is located to coincide with bosses 106W, 108W (<FIG>) when pawl <NUM> is located at the distal extremity of its range of motion within groove <NUM> of distal guide <NUM>. When in this position, drive member <NUM> extends into groove <NUM> of proximal guide <NUM> (<FIG>). However, as soon as tension is then applied to bring pawl <NUM> (and needle <NUM>) proximally along the needle track, the narrowed region <NUM> of drive member <NUM> slips past bosses 106W, 108W, so that pawl <NUM> will travel up lower leg of passage 106T when moving proximally until it passes boss 106W and emerges from the passage, ready to begin another cycle. Stated another way, bosses 106W, 108W result in a passageway between them that permits narrowed region <NUM> to slip through, but not the rest of member <NUM> or pawl <NUM>. Thus, narrowed region <NUM> permits the drive member <NUM> to travel along an upper path above bosses 106W, 108W when advancing distally, and slip past bosses 106W, 108W when region <NUM> aligns with the bosses, thus permitting drive member <NUM> and pawl <NUM> to move proximally along a lower path below bosses 106W, 108W. Housing portion <NUM> is illustrated in <FIG>. Accordingly, it can be appreciated that drive member <NUM> should ideally be metallic. Preferably, member <NUM> is made from hardened stainless steel that has been heat treated to HR <NUM>, and may have a chromium coating, such as an Armoloy ME <NUM>® coating commercially available from ME-<NUM>® West/Armoloy® of Illinois, <NUM> Simonds Avenue, DeKalb, IL <NUM>, (<NUM>) <NUM>-<NUM>. Preferably, member <NUM> is <NUM>-<NUM> PH Stainless steel, condition "C" that is then hardened to condition CH900, and then coated with a ME <NUM>® coating. Preferably, the ME-<NUM>® coating is applied after <NUM> Heat Treatment. The sequence of operations in manufacturing member <NUM> includes providing <NUM>-<NUM> PH strip stock material that is machined to size by any number of known methods (e.g., electrical discharge machining ("EDM"), shearing, milling, etc.). The drive ribbon is heat treated, and then cleaned to remove heat treatment surface oxidation, and the ME-<NUM>® coating is then applied. By way of further example, <NUM>-7PH condition "A" material can be heat treated to RH950. In other embodiments, the drive member <NUM> can be made, for example, from shape memory material such as nickel-titanium alloys sold under the trade name of NITINOL® and the like. In another embodiment, member <NUM> is made from a polymeric material. In one aspect, member <NUM> can include polyethylene terephthalate material or nylon material of high strength. If desired, a laminate of plastic and metal materials or multiple materials can be used. By way of further example, member <NUM> can be comprised of a bundle of wires or filaments, a single wire or filament, or any material in any configuration that permits driving the needle around the needle track.

The other components of suture head <NUM> including the needle (<NUM>, etc.) are preferably formed by metal injection molding ("MIM") techniques, as are known in the art from various materials, preferably stainless steel. In accordance with a preferred embodiment, <NUM>-<NUM> PH stainless steel alloy is preferably used. Device <NUM> is preferably a disposable device, and handle components are preferably made from injection molded plastic wherever desirable.

A further embodiment of a suture head <NUM>' is set forth in <FIG>. The principal difference between suture head <NUM>' and suture head <NUM> is that the drive member <NUM> in suture head <NUM>' follows a single path during reciprocation, in contrast with the alternating path of embodiment <NUM>. <FIG> illustrates suture head <NUM>' including a needle <NUM> with guides <NUM>', <NUM>' in a deployed configuration. Guides <NUM>' <NUM>' are only partially represented and are not depicted including crimps at their extremities for mating with deployment or retraction cables as with embodiment <NUM> discussed earlier. Suture head <NUM>' defines a guide path <NUM>' between housing components <NUM>', <NUM>' (<FIG>), similar to the manner in which suture head <NUM> defines a guide path between housing components <NUM> and <NUM> (<FIG>). <FIG> further illustrates an alternate path <NUM> that can be traversed by drive member <NUM>' by modifying components <NUM>', <NUM>' by removing material 112a' that acts as a pawl stop and adding material <NUM>'b in component <NUM>' to act as a new pawl stop. The end result is a different angle of incidence for the drive member <NUM>.

