JP2017018654A - Devices and methods for minimally invasive suturing - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide devices and methods for minimally invasive suturing.SOLUTION: One suturing device for minimally invasive suturing includes a proximal section, a distal end, and an intermediate region therebetween. The device includes a suture 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 the pointed end of the suturing needle is positioned within the suture head assembly prior to deployment of guides that are adapted and configured to guide the needle around a circular path when advanced by a drive mechanism having a needle driver for engaging and rotating the suturing needle.SELECTED DRAWING: Figure 1

Description

Related applications

  This application is a continuation-in-part of US patent application Ser. No. 12 / 909,606, filed Oct. 21, 2010, as U.S. Pat. No. 7,993,354, Aug. 9, 2011. , And claims the priority of US Patent Application No. 61 / 388,648, filed Oct. 1, 2010. This application also relates to international patent application PCT / US2009 / 006212 filed on November 20, 2009, which is also incorporated in US Provisional Application No. 61 / 200,180, filed November 25, 2008. Insist on priority. This application also relates to US patent application Ser. No. 11 / 231,135, filed on Sep. 20, 2005, which is also related to US Provisional Application No. 60 / 611,362 filed on Sep. 20, 2004. Claim priority over issue. This application also relates to international patent application PCT / US2008 / 06674 filed on May 23, 2008, which is also incorporated in US Provisional Application No. 60 / 939,887 filed May 24, 2007. Insist on priority. This application also relates to US patent application Ser. No. 12 / 175,442, filed Jul. 17, 2008. The entire text of each application is incorporated herein by reference.

  Embodiments disclosed herein relate to medical devices for suturing tissue, and in particular to devices for manipulation and control of a suture needle during minimally invasive suturing, methods of manufacturing such devices, and tissue It relates to a method of using such a device for suturing.

  Minimally invasive surgery (MIS) has allowed surgeons to perform a variety of operations with less pain and disability than conventional open surgery. Unlike conventional open surgery where the surgeon can easily visualize and manipulate both tissue and instruments by having the surgical site readily accessible through a large incision, in MIS, the surgeon has a small puncture hole ("keyhole surgery") or vagina. It is necessary to perform the surgery remotely by inserting and manipulating the instrument through a natural hole such as the esophagus or anus.

  In MIS, a small puncture hole is typically made in a living body. Thereafter, the medical instrument is inserted through the cannula. The cannula has a small inner diameter, typically 5-10 mm, and may be 20 mm or more. In one operation, a plurality of such cannulas can be inserted into the living body. Minimally invasive surgical instruments need to be smaller than normal and are generally longer than normal, making them difficult to manipulate accurately.

  Perhaps the most problematic surgical task in MIS is suturing. Sutures are commonly used for manual suturing (including needle holders and pick-up forceps), along with small needles and sutures that are difficult to visualize (especially if only indirect and 2D video imaging is available) It is necessary to operate the instrument with both hands. In an environment characterized by limited area, limited visualization, and limited mobility, manual minimally invasive suturing is extremely difficult and many surgeons often find it an almost impossible surgical task.

  In a preferred method of manual suturing, a pinching forceps (“needle holder”) is grasped by the surgeon and used to grasp the curved needle near the tail of the needle. The prosthesis of the surgeon's wrist joint drives the needle into the tissue. When the tip of the curved needle exits the tissue, the surgeon releases the needle from the grip of the needle holder and grasps the tip with another forceps ("pickup"). The surgeon then pulls the curved needle from the tip of the needle until the entire needle exits the tissue, preferably with a circular path along the arc of curvature of the needle so as to follow the least traumatic path through the tissue. . This causes the curved needle to move along a complete arc each time it is stitched. Individual (interrupted) stitches are made by tying and stopping after each stitch. Linked (continuous) stitches are made by repeatedly moving the curved needle along a complete arc until the length and number of stitches required. To make additional interruptions or continuous stitching, the surgeon must release the needle tip and re-hold the needle near the needle tail.

    In the manual suturing technique described above, the direct handling of the needle may result in an unexpected puncture through the surgeon's or nurse's gloves, and the potential risk of infection to the surgeon, nurse, staff and patient. It is possible that the needle becomes contaminated by pathogens that can become sexual or cause the occurrence of infection at the suture site. There is also the risk that the needle will pierce internal organs or blood vessels, causing severe and often fatal infections.

  U.S. Pat. No. 5,643,295 entitled "Methods and Apparatus for Sturing Tissue", U.S. Pat. No. 5,665,096 called "Needle Driving Apparatus and Methods of Saturing Tissue", US Pat. No. 5,665,109, US Patent No. 5,759,188, “Sturing Instrument with Rotable Mounted Needle Driver and Catcher”, US Patent No. 5,759, Endoscopic Sturing Devices and Methods 8 and 99 Su U.S. Pat. No. 5,954,733 called “Uring Instrument with Rotatable Mounted Needle Driver and Catcher”, U.S. Pat. No. 6,719,763 called “Endoscopic Sturing Device”, and U.S. Pat. No. 6,719,763 843, various devices for suturing for use in MIS are described, the entire contents of which are hereby incorporated by reference herein in order to include their teachings.

  Assignee's U.S. Pat. No. 5,437,681, U.S. Pat. No. 5,540,705, and U.S. Pat. No. 6,923,819 are thread manageable with protective cartridge, suture needle and needle rotation drive. Suture devices are disclosed, the disclosures of which are hereby incorporated by reference. The devices described in the above patents and patent applications include a mechanism for driving a protected needle, but the needle is rotated about an axis parallel to the axis of the device. Furthermore, due to the orientation and size of the suturing device, visualization is difficult and inconvenient to use for MIS.

  Thus, for those skilled in the art, a preferred method of suturing for the surgeon that can be easily manipulated within the small diameter of the cannula and functions in an environment characterized by limited space, limited visualization and limited mobility. , Allowing surgeons to fix and make knots quickly and with controlled tension, continuous stitching, and accidental needle sticks during needle handling, and internal organs and blood vessels from accidental needle sticks There remains a need for a minimally invasive suturing device that protects.

US Pat. No. 5,643,295 US Pat. No. 5,665,096 US Pat. No. 5,665,109 US Pat. No. 5,759,188 US Pat. No. 5,860,992 US Pat. No. 5,954,733 US Pat. No. 6,719,763 US Pat. No. 6,755,843

  Disclosed herein are devices and methods for minimally invasive sutures of in vivo tissue.

  In the embodiments illustrated herein, a medical device is provided for closing an opening in a patient's body that closely mimics or replicates a manual suturing action performed by a surgeon. The device has a number of advantages over conventional methods in which a surgeon sutures tissue during minimally invasive surgery, including that the device provides a portable suturing instrument that does not require external drive. The embodiments disclosed herein allow a relatively simple operation for a surgeon with only one hand.

  In the embodiment illustrated herein, the suturing head assembly may be removably attached to the actuator mechanism of the suturing device. The diameter of the device is small enough to enter a 5 mm cannula in some embodiments, so that the device can be manipulated and sutured very easily during endoscopy or other MIS procedures. In surgery, it is preferable to have as few incisions as possible and as small as possible. Thus, a device having a reduced configuration is particularly advantageous, and the suture head assembly of the device is pivotable laterally to the center left, center right, up and down once in the cannula, Ideal for use during endoscopic surgery and other less invasive procedures, including microscopy, thoracoscopy, and arthroscopy.

  The device of the embodiments disclosed herein closely mimics or replicates a manual suturing action performed by a surgeon. For example, in manual suturing, the needle is grasped by forceps and moves along an arc, and there are no obstacles in the arc. The suturing device design of the embodiments disclosed herein allows the center of the needle arc to be unobstructed during suturing. That is, there is no hub in the center of the arc of the suture needle. The whole inside the arc of the needle is unhindered. This allows the user to have better visualization while controlling the movement of the needle during operation, unlike conventional mechanical suturing methods.

