CN107736903B - Apparatus and method for minimally invasive suturing - Google Patents

Abstract

The invention discloses devices and methods for minimally invasive suturing. A suturing apparatus for minimally invasive suturing includes a proximal portion, a distal end, and an intermediate region therebetween. The apparatus includes a suturing head assembly having a suturing needle with a pointed end and a second end. The suturing needle is rotatable about an axis approximately perpendicular to a longitudinal axis of the device, wherein a pointed end of the suturing needle is positioned in the suturing head assembly prior to deployment of a guide adapted and configured to guide the needle about a circular path as a drive mechanism advances, the drive mechanism having a needle driver for engaging and rotating the suturing needle.

Description

Apparatus and method for minimally invasive suturing

This application is a divisional application of patent application 201280038779.5 entitled "apparatus and method for minimally invasive suturing" filed on 8/2012.

Cross Reference to Related Applications

This application is a continuation-in-part application of and claims benefit of priority to U.S. patent application serial No. 12/909,606, filed on 21/10/2010 and published on 9/8/2011 as U.S. patent No. 7,993,354, which in turn claims benefit of priority to U.S. patent application serial No. 61/388,648, filed on 1/10/2010. The present application also relates to international application number PCT/US2009/006212 filed on 20/11/2009, which in turn claims priority from U.S. provisional application serial No. 61/200,180 filed on 25/11/2008. This application also relates to U.S. patent application serial No. 11/231,135 filed on 20.9.2005, which in turn claims the benefit of priority of U.S. provisional application serial No. 60/611,362 filed on 20.9.2004. The present patent application also relates to international application number PCT/US2008/06674, filed on 23/5/2008, which in turn claims priority to U.S. provisional application serial number 60/939,887, filed on 24/5/2007. This patent application also relates to U.S. patent application serial No. 12/175,442 filed on 17.7.2008. Each of the above applications is incorporated by reference herein in its entirety.

Technical Field

Embodiments disclosed herein relate to a medical device for suturing tissue, and more particularly, to a device for operating and controlling a suture needle during minimally invasive suturing, a method of manufacturing such a device, and a method of suturing tissue using such a device.

Background

Minimally Invasive Surgery (MIS) has allowed physicians to perform many surgical procedures with less pain and disability than conventional open procedures. Unlike conventional open surgery, which easily reaches the surgical site through a large incision, allowing the surgeon to easily view and manipulate tissue and instruments, MIS requires the surgeon to operate remotely by inserting and manipulating instruments through small perforations ("keyhole surgery") or through natural orifices, including, for example, the vagina, esophagus, or anus.

In MIS, small perforations are typically made in the human body. The medical device is then inserted through the cannula. The cannula has a small internal diameter, typically 5-10 millimeters (mm), and sometimes up to 20 millimeters (mm) or more. A large number of such cannulas may be inserted into the body for any given procedure. Minimally invasive surgical instruments must be smaller, and also generally longer, and thus more difficult to operate accurately.

In MIS, the perhaps most problematic surgical task is suturing. Suturing requires two-handed coordinated operation of small needles and sutures, which are difficult to observe, especially when only indirect two-dimensional video imaging is available, and a number of instruments conventionally used for manual suturing, including needle drivers and pick-up forceps. In environments characterized by limited space, limited visualization, and limited mobility, many surgeons find minimally invasive suturing by hand to be a very difficult, often nearly impossible, surgical task.

In the preferred method of manual suturing, a grasping forceps ("needle driver") is held by the surgeon and is used to grasp the curved needle at the needle tail. Pronation of the surgeon's wrist drives the needle into the tissue. When the tip of the curved needle emerges from the tissue, the surgeon releases the needle from the grip of the needle driver and grasps the tip using another forceps ("picker"). The surgeon then pulls the curved needle through the tip of the needle, preferably on a circular path along the arc of curvature of the needle, to follow the most atraumatic path through the tissue until the entire length of the needle has exited the tissue. The curved needle is driven around a complete circular arc each time a stitch is set. Individual (interrupted) stitches are placed by tying a knot to the suture after placement along each stitch. Successive (continuous) stitches may be placed by repeatedly driving the curved needle in a complete circular arc until the desired length of suture and the desired number of stitches have been placed. To place additional interrupted or sustained stitches, the surgeon must release the tip of the needle and re-grasp the needle near the needle tail.

In the manual suturing techniques described above, direct manipulation of the needle may result in the needle accidentally penetrating the surgeon's or nurse's gloves, causing a possible risk of infection to the surgeon, nurse, staff and patient, or contamination of the needle with pathogenic bacteria, which may cause infection at the suture site. There is also a risk that the needle will puncture an internal organ or blood vessel and cause a serious and often fatal infection.

U.S. patent application No. 5,643,295 entitled "Methods and Apparatus for organizing Tissue", U.S. patent No. 5,665,096 entitled "Needle Driving Apparatus and Methods of organizing Tissue", U.S. patent No. 5,665,109 entitled "Methods and Apparatus for organizing Tissue", U.S. patent No. 5,759,188 entitled "organizing instruments with robust Mounted Needle Driver and Catcher", U.S. patent No. 5,860,992 entitled "Endoscopic organizing Devices and Methods", U.S. patent No. 5,954,733 entitled "Endoscopic instruments with robust Mounted Needle Driver and Catcher", U.S. patent No. 6,719,763 entitled "Endoscopic Devices and Methods", U.S. patent No. 3683 entitled "Endoscopic Devices with robust Mounted Needle Driver and Catcher", and U.S. patent No. 6,755,843 entitled "Endoscopic Devices 6,719,763", all of which are incorporated herein by reference in their entirety.

Assignee's U.S. Pat. No. 5,437,681, U.S. Pat. No. 5,540,705, and U.S. Pat. No. 6,923,819, the disclosures of which are incorporated herein by reference, disclose a suturing apparatus with thread management that includes a protective cartridge, a suturing needle, and a needle rotation drive. The devices described in the above patents and patent applications include a mechanism for driving the protected needle, however the needle rotates about an axis parallel to the device axis. Furthermore, the orientation and size of the suturing device makes it difficult to view and inconvenient for use with MIS.

Thus, there remains a need in the art for a minimally invasive suturing device that is easy to operate in small diameter cannulas, functions in environments characterized by limited space, limited visualization, and limited mobility; simulating a preferred suturing method used by the surgeon; allowing the surgeon to fix and knot quickly and with controlled tension; arranging continuous stitches; and to avoid accidental needle sticks by the user during needle handling, as well as to avoid inadvertent needle sticks of internal organs and blood vessels.

Disclosure of Invention

Disclosed herein are devices and methods for minimally invasive suturing of tissue within the human body.

According to aspects described herein, a medical device for closing an opening in the interior of a patient's body is provided that closely mimics or replicates a manual suturing operation performed by a surgeon. In minimally invasive surgery, the present apparatus provides a number of advantages over conventional methods used by surgeons in that it provides a hand-held stapling instrument that does not require an external power source. The embodiments disclosed herein provide the surgeon with ease of use of a single hand.

According to aspects described herein, the stapling head assembly may be removably coupled to an actuation mechanism of a stapling apparatus. The diameter of the device is small enough to fit within a 5mm cannula in some embodiments, thus making the device extremely easy to manipulate and suture in endoscopic or other MIS procedures. During surgery, it is desirable to form as few incisions as possible, and for those incisions to be as small as possible. Thus, a device with a small profile is very advantageous. Likewise, the suturing head assembly of the device, once inside the cannula, may be laterally hinged to the central left, right, upper and lower portions, which is ideal for use in endoscopic procedures, including laparoscopic, thoracoscopic and arthroscopic, as well as other minimally invasive procedures.

The apparatus of the embodiments disclosed herein closely mimics or replicates a manual stapling operation performed by a surgeon. For example, during manual suturing by hand, the needle is fixed in the forceps and travels in a circular arc without obstruction within the circular arc. The design of the suturing device of the embodiments disclosed herein allows for no obstruction of the center of the arc during suturing. In other words, there is no hub in the center of the circular arc of the needle. The entire area within the circular arc of the needle is unobstructed. This allows the user to better view during the procedure while maintaining control over needle movement, unlike existing mechanical suturing methods.