<FIG> illustrates the "left" housing component <NUM>' from various angles, while <FIG> illustrate the "right" housing component from various angles. Apparent from the figures is the path <NUM>' followed by the drive member <NUM>' and pawl <NUM>' (not shown). It will be appreciated that drive member <NUM>' and pawl <NUM>' can be substantially identical to embodiments <NUM>, <NUM>, but need not have the notched region <NUM>, as a single path for traversal of pawl <NUM>' is defined by cooperation of housing components <NUM>', <NUM>'. Guard <NUM>' is illustrated in <FIG>, and illustrates the location of pawl <NUM>' that helps prevent needle (e.g., <NUM>) from moving against the direction of desired travel. <FIG> illustrates the spatial relationship of guides <NUM>', <NUM>' with respect to pin face 168a' and pawl <NUM>' in their two respective locations, for purposes of illustration only. <FIG> illustrate various views of housing portion <NUM>'. <FIG> illustrate the spatial orientation of guides <NUM>', <NUM>' (which are substantially identical to guides <NUM>, <NUM>) with respect to pawl <NUM>' and further illustrates guide stops <NUM>', which help guides <NUM>', <NUM>' stop in a predetermined location when in an undeployed condition.

<FIG> illustrate aspects of the intermediate region <NUM> of device <NUM>. Intermediate region <NUM> includes an elongate, preferably metallic tube <NUM> having a proximal end and a distal end <NUM>. Distal end <NUM> of tube <NUM> is attached to a knuckle assembly <NUM>, which in turn is pivotally attached at pivot <NUM> to suture head <NUM>. A pulley <NUM> is located at pivot <NUM> to serve as a bearing surface for adjoined articulation cables <NUM>, <NUM> and cables <NUM>, <NUM> are preferably affixed to pulley <NUM> to provide leverage for accomplishing articulation. Articulation cables <NUM>, <NUM> can take any suitable form, most preferably multi-strand <NUM> series Stainless Steel cables that are. <NUM>" in diameter. By pulling on one of the articulation cables, the suture head <NUM> will articulate with respect to intermediate region <NUM> about the pivot <NUM>. Knuckle <NUM> includes a proximal end <NUM> and a distal end <NUM> (in the form of a yoke 524a, 524b for receiving suture head <NUM>) separated by an intermediate region <NUM>. Intermediate region <NUM> defines a longitudinal channel <NUM> therethrough for receiving drive member <NUM>. Preferably, member <NUM> is attached to a pull rod <NUM> in this region, and the cross-sectional profile of channel <NUM> is adapted to accommodate such a geometry, as depicted in the Figures. Openings <NUM> are also defined for receiving members <NUM>, <NUM>. Moreover, openings <NUM>, <NUM> are also provided to permit passage of pull wires/cables <NUM>, <NUM>, <NUM>, <NUM> for controlling the movement of guides <NUM>, <NUM>. The proximal end of tubular member <NUM> is attached to a roticulation mechanism that rotates the tube <NUM> and suture head <NUM> with respect to a handle <NUM> of the device, discussed below. The distal end 514a of tube <NUM> may be extended slightly to provide for tighter control of drive element <NUM> as it passes into intermediate region <NUM>.

