Tools and techniques for vaginal approach

Abstract

The present invention describes a trocar assembly and a method of use, wherein the trocar assembly is configured to provide access to the intraperitoneal space to a surgical tool through the rectouterine pouch, the surgical tool optionally including one or more surgical robot components. The diameter of the surgical tool is optionally 5 mm or greater. In some embodiments, the cannula portion has an inner cavity that is sized to provide access to the intraperitoneal space via the rectouterine pouch simultaneously through the vagina to multiple surgical tools. In some embodiments, one or two dilators are optionally used to form an incision sized to receive the distal hole of the cannula. The size of the dilator can form (optionally, starting from puncture by a needle having a diameter of 2 mm or less) a rectangular hole. In some embodiments, the width of the rectangular hole on the major axis is at least twice the width on the minor axis.

Description

[0001] This application is a divisional application of the PCT international application PCT / IL2018 / 050934 (application date: August 23, 2018; priority date: August 23, 2017) entering China's Chinese invention patent application (application number: 201880067375.6; invention name: "Tools and methods for vaginal approach"; entry into the national phase date: 2020.4.16). Summary of the invention

[0002] According to some specific embodiments of the present invention, a stepped dilator for use with a trocar kit to provide abdominal access via a body recess is provided, comprising: a dilator body having a longitudinal axis in a proximal to distal direction; a first tapered region of the dilator body that gradually narrows toward the distal end of the dilator body; and a second tapered region of the dilator body that gradually narrows in a distal direction away from the first tapered region and is separated from the first tapered region by an isolation region.

[0003] In some specific embodiments, the isolation region includes a region of constant cross-section perpendicular to a longitudinal axis extending between the first tapered region and the second tapered region.

[0004] In some specific embodiments, the isolation region includes a region having no cross-sections perpendicular to the longitudinal axis in any direction except for a maximum cross-section perpendicular to the longitudinal axis of the first tapered region.

[0005] In some embodiments, the length of the isolation region is at least 3 mm.

[0006] In some specific embodiments, the length of the isolation region is no greater than 20 mm.

[0007] In some specific embodiments, the length of the isolation region is 5-15 mm.

[0008] In some specific embodiments, the overall taper range of at least one of the first tapered region and the second tapered region gradually decreases between its minimum cross-section and its maximum cross-section, and the maximum cross-section perpendicular to the longitudinal axis is 15 mm or less above the longitudinal distance.

[0009] In some specific embodiments, a diameter of the stepped dilator perpendicular to the longitudinal axis increases by at least 7.5 mm through the range of the taper of at least one of the first tapered region and the second tapered region.

[0010] In some specific embodiments, a cross-section of the first tapered region having a maximum cross-section perpendicular to the longitudinal axis has at least one axis that is about 10 mm or longer.

[0011] In some specific embodiments, the distal tip of the first tapered region comprises 4 mm 2 or smaller front surface hole and expands in the distal direction from the front surface hole through a radius of curvature of at least 2.5 mm.

[0012] In some specific embodiments, the front surface hole is a lumen hole sized to allow a trocar having a diameter less than or equal to about 2 mm to be partially advanced through the hole in a longitudinal direction.

[0013] In some specific embodiments, a cross-section of the first tapered region having a maximum cross-section perpendicular to the longitudinal axis has at least one axis that is about 7.5 mm or longer.

[0014] According to some specific embodiments of the present invention, a kit is provided, comprising the stepped dilator according to claim 1, and a handle and a trocar; wherein the stepped dilator and the handle together define an inner cavity sized to receive the trocar from the proximal end of the handle to the distal tip of the stepped dilator.

[0015] In some embodiments, the trocar is provided with a handle that extends at least 5 cm beyond the distal end of the handle when the distal tip of the trocar is advanced 5 mm beyond the distal tip of the stepped dilator.

[0016] In some specific embodiments, the cannula needle is provided as having a sharpened, internal, spring-loaded core for use as a puncture needle having an extended position and a folded position; the core comprising: a blunt end that extends beyond the sharp tip of the cannula needle in the extended position and prevents the sharp tip from damaging tissue; and the core moves to the folded position when sufficient longitudinal force is applied so that it no longer extends past the sharp tip, allowing the sharp tip to be operable to penetrate tissue.

[0017] In some specific embodiments, the kit is provided with a stopper device configured to prevent the distal tip of the trocar from being advanced more than 5 mm beyond the distal tip of the stepped dilator.

[0018] In some specific embodiments, a cross-section of the second tapered region having a maximum cross-section perpendicular to the longitudinal axis has at least one axis that is about 21 mm or longer.

[0019] According to some specific embodiments of the present invention, there is provided a cannula for providing abdominal access via the wall of a body recess, wherein a cross section of the lumen of the cannula transverse to the longitudinal axis of the cannula has a major axis and a minor axis, and wherein the length of the major axis is at least twice the length of the minor axis.

[0020] In some specific embodiments, the length of the minor axis is between 5 mm and 10 mm.

[0021] In some specific embodiments, the length of the major axis is between 10 mm and 30 mm.

[0022] In some specific embodiments, the lumen wall defining the cross-section of the cannula includes straight sections on opposite sides of the cross-section.

[0023] In some embodiments, the straight sections are interconnected through curved sections.

[0024] In some embodiments, the length of the cannula is at least 5 cm.

[0025] In some specific embodiments, the edge of the hole defined at the distal end of the sleeve includes: a first edge portion extending along one side of the hole, and a second edge portion extending along the other side of the hole, wherein the first edge portion extends farther to the side along the longitudinal axis than the second edge portion.