The suturing apparatus of the embodiments disclosed herein provides an advantage in that the apparatus allows manipulation of suture material through a tissue incision in a manner substantially similar to that performed by a surgeon using a hand. Specifically, some embodiments of the suturing apparatus first push the suturing needle from the needle tail and drive the needle tip through the tissue. Subsequently, the device picks up the needle tip that passes through the tissue and pulls the remainder of the suture needle and the suture attached to the suture needle through the tissue. The suturing needle thus always follows an arc that follows the curve of the needle itself in a manner that minimizes trauma to the tissue through which the needle passes, which is the preferred method of suturing. An advantage of the suturing apparatus of the embodiments disclosed herein is that the suture needle pulls the suture completely through the tissue portion being closed along each stitch. When using the suturing apparatus of the embodiments disclosed herein, no auxiliary instruments or tools, such as needle holders, pick-up forceps, etc., are required to complete the suturing. Pliers or grasping instruments may be used to tighten the knot.

According to aspects described herein, embodiments of a suturing apparatus are provided that include a suture needle protected by a housing that is not exposed to or directly operated by a user, thereby preventing accidental needle sticks. The configuration of the suturing apparatus of the embodiments disclosed herein also prevents the needle from accidentally puncturing an internal organ or blood vessel because the housing acts as a shield between the organ and the needle.

In one embodiment, the suturing apparatus is equipped with a suturing head. The suturing head includes a housing defining at least one passage therein and an expandable needle track. A deployable needle track is disposed in the housing and is adapted and configured to deploy or extend from a stored or collapsed state in which the needle track is substantially disposed in the housing to an extended or deployed state in which the needle track extends outwardly from the housing to form a curved needle track. The device also includes an arcuate or annular needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally annular body. The device further includes a driver for advancing the needle about a 360 path around the needle track when the deployable needle track is in the deployed state. The driver is adapted and configured to advance the needle in a plurality of 360 ° rotations about the needle track when the deployable or expandable needle track is in the deployed or expanded state without removing the needle from the needle track. The driver is selectively engaged and disengaged with the needle to advance the needle about a 360 ° rotation.

According to other aspects, the housing of the suturing apparatus can be generally cylindrical and have an outer diameter of about 5.0 mm. The diameter of the circular path of the needle track is about 10 mm. The needle may have a non-circular cross-section if desired. Preferably, the device further comprises means for deploying the needle track from the stored state to the deployed state. When the needle track is deployed, the needle track may occupy approximately 270 of a 360 needle path. However, it should be understood that the present disclosure relates to a device having a deployable or angularly expandable needle track that can be expanded to a final extent of greater than or less than 270 °, such as in increments of 1 degree. For example, a needle track may be provided that extends from about 180 ° to about 190 °, about 200 °, about 210 °, about 220 °, about 230 °, about 240 °, about 250 °, about 260 °, about 270 °, about 280 °, about 290 °, about 300 °, about 310 °, about 320 °, or about 300 °, etc. For example, depending on the diameter of the device and the size of the needle track, it may only be necessary to have rails that increase the angle of the needle track by about 10 °, about 20 °, about 30 °, about 40 °, about 50 °, about 60 °, about 70 °, about 80 °, about 90 °, about 100 °, about 110 °, about 120 °, about 130 °, about 140 °, about 150 °, or about 160 ° from the undeployed (unstretched) configuration to the deployed (stretched) configuration. The driver may comprise an elongate resilient member which reciprocates along the longitudinal axis of the device. The driver may engage the needle or advance the needle along the needle track as the elongate resilient member is advanced proximally with respect to the housing. The needle may include first and second notches along an inner surface of the needle for engaging an anti-rotation mechanism disposed on at least one of the housing and the deployable needle track. The needle may further comprise a notch on a top surface of the needle for engaging a portion of the driver, wherein the notch on the top surface of the needle intersects one of the notches disposed on the inner surface of the needle.

According to a preferred embodiment, the deployable needle track includes at least one arcuate rail adapted to deploy from the housing along an arcuate path. Preferably, the deployable needle track includes a pair of arcuate rails adapted to deploy from the housing along an arcuate path. Preferably, the pair of arcuate rails are deployed from the housing along an arcuate path by pulling a first pair of pull wires, one pull wire attached to each rail. The pair of rails is preferably further adapted and configured to be retracted into the housing by pulling a second pair of pull wires, wherein one pull wire of the second pair of pull wires is attached to each rail. The first pair of pull wires is preferably connected to the second pair of pull wires to form a pair of continuous mechanical circuits, wherein the circuits are connected at a distal end to the rail and at a proximal end to a pair of handles, wherein movement of the handles causes movement of the rail.

The present invention 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 diameter region of the needle, and the arcuate body further defines a second notch having a projection that lies within a plane defined by a curved central axis of the needle, and wherein the first notch and the second notch intersect. The needle may also include a generally square cross-section, if desired. The needle body may include a portion having a circular cross-section separating a main portion of the needle having a generally square cross-section from a tail portion having a generally square cross-section. The needle near its trailing end may also define a third notch in the needle for receiving a portion of the drive pawl. Further, the needle may define an arcuate ridge along its length to stabilize movement of the needle in the suturing apparatus.

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

According to yet another aspect, a suturing apparatus 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 connecting the proximal and distal ends. The head further includes a deployable needle track disposed at least partially within the housing, the needle track adapted and configured to deploy from a stored state in which the needle track is disposed substantially within the housing and has an angular extent of about 180 ° to a deployed state in which the needle track has an angular extent of greater than 180 ° and extends outwardly from a peripheral side of the housing to form an arcuate needle track lying in a plane parallel to a longitudinal axis of the housing. Preferably, the needle track is angularly extendable along an annular path defining a path of needle travel, such that the track angularly extends around the annular path from a retracted condition to an extended condition. The suturing head also includes an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally annular body. The suturing head further includes a driver for advancing the needle in a plurality of 360 ° rotations about the needle track when the deployable needle track is in the deployed state, wherein the driver selectively engages and disengages the needle to advance the needle about the 360 ° rotations.

According to another aspect, the housing is generally cylindrical and has a diameter of about 5.0mm, and the path of the needle track is about 10mm in diameter. However, it should be appreciated that the diameter may be larger or smaller, as desired. The needle may have a substantially circular cross-section, a non-circular cross-section, a square or triangular cross-section, or the cross-section of the needle varies along its length to transition from one shape to another, such as from square to circular to square. The device preferably further comprises means for deploying the needle track from the stored state to the deployed state. When the needle track is deployed, the needle track preferably occupies about 270 ° of the 360 ° needle path, while the angular extent of the needle track may be greater or less than 270 °, for example in 1 degree increments, as desired.

According to another aspect, the driver preferably comprises an elongate resilient member that reciprocates along the longitudinal axis of the device. The driver preferably engages the needle and advances the needle along the needle track as the elongate resilient member is advanced proximally with respect to the housing. The deployable needle track preferably includes at least one arcuate track adapted to deploy from the housing along an arcuate path. Preferably, the deployable needle track includes a pair of arcuate rails adapted to deploy from the housing along an arcuate path. Preferably, the pair of arcuate rails are deployed from the housing along an arcuate path by pulling a first pair of pull wires, one pull wire attached to each rail. The pair of arcuate rails is preferably further adapted and configured to be retracted into the housing by pulling a second pair of pull wires, wherein one pull wire of the second pair of pull wires is attached to each rail. The first pair of pull wires is preferably connected to the second pair of pull wires to form a pair of continuous mechanical circuits, wherein the circuits are connected at a distal end to the rail and at a proximal end to a pair of handles, wherein movement of the handles causes movement of the rail.