  An advantage provided for the suturing device of the embodiments disclosed herein is that it allows the suture material to be manipulated through a tissue incision substantially similar to a surgeon's manual manner. . Specifically, in some embodiments of the suturing device, the suture needle is first pushed from the tail of the needle to move the tip of the needle through the tissue. The device then picks up the tip of the needle through the tissue and pulls the rest of the suture needle and the suture attached to the suture needle through the tissue. A suturing needle is thereby the preferred suturing method, consistently along the curved arc of the needle itself, and the least traumatic method of moving the needle through tissue. An advantage provided in the suturing device of the embodiments disclosed herein is that the suture needle can be pulled completely through the tissue portion to be closed along each stitch and the suture can be pulled. When using the suturing device disclosed herein, there is no need for auxiliary tools or tools such as needle holders, pick-up forceps, etc. to complete the stitching. Forceps or grasping instruments may be used to tighten the knot.

  In aspects illustrated herein, an embodiment of a suturing device is provided that includes a suturing needle protected by a housing, since the suturing needle is not exposed to the user and is not directly handled by the user, so that accidental needle sticks prevent. The configuration of the suturing device of the embodiments disclosed herein also protects internal organs and blood vessels from accidental entry by the needle, since the housing acts as a shield between the organ and the needle.

  In one embodiment, a suturing device having a suturing head is provided. The suturing head includes a housing defining at least one path therein and a deployable needle path. The deployable needle path is disposed within the housing and the needle path is deployed or the needle path extends out of the housing from a retracted or contracted state where the needle path is essentially disposed within the housing. And adapted and configured to be expanded or expanded to an expanded or expanded state forming a circular arc needle path. The device further includes an arc or circular needle disposed in the deployable needle path, the needle having a first tip, a second tip and a basically toroidal body. The apparatus further includes a drive for advancing the needle along a 360 ° path along the needle path when the deployable needle path is in a deployed state. When the deployable or expandable needle path is in the expanded or expanded state, the drive unit advances the needle around the needle path by a plurality of 360 ° rotations without removing the needle from the needle path. Fit and configured. The drive unit also selectively couples and releases the needle to advance the needle with a 360 ° rotation.

  In a further aspect, the suturing device housing is essentially cylindrical and may have an outer diameter of 5.0 mm. The circular path of the needle path may be 10 mm in diameter. If desired, the needle may have a non-circular cross section. Preferably, the apparatus further comprises means for deploying the needle path from the retracted state to the deployed state. The needle path occupies approximately 270 ° of the 360 ° needle path when the needle path is in the deployed state. However, the present invention may be, for example, greater than 270 ° in 1 degree increments, expandable to a smaller final range, deployable or angularly expandable, or angularly expandable needle path It will be understood that the invention relates to a device having For example, from about 180 °, especially about 190 °, about 200 °, about 210 °, about 220 °, about 230 °, about 240 °, about 250 °, about 260 °, about 270 °, about 280 °, about 290 A needle path can be provided that extends to °, about 300 °, about 310 °, about 320 °, or about 300 °. For example, depending on the diameter of the device and the dimensions of the needle path, the angle range of the needle path from an undeployed (unexpanded) configuration to a deployed (expanded) configuration is about 10 °, about 20 °, about 30 °, about 40 °, about Induction improved at 50 °, about 60 °, about 70 °, about 80 °, about 90 °, about 100 °, about 110 °, about 120 °, about 130 °, about 140 °, about 150 ° or about 160 ° Only a part may be needed. The drive may include an elongated flexible member that reciprocates along the longitudinal axis of the device. The drive may engage the needle and advance the needle along the needle path as the elongate flexible member is advanced proximally relative to the housing. The needle may include first and second notches along the inner surface of the needle to engage an anti-rotation mechanism disposed in at least one of the housing and the deployable needle path. The needle may further include a notch on the upper surface of the needle for engaging a portion of the drive, the notch on the upper surface of the needle intersecting one of the notches disposed on the inner surface of the needle.

  In a preferred embodiment, the deployable needle path includes at least one arcuate guide adapted to deploy from the housing along the arc path. Preferably, the deployable needle path includes a pair of arc guides adapted to deploy from the housing along the arc path. The pair of arc guide portions preferably expands along the arc path from the housing by pulling a first pair of pull wires connected to each guide portion by one pull wire. The pair of guides is more preferably adapted and configured to be retracted into the housing by pulling a second pair of pull wires, wherein one of the second pair of pull wires is a pull wire. Connect to each induction unit. The first pair of pull wires is preferably connected to the second pair of pull wires to form a pair of continuous mechanical loops, the loops being proximal to the guide at the distal end. The ends are connected to a pair of handles, and the movement of the handle causes the movement of the guiding portion.

  The present disclosure also provides a suture needle having an arc body with a front tip and a back tip, the arc body defined by a first notch along the inner radial region needle and a central curve axis of the needle. A second notch having a protrusion located in the plane of the first notch and the first notch intersecting the second notch. As desired, the needle may further include an essentially square cross section. The needle body may include a round cross-section portion that basically separates a main portion of a square cross section and a tail portion of an essentially square cross section. The needle may further define a third notch in the needle near the rear tip to receive the drive pawl. The needle may also define an arc keel along the entire needle to stabilize movement within the suturing device.

  In the embodiments illustrated herein, a suture needle is inserted into a living body to insert a distal end of a suturing device having a sharpened suture needle and to crotch a plurality of separated tissue segments. Positioning the actuator, activating the actuator once, extending beyond the protective housing of the cartridge to engage a plurality of separated tissue segments at the sharpened end of the suture needle, and the suture needle Enabling the actuator once more to complete a full turn and pull the suture extending from the suture needle through the plurality of separated tissue segments to form the stitch, A method for tissue suturing during surgery is provided.

  In another aspect, a suturing device having a suturing head is provided. The suturing head includes a housing defining at least one penetration therein and having a proximal end, a distal end, and a peripheral side connecting the proximal end and the distal end. The head further includes a deployable needle path located at least partially within the housing, the needle path adapted and configured to deploy from a retracted state, the needle path being substantially disposed within the housing and in the deployed state With an angular range of approximately 180 ° relative to the arc, the needle path having an angular range of greater than 180 °, extending outwardly from the peripheral side of the housing and located in a plane parallel to the longitudinal axis of the housing Form a needle path. Preferably, the needle path is angularly expandable along a circular path that defines a path of needle movement, and the path is angularly expanded along a circular arc path from a reduced state to an expanded state. The suturing head further comprises an arcuate needle disposed in the deployable needle path, the needle having a first end, a second end and an essentially toroidal body. The suturing head further includes a drive unit that advances the needle by a plurality of 360 ° rotations around the needle path when the deployable needle path is in the deployed state, and the drive unit selectively engages the needle. Or release and advance the needle by 360 ° rotation.

  In another aspect, the housing is essentially cylindrical and has a diameter of about 5.0 mm and the path of the needle path has a diameter of about 10 mm. However, it will be appreciated that the diameter may be larger or smaller as desired. The needle has a substantially circular cross-section, a circular cross-section, a non-circular cross-section, a square or triangular cross-section, or a cross-section that transitions from one shape to another along the entire needle, for example from square to circular, and It may also have a cross section that transitions to a square. The apparatus preferably further comprises means for deploying the needle path from the retracted state to the deployed state. The needle path preferably occupies about 270 ° of the 360 ° of the path during deployment of the needle path, but the angular range of the path can be greater than 270 °, for example, in 1 degree increments. Or smaller.