For purposes of illustration, and not limitation, handle <NUM> of device <NUM> is illustrated from <FIG>. Handle <NUM> includes many components and systems for operating suture head <NUM>, <NUM>'. <FIG> illustrates a head-on view of handle with tube <NUM> removed, illustrating roticulation handle <NUM>, wherein relative rotational motion of handle <NUM> with respect to handle <NUM> will cause the suture head <NUM>, <NUM>' to rotate with respect to handle <NUM>. <FIG> depicts a rear view of handle <NUM>. <FIG> depicts handle with roticulation handle <NUM> removed, and depicting proximal cable guide <NUM>, left tube collar <NUM> and right tube collar <NUM>. Tube collar portions <NUM>, <NUM> cooperate to capture the proximal end <NUM> of tube <NUM>, which can be, for example and not limitation, a <NUM> nominal outside diameter stainless steel hypotube. Also illustrated is articulation handle <NUM> that can be used to articulate suture head <NUM> about its pivot point as discussed above. Housing <NUM> includes two main housing halves including a right side <NUM> and a left side <NUM>. <FIG> illustrates handle <NUM> with tube collars <NUM>, <NUM> removed. Proximal cable guide <NUM> is anchored within hypotube, such as by interference fit. The longitudinal distance along tube <NUM> between the distal disc 606b of proximal cable guide <NUM> and cable disc <NUM> (<FIG>) represents a twist region over which all cables routed through tube <NUM> can rotate and twist about each other when the suture head is roticulated, or rotated with respect to the handle <NUM>. The twist region is preferably between about three and six inches (between <NUM> and <NUM>) long, most preferably about four inches (<NUM>) long. In a preferred embodiment, suture head has a total angular range of motion of about <NUM> degrees with respect to handle <NUM>, desirably about <NUM> degrees in either direction from the home position illustrated in the Figures. Detents in roticulation handle <NUM> (<FIG>) are adapted and configured to engage with a pawl <NUM> housed in an opening in left handle portion <NUM> (<FIG>).

Tube collars (<FIG>) are essentially mirror images of each other (across a vertical centerplane of the device <NUM>) and cooperate to define a hollow, generally cylindrical interior for receiving proximal end <NUM> of tube <NUM>. In particular, lugs 632a, 634a are provided to mate with openings <NUM> near the proximal end <NUM> of tube <NUM> (<FIG>). Tube collars also define radially oriented detents 632b, 634b along their proximal faces to mate with raised portions 644b on the distal face of roticulator plate <NUM> (<FIG>). Roticulator plate <NUM> further includes a proximal portion 644c having a square cross section for being received by the left and right housing side portions <NUM>, <NUM>.

Roticulator plate <NUM> is received in housing <NUM> between adjacent ribs 614r (<FIG>) as is cable disc <NUM>. Cable disc <NUM> (<FIG>) defines a circumferential groove 648b about its periphery for mating with a rib 614r as well as an annularly-shaped channel 648a in its distal face for receiving a roticulator spring <NUM>. Spring <NUM> is adapted and configured to urge roticulator plate into contact with detents 632b, 634b to facilitate stepwise rotational movement, cable disc <NUM> further defines a plurality of openings 648c therethrough to permit passage of cables/wires <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>.

As illustrated in <FIG>, a cable path guide <NUM> is provided for directing cables <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> through the handle <NUM>. In particular, guide <NUM> provides a first set of guides <NUM> for guiding cables <NUM>, <NUM>, <NUM>, <NUM>, and a second set of guides, or bosses, <NUM>, <NUM> for directing cables <NUM>, <NUM> through the handle <NUM>. Grooves <NUM> are provided in guide <NUM> for receiving ribs 612r of right housing portion <NUM> (<FIG>).