In another embodiment, the suturing apparatus is equipped with a suturing head. The suturing head includes an elongated housing having a proximal end, a distal end, and a peripheral side connecting 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 deploy along an arcuate path from a undeployed state, wherein the needle track has an arcuate area of about 180 degrees and is disposed substantially within the housing, to a deployed state, wherein the needle track has an arcuate area exceeding 180 degrees, and wherein the needle track lies in a plane parallel to a longitudinal axis of the housing. The suturing head also includes an arcuate needle disposed in the deployable needle track, the needle having a first end, a second end, and a generally annular body. The suturing head further includes a driver for advancing the needle in a plurality of 360 ° rotations about the needle track when the deployable needle track is in the deployed state, wherein the driver selectively engages and disengages the needle to advance the needle about the 360 ° rotations.

According to yet another aspect, the housing may be generally cylindrical or rectilinear, as desired. The deployable or expandable needle track can include one or more arcuate rails adapted to deploy from the housing along an arcuate path. The deployable or expandable needle track may include a pair of arcuate rails adapted to deploy from the housing along an arcuate path. Thus, by pulling the first pair of pull wires, the pair of arcuate rails may be unwound from the housing along an arcuate path, with one pull wire attached to each rail. In one embodiment, the deployable or expandable needle track occupies about 270 ° of the 360 ° needle path when the needle track is in the expanded state, and the angular extent of the needle track may be greater or less than 270 °, for example in 1 degree increments, as desired.

These and other advantages of embodiments of the present invention are illustrated by the embodiments described below. Embodiments of the invention accordingly include the features of construction, combination of elements, and arrangement of parts which will be exemplified in the detailed description hereinafter.

Drawings

Embodiments of the present disclosure will be further explained with reference to the drawings, wherein like reference numerals refer to like structures throughout the several views. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of embodiments of the invention, wherein:

figures 1-3 generally illustrate a suturing apparatus made in accordance with the present invention.

Fig. 4-32 and 47(a) -47(D) show aspects of a first embodiment of a suturing head of a suturing apparatus made in accordance with the present invention.

Fig. 33-37 show aspects of an embodiment of a needle loader made in accordance with the present invention.

FIGS. 38-40 show aspects of a first embodiment of a suturing needle made in accordance with the present invention.

FIGS. 41-44 illustrate aspects of a second embodiment of a suturing needle made in accordance with the present invention.

FIG. 45 shows aspects of a third embodiment of a suturing needle made in accordance with the present invention.

FIG. 46 shows aspects of a fourth embodiment of a suturing needle made in accordance with the present invention.

FIGS. 47(E) -55 show aspects of a second embodiment of a suturing head of a suturing apparatus made in accordance with the present invention.

FIGS. 56-59 illustrate aspects of a middle region of the suturing apparatus shown in FIGS. 1-3.

FIGS. 60-122 illustrate aspects of a handle portion of the suturing apparatus shown in FIGS. 1-3.

Fig. 123-131 illustrate the operation of the suturing head of fig. 4-32 and 47(a) -47 (D).

While the drawings illustrate embodiments of the invention, other embodiments are also contemplated, as noted herein. The present invention is shown by way of illustration, and not limitation, of exemplary embodiments. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of this invention.

Detailed Description

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

Broadly speaking, the features of embodiments of the suturing apparatus provided by the present invention allow the apparatus to be constructed with smaller dimensions and with a smaller profile than embodiments discussed in the prior art and in the patent applications incorporated herein by reference. Specifically, embodiments formed in accordance with the present invention have been constructed that are adapted and configured to fit through a 5mm trocar. Advantageously, embodiments of the present invention still use relatively large suture needles, thereby allowing substantial capture of tissue during surgery, resulting in an effective suture.

For purposes of illustration and not limitation, as embodied herein, an exemplary embodiment of a suturing apparatus 1000 is shown in fig. 1. Device 1000 includes three regions, including suturing head 100, intermediate region 500, and handle 600. Each of these regions will be discussed in detail below. Fig. 2-3 show the device 1000 with portions removed. Specifically, fig. 2 shows the device 1000 with a needle loader (discussed further below) removed, while fig. 3 shows the device 1000 with certain portions of the handle housing removed.

For purposes of illustration and not limitation, suturing head 100 is shown in fig. 4 separated from the remainder of apparatus 1000. Suturing head 100 includes a proximal end 102, a distal end 104, and is formed by three main housing components (106, 108, 112) that cooperate together to define a gap 110 for receiving patient tissue to be sutured together. Suturing head 100 is adapted and configured to guide a semi-circular needle (300, 350, 400) around the semi-circular track and across gap 110 to form a series of sutures through the tissue to be sutured.

Before advancing the needle across gap 110, suturing head 100 must be converted from the delivery configuration to the deployed configuration. As shown in FIGS. 4 and 5, suturing head 100 is initially provided with a predetermined transverse dimension or diameter

In a compact form. The transverse dimension

May be of any desired size and is preferably about 5 mm. In particular, the size is preferably selected

Such that, for example, during laparoscopic surgery, the suturing head 100 may be passed through a standard 5mm trocar (trocar) into the patient's abdominal cavity. Fig. 5 shows suturing head 100 at an opposite angle as compared to fig. 4, including pivot boss 114, which pivot boss 114 mates with intermediate portion 500 of device 1000.

Suturing head 100 is shown in an expanded configuration in fig. 6. As shown in fig. 6, in the deployed configuration, the proximal and distal rails 120, 130 are moved outwardly from their nested positions, which are defined by the housing members 106, 108, which will be discussed in greater detail below. When deployed as in fig. 6, the guide rails 120, 130 define an annular needle path or needle track 140 that lies in a plane P parallel to the longitudinal axis X of the device 1000. Further, as shown, the forward tip 302 of the needle 300 is pushed slightly forward by dragging with the pawl 125 on the proximal rail 120 engaging a notch 306 provided along the inner surface of the needle 300, as discussed in detail below.

After the rails 120, 130 are in the deployed state and the needle track 140 is defined, the needle 300 may be advanced by advancing the pawl 160 distally along its reciprocating path. Fig. 7 shows the needle 300 spanning the gap 110, with the needle 300 having an arc of about 180 ° located substantially outside of the enclosure defined by the housing sections 106, 108, 112.

Fig. 8-10 illustrate the function of suturing head 110 from the opposite side of the suturing head. Fig. 8 shows suturing head 100 in a delivery configuration with guide rails 120, 130 retracted. As can be seen, the engagement pawl 160 is withdrawn to a proximal position on the needle 300, with the trailing end 304 of the needle 300 visible. Fig. 9 shows the suturing head in an expanded configuration with the rails 120, 130 expanded. As can be seen in fig. 9, the distal guide track 130 defines an arcuate recess 135 that receives the pawl 160 at its reciprocating distal end, as best seen in fig. 10. As is apparent from fig. 10, the notch 158 in the drive member 150 advances in the distal direction as does the pawl 160.

Fig. 11(a) -1l (d) show the structure of the engaging pawl 160. Pawl 160 includes a housing 166 that is attached (e.g., welded) to distal end 154 of drive member 150. The housing 166 is preferably a metal tubular structure and houses a detent spring 164 biased between a movable pin 168 and the cap portion 162. The cap 162 is preferably connected to the housing 166, such as by welding.

Fig. 12 shows suturing head 100 with cover portion 106 removed, revealing the reciprocating rail path along which drive member 150 and pawl 160 follow, as well as rails 120, 130. The rails 120, 130 are advanced from the delivery configuration to the deployed configuration by guiding four pusher wires, cables or wires 172, 174, 176, 178 around a series of bosses in the housing portion 106. Specifically, each guide rail 120, 130 includes a curl 120a, 120b, 130a, 130b that integrally forms an end of each guide rail 120, 130. Each crimp includes a channel formed therein for receiving the ends of the wires 172 and 178. The lines 172- "178 may take any suitable form, most preferably a multi-strand 300 series stainless steel cable of diameter.009". These ends are then crimped, glued or otherwise connected to the crimp. The rails 120, 130 are then pulled into or out of the stapling head 100 by applying tension to one wire of each pair connected to each rail.