  In another aspect, the drive preferably includes an elongated flexible member that reciprocates along the longitudinal axis of the device. Also, the drive preferably couples with the needle and advances the needle in the needle path when the elongated flexible member is advanced proximally relative to the housing. The deployable needle path preferably includes at least one arcuate guide adapted to deploy from the housing along an arcuate path. The deployable needle path also preferably includes a pair of arc guides adapted to deploy from the housing along an arc path. The pair of arc guiding portions preferably expands from the housing along the arc path by pulling a first pair of pull wires connected by one pull wire to each guiding portion. The pair of circular arc guide portions are preferably stored in the housing by pulling a second pair of pull wires connected to each guide portion by one pull wire of the second pair of pull wires. Conforms to and is configured. The first pair of pull wires preferably form a pair of continuous mechanical loops by connecting to the second pair of pull wires, the loops being distal to the guide and A proximal end is connected to the pair of handles, and movement of the handle causes movement of the guide portion.

  In another embodiment, a suturing device having a suturing head is provided. The suturing head includes an elongate housing having a proximal end, a distal end and a peripheral side connecting the proximal and distal ends, the housing defining a longitudinal axis from the proximal end to the distal end. The suturing head further includes a deployable needle path disposed at least partially within the housing, wherein at least a portion of the needle path is approximately 180 degrees arc extent, and is substantially disposed within the housing. Adapted to deploy along the arc path from the unexpanded state to the deployed state where the needle path has an arc range exceeding 180 degrees and the needle path is located in a plane parallel to the longitudinal axis of the housing And composed. The suturing head further includes an arcuate needle disposed within the deployable needle path, the needle having a first tip, a second tip, and a basically toroidal body. The suturing head includes a drive for advancing the needle at a plurality of 360 ° rotations around the needle path when the deployable needle path is in the deployed state, the drive advancing the needle at a 360 ° rotation. In order to achieve this, the needle is selectively coupled or released.

  In other embodiments, the housing may be essentially cylindrical or rectangular as desired. The deployable or expandable needle path may include one or more arc guides adapted to deploy along the arc path from the housing. The deployable or expandable needle path may also include a pair of arc guides adapted to deploy along the arc path from the housing. Accordingly, the pair of arc guiding portions can be deployed along the arc path from the housing by pulling the first pull wire, and one pull wire is connected to each guiding portion. In one embodiment, the deployable or expandable needle path occupies about 270 ° of the 360 ° needle path when the needle path is in the expanded state, but the angle range of the path is as desired, for example, 1 degree. May be larger than 270 ° or smaller.

  In the embodiments disclosed herein, these and other advantages are illustrated in all the embodiments described below. Accordingly, the embodiments disclosed herein include structural features, element combinations, and arrangements of parts, which are exemplified in the detailed description below.

  Embodiments disclosed herein are further described by reference to the accompanying drawings, in which like structures are identified with like numbers throughout the various drawings. The drawings described are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the embodiments disclosed herein.

1 generally depicts a suturing device made in accordance with the present disclosure. 1 generally depicts a suturing device made in accordance with the present disclosure. 1 generally depicts a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 4 illustrates aspects relating to one embodiment of a needle loader in accordance with the present disclosure. FIG. 3 illustrates aspects relating to a first embodiment of a suture needle made in accordance with the present disclosure. FIG. 3 illustrates aspects relating to a first embodiment of a suture needle made in accordance with the present disclosure. FIG. 3 illustrates aspects relating to a first embodiment of a suture needle made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suture needle made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suture needle made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suture needle made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suture needle made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a third embodiment of a suture needle made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a fourth embodiment of a suture needle made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. 1 illustrates aspects relating to a first embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. FIG. 6 illustrates aspects relating to a second embodiment of a suturing head of a suturing device made in accordance with the present disclosure. Fig. 4 illustrates an embodiment of an intermediate region of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of an intermediate region of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of an intermediate region of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of an intermediate region of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. Fig. 4 illustrates an embodiment of a handle portion of the suturing device illustrated in Figs. 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D). 4 illustrates the operation of the suturing head described in FIGS. 4 to 32 and 47 (A) to 47 (D).

  Although the drawings describe embodiments disclosed herein, other embodiments are contemplated as described. This disclosure presents exemplary embodiments by way of representation and not limitation. Those skilled in the art can devise numerous other modifications and embodiments in accordance with the scope and spirit of the principles of the embodiments disclosed herein.

  In the following, preferred embodiments of the present disclosure will be described in detail, examples of which are illustrated in the accompanying drawings. The methods and corresponding steps of the disclosed embodiments are described along with a detailed description of the system.

  Roughly speaking, the present disclosure has features that allow the device to be constructed on a smaller scale and has a smaller configuration than the embodiments described in the prior art and patent applications incorporated by reference herein. An embodiment of a suturing device is provided. Specifically, embodiments made in accordance with the present disclosure have a structure that is adapted and configured to be inserted into a 5 mm trocar. As an advantage, the disclosed embodiments still use a relatively large suture needle, thereby allowing substantial tissue to be captured during manipulation, resulting in an effective suture.

  For purposes of illustration and not limitation, an exemplary embodiment of a suturing device 1000 is illustrated in FIG. 1 as an embodiment herein. The device 1000 includes three regions and includes a suturing head 100, an intermediate region 500, and a handle 600. Each region is described in detail below. 2-3 illustrate apparatus 1000 with some portions removed. Specifically, FIG. 2 illustrates the device 1000 with the needle loader removed (described in detail below), and FIG. 3 illustrates the device 1000 with a portion of the handle housing removed.

  For purposes of illustration and not limitation, the suturing head 100 is illustrated in FIG. The suturing head 100 comprises a proximal end 102 and a distal end 104 and by the cooperation of three main housing components (106, 108, 112) defining a gap 110 for receiving the patient tissue to be sutured. Form. The suturing head 100 is adapted to guide a semi-circular needle (300, 350, 400) across the gap 110 along a semi-circular path to form a series of sutures through the tissue to be sutured. And configure.

  Prior to advancing the needle across the gap 110, the suturing head 100 must be converted from a delivery configuration to a deployed configuration. As shown in FIGS. 4 and 5, the suturing head 100 is initially provided in a compact form having a predetermined left-right dimension or diameter φ. The left-right dimension φ may be any dimension, and is preferably about 5 mm. Specifically, the dimension φ is preferably selected so that the suture head 100 can penetrate a standard 5 mm trocar into the patient's abdomen, for example during laparoscopic surgery. FIG. 5 shows the suturing head 100 from an opposite angle as compared to FIG. 4 and includes a pivot boss 114 that engages the intermediate region 500 of the device 1000.

  The suturing head 100 is shown in a deployed configuration in FIG. As shown in FIG. 6, in the deployed configuration, the proximal guide 120 and the distal guide 130 are moved outwardly from the storage position defined by the housing components 106, 108 described in detail below. When deployed as in FIG. 6, the guides 120, 130 define a circular needle path or path 140 that lies in a plane P parallel to the longitudinal axis X of the device 1000. Further, as shown, the front tip 302 of the needle 300 is engaged by a notch 306 located on the inner surface of the needle 300 by the pawl 125 of the proximal guide 120, as will be described in detail below. Advance slightly to pull.

  After the guides 120, 130 are deployed and define the needle path 140, the needle 300 can be advanced along the path by advancing the pawl 160 to the distal tip of its reciprocating path. . FIG. 7 shows that the needle 300 is crotch through the gap 110, and the needle 300 has an arc range of about 180 ° and is basically located outside the container defined by the housing segments 106, 108, 112. FIG.

  8-10 illustrate the functionality of the suturing head 110 from the opposite side of the head. FIG. 8 illustrates the suturing head 100 in a delivery configuration in which the guides 120, 130 are retracted. As shown, the engagement pawl 160 is retracted to the proximal position of the needle 300 and the rear tip 304 of the needle 300 is visible. FIG. 9 illustrates the suturing head in a deployed configuration for deploying the guides 120, 130. As shown in FIG. 9, the distal guide 130 defines an arcuate groove 135 that receives the pawl 160 at the reciprocating distal tip, which can be better understood with reference to FIG. As becomes apparent in FIG. 10, the notch 158 of the drive member 150 is advanced distally with the pawl 160.