<FIG> illustrate a cutaway view of handle <NUM> wherein right housing portion <NUM> has been removed to permit view of interior components of handle <NUM>. <FIG> illustrates trigger <NUM>, or actuator, in a locked position, whereas <FIG> illustrates trigger <NUM> in a released position wherein the trigger can be depressed, thus advancing needle (e.g., <NUM>) about needle track <NUM>. As illustrated in <FIG>, handle includes trigger <NUM>, pull cable/ribbon <NUM>, trigger spring capsule <NUM>, trigger return spring <NUM>, pull cable <NUM>, pulley <NUM> and brake handle <NUM> for preventing articulation knob <NUM> from being rotated. As stop surface <NUM> is defined in left housing <NUM> to define a stop point for trigger <NUM> when trigger <NUM> is locked. Right housing <NUM> includes a similar stop feature <NUM> (<FIG>). Articulation knob <NUM> (<FIG>) includes a handle portion <NUM>, an elongate shaft <NUM> for engaging with brake rotate fitting <NUM> (<FIG>), and a distal portion <NUM> that is preferably threaded for receiving a hex nut <NUM> (<FIG>). Right and left handle cap portions <NUM>, <NUM> (<FIG>) are provided with bosses 616a, 618a for receiving and supporting the edges 835b of brake springs <NUM> (<FIG>). Bearing portion 835a of brake springs <NUM> bear against brake rotate fittings <NUM>, which in turn urges brake rotate fittings <NUM> against shaft <NUM> of knob <NUM>. Portion <NUM> of knob <NUM> preferably includes a resilient layer or coating that can grip serrated portion <NUM> of fittings <NUM>, wherein rotation of the knob <NUM> causes the fittings <NUM>, and hence cables <NUM>, <NUM> to advance along a proximal-distal direction with respect to device <NUM>, resulting in articulation of suture head <NUM>, <NUM>'. <FIG> illustrates handle <NUM> with components <NUM>, <NUM>, <NUM> removed. <FIG> illustrate inner and outer views of left and right handle portions <NUM>, <NUM>. <FIG> illustrate the inner workings of handle <NUM> with both handle portions <NUM>, <NUM> removed with the trigger <NUM> locked, and released, respectively. <FIG> illustrates a close up view of the inner workings of handle <NUM>, showing the upper brake pad <NUM> removed, fully revealing the positioning of fittings <NUM> and springs <NUM> with the trigger <NUM> released. Also illustrated is knuckle pulley <NUM>, which is rotationally supported by knuckle pulley holder <NUM>, which in turn is biased by a guide spring <NUM> against bracket <NUM> to maintain tension on cables <NUM>, <NUM>. <FIG> further illustrate fittings <NUM>, spring <NUM> and spring <NUM>.

<FIG> illustrate the movement of shuttle <NUM> (<FIG>), which moves proximally upon the release of trigger <NUM>. Proximal movement of shuttle <NUM> prevents handle 892r from being articulated, which, in turn, prevents guides <NUM>, <NUM> from being withdrawn into suture head <NUM>, <NUM>' while trigger <NUM> is actuated, advancing the needle (e.g., <NUM>) about circular needle track <NUM>, <NUM>'. Components <NUM>, <NUM> have been removed in <FIG> to better illustrate lower brake pad <NUM>. Brake pads <NUM>, <NUM> are preferably made from resilient and somewhat compressible material, such as silicone. <FIG> further illustrates lower brake pad <NUM>, while <FIG> illustrate brake bracket <NUM>. Bracket <NUM> defines a circular boss <NUM> thereon for receiving lower brake pad <NUM>, as well as brake handle components <NUM>, <NUM>, 884a (<FIG>). <FIG> illustrate remaining inner workings of handle with brake pad removed (<FIG>) and further with pulley holder <NUM> and brake bracket <NUM> removed. <FIG> further illustrates coupling knuckle <NUM>, which includes longitudinal openings 872a having narrowed portions 872c that are wide enough to permit passage of a cable <NUM>, <NUM>, but not wide enough to permit passage of cable terminations <NUM> (<FIG>). Opening 872b, in contrast, is large enough to permit terminations <NUM> to pass into knuckle <NUM>, thus joining cable <NUM> to cable <NUM>, and providing a closed loop to facilitate articulation by way of articulation and brake control <NUM>. Brake trigger <NUM> can be pulled, causing a camming effect of by moving an upper portion of handle component <NUM> (and its counterpart on the left side of the device) into contact with lower brake pad <NUM>, causing the brake pad <NUM> to compress components <NUM> between the upper and lower brake pads <NUM>, <NUM>.

<FIG> illustrate aspects of the operation and control for the guides <NUM>, <NUM> as well as the locking mechanism for trigger <NUM>. Guides <NUM>, <NUM> are deployed or withdrawn by rotating handles <NUM>. Cables <NUM>-<NUM> are routed over guide <NUM>, which is held in place by housing components <NUM>, <NUM> 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 <NUM> where all four cables, <NUM>, <NUM>, <NUM>, <NUM> are held in place in openings 892b in handles <NUM> by tapered pins <NUM>. The other pair of cables is routed about guide <NUM> directly into handles <NUM>. Guide <NUM> (<FIG>) is a generally curved planar member having a plurality of cable guides 885a, wherein the cables <NUM>-<NUM> bear over its upper surface on their route to handles <NUM>. <FIG> illustrates guides <NUM> and <NUM> in situ in relation to other internal components of handle <NUM>. Guide <NUM> (<FIG>) include bosses 887a to be received by housing portions <NUM>, <NUM>, and grooves 887b defined by fins 887c for routing cables/wires. Handles <NUM> include grips 892a and grooves 892c and channels 892d for directing cables/wires into openings 892b (<FIG>). Both handles <NUM> can be essentially identical in form.