Fig. 13 shows the rails 120, 130 in the deployed state, and for simplicity, lines 172 and 178 are not shown. Fig. 14 shows a drive member 150 having a pawl 160 at its most distal end of travel, the drive member 150 riding within a groove 135 on the side of rail 130. The height 130e of the wall 130d may be increased and may be thickened to conform to the groove 135 to provide an enhanced bearing surface for the pawl 160. Stops (not shown) are preferably provided in the form of raised surfaces on the rails 120, 130 and housing components to help prevent the rails 120, 130 from disengaging from the stapling head.

It is also apparent that the groove 125 on the side of the rail 120 becomes a passage into which the pawl can enter when the rail is in the deployed state. As shown in fig. 14, the rail 150 spans an arcuate path along the rail and follows a path with the needle. Fig. 15 shows the spatial relationship of the drive member 150 to the needle with other device components removed. FIG. 16 shows the relative position of the needle 300 with respect to the anti-rotation spring 115 and the drive pin 168 housed in the pawl 160. Fig. 17 shows the drive pin 168 in detail, wherein the pin 168 comprises: a distal face 168a of the body of the contact pin; a circumferential generally cylindrical face 168b, the distal end of which contacts a recess surface in the needle 100 or the distal end 304 of the needle; a proximal end face 168d of the contact pawl spring 164; an enlarged head portion 168 c; and a circumferential distal face 168e that contacts a narrowed portion of housing 166 of pawl 160 to prevent pin 168 from sliding off of housing 166.

Fig. 18-21 are additional views of suturing head 100 showing the progressive removal of parts. Fig. 18 shows the completed suturing head 100, while fig. 19-20 show the positioning of bosses 106a, 106b, 106c on the housing portion 106, which define support points for guide cables 172, 174, 176, 178 (not shown). Spacers 106d may also be provided to maintain a desired distance between the respective housing components 106, 108 to allow movement of the components within the suturing head 100, and the spacers 106d may also act as bearing surfaces for the wires 176, 178 (fig. 29). Fig. 20-21 show the removal guard 109 providing an internal support means against which the rails 120, 130 bear. The rails 120, 130 ride in arcuate channels defined by the cooperative cooperation of the components 106, 108 and 109.

Fig. 22 shows the proximal rail 120 and the distal rail 130 in the same spatial relationship as in fig. 21. A view of the proximal rail 120 is shown in fig. 23(a) -23 (B). The rails 120, 130 are preferably made of a metallic material by assembly, such as by laser welding, a series of metallic sub-components, and once assembled form a unitary body. The guide rails may be considered to have a "top" face facing the drive member 150 and a "bottom" face facing the housing portion 108. The proximal rail 120 defines a curved channel 125 in its top surface 122. Proximal rail 120 further defines a lower face 124 having a recess 124b defined therein, an inner face 126 bearing against an inner surface of guard 109, and an outer face 128 bearing against housing components 106, 108. As shown in fig. 24(a) -24(B), distal guide rail 130 defines a curved channel 135 in top surface 132 for guiding pawl 160. The distal rail 130 further defines a lower face 134 defining a recess 134b therein, an inner face 136 that bears against the inner surface of the guard 109, and an outer face 138 that bears against the housing components 106, 108.

Fig. 25-32 illustrate the cooperation between the wire/ filament 172 and 178 and the rails 120, 130. As shown in these figures, the wires 172, 174, 176, and 178 cooperate with the bosses 106a, 106b, 106c and other components of the suturing head 100 to allow for selective advancement and retraction of the rails 120, 130. The wire 178 terminates in the curl 130b of the guide rail 130. Tension is applied to wire 178 wrapped around boss 106a (fig. 28) to advance guide rail 120 out of suturing head 100. In contrast, tension is applied to the thread 176 terminating in the crimp 130a of the guide 130 (fig. 30), causing the guide 130 to retract into the stapling head 100. Similarly, tension is applied to the wire 172 wrapped around the boss 106c and connected to the rail 120 at the curl 120b, causing the rail 120 to be advanced out of the suture head, while tension is applied to the wire 174 wrapped around the boss 106c in a direction opposite the wire 172, pulling the connection point at the curl 120a, causing the rail 120 to be withdrawn into the housing.

Fig. 33-37 illustrate an embodiment of a needle loader 180 configured for loading a suture needle (300, 350, 400) into a suture head 100. Needle loader 180 has two main components, including a body portion 182 and a pusher portion 184. The pin 184a of the pusher portion is received in the opening 182a of the body portion 182. The body portion 182 defines a recess 182f for receiving a suture needle (300, 350, 400). Body portion 182 includes a central portion 182d and clamping portions 182c, 182e mounted on suturing head 100. If desired, clamping portions 182c, 182e can be adapted to snap onto suturing head 100. Distal stop plate 182b is provided to facilitate axial alignment of loader 180 and stapling head 100. The advancing portion 184 rotates in the opening 182a of the body portion 182 and also includes a needle advancing arm 186. In operation, the needle is positioned in needle track 184f with suture material attached to the trailing end, as discussed herein. The cartridge 180 is then snapped onto the stapling head. Preferably, the arm 186 is now near the trailing end of the needle. Subsequently, the arm 186 is rotated, thereby pushing the needle (300, 350, 400) into the needle track 140. If desired, the needles (300, 350, 400) may be pushed back into the needle loader 180 as the arms 186 are sized to pass through the recesses 124b, 134b of the distal and proximal rails 130, 120, respectively.

FIGS. 38-40 illustrate a first embodiment of a suture needle 300. Needle 300 includes an arcuate body defined by a leading tip 302, a trailing end 304, and a generally annular surface 305. Needle 300 includes a plurality of notches 306, 308, 310 formed therein, and an opening 312 in trailing end 304 for receiving an end of a length of suture material 312 a. Notches 306, 308 are located on an inner diameter region 322 of the needle, while notch 310 has a convex portion located within a plane P 'defined by the central bending axis X' of the needle. Notch 310 includes a first portion 310a substantially perpendicular to plane P 'and a portion 310b substantially within plane P', and an angled portion 310 c. The recesses 306, 308 have a convex portion substantially perpendicular to the plane P'. The first portions 306a, 308a of the notches 308, 306 are substantially parallel to the cross-section of the needle at that location, while the angled portions 306b, 308b are angled (such as 60 degrees) with respect to the portions 306a, 308 a. Notches 308, 310 intersect to facilitate the function of the particular embodiments of suturing heads 100, 100' described herein.

FIGS. 41-44 illustrate a second embodiment of a suture needle 350. Needle 350 includes an arcuate body defined by a leading tip 352, a trailing end 354, and a generally annular surface 355. The needle 350 includes a plurality of notches 356, 358, 360 formed therein, and an opening 362 in the trailing end 354 for receiving an end of the length of suture material. The recesses 356, 358 are located on an inner diameter region 372 of the needle, while the recess 360 has a convex portion located within a plane P 'defined by the curved central axis X' of the needle. The recess 360 includes a first portion 360a substantially perpendicular to the plane P 'and a portion 360b substantially within the plane P', and an inclined portion 360 c. The recesses 356, 358 have projections that are substantially perpendicular to the plane P'. The first portions 356a, 358a of the recesses 358, 356 are substantially parallel to the cross-section of the needle at that location, while the inclined portions 356b, 358b are angled (such as 60 degrees) with respect to the portions 356a, 358 a. Notches 358, 360 intersect to facilitate the function of the particular embodiment of suturing head 100, 100' described herein. The needle 350 also includes a substantially square cross-section having a circular portion 366 and a tail portion 364, which also has a circular cross-section. In other words, the needle body includes a portion having a circular cross-section 366 that separates a main portion of the needle having a substantially square cross-section from a tail portion 364 having a substantially square cross-section. It is believed that the use of a needle having a square cross-section helps the needle 350 to span the gap 110 of the suturing head and re-enter the suturing head with better alignment than the needle 300.