[0026] In some specific embodiments, the first edge portion and the second edge portion extend along opposite sides of the hole.

[0027] In some specific embodiments, the first edge portion and the second edge portion extend along the major cross-sectional axis.

[0028] In some specific embodiments, the cannula includes a handle extending at least 10 cm from the proximal end of the cannula.

[0029] According to some specific embodiments of the present invention, a cannula for use with a cannula needle to provide abdominal access via a body recess is provided, characterized in that the edge of the hole defined at the distal end of the cannula includes: a first edge portion extending along one side of the hole, and a second edge portion extending along the other side of the hole, wherein the first edge portion extends farther to the side along the longitudinal axis than the second edge portion.

[0030] In some embodiments, the first edge portion is positioned at least 5 mm further than the second edge portion.

[0031] In some specific embodiments, each edge portion of the first edge portion and the second edge portion includes a respective straight segment.

[0032] According to some specific embodiments of the present invention, a method of using a sleeve to provide abdominal access to a body recess via a body recess is provided, the method comprising: inserting the distal end of the sleeve into a dilated hole of a rectouterine pouch via a transvaginal approach; wherein the edge of the hole defined at the distal end of the sleeve comprises: a first edge portion extending along one side of the hole, and a second edge portion extending along the other side of the hole, wherein the first edge portion is positioned to extend further along the sleeve and further away from the dilated hole than the second edge portion; and wherein the sleeve is inserted such that the hole at the distal end of the sleeve is oriented to be open toward the side of the second edge portion and face the rectum adjacent to the rectouterine pouch.

[0033] In some specific embodiments, the method includes inserting a flexible robotic arm through the cannula into the rectouterine pouch such that it exits the aperture in a direction away from the rectum.

[0034] In some specific embodiments, inserting the distal end of the sleeve into the rectouterine pouch includes sliding the sleeve on an outer dilator; the outer dilator has a tapered distal insertion end, which is sized and shaped to slide on an inner dilator having a tapered distal insertion end, and the inner dilator has a rounded tip; the sleeve slides cooperatively over the outer dilator; and at least the outer dilator is inserted into the rectouterine pouch via a transvaginal approach.

[0035] In some specific embodiments, the method includes sliding the sleeve over the outer dilator while the inner dilator remains within the outer dilator.

[0036] In some specific embodiments, inserting the distal end of the sleeve into the rectouterine pouch includes sliding the sleeve on a stepped dilator; the stepped dilator has a tapered distal insertion end having a rounded tip, a second tapered area, and a separation area between the second tapered area and the tapered distal insertion end; the sleeve is cooperatively slid on the stepped dilator; and the dilator is inserted into the rectouterine pouch via a transvaginal approach.

[0037] In some specific embodiments, the rounded tip has a hole sized to pass through a trocar having a diameter of less than or equal to about 2 mm.

[0038] According to some specific embodiments of the present invention, there is provided a kit for providing abdominal access via a body recess, comprising: a cannula, wherein a cross-section of an inner cavity of the cannula transverse to the longitudinal axis of the cannula has an axis long enough to allow simultaneous insertion of at least two cylindrical members, each having a diameter of at least 8 mm; a stepped dilator having a dilator body, the dilator body having: a first tapered region of the dilator body that gradually narrows toward a distal end of the dilator body; and a second tapered region of the dilator body that gradually narrows in a distal direction, is located proximal to the first tapered region, and is separated from the first tapered region by an isolation region; and a trocar provided with a handle region that extends beyond the proximal end of the inner dilator when the distal tip of the trocar is advanced to the distal tip of the inner dilator.

[0039] In some specific embodiments, the length of the major axis of the cross-section of the cannula lumen is at least 21 mm.

[0040] In some specific embodiments, the sleeve has a short cross-sectional axis; and the length of the long cross-sectional axis is at least twice the length of the short cross-sectional axis.

[0041] In some specific embodiments, the kit includes: arm sheaths for a plurality of robotic arms, the dimensions of which are set to have a minimum diameter of about 10 mm and a maximum diameter of at least twice the minimum diameter to fit within the cannula.

[0042] According to some specific embodiments of the present invention, a method for obtaining abdominal access through a body indentation is provided, which comprises: inserting a first step of a stepped dilator into the rectouterine pouch to widen a hole in the wall of the rectouterine pouch; and inserting a second step of the stepped dilator into the rectouterine pouch to widen the hole; wherein the first step and the second step of the stepped dilator each include an area narrowed in a distal direction, and wherein the first step and the second step of the stepped dilator are separated by an isolation area of ​​at least 3 mm in length.

[0043] In some specific embodiments, the method is performed after the following steps: inserting the stepped dilator laterally into the wall of the rectouterine pouch; and advancing a trocar from within the stepped dilator to create the hole in the wall of the rectouterine pouch.

[0044] In some specific embodiments, the lumen of the cannula has at least a 20 mm long cross-sectional axis.

[0045] In some specific embodiments, the lumen of the cannula has at least a cross-sectional axis of about 12 mm in length.

[0046] According to some specific embodiments of the present invention, a method for obtaining abdominal access through a body indentation is provided, which includes: inserting a camera into an intra-abdominal space with a wall of a rectouterine pouch in the field of view of the camera; illuminating the wall of the rectouterine pouch using an illumination device positioned in the abdominal cavity; selecting a position of a hole in the wall of the rectouterine pouch based on light from the illumination device visible from outside the rectouterine pouch; advancing a trocar from outside the rectouterine pouch to press against the selected position in the wall of the rectouterine pouch; verifying the position of the trocar based on one or more images from the camera within the intraperitoneal space; and puncturing the rectouterine pouch using the trocar to pass through the hole.