Guide handles <NUM> also play a role in releasing trigger lock <NUM>, thereby permitting trigger <NUM> to actuate the movement of needle (e.g., <NUM>). As illustrated in <FIG>, trigger lock <NUM> is attached to a cable at ferrule <NUM>, which is disposed in opening <NUM> at bifurcation <NUM> of trigger lock (<FIG>). Trigger lock <NUM> is slidably disposed on a cylindrical rail <NUM>, and is biased toward a locked position by spring <NUM>. A bifurcation <NUM> at the opposite end of trigger lock <NUM> is adapted and configured to interlock with trigger <NUM>. When the cable to which ferrule <NUM> is attached is advanced upwardly (<FIG>) by rotating handle <NUM>, bifurcation <NUM> of trigger lock <NUM> disengages from trigger <NUM>, permitting free movement of trigger. Handles <NUM>, 892R are pivotally disposed on axle <NUM> (<FIG>, <FIG>). <FIG> further illustrate additional features of the actuation system for guides <NUM>, <NUM> with progressively additional components removed to better illustrate other components, and their relative positions. <FIG> further illustrates additional aspects and views of components <NUM>, <NUM>, <NUM>.

<FIG> illustrate aspects of the operation of reciprocating trigger mechanism <NUM>. <FIG> illustrates the relative positions of trigger <NUM>, pull cable/ribbon <NUM>, trigger spring capsule <NUM>, trigger return spring <NUM>, pull cable <NUM> and pulley <NUM>. <FIG> removes components <NUM>, <NUM> and handle <NUM> to reveal ferrule <NUM>, which is fixed to a terminal end of pull cable <NUM> and resides within an opening <NUM> within handle <NUM> (<FIG>). Trigger <NUM> is further illustrated in <FIG> from two additional angles, showing bifurcated yoke <NUM> proximate the top end of trigger <NUM>. Yoke cap <NUM> is received in trigger handle <NUM> by securing studs 704a into holes 700a by interference fit and/or ultrasonic welding, adhesive or the like. Yoke <NUM> and yoke cap <NUM> define openings 702a, 704a therein for receiving bosses 888a of shuttle link <NUM> (<FIG>). <FIG> illustrates the interior of capsule <NUM>, revealing clutch spring <NUM>. <FIG> illustrate housing portion 720a, which mates with housing portion 720b. Housing portion 720b is an identical mirror image of portion 720a, so only 720a is illustrated. Clutch spring <NUM> is removed in <FIG>, clearly illustrating pull cable <NUM>, clutch spring ferrule <NUM> and clutch washer <NUM>. <FIG> illustrates the assembly with spring <NUM> and housing portion 720b removed. <FIG> illustrates a closeup of the connection of drive member <NUM> to assembly <NUM>, showing the manner in which tabs <NUM>, <NUM> at proximal end of drive member <NUM> are bent and inserted through the slot 721a in washer plate <NUM>. O-rings <NUM>, which may be silicone or other suitable material, are illustrated in <FIG> and <FIG>. O-rings <NUM> provide a seal against housing segments <NUM>, <NUM>. Ferrule <NUM> is secured to cable <NUM>. <FIG> provide closer views of ferrule <NUM>, washer plate <NUM> and proximal end of member <NUM>, respectively.