FIG. 45 shows a third embodiment of a suture needle 400. Needle 400 includes an arcuate body defined by a leading tip 402, a trailing end 404, and a generally annular surface 405. The needle 400 includes a plurality of notches 406, 408, 410 formed therein, and an opening 412 in the trailing end 404 for receiving an end of the length of suture material. The notches 406, 408 are located on the inner diameter region 422 of the needle, while the notch 410 has a convex portion located within a plane P 'defined by the curved central axis X' of the needle. The notches 406, 408, 410 are substantially similar to those described with respect to the needle 300. The primary difference between the needles 300, 400 is the addition of an additional notch 415 cut into the needle near its trailing end 404. Recess 415 has a projection in plane P' and is shaped to receive housing 166 of pawl 160. It is believed that the use of a needle having notches 415 facilitates needle 400 spanning gap 110 of the suturing head and re-entering the suturing head with better alignment than needle 300.

FIG. 46 shows a fourth embodiment of a suturing needle 450. Needle 450 is substantially the same as needle 300 except that it further includes an arcuate ridge 475 or convex surface along its length. Ridge 475 is adapted and configured to ride in grooves 124b, 134b of guides 120, 130 to stabilize needle 450 as needle 450 crosses gap 110 of the suturing head and reenters the suturing head with better alignment (as compared to needle 300).

Fig. 47(F) -55 illustrate aspects of an alternative embodiment of a suturing head 100' made in accordance with the present invention. The primary difference between suturing head 100 and suturing head 100' is the path of travel of drive element 150.

Embodiment of suturing head 100 includes a drive member 150 defining a narrow or notched area 158, as shown, for example, in fig. 12. In operation, notch region 158 is positioned to coincide with bosses 106W, 108W (fig. 47(a) -47(D)) when pawl 160 is at the distal end of its range of movement within groove 135 of distal end rail 130. When in this position, drive member 150 extends into recess 125 of proximal rail 120 (fig. 14). However, once tension is applied to cause pawl 160 (and needle 300) to follow the needle track proximally, narrow region 158 of drive member 150 slides over bosses 106W, 108W so that when moved proximally, pawl 160 will travel past the lower shelf of channel 106T until it passes boss 106W and emerges from the channel in preparation for the start of another cycle. In other words, the bosses 106W, 108W form a channel therebetween that allows the narrow region 158 to slide through, but the remainder of the member 150 or the pawl 160 cannot slide through. Thus, the narrow region 158 allows the drive member 150 to travel along an upward path on the bosses 106W, 108W as it advances distally, and to slide beyond the bosses 106W, 108W as the region 158 aligns with the bosses, thus allowing the drive member 150 and the pawl 160 to move proximally along a downward path under the bosses 106W, 108W. The housing portion 112 is shown in fig. 47 (E).

Thus, it should be appreciated that the drive member 150 should ideally be metallic. Preferably, the component 150 is made of hardened stainless steel (which has been heat treated to HR900) and may have a chromium coating, such as may be selected from ME-

Armoloy commercially available as Illinois,118 Simmonds Avenue, DeKalb, IL60115, (815)758-

Preferably, the component 150 is 17-7PH stainless steel, with a state of "C", hardened to a condition CH900, and then clad with

And (4) coating. Preferably, ME is applied after 900 heat treatments

And (4) coating. The sequence of operations for manufacturing the component 150 includes providing a stock material in the 17-7PH strip form that is machined to the appropriate dimensions by any number of known methods, such as electrical discharge machining ("EDM"), shearing, edging, etc. The drive belt is heat treated, then cleaned to remove heat treated surface oxides, and then ME is applied

And (4) coating. As another example, a material with a pH of 17-7 and an "A" state can be heat treated to RH 950. In other embodiments, for exampleSuch as may be represented by the trade name

Or the like, may be used to form drive member 150. In another embodiment, the member 150 is made of a polymeric material. In one aspect, the member 150 may comprise a high strength polyethylene terephthalate material or a nylon material. Laminates of plastic and metal materials or multiple materials may be used if desired. As another example, member 150 may comprise a bundle of wires or filaments, a single wire or filament, or any material having any configuration that allows for driving a needle around a needle track.

The other components of suturing head 100, including the needle (300, etc.), are preferably formed by metal injection molding ("MIM") techniques, as are known in the art, using various materials, preferably stainless steel. According to a preferred embodiment, stainless steel alloys of the 17-4PH type are preferably used. The device 1000 is preferably a disposable device, while the handle member is preferably made of injection molded plastic where desired.

Yet another embodiment of a suturing head 100' is shown in fig. 47(F) -55. The primary difference between suturing head 100 'and suturing head 100 is that the drive member 150 of suturing head 100' follows a single path during reciprocation, as compared to the alternating path of embodiment 100. Fig. 47(F) shows suturing head 100 ' including needle 300 with rails 120 ', 130 ' in a deployed configuration. The rails 120 ', 130' are shown only partially and are not shown with a crimp at their ends for mating with a deployment or retraction cable as in the earlier discussed embodiment 100. Suturing head 100 'defines a guide path 153' between housing components 106 ', 112' (fig. 48), similar to the manner in which suturing head 100 defines a guide path between housing components 106 and 112 (fig. 21). Fig. 48 also shows an alternate path 1001 that can be traversed by drive member 150 'by modifying members 106', 112 'by removing material 112 a' that acts as a detent stop and adding material 106 'b in member 106' to act as a new detent stop. The end result is that the drive member 150 enters at a different angle.

Fig. 49 shows the "left" housing part 108' from different angles, while fig. 50(a) -50(E) show the "right" housing part from different angles. As is evident from the figure, the path 153 ' followed by the drive member 150 ' and the pawl 160 ' (not shown). It will be appreciated that the drive member 150 ' and pawl 160 ' may be substantially identical to the embodiments 150, 160, but need not have a notched region 158, as the single path for the pawl 160 ' to traverse is collectively defined by the housing members 106 ', 108 '. Guard 109 'is shown in fig. 51(a) -51(B) and illustrates the position of pawl 115' which helps prevent needle (e.g., 300) from moving against the desired direction of travel. For illustrative purposes only, fig. 52 shows the spatial relationship of the rails 120 ', 130' in two different positions with respect to the pin surface 168a 'and the pawl 160'. Fig. 53(a) -53(D) show various views of housing portion 112'. Fig. 54-55 illustrate the spatial orientation of the rails 120 ', 130' (substantially identical to the rails 120, 130) with respect to the pawl 115 ', and also illustrate the rail stops 117' that help the rails 120 ', 130' to stop at a predetermined position in the undeployed state.

Fig. 56-59 illustrate aspects of the middle region 500 of the device 1000. The intermediate region 500 includes an elongated, preferably metallic tube 510 having a proximal end and a distal end 514. The distal end 514 of the tube 510 is connected to a knuckle assembly 520, which knuckle assembly 520 is in turn pivotably connected to the stapling head 110 at pivot 114. Pulley 515 is located at pivot 114 to act as a bearing surface for the engaged hinge connection cables 532, 534, and cables 532, 534 are preferably connected to pulley 515 to provide leverage for effecting the hinge connection. The hinged cables 532, 534 can take any suitable form, most preferably a multi-strand 300 series stainless steel cable having a diameter of.020 ". By pulling on a hinge cable, suturing head 100 will hinge about pivot point 114 about intermediate region 500. Knuckle 520 includes a proximal end 522 and a distal end 524 (in the form of brackets 524a, 524b for receiving suturing head 100) separated by a mid-region 526. The intermediate region 526 defines a longitudinal channel 528 therethrough for receiving the drive member 150. Preferably, the member 150 is connected to the tension rod 151 in said area, while the cross-sectional profile of the channel 528 is adapted to accommodate this geometry, as shown in the figures. An opening 523 is also defined for receiving the members 532, 534. Also, openings 525, 527 are also provided to allow for the movement of the guide rails 120, 130 to be controlled by the drawing wires/ cables 172, 174, 176, 178. The proximal end of tubular member 510 is connected to a hinged rotation mechanism that rotates tube 510 of suturing head 100 with respect to handle 600 of the device, as discussed below. The distal end 514a of the tube 510 may be slightly extended to more tightly control the drive element 150 as the drive element 150 passes through the intermediate region 500.