  FIGS. 11A to 11D illustrate the structure of the engaging pawl 160. FIG. The pawl 160 includes a housing 166 attached to the distal tip 154 of the drive member 150 (eg, by welding). The housing 166 is preferably a metal tube-shaped structure and houses a pawl spring 164 that biases between the movable pin 168 and the cap portion 162. The cap portion 162 is preferably attached to the housing 166 by welding, for example.

  FIG. 12 illustrates the suturing head 100 with the lid 106 removed, and shows the reciprocal guiding path followed by the guiding portions 120 and 130 together with the driving member 150 and the pawl 160. Guides 120, 130 are advanced from the delivery configuration to the deployed configuration by four advance wires, cables or filaments 172, 174, 176, 178 guided around a series of bosses in lid 106, as described below. Is done. Specifically, each guiding portion 120, 130 includes a crimp 102a, 120b, 130a, 130b that completely forms the tip of each guiding portion 120, 130. Each crimp includes a penetration formed therein to receive the distal ends of the wires 172-178. Wires 172-178 may be of any suitable shape, and most preferably are 0.009 inch diameter multiple strand 300 series stainless steel cables. These tips are compressed and glued or otherwise attached to the crimp. Thereafter, the guides 120, 130 are pulled into or out of the suturing head 100 by applying tension to a pair of wires attached to each guide.

  FIG. 13 illustrates the unfolded guides 120 and 130, and the wires 172 to 178 are not shown for clarity only. FIG. 14 illustrates the drive member 150 with pawl 160 moved into the groove 135 on the side of the guide 130 at the most distal portion of travel. The height 130e of the wall 130d may be improved to overlap the groove 135 or thicker to provide a high load bearing surface for the pawl 160. Stops (not shown) are preferably provided in the form of raised surfaces on the guides 120, 130 and housing components to prevent the guides 120, 130 from falling off the suturing head.

  Obviously, the groove 125 on the side surface of the guide 120 can be used for pawl penetration when the guide is in the deployed state. As illustrated in FIG. 14, the guide unit 150 follows an arc path along the guide unit and matches the path of the needle. FIG. 15 illustrates the spatial relationship between the drive member 150 and the needle with other device components removed. FIG. 16 illustrates the relative position of the needle 300 with respect to the anti-rotation spring 115 and the drive pin 168 stored in the pawl 160. FIG. 17 illustrates in detail the drive pin 168, which includes a distal surface 168a that contacts the needle body, the distal tip of which is the notch surface of the needle 100 or the distal tip 304 of the needle. Contacting the essentially cylindrical surface 168b of the contact circumference, the proximal surface 168d contacting the pawl spring 164, the enlarged head portion 168c, and the narrow portion of the housing 166 of the pawl 160 that prevents the pin 168 from falling off the housing 166 A circumferential distal surface 168e.

  18-21 are additional views of the suturing head 100 with stepwise removal of components. FIG. 18 illustrates the complete suturing head 100 and FIGS. 19-20 illustrate the position of the bosses 106a, 106b, 106c of the housing portion 106 that define the strength points for the guide cables 172, 174, 176, 178 (not shown). Illustrated. A spacer 106d may also be provided to maintain a desired distance between the housing components 106, 108 to allow component movement within the suturing head 100 and serve as a load bearing surface for the wires 176, 178. Obtain (FIG. 29). 20-21 illustrate the removal of the protector 109 that provides internal support for the guides 120, 130 to press against. Guides 120, 130 follow an arc channel defined by the cooperation of components 106, 108 and 109.

  FIG. 22 illustrates the proximal and distal guides 120, 130 in the same spatial relationship as FIG. The proximal guide 120 is depicted in FIGS. 23 (A) -23 (B). The guides 120, 130 are preferably made from a metallic material, for example by using laser welding and assembling metal sub-components, and are integrated and integrated once assembled. The guide portion may be considered to have an “upper surface” facing the drive member 150 and a “lower surface” facing the housing portion 108. Proximal guide 120 defines a curved channel 125 in its upper surface 122. The proximal guide 120 further defines a lower surface 124 having a groove 124b defined therein, an inner surface 126 that presses against the inner surface of the protector 109, and an outer surface 128 that presses against the housing components 106,108. As shown in FIGS. 24 (A) to 24 (B), the distal guide 130 defines a curved channel 135 at its upper surface 132 to guide the pawl 160. The distal guide 130 further defines a lower surface 134 having a groove 134b defined therein, an inner surface 136 that presses against the inner surface of the protector 109, and an outer surface 138 that presses against the housing components 106,108.

  FIGS. 25-32 illustrate the cooperation between the wire / filaments 172-178 and the guides 120, 130. As shown in these drawings, wires / filaments 172, 174, 176 and 178 cooperate with bosses 106a, 106b, 106c and other components of suturing head 100 to selectively advance guides 120, 130. And can be stored. The wire 178 ends at the crimp 130b of the guide part 130. When tension is applied to the wire 178 that wraps the boss 106a (FIG. 28), the guiding portion 120 is advanced outward from the suturing head 100 as a result. Conversely, when tension is applied to the wire 176 that ends at the crimp 130a of the guide portion 130 (FIG. 30), the guide portion 130 is stored in the suturing head 100. Similarly, when tension is applied to the wire 172 that wraps the boss 106c and is attached to the guiding portion 120 with the crimp 120b, the wire 174 that wraps the boss 106c in the opposite direction to the wire 172 while the guiding portion 120 is advanced outward from the stitching head. When the tension is applied, the attachment point is pulled by the crimp 120a, and the guiding portion 120 is returned to the housing and retracted.

  33-37 illustrate an embodiment of a needle loader 180 that is configured to mount a suture needle (300, 350, 400) on the suture head 100. FIG. Needle loader 180 has two main components and includes a body 182 and an advancement 184. The forward pin 184 a is received by the opening 182 a of the main body 182. The body 182 defines a groove 182f for receiving a suture needle (300, 350, 400). The main body 182 includes a central portion 182d and clip portions 182c and 182e that cover the suturing head 100. As desired, the clip portions 182c, 182e can be adapted to cover the suturing head 100 with a snap. A distal stop plate 182b is provided to facilitate axial positioning between the loader 180 and the suturing head 100. The advance portion 184 rotates within the opening 182 a of the main body 182 and further includes a needle pushing arm 186. In operation, as described herein, a needle with a suture material on the back tip is positioned in the path 184f. Next, the loader 180 is snap-mounted on the stitching head. At present, the arm 186 is preferably located near the posterior tip of the needle. The arm 186 is then rotated so that the needle (300, 350, 400) is advanced into the needle path 140. If desired, the needle (300, 350, 400) is a needle loader so that the dimensions of the arm 186 are configured to penetrate through the respective grooves 124b, 134b of the proximal guide 120 and the distal guide 130. You may return to 180 and advance.

  38-40 illustrate a first embodiment of the suturing needle 300. FIG. Needle 300 includes an arcuate structure defined by a front tip 302, a back tip 304 and a surface 305 that is essentially toroidal. Needle 300 includes an opening 312 located in a posterior tip 304 that receives a distal end of a length of suture material 312a with a plurality of notches 306, 308, 310 formed therein. The notches 306, 308 are located in the inner radius region 322 of the needle, while the notch 310 has a protrusion located within a plane P 'defined by the central curve axis X' of the needle. The notch 310 includes a first portion 310a that is basically perpendicular to the plane P ', a portion 310b that is basically located within the plane P', and an inclined portion 310c. The notches 306, 308 have protrusions that are essentially perpendicular to the plane P '. The notches 308, 306 are angled relative to the first portion 306a, 308a and the portions 306a, 308a that are essentially parallel to the cross-section of the needle in that position (eg, an angle of 60 degrees) 306b, 308b Have Notches 308, 310 intersect to simplify the functionality of the specific embodiments of suturing heads 100, 100 'described herein.