<FIG> further illustrate the connections between drive member <NUM> and drive members <NUM>/<NUM>. As illustrated in <FIG>, proximal drive member, which can include ribbon-element <NUM> described above attached to intermediate cable section <NUM> in intermediate region <NUM>, is received by a ferrule <NUM> which is affixed in place after termination <NUM> is attached, and positioned into cavity <NUM> in coupling by passing cable/rod <NUM> through slot <NUM> in coupling <NUM>. Rounded portion <NUM> of termination faces distally, permitting movement between member <NUM> and coupling <NUM>. As illustrated in <FIG>, termination <NUM> defines a passage <NUM> therethrough for receiving cable <NUM>, and defines a generally cylindrical proximal section <NUM>. Ferrule <NUM> defines a passage <NUM> therethrough for receiving cable <NUM>, and a transverse opening <NUM> therethrough, such as for receiving brazing or soldering material or other material for holding ferrule in place on cable <NUM>. Coupling <NUM> includes a proximal face 922a, a distal face <NUM> and a bore <NUM> therethrough. As illustrated in <FIG> in cooperation with <FIG>, threaded male fitting <NUM> is received within threaded opening <NUM> of coupling, and receives a retaining hex nut <NUM> thereon. Proximal end <NUM> of fitting <NUM> faces proximally, and defines a cavity <NUM> therein for receiving distal tip <NUM> of drive ribbon/cable <NUM>. Tip <NUM> is inserted into cavity <NUM> until stop <NUM> contacts proximal face <NUM>. Threads <NUM>, <NUM> are defined on fitting <NUM> and nut <NUM>. Components <NUM>, <NUM> may be coupled by any suitable means, including but not limited to interference fit and/or welding, soldering, brazing, adhesive and the like. <FIG> illustrate torsion spring <NUM> and guide spring <NUM> and their positioning with respect to the other components within handle <NUM>. Springs <NUM>, <NUM> are a part of the control mechanism for deploying and retracting guides <NUM>, <NUM>. Return spring <NUM>, <NUM> is illustrated in <FIG>.

An exemplary method of operation of suture head <NUM> is set forth in <FIG>. <FIG> illustrates a cutaway view of suture head <NUM> with needle <NUM> disposed therein in a delivery configuration with guides <NUM>, <NUM> retracted. Needle <NUM> is wholly contained within device <NUM>, and pawl spring 115b prevents needle <NUM> from moving in a counterclockwise direction. Similarly, pawl spring 115a is biased against the inner circumferential surface <NUM> of needle, tending to prevent needle from moving in a clockwise direction. As set forth in <FIG>, it is apparent from the instant disclosure that the drive system of the device <NUM> is adapted and configured to advance the needle <NUM> in multiple <NUM>° revolutions about the needle track when the needle track is in a deployed condition. It is further evident that the needle track is about <NUM>° in extent prior to deployment, and greater than <NUM>° in angular extent after deployment.

<FIG> illustrates the initial deployment of guides. Pawl 115a is dragged along surface <NUM> of needle <NUM> until it engages with notch <NUM> and pawl 115b engages with notch <NUM>. Guides are then fully retracted in <FIG>, and pawl 115a situated in guide <NUM> drags needle <NUM> in a clockwise direction to present it for suturing. Pawl <NUM> meanwhile is advanced along its arcuate track along guides <NUM>, <NUM> to its distalmost extent, causing notch <NUM> in the drive member <NUM> to align with boss 108a, and pawl 115b bears against surface <NUM> of needle <NUM>. When drive member <NUM> is then pulled proximally, notched region <NUM> of member <NUM> slips past bosses 106a, 108a and drive member <NUM> drops into lower passage defined in part by passage 108T. Further proximal movement of drive member <NUM> causes the distally located wider portion of ribbon <NUM> to bear against the underside of bosses 106a, 108a, and pawl <NUM> makes contact with the trailing end of the needle <NUM>, and needle is advanced about <NUM>°, as illustrated in <FIG>. The distal movement of pawl <NUM> is then repeated, such that pawl <NUM> engages with notch <NUM> in needle <NUM>. Region <NUM> slips past bosses 106a, 108a as before, and pawl <NUM> and the leading tip <NUM> of needle are pulled along the arcuate needle track <NUM>, resulting in the needle being returned to its starting point, as illustrated in <FIG>. <FIG> illustrates guides <NUM>, <NUM> in partial retraction such that needle is moved counterclockwise until notch <NUM> meets with pawl 115b. <FIG> illustrates guides <NUM>, <NUM> retracted even further, illustrating how pawl 115a is pulled out of notch <NUM> and is dragged along surface <NUM> of needle. further counterclockwise movement of needle <NUM> is prevented by pawl 115b being locked into notch <NUM>. <FIG> illustrates suture head <NUM> once again in delivery or removal configuration with guides <NUM>, <NUM> fully withdrawn. Thus, a device is provided herein that can rotate the disclosed needle through <NUM>°, <NUM>°, or any further multiple of <NUM>° as desired. If desired, the angular increments of advancement could be increments of more or less than <NUM>° as desired.