[0047] According to some specific embodiments of the present invention, a kit is provided for setting the position of a robotic arm system along the longitudinal axis of a sleeve inserted into a body orifice, wherein the robotic arm system includes a motor unit and at least one robotic arm, and the robotic arm is positioned away from the motor unit along the longitudinal axis, and the kit includes: a sleeve, including a sleeve body, which is configured for insertion into the body orifice; a mounting block, which is configured for attachment to the sleeve; and an assembly, which is attached to the mounting block and includes a spacing arm and an alignment arm, and is movable between a stowed position and a deployed position; wherein the deployed position of the assembly places an element of the alignment arm, and in the deployed position, the assembly indicates a predetermined position along the longitudinal axis.

[0048] In some specific embodiments, the mounting block is attached to the cannula by connecting to an access device having a lumen sized to fittingly receive the cannula therein.

[0049] In some specific embodiments, the spacing arm and the alignment arm are arranged by being hinged about a plurality of stop hinges, each stop hinge defining at least one of a stopped deployed position and a stopped stowed position.

[0050] In some specific embodiments, the kit also includes: the motor unit and the at least one robotic arm extend distally from the motor unit to a predetermined distance from a stopper receiving portion of the motor unit; wherein, when the at least one robotic arm is inserted into the sleeve, the distal end of the at least one robotic arm is aligned with the distal end of the sleeve, and the stop portion of the alignment arm contacts the stopper receiving portion of the motor unit to prevent longitudinal advancement of the motor unit.

[0051] In some specific embodiments, the kit includes: an arm sheath having an inner cavity sized to receive the at least one robotic arm; and an outer surface sized to fit within the sleeve.

[0052] According to some specific embodiments of the present invention, there is provided an inner dilator for use with a trocar kit to provide abdominal access via a body recess, the inner dilator having a distal insertion end with a longitudinal distance of 15 mm or less between the distal tip and the fully expanded cross-section of the inner dilator, wherein: the fully expanded cross-section of the inner dilator has at least one axis of about 10 mm or longer; the distal tip of the insertion end includes a 4 mm 2 or smaller front surface hole, and the distal tip of the insertion end expands along the cone from the front surface hole through a radius of curvature of at least 2.5 mm; and the front surface hole is a hole of the inner cavity, the size of which is set to allow a cannula needle with a diameter less than or equal to about 2 mm to be partially advanced through the hole in the longitudinal direction.

[0053] In some specific embodiments, the fully expanded cross-section of the inner dilator has at least one axis of about 7.5 mm or less.

[0054] According to some specific embodiments of the present invention, a kit is provided, comprising the inner dilator as described above, together with a trocar, wherein the length of the inner dilator is at least 17 cm, and the trocar is provided with a handle extending at least 5 cm beyond the proximal end of the inner dilator, when the distal tip of the trocar is advanced 5 mm beyond the distal tip of the inner dilator.

[0055] In some embodiments, the trocar is provided with a sharpened, internal, spring-loaded core for use as a puncture needle; wherein the core prevents the sharp tip of the trocar from damaging tissue in its extended position, but when sufficient longitudinal force is applied, the core collapses so that the sharp tip can be operated to penetrate tissue.

[0056] In some specific embodiments, the kit is provided with a stopper device configured to prevent the distal tip of the trocar from being advanced more than 5 mm beyond the distal tip of the stepped dilator.

[0057] According to some specific embodiments of the present invention, a kit is provided, comprising the inner dilator described above, together with an outer dilator, wherein the outer dilator has a distal insertion end, which tapers over the longitudinal distance between the distal opening and the fully expanded cross-section of the outer dilator, wherein the fully expanded cross-section of the inner dilator has at least one axis of about 21 mm or longer.

[0058] In some specific embodiments, the distal opening has an inner lumen sized to fittingly surround a fully expanded cross-section of the inner dilator.

[0059] In some specific embodiments, the kit is provided with a stopper configured to prevent the distal tip of the outer dilator from being advanced more than 15 mm beyond the distal tip of the inner dilator.

[0060] According to some specific embodiments of the present invention, there is provided a trocar kit for providing abdominal access via a body recess, comprising: a cannula having an inner lumen having a cross-section transverse to the longitudinal axis of the cannula having an axis long enough to allow simultaneous insertion of at least two cylindrical members, each having a diameter of at least 8 mm; an inner dilator at least long enough to leave an external treatment area of ​​about 10 cm while being fully inserted into a body hole of 7 cm in length, and having a distal insertion end that tapers over a sufficiently short longitudinal distance to be inserted at 4 mm. 2 The present invention relates to a method for achieving a complete first step expansion by moving between a distal tip of an area of ​​15 mm or less and a fully expanded cross-section of an inner dilator, wherein the fully expanded cross-section of the inner dilator has at least one axis whose length is approximately half of the major axis of the cannula cross-section; when the distal tip of the cannula needle is advanced to the distal tip of the inner dilator, the cannula needle has a handle area extending beyond the proximal end of the inner dilator; and an outer dilator, wherein the outer dilator has a distal insertion end, the distal insertion end extending between a distal opening of 15 mm or less in length and the fully expanded cross-section of the outer dilator, wherein the fully expanded cross-section of the outer dilator is sized to be fitably surrounded by the inner cavity of the cannula.

[0061] In some specific embodiments, the length of the major cross-sectional axis of the cannula lumen is at least 21 mm.

[0062] In some specific embodiments, the sleeve has a short cross-sectional axis; and the length of the long cross-sectional axis is at least twice the length of the short cross-sectional axis.