For purposes of illustration and not limitation, fig. 60-122 illustrate a handle 600 of a device 1000. Handle 600 includes many components and systems for operating suturing head 100, 100'. Fig. 61 shows a front view of the handle with the tube 510 removed, showing a hinged swivel handle 620 where relative rotational movement of the handle 620 relative to the handle 600 will cause rotation of the stapling head 100, 100' relative to the handle 600. Fig. 60 shows a rear view of the handle 600. Fig. 62 shows the handle with the rotating handle 620 removed, and shows the proximal cable guide 606, left tube loop 634, and right tube loop 642. The tube loop portions 632, 634 cooperate to capture the proximal end 512 of the tube 510, which may be, for example, but not limited to, a 5mm nominal outer diameter stainless steel hypotube (hypotube). Also shown is a hinged handle 630 which may be used to hinge suturing head 100 about its pivot point, as discussed above. The housing 600 includes two main housing halves including a right side 612 and a left side 614. Fig. 63 shows the handle 600 with the tube collars 632, 634 removed. Proximal cable guide 606 is riveted into the hypotube, such as by an interference fit. The longitudinal distance between the distal end disk 606b of the proximal cable guide 606 and the cable disk 648 (fig. 71-72) along the tube 510 represents a twist zone, and all cables routed through the tube 510 can rotate and twist with respect to each other or the handle 600 when the suture head is hingedly rotated. The twisted area is preferably between about three and six inches in length, most preferably about four inches in length. In a preferred embodiment, the total angular range of movement of the suturing head is about 270 degrees with respect to the handle 600, desirably about 135 degrees in either direction from the home position shown in the figures. The detent of the hinged swivel handle 620 (fig. 64) is adapted and configured to engage a pawl 614g (fig. 79(a)) received in an opening in the left handle portion 614.

The collars (fig. 66-67) are substantially mirror images of each other (across the vertical mid-line plane of the device 1000) and cooperate to define a hollow, generally cylindrical interior for receiving the proximal end 512 of the tube 510. Specifically, lugs 632a, 634a are provided to mate with openings 518 near the proximal end 512 of the tube 510 (fig. 69). The collar also defines radial stops 632b, 634b along its proximal face to mate with a raised portion 644b on the distal face of the rototransporter plate 644 (fig. 68). The rotator plate 644 also includes a proximal portion 644c having a square cross-section for receipt by the left and right housing side portions 612, 614.

A rototransporter plate 644 is received in housing 614 between adjacent ribs 614r (fig. 70) as with cable tray 648. The cable drum 648 (fig. 71-72) defines a circumferential groove 648b about its outer periphery for mating with the rib 614r, and the cable drum 648 defines an annular channel 648a in its distal face for receiving the hinged swivel spring 646. Spring 646 is adapted and configured to urge the rotating barrier into contact with stops 632b, 634b to facilitate a stepwise rotational movement, cable tray 648 further defining a plurality of openings 648c therethrough to allow passage of cables/ wires 172, 174, 176, 178, 532, 534 and 551.

As shown in fig. 73-74, cable path guides 650 are provided for guiding the cables 172, 174, 176, 178, 532, 534 through the handle 600. Specifically, the guide 650 provides a first set of guides 654 for guiding the cables 172, 174, 176, 178 and a second set of guides or bosses 652, 654 for guiding the cables 532, 534 through the handle 600. A groove 658 is provided in rail 650 for receiving rib 612r of right housing portion 612 (fig. 79 (D)).

Fig. 75-76 show a partial cut-away view of the handle 600 with the right housing portion 612 removed to allow viewing of the internal components of the handle 600. Fig. 75 shows the trigger 700 or actuator in a locked position, whereas fig. 76 shows the trigger 700 in a released position, wherein the trigger can be depressed, thus advancing the needle (e.g., 300) around the needle track 140. As shown in fig. 75-76, the handle includes a trigger 700, a pull cable/strap 710, a trigger spring wrap 720, a trigger return spring 730, a pull cable 727, a pulley 750, and a brake handle 800 for preventing rotation of an articulation knob 810. When the trigger 700 is locked, a stop surface 614s is defined in the left housing 614 to define a stop point for the trigger 700. The right side housing 612 includes a similar stopper part 612s (fig. 79 (D)). The articulating knob 810 (fig. 77(E)) includes a handle portion 812, an elongate shaft 814 (fig. 83) for engagement with the detent rotational fitting 830, and a distal portion 816 (fig. 90) that is preferably threaded to receive a hex nut 886. The right and left handle cap portions 616, 618 (fig. 77(a) -77(D)) are provided with bosses 616a, 618a for receiving and supporting edges 835b (fig. 84) of a detent spring 835. The bearing portion 835a of the brake spring 835 bears against the brake rotation fitting 830, and the brake rotation fitting 830 in turn urges the brake rotation fitting 830 against the shaft 814 of the knob 810. Portion 814 of knob 810 preferably includes an elastic layer or coating that can grip serrated portion 834 of fitting 830, wherein rotation of knob 810 causes fitting 830, and thus cables 532, 534, to advance in a proximal-distal direction with respect to device 1000, resulting in a hinged connection of suture heads 100, 100'. Fig. 78 shows the handle 600 with the components 810, 616, 618 removed. Fig. 79(a) -79(D) show inside and outside views of left and right handle portions 612, 614. Fig. 80-81 show the inner working area of the handle 600 with the two handle portions 612, 614 removed and the trigger 700 locked and released, respectively. FIG. 82 shows a close-up view of the inner working area of handle 600, showing the upper brake pad 820 removed, fully revealing the positioning of fitting 830 and spring 835, with trigger 700 released. Also shown is knuckle pulley 842, which is supported by knuckle pulley holder 840, which in turn is biased against bracket 870 by rail spring 845 to maintain tension on cables 532, 534. Also shown in fig. 83-85 are fitting 830, spring 835 and spring 845.

Fig. 86(a) -86(B) show the shuttle 888 (fig. 99(a) -99(B)) moving proximally after release of the trigger 700. Proximal movement of shuttle 888 prevents handle 892r from being hinged, which in turn prevents guide rails 120, 130 from being withdrawn into suturing head 100, 100 'as trigger 700 is actuated to advance a needle (e.g., 300) around circumferential needle track 140, 140'. Components 830, 835 have been removed in fig. 86 to better illustrate lower brake pad 850. Brake pads 820, 850 are preferably made of a resilient and slightly compressible material, such as silicone. Fig. 87(a) also shows a lower brake pad 850, while fig. 87(B) -87(D) show a brake bracket 860. Bracket 860 defines an annular boss 862 thereon for receiving lower brake pad 850 and brake handle components 882, 884a (fig. 91 (B)). Fig. 88-89(a) show the remaining inner working area of the handle with the brake pads removed (fig. 88), and also with the pulley retainer 840 and brake bracket 860 removed. Fig. 89(a) -89(B) also show a coupling knuckle 872 that includes a longitudinal opening 872a with a narrowed portion 872c that is wide enough to allow passage of cables 532, 534, but not wide enough to allow passage of cable termination 874 (fig. 91). In contrast, opening 872b is large enough to allow terminal 874 to pass into knuckle 872, thus connecting cable 532 to cable 534 and providing a closed loop to facilitate the hinged connection by way of hinge connection and brake control device 800. Brake trigger 884 may be pulled causing a camming effect by moving an upper portion of handle component 882 (and the corresponding component on the left side of the device) into contact with lower brake pad 850, causing brake pad 850 to compress component 830 between upper and lower brake pads 820, 850.