The suturing devices of the presently disclosed embodiments can be used for laparoscopic procedures, including but not limited to laparoscopic colostomy, colectomy, adrenalectomy, splenectomy, repair of paraesophageal hernia, inguinal hernia repair, ventral hernia repair, Nissen fundoplication, liver lobectomy, gastrectomy, small bowel resection, treatment of small bowel obstruction, distal pancreatectomy, nephrectomy and gastric bypass. Those skilled in the art will recognize that the presently disclosed embodiments can be used in other laparoscopic procedures.

In using the devices of the presently disclosed embodiments, the abdomen is insufflated with gas to create a working space for the user. Any gas known to those skilled in the art including, but not limited to, nitrogen or carbon dioxide, can be used. Access portals are established using trocars in locations to suit the particular surgical procedure. A variety of surgical instruments may then be inserted into the body through these access ports/cannulas. The user then introduces the distal end portion of the suturing device into a cannula, and then articulates the suture head assembly (e.g., <NUM>, <NUM>'). The suture head assembly is then positioned relative to the tissue/vessel to be sutured together, and the user preferably locks the suture head assembly in place. The user then, through manipulation of the suturing device, positions a plurality of separated tissue segments into the opening defined at the distal end portion of the suture head assembly. The user, using only one hand, may manipulate the device while actuating the handle to close an incision with a continuous suture whose stitches may be individually tensioned precisely and uniformly along the length of the suture similar to suturing done by hand in the conventional way. The user may employ a single suture which would extend the entire length of the incision or multiple sutures. Thus, by placement of the device spanning the incised tissue segments and actuating the handle, the suturing device enables the user to lay down a running stitch or interrupted stitch to close the tissue incision in a time efficient manner. Those skilled in the art will recognize that any conventional procedure for conducting laparoscopic surgery can be used with the device.

The minimalized structural design of the suture head assembly enables the user to have a clear, unobstructed view of the suturing needle during advancement through the tissue segments during the course of a suturing operation, thereby enabling precise placement of the suturing device to provide uniform sutures and precluding the risk of tearing tissue by placement too close to the edge of the incision. The suturing device is then advanced a short distance along the incision and the aforementioned operation is repeated to produce another stitch comprising the suturing material or thread.

The user may continue to manipulate the suturing device, alternately advancing and actuating rotation of the needle about an axis that is generally parallel to the direction of advancement to create a continuous suture which may extend through the entire length of the incision or a series of interrupted stitches. After each individual stitch is laid down, the stitch is tightened by exerting a pull on the suturing material or thread so that the resultant suture is tensioned uniformly along the length of the incised tissue segments. Therefore, a tight closure of the segments is accomplished and bleeding and tearing of tissue are minimized. Once the appropriate amount of suture material or thread <NUM> has been placed, the user can use a needle grasper to tighten and knot the formed stitches.

Claim 1:
A suturing device (<NUM>) comprising:
a housing;
a deployable needle track (<NUM>) defining an arcuate path, the deployable needle track being deployable from a delivery configuration wherein the deployable needle track is retracted into the housing to a deployed configuration wherein the deployable needle track extends outwardly from the housing; and
a drive configured to selectively engage with and disengage from an arcuate needle disposed in the deployable needle track to advance the arcuate needle along a first direction along the arcuate path of the deployable needle track,
wherein the drive is operable to advance the arcuate needle in multiple <NUM> degree revolutions along the deployable needle track (<NUM>) along the first direction when the deployable needle track (<NUM>) is in the deployed configuration.