[0063] According to some specific embodiments of the present invention, a trocar kit for providing abdominal access via a body recess is provided, comprising: an inner dilator, an outer dilator, and a cannula; wherein: the size and shape of the outer dilator are set to be inserted in a fitting manner on the inner dilator; the size and shape of the cannula are set to be inserted in a fitting manner on the outer dilator; the inner dilator is provided to have a rounded distal tip, which has a hole whose size is set for longitudinal passage of a trocar portion whose diameter is less than or equal to about 2 mm; and the inner cavity of the cannula has at least one cross-sectional axis of at least 20 mm; and the inner cavity of the cannula has at least one cross-sectional axis of less than about 12 mm.

[0064] In some specific embodiments, the inner dilator and the outer dilator are tapered from their respective narrower distal insertion ends to their respective full-size cross-sections within 15 mm along the longitudinal axis.

[0065] According to some specific embodiments of the present invention, a method for obtaining abdominal access through a body indentation is provided, comprising: inserting an inner dilator laterally into the wall of the rectouterine pouch; advancing a trocar from within the inner dilator to create a hole in the wall of the rectouterine pouch; inserting the inner dilator having a length not exceeding 15 mm into the rectouterine pouch to widen the hole; inserting the distal end of the cannula into the rectouterine pouch by sliding the outer dilator over the inner dilator and passing through the hole while the hole is held open by the inner dilator; wherein the inner lumen of the cannula has at least one cross-sectional axis having a length of at least 20 mm.

[0066] In some specific embodiments, the lumen of the cannula has at least one cross-sectional axis that is less than about 12 mm.

[0067] According to some specific embodiments of the present invention, a method for obtaining abdominal access through a body indentation is provided, comprising: inserting a camera into an intra-abdominal space having a wall of a rectouterine pouch in the field of view of the camera; illuminating the wall of the rectouterine pouch using an illumination device positioned in the abdominal cavity; selecting a position of a hole in the wall of the rectouterine pouch based on light from the illumination device visible from outside the rectouterine pouch; advancing a trocar from outside the rectouterine pouch to press against the selected position in the wall of the rectouterine pouch; verifying the position of the trocar based on one or more images from the camera within the intraperitoneal space; and puncturing the rectouterine pouch using the trocar to pass through the hole.

[0068] According to some specific embodiments of the present invention, there is provided a kit for setting the position of a robotic arm system along the longitudinal axis of a cannula inserted into a body orifice, wherein the robotic arm system includes a motor unit and at least one robotic arm, the robotic arm being positioned away from the motor unit along the longitudinal axis, the kit comprising: a cannula, comprising: a cannula body, which is configured for insertion into the body orifice; and a cannula handle extending distally along the longitudinal axis of the cannula; a mounting block, comprising: a mounting block body, and a clamp configured to clamp the cannula handle at a selected longitudinal position relative to the mounting block body; and a motor unit. A stopper comprising a longitudinally extending member attached to the mounting block body and movable between a first position and a second position, the first position being a proximal end extending from the mounting block body by a predetermined length to the motor unit stopper; wherein, when at least one robotic arm is inserted into the sleeve, the proximal end of the motor unit stopper in the first position is positioned to contact and prevent longitudinal advancement of the motor unit, thereby defining a predetermined longitudinal position of the robotic arm system relative to the sleeve; and wherein the second position of the motor unit stopper removes the proximal end of the motor unit stopper from a position that prevents longitudinal advancement of the motor unit from the predetermined longitudinal position.

[0069] In some specific embodiments, the motor unit stop is attached to the mounting block body by a hinge, the first position includes the orientation of the motor unit stop along the longitudinal axis of the cannula, and the movement between the first position and the second position includes the rotation of the motor unit stop on the hinge.

[0070] In some specific embodiments, the motor unit stop is movable between the first position and the second position, and when the at least one robotic arm is inserted into the cannula, the at least one robotic arm does not interfere with the position of the cannula or the motor unit.

[0071] In some specific embodiments, the kit also includes: a motor unit and at least one robotic arm extending distally from the motor unit to a predetermined distance from a stopper receiving portion of the motor unit; wherein, when the at least one robotic arm is inserted into the sleeve, the distal end of the at least one robotic arm is aligned with the distal end of the sleeve, and the motor unit stop contacts the stopper receiving portion of the motor unit to prevent longitudinal advancement of the motor unit.

[0072] In some specific embodiments, the kit includes a plurality of extenders, each extender including a tube having an inner cavity cross-section sized to receive a robotic arm having a cross-sectional axis at least 7 mm long, the length of the cross-sectional axis being configured to extend longitudinally from a proximal end of the stopper to a longitudinal position distal to the mounting block body.

[0073] In some embodiments, the mounting block body is insertable to receive a plurality of extenders in a position and orientation to allow the robotic arm to be guided along the longitudinal axis to the bore of the cannula body.

[0074] According to some specific embodiments of the present invention, a kit is provided, comprising: an inner dilator, a distal tip of which is sized to partially dilate an incision, and an outer dilator, a size of which is set to slide distally over the inner dilator to further dilate the incision and the distal tip of the outer dilator, wherein: the overall expansion of the inner dilator and the outer dilator is at least sufficient to allow simultaneous insertion of at least two cylindrical members, each cylindrical member having a diameter of at least about 8 mm, and a longitudinal distance along each of the inner and outer dilators is less than about 20 mm; at least one of the inner and outer dilators is marked near the proximal end to indicate the relative position of the two dilators, the relative position including at least one mark indicating the alignment of the distal ends of the two dilators, and a mark indicating the longitudinal position difference of one dilator relative to the longitudinal distance at which the expansion occurs.