Fig. 92-102 illustrate aspects of a locking mechanism for operation and control of the rails 120, 130 and the trigger 700. The guide rails 120, 130 are deployed or retracted by rotating the handle 892. The cables 172 and 178 are routed on guide rails 885, which are held in place by housing members 612, 614, and are split into two pairs of wires, one of which is guided down around spring-loaded pulleys 894a, 896a and all the way to the handle 192, with all four cables 172, 174, 176, 178 held in place in openings 892b in the handle 892 by tapered pins 893. Another pair of cables is routed around guide 887 directly into handle 892. Guide 885 (fig. 93(B)) is a generally curved planar member having a plurality of cable guides 885a, wherein cables 172 and 178 are supported on an upper surface of the generally curved planar member in their routing path to handle 892. Fig. 93(a) shows the relationship of the rails 887 and 885 in situ with respect to the other internal components of the handle 600. The guide 887 (fig. 93(C) -93(D)) includes a boss 887a to be received by the housing portions 612, 614, and a groove 887b defined by a fin 887C for providing a path for the cable/wire. The handle 892 includes a gripping portion 892a and a recess 802c, and a passage 892d for guiding a cable/wire into the opening 892b (fig. 94(a) -94 (E)). The two handles 892 may be substantially identical in form.

Guide handle 892 also acts to release trigger lock 780, thereby allowing trigger 700 to initiate movement of the needle (e.g., 300). As shown in fig. 95(a) -95(B), the trigger lock 780 is connected to the cable at a ferrule 781 disposed in an opening 783 at a bifurcation 782 of the trigger lock (fig. 95(C) -95 (D)). A trigger lock 780 is slidably disposed on the barrel track 786 and is biased toward the locked position by a 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 pushed upward (fig. 95(B)) by rotating handle 892L, prong 784 of trigger lock 780 disengages from trigger 700, allowing the trigger to move freely. Handles 892L, 892R are pivotally disposed on the axle 891 (fig. 96, 122). Fig. 97-101 also show additional features of the actuation system of the rails 120, 130, with additional components removed step by step to better illustrate other components and their relative positions. Fig. 102 also illustrates additional aspects and views of components 840, 894, 896.

103-113 illustrate aspects of the operation of the toggle trigger mechanism 700. Fig. 103 shows the relative positions of trigger 700, pull cable/strap 710, trigger spring housing 720, trigger return spring 730, pull cable 727 and pulley 750. Fig. 103 has the components 786, 787 and the handle 700 removed to show a ferrule 752 secured to the terminal end of the pull cable 727 and seated in the opening 701 in the handle 700 (fig. 105). In fig. 106(a) -106(B), the trigger 700 is shown from two additional angles, showing the bifurcated bracket 702 near the top of the trigger 700. Bracket cover 704 is received in trigger handle 700 by securing bolt 704a in bore 700a using an interference fit and/or ultrasonic welding, adhesive, or the like. The bracket 702 and the bracket cover 704 define openings 702a, 704a therein for receiving bosses 888a of the shuttle link 888 (fig. 99 (B)). Fig. 107(a) shows the interior of capsule 720, showing clutch spring 724. Fig. 107(B) -107(C) show housing portion 720a mated with housing portion 720B. Housing portion 720b is the same mirror image of portion 720a, so only 720a is shown. Clutch spring 724 is removed in fig. 108, clearly showing pull cable 727, clutch spring ferrule 723 and clutch washer 726. Fig. 109 shows the assembly with spring 730 and housing portion 720b removed. Fig. 110 shows a close-up of the connection of the drive component 710 to the assembly 720, showing the manner in which tabs 711, 712 at the proximal end of the drive component 710 are bent and inserted through slots 721a in the washer plate 721. An O-ring 720, which may be silicone or other suitable material, is shown in fig. 104 and 109. O-rings 729 provide seals against housing segments 612, 614. Ferrule 723 is secured to cable 727. Fig. 111-113 provide closer views of the ferrule 723, washer plate 721 and proximal end of the member 710, respectively.

Fig. 114-120 also illustrate the connection between the drive member 710 and the drive member 150/151. As shown in fig. 114, a proximal drive component may include a band element 150 connected to a portion of an intermediate cable 551 at an intermediate region 500 as described above, the proximal drive component being received by a ferrule 910, the ferrule 910 being secured in place after a terminal end 930 is connected, and such that cable/rod 551 is positioned within a cavity 922 in coupler 920 through slot 924 in coupler 920. The rounded portion 932 of the terminal is distally facing to allow movement between the member 551 and the coupling 920. As shown in FIGS. 115-117, terminal end 930 defines a passage 936 therethrough for receiving cable 551 and defines a generally cylindrical proximal portion 934. Ferrule 910 defines a channel 912 therethrough for receiving cable 551, and an opening 914 therethrough, such as for receiving a brazing or soldering material or other material for securing the ferrule in place on cable 551. The coupling 920 includes a proximal end surface 922a, a distal end surface 928, and a bore 922 therethrough. As shown in cooperation in fig. 114 and 118 and 120, an externally threaded fitting 940 is received in the threaded opening 922 of the coupling and a retaining hex nut 950 is received on the externally threaded fitting 940. Proximal end 943 of fitting 940 faces proximally and defines a lumen 946 in fitting 940 for receiving distal tip 717 of drive belt/cable 710. Tip 717 is inserted into cavity 946 until stop 719 contacts distal face 943. Threads 942, 952 are defined on fitting 940 and nut 950. The components 940, 710 may be coupled by any suitable means, including but not limited to interference fit and/or welding, soldering, brazing, adhesives, and the like. Fig. 121-122 illustrate torsion spring 960 and rail spring 970 and their positioning with respect to other components in handle 600. The springs 960, 970 are part of a control mechanism for deploying and retracting the rails 120, 130. Fig. 121(C) shows return springs 895, 897.

An exemplary method of operation of suturing head 100 is shown in fig. 123-131. Fig. 123 shows a cut-away view of suturing head 100 in a delivery configuration with needle 300 disposed therein and rails 120, 130 retracted. The needle 300 is fully contained within the device 1000 and the detent spring 115b prevents the needle 300 from moving in a counterclockwise direction. Similarly, the pawl spring 115a is biased against the inner circumferential surface 322 of the needle, helping to prevent the needle from rotating in the clockwise direction. As shown in fig. 123-131, it will be apparent from this disclosure that the drive system of the device 1000 is adapted and configured to advance the needle 300 through a plurality of 360 ° rotations about the needle track when the needle track is in the deployed state. It is also apparent that the needle track ranges approximately 180 ° before deployment and the angular range is greater than 180 ° after deployment.

Fig. 124 shows the initial deployment of the guide rails. Pawl 115a is pulled along surface 322 of needle 300 until pawl 115a engages notch 308 and pawl 115b engages notch 306. Subsequently, in FIG. 125, the rail is fully retracted and the pawl 115a located in the rail 120 pulls the needle 300 in a clockwise direction to present the needle 300 in a condition for suturing. At the same time, pawl 160 is advanced along its arcuate path on rails 120, 130 to its distal most end such that notch 158 in drive member 150 is aligned with boss 108a and pawl 115b bears against surface 122 of needle 300. When drive member 150 is subsequently pulled proximally, notched area 158 of drive member 150 slides beyond bosses 106a, 108a, and drive member 150 drops into the lower channel partially defined by channel 108T. Further proximal movement of the drive member 150 causes the wider portion of the distal end of the band 150 to bear against the underside of the bosses 106a, 108a, while the pawl 160 contacts the trailing end of the needle 300 and the needle is advanced approximately 180 deg., as shown in fig. 126. Subsequently, distal movement of pawl 160 is repeated so that pawl 160 engages notch 310 in needle 300. Area 158 slides over bosses 106a, 108a as before, pulling pawl 160 and the forward tip 302 of the needle along arcuate needle track 140, which returns the needle to its starting point, as shown in fig. 128. Fig. 129 shows the rails 120, 130 partially retracted so that the needle moves counterclockwise until the notch 306 engages the pawl 115 b. Fig. 130 shows the rails 120, 130 retracted even further, showing how the pawl 115a is pulled out of the recess 308 and pulled along the surface 322 of the needle, preventing further counterclockwise movement of the needle 300 by the pawl 115b being locked in the recess 306. Fig. 131 shows suturing head 110 once again in the delivery or removal configuration with guide rails 120, 130 fully retracted. Thus, provided herein is an apparatus that can rotate the disclosed needle through 180 °, 360 °, or any other multiple of 180 ° as desired. The angular increment of advancement may be an increment of greater or less than 180 deg. set as desired, if desired.