  41-44 illustrate a second embodiment of the suture needle 350. FIG. Needle 350 includes an arcuate structure defined by a front tip 352, a rear tip 354 and a basically toroidal surface 355. Needle 350 includes an opening 362 located in a rear tip 354 that receives a length of suture material tip along with a plurality of notches 356, 358, 360 formed therein. Notches 356, 358 are located in the inner radius region 372 of the needle, while notch 360 has a protrusion located within a plane P 'defined by the central curve axis X' of the needle. The notch 360 includes a first portion 360a that is basically perpendicular to the plane P ', a portion 360b that is basically located within the plane P', and an inclined portion 360c. The notches 356, 358 have protrusions that are essentially perpendicular to the plane P '. The notches 358, 356 are angled with respect to the first portion 356a, 358a and the portions 356a, 358a that are essentially parallel to the cross-section of the needle at that position (eg, an angle of 60 degrees) 356b, 358b. Have Notches 358, 360 intersect to simplify the function of the specific embodiments of suturing heads 100, 100 'described herein. Needle 350 comprises an essentially square cross section with a round portion 366 and a tail portion 364 having a round cross section. That is, the needle structure includes a round cross-section portion 366 that separates a needle body having a basically square cross section and a tail 364 having a basically square cross section. It is believed that using a square cross-section needle helps the needle 350 cross the suture head gap 110 and re-enter the suture head in a better position compared to the needle 300.

  FIG. 45 illustrates a third embodiment of the suture needle 400. Needle 400 includes an arcuate structure defined by a front tip 402, a back tip 404 and a basically toroidal surface 405. Needle 400 includes an opening 412 located at rear tip 404 that receives a length of suture material tip, along with a plurality of notches 406, 408, 410 formed therein. The notches 406, 408 are located in the inner radius region 422 of the needle, while the notches 410 have a protrusion located within a plane P 'defined by the central curve axis X' of the needle. The notches 406, 408, 410 are basically the same as those for the needle 300. The main difference between the needles 300, 400 is the addition of an additional cutout 415 that cuts into the needle near the rear tip 404. The notch 415 has a protrusion in the plane P ′ and is formed to receive the housing 166 of the pawl 160. It is believed that using a needle with a notch 415 helps the needle 400 cross the suture head gap 110 and re-enter the suture head in a better position compared to the needle 300.

  FIG. 46 illustrates a fourth embodiment of the suture needle 450. The suture needle 450 is essentially the same as the needle 300 but further comprises an arc keel 475 or raised surface along its entirety. The keel 475 is formed in the grooves 124b, 134b of the guides 120, 130 to stabilize the needle 450 while the needle 450 crosses the suture head gap 110 and reenters the suture head in a better position compared to the needle 300. Fit and configure to move in.

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

  The suturing head embodiment 100 includes a drive member 150 that defines a narrowed or notched region 158, for example as illustrated in FIG. In operation, the notch region 158 is formed so that the boss 106W, 108W (FIGS. 47A-47D) when the pawl 160 is located at the distal tip of the moving range within the groove 135 of the distal guide 130. ). In this position, the drive member 150 extends into the groove 125 of the proximal guide 120 (FIG. 14). However, when tension is then applied to move pawl 160 (and needle 300) proximally along the needle path, narrowed region 158 of drive member 150 passes past bosses 106W, 108W, thereby pawl 160. Can follow the foot under the penetration 106T until it passes the boss 106W when moving in the proximal direction, and can exit the penetration and begin another cycle. That is, the bosses 106W and 108W form a through portion between which the narrowed region 158 can pass but the other part of the member 150 or the pawl 160 cannot pass. Thus, the narrowed area 158 follows the upper path over the bosses 106W, 108W as the drive member 150 advances distally and allows the area 158 to pass over the bosses 106W, 108W when positioned as a boss. , Thereby allowing the drive member 150 and pawl 160 to follow the lower path under the bosses 106W, 108W and move proximally. The housing portion 112 is illustrated in FIG.

  Thus, it will be appreciated that the drive member 150 is ideally metal. Preferably, the drive member 150 is made of hardened stainless steel that has been heat treated to HR900 and may have a chromium coating, such as ME-92® West / Armoloy® of Illinois, 118 Simons Avenue, DeKalb, Mention is given of the commercially coated Armoloy ME 92® from IL 60115, (815) 758-6691. Preferably, the drive member 150 is 17-7 PH stainless steel that hardens from the “C” state to the CH900 state and is coated with a ME 92® coating. Preferably, the ME-92® coating is applied after 900 heat treatment. In the manufacture of member 150, the sequence of steps is a 17-7 PH strip stock machined to the desired size by any number of known methods (eg, electrical discharge machining (EDM), shearing, milling, etc.). Providing the material. The drive ribbon is heat treated and then washed to remove surface oxidation due to the heat treatment, and then a ME-92® coating is applied. As another example, a 17-7PH “A” state material can be heat treated to the RH950 state. In another embodiment, the drive member 150 may be made from a shape memory material, such as a nickel-titanium alloy sold under the trade name, such as NITINOL®. In another embodiment, the drive member 150 is made from a polymeric material. In one aspect, the drive member 150 can comprise a polyethylene terephthalate material or a high strength nylon material. A sheet of plastic and metal material or multiple materials may be used as desired. As another example, the drive member 150 can comprise a bundle of wires or filaments, a single wire or filament, or any material in any configuration that can drive the needle around the needle path.

  The other components of the suturing head 100, including the needle (300, etc.) are preferably formed by metal injection molding (MIM) techniques known from various materials, preferably stainless steel prior art. In a preferred embodiment, preferably a 17-4PH stainless steel alloy is used. The device 1000 is preferably a disposable device and the handle component may preferably be made from injection molded plastic as desired.

  A further embodiment of a suturing head 100 'is illustrated in Figs. 47 (F) -55. The main difference between the suturing head 100 ′ and the suturing head 100 is that, unlike the alternate path of the embodiment 100, the drive member 150 in the suturing head 100 ′ follows a single path during reciprocation. FIG. 47 (F) illustrates the suturing head 100 'including the needle 300 with the guides 120', 130 'in the deployed configuration. The guides 120 'and 130' are only partially displayed, and do not depict a configuration with a crimp at the tip to engage the deployment or storage cable as in the embodiment 100 above. The suturing head 100 ′ defines a guiding path 153 ′ between the housing components 106 ′ and 112 ′, similar to the suturing head 100 defining a guiding path between the housing components 106 and 112 (FIG. 21). (FIG. 48). FIG. 48 excludes the material 112a ′ that acts as a pawl and changes the components 106 ′, 112 ′ by adding the material 106′b to the component 106 ′ to act as a new pawl. An alternative route 1001 followed by 'is further illustrated. The end result is another angle of incidence on the drive member 150.

  FIG. 49 illustrates the “left” housing component 108 ′ from various angles, and FIGS. 50A-50E illustrate the “right” housing component from various angles. From these figures, the path 153 'followed by the drive member 150' and pawl 160 '(not shown) is evident. The drive member 150 ′ and pawl 160 ′ may be substantially identical to the embodiments 150, 160, but follow a single path that the pawl 160 ′ follows in cooperation with the housing components 106 ′, 108 ′. It will be appreciated that the notch region 158 is not required for definition. 51 (A) -51 (B) illustrate the protector 109 'and illustrate the position of the pawl 115' that assists in preventing the needle (eg, 300) from moving in the opposite direction of the desired movement. To do. FIG. 52 illustrates, for illustrative purposes only, the spatial relationship of the guides 120 ′, 130 ′ with respect to the pin surface 168 a ′ and pawl 160 ′ in each of the two positions. 53 (A) -53 (D) illustrate the housing portion 112 'from various angles. 54-55 illustrate the spatial positioning of the guides 120 ', 130' (substantially the same as the guides 120, 130) with respect to the pawl 115 ', and the guides 120', 130 'are non- A guide stop 117 ′ that assists in stopping at a predetermined position in the deployed state is illustrated.