[0075] In some embodiments, the inner and outer dilators are marked with a distance ruler indicating the distance along each dilator to its distal end.

[0076] In some embodiments, the distance scales of the inner and outer dilators are digitally calibrated when the distal ends of each dilator are aligned.

[0077] In some specific embodiments, the kit includes an indexing index configured to vary the force required to longitudinally translate the inner and outer dilators based on the relative longitudinal positions of the inner and outer dilators.

[0078] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the invention belongs. Although methods and materials similar or equivalent to the methods and materials described herein may be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification (including definitions) will control. In addition, the materials, methods and examples are only illustrative, rather than necessarily limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0079] Some specific embodiments of the present invention are described below with reference to the accompanying drawings by way of example only. Specifically, reference will now be made in detail to the accompanying drawings, where the details shown are described by way of example only and for purposes of illustrative discussion. In this regard, it will be apparent to those skilled in the art that the accompanying drawings are not exhaustive or complex. Figure 1It will be apparent from the description how to practice the embodiments of the invention.

[0080] In these drawings:

[0081] Figure 1 is a schematic diagram of a portion of a human female pelvic anatomy for reference herein according to some embodiments of the present invention.

[0082] Figure 2A A kit of trocar assemblies according to some specific embodiments of the present invention is schematically shown.

[0083] Figure 2B The distal end portion of the components in the kit of trocar assemblies according to some specific embodiments of the present invention is schematically shown.

[0084] 3A to 3H A method of using a trocar assembly to establish an intraperitoneal channel through the wall of the rectouterine pouch or another body wall according to some embodiments of the present invention is schematically illustrated.

[0085] Fig. 3I Schematically shows some specific embodiments of the present invention. Figure 3H The sleeve structure and the insertion tool.

[0086] Figure 3J is a schematic flow chart outlining preparation for laparoscopic surgery using a trocar according to some embodiments of the present invention.

[0087] Figure 3K is a schematic flow chart showing a method of dilating an access incision and inserting a cannula into the rectouterine pouch according to some specific embodiments of the present invention.

[0088] Figure 3L Schematically illustrates a wider view (with reference to FIG. 1 ) of the positioning of a cannula according to some embodiments of the present invention relative to the anatomy of the female lower abdominal / pelvic region. Figure 3H compared to).

[0089] Figure 4 A dual verification method for positioning an incision for providing transvaginal access to the rectouterine pouch according to some specific embodiments of the present invention is schematically illustrated.

[0090] FIG. 5A to FIG. 5C Different stopper mechanisms for trocar components according to some specific embodiments of the present invention are schematically illustrated.

[0091] FIG. 5D to FIG. 5F The needle, the needle holder and the needle handle according to some specific embodiments of the present invention are schematically shown.

[0092] Figure 5G to Figure 5I The mechanism for controlling the relative positions of the inner dilator, the outer dilator and the needle according to some specific embodiments of the present invention is schematically shown.

[0093] Figure 5J is a flow chart schematically outlining a method of using an indicator to establish and maintain a known penetration depth of a trocar, dilator, and / or cannula component according to some embodiments of the present invention.

[0094] Figure 5K It is shown that according to some specific embodiments of the present invention, the Figures 3A-3I and 5D to Fig.5I Examples of expansion of the components and manufacture of the cannula kit are described and shown in FIG.

[0095] FIG. 6A to FIG. 6E Dilation using a single dilator trocar kit according to some embodiments of the present invention is schematically illustrated.

[0096] FIG. 7A to FIG. 7B According to some specific embodiments of the present invention, Fig. 3I Similar configuration with images taken from inside the abdomen of the insufflator inserted through the cannula in the robotic arm.

[0097] FIG. 8A to FIG. 8B Dimensional features of an outer expander and an inner expander according to some specific embodiments of the present invention are shown.

[0098] 9A to 9D Included are views showing an instrument holder for a cannula and its use configuration according to some specific embodiments of the present invention, wherein the instrument holder includes a motor unit stop for setting an initial robot arm position.

[0099] FIG. 10A to FIG. 10E Schematically illustrated are views showing a collapsing instrument holder for a cannula and its configuration according to some specific embodiments of the present invention, wherein the collapsing instrument holder is used to set an initial robot arm position relative to the cannula.

[0100] FIG. 10F to FIG. 10J Components of a foldable instrument stand according to some specific embodiments of the present invention are schematically shown.

[0101] Figures 11A-11E A stepped dilator, dilator handle and trocar according to some embodiments of the present invention are schematically shown.

[0102] FIG. 12A to FIG. 12CA duckbill gasket according to some embodiments of the present invention is schematically shown for sealing access to a proximal port of an access device. DETAILED DESCRIPTION

[0103] In some embodiments of the present invention, the present invention relates to the field of abdominal surgery, and more particularly, to devices and methods for laparoscopic access to the abdominal space.

[0104] Overview

[0105] Broad aspects of some embodiments of the invention relate to trocar components (alone and / or in a kit) configured to provide access to an abdominal space for surgical tools via the rectouterine pouch, optionally including one or more surgical robotic members (referred to herein as "robotic arms"). Rectouterine pouch access to the peritoneal space offers potential advantages over, for example, umbilical access to the abdominal space, for reduced invasiveness, reduced patient trauma, reduced visible scarring, and / or speed of procedure.

[0106] One aspect of some embodiments of the present invention relates to a cannula having a lumen of elliptical cross-section and configured to simultaneously receive two or more substantially cylindrical tools extending side-by-side along the lumen.