The suturing device of embodiments of the present invention may be used in laparoscopic procedures including, but not limited to, laparoscopic colostomy, colectomy, adrenal resection, splenectomy, lateral esophageal hernia repair, inguinal hernia repair, ventral hernia repair, nisen fundoplication, hepatectomy, gastrectomy, small bowel resection, treatment of small bowel obstruction, distal pancreatectomy, nephrectomy, and gastric bypass. Those skilled in the art will appreciate that embodiments of the present invention may be used in other laparoscopic procedures.

In using the apparatus of embodiments of the present invention, gas is used to insufflate the abdominal cavity to form a working space for the user. Any gas known in the art may be used, including but not limited to nitrogen or carbon dioxide. Access ports are formed at various locations using trocars to accommodate particular surgical procedures. Subsequently, various surgical instruments may be passed through these proximal portals/cannulas into the body. The user then introduces the distal portion of the stapling apparatus into the cannula, and then movably attaches the stapling head assembly (e.g., 100'). The suturing head is then positioned relative to the tissue/vessel to be sutured together, and the user preferably locks the suturing head assembly in place. Subsequently, the user positions the plurality of separated tissue portions in the openings defined at the distal end portion of the stapling head assembly by operating the stapling apparatus. The user can operate the device with only one hand while actuating the handle to close the incision with continuous suturing, the stitches of which can be individually drawn together precisely and uniformly along the length of the suture, similar to manual suturing in a conventional manner. The user may employ a single suture or multiple sutures extending the entire length of the incision. Thus, by placing the device across the severed tissue portion and actuating the handle, the suturing device allows the user to place continuous or intermittent stitches to close the tissue incision in a time efficient manner. Those skilled in the art will appreciate that the apparatus may be used in any conventional procedure for performing laparoscopic surgery.

The compact structural design of the stapling head assembly allows the user to clearly and unobstructedly view the suturing needle during its advancement through a tissue portion during a suturing operation, thereby allowing the suturing device to be accurately positioned to provide uniform suturing and eliminating the risk of tearing tissue by being positioned too close to the edge of the incision. Subsequently, the suturing apparatus is advanced a short distance along the incision and the foregoing operations are repeated to form another stitch comprising a suturing material or thread.

The user may continue to operate the suturing device to alternately advance and activate rotation of the needle about an axis substantially parallel to the direction of advancement to form a continuous suture or a series of intermittent stitches that may extend through the entire length of the incision. After each individual stitch is placed, the stitch is tightened by applying a pulling force on the suture material or thread, thereby uniformly tightening the resulting suture along the length of the severed tissue portion. Thus, a tight closure of the various parts is accomplished and bleeding and tissue tearing are minimized. Once the appropriate amount of suture material or thread 246 has been set, the user may use the needle holder to tighten the stitch formed and tie a knot thereto.

All patents, patent applications, and published references cited herein are hereby incorporated by reference in their entirety. It will be appreciated that various of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the present invention.

Claims (19)

1. A suturing apparatus comprising:

an arcuate needle having a leading end, a trailing end, and a length of suture, the arcuate needle disposed within a linear housing at a distal end of the suturing apparatus;

an arcuate needle track defined in the linear housing for receiving the needle, the arcuate needle track defining a circular path;

a needle driver configured to drive the needle in a first rotational direction along the circular path, the needle driver including a drive pawl configured to engage the needle and advance the needle in the first rotational direction along the needle track, an

A plurality of anti-rotation detents disposed in the linear housing and projecting into the arcuate needle track, the plurality of anti-rotation detents being spaced apart from one another along the circular path defined by the needle track, each anti-rotation detent being configured to engage the trailing end of the needle to prevent rotation of the needle in a second rotational direction opposite the first rotational direction when the needle driver reciprocates between a drive stroke and a return stroke, wherein the drive stroke drives the needle along the needle track greater than 180 degrees.

2. The suturing apparatus of claim 1, wherein at least one of the anti-rotation detents is positioned adjacent the trailing end of the needle after completion of the drive stroke.

3. The suturing device of claim 1, wherein at least one of the anti-rotation detents is integral with a portion of a housing of the suturing device.

4. The suturing apparatus of claim 1, wherein each of the anti-rotation detents interferes with the needle in the needle track when the needle and each of the anti-rotation detents are present in the same location of the needle track.

5. A suturing apparatus comprising:

an arcuate needle having a leading end, a trailing end, and a length of suture, the arcuate needle disposed within a linear housing at a distal end of the suturing apparatus;

an arcuate needle track defined in the linear housing for receiving the needle, the arcuate needle track defining a circular path;

a needle driver configured to drive the needle in a first rotational direction along the circular path, the needle driver including a drive pawl configured to engage the needle and advance the needle in the first rotational direction along the needle track; and

a pair of pawls disposed in the linear housing and projecting into the arcuate needle track, the pair of pawls spaced apart from one another along the circular path defined by the needle track, both pawls configured to simultaneously engage an anti-rotation surface of the needle to prevent rotation of the needle in a second rotational direction opposite the first rotational direction when the needle driver reciprocates between a drive stroke and a return stroke, wherein the drive stroke drives the needle greater than 180 degrees.

6. The suturing apparatus of claim 5, wherein at least one of the pawls is positioned adjacent the trailing end of the needle after completion of the drive stroke.

7. The suturing device of claim 5, wherein at least one of the pawls is integral with a portion of the linear housing.

8. The suturing apparatus of claim 5, wherein each of the pawls interferes with the needle in the needle track when the needle is present in the same location of the needle track as each of the pawls.

9. A suturing apparatus comprising:

an arcuate needle having a leading end, a trailing end, an inner radial surface, an outer radial surface, and a length of suture, the needle disposed within a linear housing at a distal end of the suturing apparatus, the arcuate needle including at least one engagement surface formed into the inner radial surface;

an arcuate needle track defined in the linear housing for receiving the needle, the arcuate needle track defining a circular path;

a needle driver configured to drive the needle in a first rotational direction along the circular path, the needle driver comprising a drive pawl configured to engage the needle and advance the needle in the first rotational direction along the needle track, wherein the needle driver reciprocates between a drive stroke and a return stroke, and further wherein the drive stroke drives the needle greater than 180 degrees; and

at least one anti-rotation detent projecting radially outward from a location within the circular path of the needle into the arcuate needle track, the at least one anti-rotation detent configured to engage with the at least one engagement surface formed into the inner radial surface of the needle, the at least one anti-rotation detent remaining stationary relative to the needle track as the needle driver reciprocates relative to the needle track.

10. The suturing apparatus according to claim 9, further comprising a second anti-rotation detent projecting radially outward into the arcuate needle track, said second anti-rotation detent configured to engage the at least one engagement surface formed into the inner radial surface of the needle.

11. The suturing apparatus according to claim 10, wherein the at least one engagement surface of the needle is configured to simultaneously engage the anti-rotation pawl to prevent movement of the needle in a direction opposite the first rotational direction.

12. The suturing device of claim 1, wherein the needle driver comprises an elongate resilient member that reciprocates along a longitudinal axis of the suturing device.

13. The suturing device of claim 12, wherein the elongate elastic member is heat treated to RH 950.

14. The suturing apparatus according to claim 12, wherein the elongate resilient member is made of a shape memory material.

15. The suturing apparatus according to claim 12, wherein said elongate resilient member is made of a polymeric material.

16. The suturing apparatus according to claim 12, wherein said elongate resilient member is made from a laminate of plastic and metal materials.

17. The suturing apparatus according to claim 12, wherein the elongate resilient member is made from a plurality of materials.

18. The suturing device of claim 12, wherein the elongate elastic member is made of a bundle of wires or filaments.

19. The suturing apparatus according to claim 12, wherein said elongate elastic member is made from a single thread or filament.

Images