  56-59 illustrate aspects of the intermediate region 500 of the apparatus 1000. The intermediate region 500 comprises an elongated, preferably metal tube 510 having a proximal end and a distal end 514. The distal end 514 of the tube 510 is attached to the articulation assembly 520 which is then pivotally attached to the suturing head 110 at the pivot 114. A pulley 515 is located on the pivot 114 to serve as a load bearing surface for the tethered articulated cables 532, 534, and the cables 532, 534 are preferably secured to the pulley 515 to provide mechanical efficiency to achieve the joint. Let The articulation cables 532, 534 may be in any suitable form, most preferably. 020 inch diameter multiple strand 300 series stainless steel cable. By pulling one articulation cable, the suturing head 100 is articulated with respect to the intermediate region 500 around the pivot 114. The joint 520 includes a proximal end 522 and a distal end 524 separated by an intermediate region 526 (in the form of yokes 524a, 524b that receive the suturing head 100). The intermediate region 526 defines a longitudinal channel 528 that passes therethrough and receives the drive member 150. Preferably, the drive member 150 is attached to the pull bar 151 within this region, and the cross-sectional profile of the channel 528 is adapted to accommodate such a configuration as shown in the drawings. An opening 523 that receives members 532, 534 is also defined. Openings 525, 527 are also provided to allow penetration of pull wires / cables 172, 174, 176, 178 to control movement of the guides 120, 130. The proximal end of the tubular member 510 is attached to a rotary mechanism that rotates the tube 510 and the suturing head 100 relative to the handle 600 of the device, as described below. The distal end 514a of the tube 510 may extend slightly so that it can be more tightly controlled as the drive element 150 penetrates the intermediate region 500.

  For purposes of illustration and not limitation, the handle 600 of the device 1000 is illustrated in FIGS. The handle 600 includes a number of components and systems for manipulating the suturing heads 100, 100 '. 61 is a front view of the handle, excluding the tube 510, illustrating the rotator suturing device handle 620, and the relative rotational movement of the handle 620 relative to the handle 600 causes the suturing heads 100, 100 ′ to move relative to the handle 600. FIG. Rotate. FIG. 60 is a rear view of the handle 600. FIG. 62 depicts a handle excluding the rotator suture handle 620 and depicts the proximal cable guide 606, the left tube ring 634 and the right tube ring 632. The tube ring portions 632, 634 cooperate to capture the proximal end 512 of the tube 510, which may be, by way of example and not limitation, a 5mm nominal outer diameter stainless steel hypotube. Also illustrated is a joint handle 630 that can be used to move the suturing head 100 like a joint about its pivot point, as described above. The housing 600 includes two main housing halves, including a right side 612 and a left side 614. FIG. 63 illustrates the handle 600 with the tube rings 632, 634 removed. The proximal cable guide 606 is secured within the hypotube, for example, by an interference fit. Along the tube 510, the vertical distance between the distal disk 606 b of the proximal cable guide 606 and the cable disk 648 (FIGS. 71-72) is determined when the suture head is rotated or rotated relative to the handle 600. This is a torsional area where all the cables guided through the tube 510 over such a distance can rotate and twist with respect to each other. The torsional region is preferably about 3-6 inches, and most preferably 4 inches. In a preferred embodiment, the suturing head has a total angular travel range of about 270 degrees relative to the handle 600, preferably about 135 degrees in both directions from the home position shown in the drawings. The detent of the rotator suturer handle 620 (FIG. 64) is adapted and configured to engage the pawl 614g stored in the opening of the left handle portion 614 (FIG. 79A).

  The tube rings (FIGS. 66-67) are essentially mirror-symmetric with respect to each other (with respect to the vertical central plane of the device 1000) and are hollow, essentially cylindrical that receive the proximal end 512 of the tube 510. Cooperate to define the interior of the shape. Specifically, the lugs 632a, 634a are provided to engage the opening 518 near the proximal end 512 of the tube 510 (FIG. 69). The tube ring also defines detents 632b, 634b radially oriented along such a proximal surface for engaging the protrusions 644b on the distal surface of the rotator suture plate 644 (FIG. 68). . The rotator suture plate 644 further includes a square-section proximal portion 644c for receipt by the left and right housing side portions 612,614.

  The rotator suture plate 644 is received within the housing 614 between adjacent ribs 614r (FIG. 70), as does the cable disk 648. The cable disk 648 (FIGS. 71-72) defines a distal-side annular channel 648a that receives the rotator suturing spring 646 with a peripheral groove 648b around it that engages the rib 614r. The spring 646 is adapted and configured to bring the rotator suture plate into contact with the detents 632b, 634b to facilitate gradual rotational movement. Cable disk 648 further defines a plurality of openings 648c therethrough to allow penetration of cables / wires 172, 174, 176, 178, 532, 534 and 551.

  As shown in FIGS. 73-74, a cable path guide 650 is provided to guide cables 172, 174, 176, 178, 532, 534 through the handle 600. Specifically, the guide 650 includes a first series of guides 654 that guide the cables 172, 174, 176, 178 through the handle 600 and a second series of guides or bosses 652 that guide the cables 532, 534. 654. In order to receive the rib 612r of the right housing portion 612, a groove 658 is provided in the guide portion 650 (FIG. 79 (D)).

  75-76 are cutaway views of the handle 600 with the right housing portion 612 removed so that the internal components of the handle 600 can be seen. FIG. 75 illustrates a trigger 700 or actuator in a locked position, while FIG. 76 illustrates a trigger 700 in a released position that can push the trigger, thereby advancing a needle (eg, 300) around the needle path 140. Illustrated. 75-76, the handle prevents trigger 700, pull cable / ribbon 710, trigger spring capsule 720, trigger telescopic spring 730, pull cable 727, pulley 750, and articulation knob 810 from rotating. The brake handle 800 is provided. A stop surface 614s is defined on the left housing 614 to define a stop point for the trigger 700 when the trigger 700 is in the locked state. The right housing 612 includes a similar stop feature 612s (FIG. 79 (D)). The articulation knob 810 (FIG. 77E) has a distal portion 816 that is threaded to receive a handle portion 812, an elongated shaft 814 (FIG. 83) that engages the brake rotating fitting 830, and preferably a hex nut 886. (FIG. 90). The right and left handle cap portions 616, 618 (FIGS. 77 (A) -77 (D)) include bosses 616a, 618a to receive and support the edge 835b of the brake spring 835 (FIG. 84). The load bearing portion 835 a of the brake spring 835 pushes against the brake rotating metal fitting 830, thereby pushing the brake rotating metal fitting 830 against the shaft 814 of the knob 810. The portion 814 of the knob 810 preferably includes a resilient layer or sheath that can grip the serrated 834 of the bracket 830 so that when the knob 810 rotates, the cables 532, 534 along with the bracket 830 are proximally distal to the device 1000. Advances in the direction, resulting in the joints of the suturing heads 100, 100 ′. FIG. 78 illustrates the handle 600 with the components 810, 616, 618 excluded. 79 (A) to 79 (D) illustrate the inside and outside of the left and right handle portions 612, 614. FIG. FIGS. 80-81 illustrate the internal mechanism of the handle 600 with both the handle portions 612, 614 excluded, with the trigger 700 in a locked and released state, respectively. FIG. 82 is a close-up view of the internal mechanism of the handle 600, showing the state where the upper brake pad 820 is removed, and fully illustrating the arrangement of the bracket 830 and spring 835 with the trigger 700 in the released state. An articulated pulley 842 is also shown and is rotationally supported by the articulated pulley holder 840 and is itself biased by a guide spring 845 relative to the bracket 870 to maintain tension on the cables 532, 534. FIGS. 83-85 further illustrate the metal fitting 830, the spring 835, and the spring 845.