[0107] In some embodiments, a cannula component is provided that has a sufficient longitudinal length to extend between the wall of the rectouterine pouch and a location near the entrance to the vagina, for example, a longitudinal length of about 7-15 cm. Optionally, the intravaginal length of the cannula can be selectively extended (e.g., between 7 cm and about 15 cm) by using the cannula together with an attachment.

[0108] Optionally, the size of the cannula lumen cross section is configured to allow for simultaneous, side-by-side intraperitoneal access to two substantially cylindrical (e.g., tubular) tools having a diameter of approximately 8.6 mm. In some embodiments, the substantially cylindrical tool comprises a tubular robotic arm. In some embodiments, the length of the longest axis of the lumen cross section of the cannula is at least twice the length of the shortest axis. Optionally, the size of the cross section of the cannula is determined to make the maximum axial length of the cross section of the third tool to be approximately 6 mm or less. Compared to a circular cross section that is sized to pass through two or more such cylindrical tools, this elliptical cross section has a potential advantage in that a smaller total cannula circumference can be allowed and a correspondingly smaller incision is required to accommodate the cannula.

[0109] In some embodiments, the cannula has a distal aperture that is angled relative to the longitudinal axis of the cannula so that when inserted into the rectouterine pouch, it opens in the direction of the intraperitoneal space. Potentially, this helps provide space for robotic members and / or other tools to bend to enter the intraperitoneal space.

[0110] Optionally, the cannula is made of stainless steel or another material that can be sterilized and resterilized to surgical use standards. Optionally, the cannula is disposable and provided in a sterile state.

[0111] One aspect of some embodiments of the present invention relates to the geometry of a dilator configured to achieve incision dilation while advancing to maintain a short and / or controlled longitudinal distance to avoid damage to delicate tissue near the rectouterine pouch; and a dilation method adjusted to the geometry of the dilator.

[0112] A significant potential complication of opening the rectouterine pouch incision to the peritoneal cavity is damage to the rectum. Damage may be due, for example, to overpenetration resulting in puncture, scraping, and / or crushing during initial puncture and / or incision dilation. In some embodiments, the limit of maximum longitudinal travel is set by the width of the rectouterine pouch and the need to reduce the possibility of accidental damage to nearby internal organs such as the rectum.

[0113] In some embodiments of the present invention, features of the trocar kit and / or methods of use thereof are potentially used to reduce the risk of injury due to over-penetration during cannulation. In particular, in some embodiments, the target insertion depth (e.g., the minimum depth when fully expanded) is kept low (e.g., expansion occurs up to about 7.5 to 15 mm at a longitudinal insertion depth of about 10-20 mm (e.g., 13 mm, 15 mm, 17 mm, 19 mm, or 20 mm). In some embodiments, expansion occurs at an insertion depth of about up to 30 mm, 40 mm, or 50 mm.

[0114] After the dilator itself is completed, the total insertion depth of the dilator is optionally slightly greater than this (e.g., a maximum of about 2 to 5.5 cm). However, during the dilation phase, the dilator portion of the dilator is advanced through the incision, and potentially injurious forces are particularly likely to be applied because this is the stage of the dilator operation in which resistance is expected to be overcome by the application of additional force.

[0115] Alternatively, insertion to too deep a depth during the dilation phase of the procedure may be deemed inherently more risky to cause injury (eg, due to internal proximity of delicate tissue) than would be caused by reducing the maximum peak insertion force, which would shorten the mechanical advantage of the dilation depth.

[0116] In some embodiments, the expander is provided as a pair of expanders. In some embodiments, the pair of expanders includes a first expander and a second expander, wherein the cross-section of the first expander is smaller than the cross-section of the second expander. Optionally, the first expander is provided as an "inner" expander relative to a second, larger and "outer" expander. The inner and outer expanders are configured to slide longitudinally relative to each other.

[0117] In some embodiments, the dilator is provided as a single dilator that is expanded using a stepwise, multiple (eg, two or three) stage dilator expansion approach.

[0118] In some embodiments, each dilator or dilator step provides each stage of expansion from an initial incision width (the smallest cross-sectional area of ​​the dilator stage) to a final incision width (the largest cross-sectional area of ​​the dilator stage) within about 15 mm of longitudinal advancement. Optionally, expansion occurs within another longitudinal advance distance, for example, a distance in the range of about 10 to 20 mm, such as within the range of 13 mm, 15 mm, 17 mm, 19 mm, or 20 mm.

[0119] The widening over the travel of the dilator stage itself is optionally in the range of about 7.5 to 15 mm, such as about 7.5 mm, 10 mm, 12 mm, 12.5 mm or 15 mm. The relatively fast rate of expansion as a function of longitudinal advancement accepts a loss of mechanical advantage in exchange for a reduced required insertion depth to complete the expansion. When multiple dilators are used, the total insertion depth during expansion can be about the length of one step (optionally, plus a few millimeters after the expansion portion of the dilator, for example, plus 5 to 10 mm). Wherein the subsequent dilator is inserted onto the previous dilator. When using separate (step-by-step expansion) dilators, the insertion depth during expansion can be the sum of the lengths of the individual expansion steps. Add an optional isolation region between the expansion steps, the length of which is, for example, about 5 to 15 mm; and optionally add a few millimeters (e.g., 5 to 10 mm) outside the expansion portion of the dilator. For example, the total insertion depth can be about 50 mm. In some embodiments, the length of the isolation region is at least 3 mm. Additionally or alternatively, the length of the isolation region is less than about 20 mm.

[0120] In this regard, the inventors have recognized that the mechanical properties of the pouch wall tissue in relation to resistance to dilation (e.g., resistance to tearing and / or stretching) are potentially lower mechanical advantages than other entry locations such as the skin, fat and / or muscle layers of the umbilical region, compared to the mechanical properties of the rest of the peritoneal lining. This allows the use of dilator designs with reduced mechanical advantages (blunt) in exchange for potential advantages such as shorter dilator insertion depths and / or fewer number of dilation steps.

[0121] Greater control over the expansion can potentially be provided by providing stop points mid-expansion, dividing the expansion into multiple stages (e.g., by using multiple dilators and / or multiple independent dilator steps). This potentially reduces the chance of uncontrolled tearing during expansion, and / or allows the initial expansion to be checked to ensure that there is no unintended damage (e.g., excessive bleeding) that could be exacerbated by further expansion.

[0122] In some embodiments, the first dilator and / or dilator step has a blunted distal-most portion. The distal-most portion optionally has a port through which a trocar can extend. Optionally, the distal-most portion is proximally curved, with both width and height widened by a radius of at least about 2.5 mm, and then expanded primarily in width to form a wide elliptical cross-section of about 15 mm (or another distance, e.g., in the range of about 10-20 mm) at the proximal end of the distal-most portion.

[0123] In some embodiments, the second dilator and / or dilator step has a distal-most portion that defines an inner cavity that is sized to slide over the first dilator. The outer periphery of the distal-most cross-section is only slightly larger than the rectangular cross-section at the proximal end of the expanded cross-sectional area of ​​the first dilator. From there, the cross-section of the second dilator also expands proximally by about 15 mm (or another distance, such as in the range of about 10 to 20 mm). The maximum value of further expansion is about 5 mm, 7.5 mm, 10 mm, or 12.5 mm, for example. Optionally, the expansion along one axis of the incision cross-section is greater than the expansion along another axis; for example, there may be a relative expansion coefficient of about 1:1.5, 1:2, or 1:3.

[0124] In some embodiments, the cannula is sized to slide appropriately over the second dilator to a position where its distal hole is inserted into the rectouterine pouch.

[0125] In some embodiments, a trocar for use with the first dilator is provided with a retainer and / or handle that is sized such that maximum distal advancement of the trocar is limited by interference between the handle and / or retainer. In some embodiments, the dilators are provided with stops and / or indicator indexes that allow tracking of their relative positions, and / or resist, indicate, and / or prevent over-advancement of one dilator relative to another.

[0126] Optionally, the dilator, handle, holder and / or trocar are made of stainless steel or another suitable material that can be sterilized and resterilized to surgical use standards (e.g., by autoclaving). Optionally, one or more of these components are disposable and provided in a sterile state.

[0127]

[0013] An aspect of some embodiments of the invention relates to maintaining and / or enhancing dilator safety features through feedback features and / or methods that aid in monitoring dilator advancement.

[0128] In some embodiments, the possibility of losing control of position (e.g., sudden unexpected advancement as tissue yields and / or when the end of the dilator's expansion zone is reached) is reduced by moving each dilator relative to a fixed reference (e.g., fixed to the patient's bedside). For example, a first dilator is moved with reference to its initial position and / or an already inserted needle; and / or a second dilator is moved relative to the insertion position of the first dilator. Monitoring of the position relative to the fixed reference position potentially encourages the user of the dilator to ease up on the applied force as the dilator's target position is approached.

[0129] In some embodiments, when approaching and / or reaching the target dilator advancement limit, the stop is set to change (e.g., increase) the sliding resistance between the two components in relative motion. This change can indicate to the user that the target position has been reached, and / or mechanically resist advancement beyond the target position.

[0130] One aspect of some embodiments of the present invention relates to a method of cannulating the wall of the rectouterine pouch while monitoring the puncture using information transmitted across the rectouterine pouch. In some embodiments, initial rectouterine pouch penetration (e.g., using a trocar) is visualized by using a camera and / or light source that has been inserted into the intraperitoneal space from another location (e.g., the umbilical cord). After needle contact, the indentation area may be observed internally before the actual puncture. Alternatively or additionally, transillumination of the rectal sarcoma pouch wall by an intraperitoneally positioned light source is observed from the outside of the pouch to aid in the positioning of the needle for initial penetration. This method has potential advantages because the outer wall of the rectum is located in an area that is difficult to directly access (due to its location deep in the vagina) and nearby sensitive internal structures that may cause surgical complications if damaged during the cannulation process. Dual needle position verification from inside to outside and outside to inside allows the target port location (aimed by the needle that will form the initial opening) to be seen from the outside (by illumination) relative to the reasonable position to the internal structure to be avoided, and then confirming that the actual port location that the needle will actually create is located at the target location.

[0131] It is important to note that the methods described with respect to the rectouterine pouch may be applicable to cannulation of other regions, where the first introduction of the camera and light source is from a first port into the body space and will occur by performing the cannulation. Another port in one region may offer some advantages (e.g., being better suited to accommodate the larger incisions required for larger tools, and / or providing a preferred direction and / or location for tool entry), but may also present a greater risk of complications during creation (e.g., because it is located in an area that is more difficult to target externally, and / or is associated with certain safety risks due to improper execution). More generally, in some embodiments, where multiple ports are to be used, a second and subsequent ports may be opened under lateral observation after the camera and lighting are established in the first port.

[0132] One aspect of some embodiments of the present invention relates to achieving reliable and preferably rapid initial positioning of a robotic arm relative to a cannulated surgical channel. The cannula helps provide access to a surgical area that is not only internal but also at the end of a restrictive tunnel. The robotic arms themselves can be articulated along their length so that the results of commanded motion vary depending on their starting position relative to potential motion restrictions imposed by the cannula and / or with respect to the geometry of the internal body space in which they operate.