  86 (A) -86 (B) illustrate the movement of shuttle 888 (FIGS. 99 (A) -99 (B)) moving in the proximal direction upon release of trigger 700. FIG. Proximal movement of the shuttle 888 prevents the handle 892r from articulating, which in turn prevents the guides 120, 130 from being retracted into the suturing head 100, 100 ′ while the trigger 700 is activated, A needle (eg, 300) is advanced around the circular needle path 140, 140 ′. In FIG. 86, components 830 and 835 have been omitted to better illustrate the lower brake pad 850. The brake pads 820, 850 are preferably made from an elastic and somewhat compressible material, such as silicone. 87A further illustrates the lower brake pad 850, and FIGS. 87B-87D illustrate the brake bracket 860. FIG. Above bracket 860, a circular boss 862 is defined to receive brake handle components 882, 884, 884a (FIG. 91B) along with lower brake pad 850. FIGS. 88-89 (A) illustrate the remaining internal mechanism of the handle, excluding the brake pads (FIG. 88) and the pulley retainer 840 and brake bracket 860. 89 (A) -89 (B) are vertical openings having a narrowed portion 872c that is wide enough to penetrate cables 532, 534 but not wide enough to penetrate cable end 874 (FIG. 91). Further illustrated is a joint joint portion 872 comprising a portion 872a. 872b, on the other hand, is large enough for the end 874 to penetrate the joint 872, thus connecting the cable 532 to the cable 534 and providing a closed loop that simplifies the joint with the joint and brake controller brake handle 800. . The brake trigger 884 can be pulled, the top of the handle component 882 (and the equivalent on the left side of the device) contacts the lower brake pad 850, and the brake pad 850 is configured between the upper and lower brake pads 820, 850 Compressing element 830 causes camming.

  FIGS. 92 to 102 illustrate the lock mechanism of the trigger 700 together with the manner of operation and control of the guides 120 and 130. The guiding portions 120 and 130 are expanded or retracted by the rotary handle 892. Cables 172-178 are guided on a guide 885 that is secured by housing components 612 and 614 and split into two pairs of wires, a series of wires guided down spring loaded pulleys 894a and 896a. The four cables 172, 174, 176, and 178 are fixed to the opening 892 b of the handle 892 by a tapered pin 893. The other pair of cables is guided around handle 887 directly into handle 892. The guiding portion 885 (FIG. 93B) is basically a curved flat member having a plurality of cable guiding portions 885a, and the cables 172 to 178 push the upper surface thereof along the route to the handle 892. FIG. 93A illustrates guides 887 and 885 in situ relative to other internal components of handle 600. FIG. Guide portion 887 (FIGS. 93C-93D) includes a groove 887b defined by boss 887a received by housing portions 612, 614 and fins 887c for guiding cables / wires. The handle 892 includes a grip portion 892a, a groove 892c, and a channel 892d for guiding the cable / wire into the opening 892b (FIGS. 94A to 94E). Both handles 892 may basically have the same form.

  Guide handle 892 plays a role in releasing trigger lock 780, thus allowing trigger 700 to actuate the movement of a needle (eg, 300). As shown in FIGS. 95 (A) to 95 (B), the trigger lock 780 is attached to the cable with a ferrule 781 disposed in the opening 783 by the bifurcation 782 of the trigger lock (FIGS. 95 (C) to 95 (D). ). The trigger lock 780 is slidably disposed on the cylindrical rail 786 and biased to a locked position by a spring 787. A bifurcated 784 at the opposite end of the trigger lock 780 is adapted and configured to couple with the trigger 700. When the cable attached to the ferrule 781 is advanced upward by rotating the handle 892L (FIG. 95B), the fork 784 of the trigger lock 780 is released from the trigger 700, and the trigger can be freely moved. It becomes. The handles 892L and 892R are arranged as pivots on the shaft 891 (FIGS. 96 and 122). FIGS. 97-101 further illustrate additional features of the actuation system for guides 120, 130, stepping out components to better illustrate other components and their relative positions. FIG. 102 further illustrates additional aspects and views of components 840, 894, 896.

  103 to 113 illustrate an operation mode of the reciprocating trigger mechanism 700. 103 illustrates the relative positions of trigger 700, pull cable / ribbon 710, trigger spring capsule 720, trigger telescopic spring 730, pull cable 727, and pulley 750. FIG. FIG. 103 shows a ferrule 752 that excludes components 786, 787 and handle 700 and is secured to the end of pull cable 727 and located within opening 701 in handle 700 (FIG. 105). The trigger 700 is further illustrated in FIGS. 106 (A) -106 (B) from two additional angles, showing a bifurcated yoke 702 near the upper end of the trigger 700. The yoke cap 704 is received within the trigger handle 700 by securing the stud 704a to the hole 700a by interference fit and / or ultrasonic welding, adhesive or the like. The yoke 702 and the yoke cap 704 define openings 702a and 704a for receiving the boss 888a of the shuttle link 888 (FIG. 99 (B)). FIG. 107 (A) illustrates the inside of the capsule 720 and shows the clutch spring 724. 107 (B) to 107 (C) illustrate the housing portion 720a that engages with the housing portion 720b. Since the housing portion 720b is the same mirror image as the portion 720a, only the portion 720a is illustrated. 108 excludes the clutch spring 724 and clearly illustrates the pull cable 727, the clutch spring ferrule 723, and the clutch washer 726. FIG. 109 illustrates the assembly without the spring 730 and the housing portion 720b. FIG. 110 illustrates a close-up of the connection between the drive member 710 and the assembly 720 and how the tabs 711, 712 at the proximal end of the drive member 710 are bent and inserted into the slot 721 a of the washer plate 721. Show. 104 and 109 illustrate an O-ring 720 that can be silicone or other suitable material. O-ring 729 provides a seal for housing segments 612, 614. Ferrule 723 is fixed to cable 727. 111-113 illustrate the ferrule 723, washer plate 721, and the proximal end of member 710 in greater detail, respectively.

  114-120 further illustrate the connection between drive member 710 and drive member 150/551. As illustrated in FIG. 114, the proximal drive member can include the ribbon element 150 described above attached to the intermediate cable section 551 in the intermediate region 500 and secured in place after the end 930 is attached. And is positioned in the cavity 922 in the joint by passing the cable / rod 551 through the slot 924 in the joint 920. The distal round portion 932 faces distally to allow movement between the member 551 and the fitting 920. As illustrated in FIGS. 115-117, the distal end 930 defines a penetration 936 that passes therethrough for receiving the cable 551 and defines a substantially cylindrical proximal section 934. Ferrule 910 penetrates through 912 to receive cable 551 and transverse through to receive brazing or soldering material or other material to hold the ferrule in place on cable 551, etc. An opening 914 is defined. Fitting 920 includes a proximal surface 922a, a distal surface 928, and a bore 922 extending therethrough. As illustrated in FIG. 114 in conjunction with FIGS. 118-120, a threaded male fitting 940 is received within the threaded opening 922 of the fitting and receives a retaining hex nut 950 thereon. The proximal end 943 of the fitting 940 faces proximally and defines a cavity 946 therein for receiving the distal tip 717 of the drive ribbon / cable 710. Tip 717 is inserted into cavity 946 until stop 719 contacts proximal surface 943. Threads 942, 952 are defined on the fitting 940 and nut 950. Components 940, 710 may be joined by any suitable means including, but not limited to, interference fit and / or welding, soldering, brazing, adhesives, and the like. 121-122 illustrate their positioning relative to torsion spring 960 and guide spring 970 and other components within handle 600. FIG. The springs 960 and 970 are part of a control mechanism for deploying and retracting the guiding portions 120 and 130. The extension springs 895 and 897 are shown in FIG. 121 (C).

  An exemplary method of operation of the suturing head 100 is described in FIGS. FIG. 123 illustrates a cut-away view of the suturing head 100 with the needle 300 disposed therein in a delivery configuration in which the guides 120, 130 are stored. Needle 300 is completely contained within device 1000 and pawl spring 115b prevents needle 300 from moving in a counterclockwise direction. Similarly, pawl spring 115a is biased against the inner peripheral surface 322 of the needle to help prevent the needle from moving in the clockwise direction. As described in FIGS. 123-131, the drive system of the apparatus 1000 is adapted and configured to advance the needle 300 with a plurality of 360 ° rotations around the needle path when the needle path is in the deployed state. It will be clear from this disclosure. It is further evident that the needle path is in the range of about 180 ° before deployment and beyond 180 ° in angular range after deployment.

  FIG. 124 illustrates the initial deployment of the guide. The pawl 115a is pulled along the surface 322 of the needle 300 until it engages the notch 308, and the pawl 115b engages the notch 306. The guide is then fully retracted in FIG. 125 and pawl 115a located within guide 120 pulls needle 300 in a clockwise direction and presents it for suturing. On the other hand, pawl 160 is advanced along its circular path along guides 120, 130 to its most distal extent, aligning notch 158 in drive member 150 with boss 108a and pawl 115b. Pressed against the surface 122 of 300. When the drive member 150 is then pulled proximally, the notch area 158 of the member 150 slides over the bosses 106a, 108a and the drive member 150 is lowered into the lower penetration that is partially defined by the penetration 108T. To do. With further proximal movement of the drive member 150, the wider portion of the ribbon 150 that is distal is pressed against the underside of the bosses 106a, 108a and the pawl 160 contacts the trailing edge of the needle 300; The needle is advanced approximately 180 ° as shown in FIG. The distal movement of pawl 160 is then repeated so that pawl 160 engages notch 310 in needle 300. Region 158 slides past bosses 106a, 108a as before, pawl 160 and needle tip 302 are pulled along arc needle path 140, and the needle is at its starting point as illustrated in FIG. Will result in a return. FIG. 129 illustrates the guides 120, 130 partially retracted so that the needle is moved counterclockwise until the notch 306 meets the pawl 115b. FIG. 130 illustrates the guides 120, 130 stored further away, and illustrates how the pawl 115 a is pulled out of the notch 308 and pulled along the needle surface 322. Further counterclockwise movement of the needle 300 is prevented by locking the pawl 115b in the notch 306. FIG. 131 again illustrates the suturing head 110 in a delivery or removal configuration with the guides 120, 130 fully retracted. Accordingly, provided herein are devices that can rotate the disclosed needle through 180 °, 360 °, or any additional multiple of 180 ° as desired. If desired, the forward angle increment could be greater or less than 180 ° as desired.

  The suture device disclosed in the present specification includes laparoscopic colostomy, colectomy, adrenalectomy, splenectomy, paraesophageal hernia, inguinal hernia, abdominal hernia, Nissen cardioplasty, liver It can be used for laparoscopic procedures including but not limited to lobectomy, gastrectomy, small bowel resection, treatment of small bowel obstruction, pancreatic tail resection, nephrectomy and gastric bypass. One skilled in the art will appreciate that the embodiments disclosed herein can be used for other laparoscopic procedures.

  In using the apparatus of the embodiments disclosed herein, gas is blown into the abdomen to create a working space for the user. Any gas known to those skilled in the art may be used, including but not limited to nitrogen or carbon dioxide. An access portal is established by using a trocar at the appropriate location for a particular operation. Various surgical instruments can then be inserted into the living body through these access ports / cannulas. The user inserts the distal tip of the suturing device into the cannula and moves the suturing head assembly (eg, 100, 100 ') articulated. Thereafter, the suture head assembly is positioned relative to the tissue / vessel to be sutured and the user preferably secures the suture head assembly in that position. The user then manipulates the suturing device to insert a plurality of separated tissue segments into the opening defined by the distal tip of the suturing head assembly. The user operates the handle using only one hand to close the incision with a continuous suture that can be individually and accurately tensioned along the entire suture as well as traditional manual stitching. The device can be operated. The user may use a single suture or multiple sutures that extend throughout the incision. Thus, by positioning the device to crotch the incised tissue segment and actuating the handle, the suturing device can be sewn to the user to effectively close the tissue incision in terms of time. Or it is possible to tie interrupted stitches. One skilled in the art will appreciate that the device can be used in any conventional procedure for performing laparoscopic surgery.

  The minimized structural design of the suturing head assembly provides the user with an unobstructed view of the suturing needle during advancement through the tissue segment during the suturing operation, thereby providing a uniform suturing and incision edge Allows precise positioning of the suturing device to prevent the risk of damaging tissue due to being too close. The suturing device is then advanced a short distance along the incision and the above operation is repeated to produce another stitch with suture material or thread.

  The user may continue to operate the suturing device, as the needle is advanced in turns and is rotated around an axis essentially parallel to the direction of advancement, or a continuous stitch or series that can extend over the entire incision. Generate interrupted stitches. After tying each individual stitch, the stitch is tightened by pulling the suture material or thread so that the resulting suture has a uniform tension along the entire incised tissue segment. Thus, a tight closure of the segment is achieved, with minimal bleeding and tissue breaking. Once the appropriate amount of suture material or thread 246 has been positioned, the user can use the needle gripping device to tighten and tie the formed stitch.

  In the description herein, all patents, patent applications and published reference materials are hereby incorporated by reference in their entirety. It should be understood that the various disclosed and other features and functions, or alternatives thereof, are preferably combined in many other different systems and applications. At this time, unexpected or unforeseen alternatives, modifications, changes or improvements may be made to those skilled in the art and are intended to be covered by this disclosure.

In the embodiments disclosed herein, these and other advantages are illustrated in all the embodiments described below. Accordingly, the embodiments disclosed herein include structural features, element combinations, and arrangements of parts, which are exemplified in the detailed description below.
[Aspect 1]
A suturing needle having an arcuate body with an anterior tip and a trailing edge, the arcuate body having a first score along the inner radial region needle and a protrusion located in a plane defined by the central curve axis of the needle. A suturing needle that defines a second score having a cross and further intersects the first score and the second score.
[Aspect 2]
The suture needle according to aspect 1, wherein the needle further comprises a generally square cross-section.
[Aspect 3]
A suture needle according to aspect 2, wherein the needle body includes a portion having a circular cross section that separates a main portion of the needle having a generally square cross section and a tail portion having a generally square cross section.
[Aspect 4]
The suturing needle according to aspect 1, wherein the needle further defines a third score for receiving a portion of the drive pawl near the trailing edge.
[Aspect 5]
The suture needle according to aspect 1, further defining an arcuate keel along the longitudinal axis.

Claims (5)

  A suturing needle having an arcuate body with an anterior tip and a trailing edge, the arcuate body having a first score along the inner radial region needle and a protrusion located in a plane defined by the central curve axis of the needle. A suturing needle that defines a second score having a cross and further intersects the first score and the second score.   The suturing needle according to claim 1, wherein the needle further comprises a generally square cross-section.   The suturing needle according to claim 2, wherein the needle body includes a portion having a circular cross section separating a main portion of the needle having a generally square cross section and a tail portion having a generally square cross section.   The suturing needle according to claim 1, wherein the needle further defines a third score for receiving a portion of the drive pawl near the trailing edge.   The suture needle according to claim 1, further defining an arcuate keel along the longitudinal axis.

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