[0133] Two particularly important parameters are: the longitudinal advancement distance of one or more robotic arms through the cannula lumen, and the approach angle of one or more robotic arms. Incorrect longitudinal travel distance may result in unexpected motion restriction (e.g., due to the articulated arm portion not exiting the cannula early as expected) or even injury (e.g., collision with body tissue due to advancement). Incorrect approach angles may result in twisting of the robotic arms and / or cannula due to interference with each other as the robotic arms advance. In some more extreme cases, this may result in difficulty in advancing the robotic arms, and / or confusion in the position of the cannula. Even if the alignment is correct enough to enable safe introduction of the robotic arms into the surgical field, the robotic arms may not fully function as intended due to lateral interference forces. Such forces may be difficult to judge by visual inspection for correction or compensation.

[0134] These concerns potentially apply to either or both of robotic arm movements that are entirely under the surgeon's direct direction and robotic arm movements that are at least partially under automated control. In addition, it may be difficult to judge the angle of approach and initial distance of longitudinal advancement required for the intended device operation, potentially leading to a repetitive and / or laborious setup period prior to commencing a surgical procedure.

[0135] In some embodiments of the invention, elements of the device attached to the cannula are configured to provide an indication of where the robotic arm device should be placed. In some embodiments, these elements include spacers and / or guides that, once deployed, provide a clear indication of whether the robotic arm-cannula alignment is correct and / or help prevent incorrect alignment.

[0136] Before explaining at least one embodiment of the present invention in detail, it should be understood that the application of the present invention is not necessarily limited to the construction details and arrangements of the components and / or methods described and / or illustrated below, and / or illustrated in the accompanying drawings. The present invention can be implemented or carried out in other embodiments or in various ways.

[0137] Dilators and cannulas for the rectouterine pouch

[0138] Reference now Figure 1 , Figure 1 is a schematic diagram of a portion of the human female pelvic anatomy referenced herein as described in accordance with some embodiments of the present invention.

[0139] Of particular reference herein by way of description is the rectouterine pouch 19, which comprises a portion of the rectouterine pouch wall 3 accessible from the vagina 17. Figure 1 Also shown in the figure are the bladder 15, the uterus 13, and the rectum 11. As shown, the uterus 13 is in a flexed position (i.e., tilted toward the bladder). In a large number of patients, the uterus 13 may be inverted (i.e., tilted backward) or in another position. In some embodiments, the uterus may be retrogradely manipulated into a position that improves intraperitoneal access through the wall of the rectouterine pouch 3; for example, by using a uterine manipulator.

[0140] Reference now Figure 2A , which schematically illustrates a kit of trocar assemblies 200 according to some specific embodiments of the present invention.

[0141] In some embodiments, trocar assembly 200 is sized and shaped to transvaginally open an intraperitoneal orifice in rectouterine pouch 19 through vagina 17 .

[0142] In some embodiments, the trocar assembly 200 includes a trocar 207, an inner dilator 205, an outer dilator 203, and / or a cannula 201, 1010. These components are optionally sized and shaped to nest one within the next in the order listed. Optionally, by using a stop and / or an indexing device, such as a leaf spring device 503 or another device, such as relative to FIG. 5A to FIG. 5C As described, to indicate and / or limit the distance that trocar components 200 are advanced longitudinally relative to each other.

[0143] Reference now Figure 2B , which schematically illustrates the distal portion of the components in the kit of the trocar assembly 200 according to some specific embodiments of the present invention. 3A to 3H , which schematically illustrate methods of using a trocar assembly 200 to establish intraperitoneal access through the rectouterine pouch wall 3 or another body wall according to some specific embodiments of the present invention.

[0144] although 3A to 3H The expansion process with two dilators is shown, but it should be understood that more dilators (e.g., three, four, five, or more) may optionally be used. Optionally, using more dilators in combination with a steeper dilator tip design (i.e., less expansion per millimeter of advancement) may help reduce insertion resistance. Optionally, only one dilator may be used (e.g., as described herein with respect to FIG. 6A to FIG. 6E The inventors have found that two dilators, each expanding along a longitudinal distance of about 15 mm, are apparently sufficient to achieve a fully expanded size of about 30 mm x 10 mm without excessive insertion force and / or increased risk of injury to the patient. In particular, 15 mm appears to be a safe distance to penetrate directly through the wall 3 of the vagina into the rectouterine pouch 19 without causing significant damage to the adjacent rectouterine pouch 19.

[0145] exist Figure 3A In FIG. 1 , the distal end of the internal dilator 205 is shown, for example, the blunt tip 215 is positioned to contact the rectouterine pouch wall 3, and the distal end extends forward to the wall 3 of the rectouterine pouch 19. In some embodiments, the vagina is advanced. 3A to 3H The vagina 17 is not shown in the sequence, but can be understood as the distal portion of the cannula needle assembly surrounding the rectouterine pouch wall 3.

[0146] exist Figure 3B In the embodiment of the present invention, the sharp tip 217 of the trocar 207 extends from the distal port 216 of the internal dilator 205 enough to pierce the rectouterine pouch wall 3 and enter the rectouterine pouch 19.

[0147] Optionally, the diameter of the trocar 207 does not exceed 2 mm (the distal port 216 is sized large enough to pass through the trocar 207; for example, the distal port 216 may be approximately 2.1 mm in diameter to pass through a 2 mm diameter trocar 207). This limitation in diameter may help reduce the risk of serious complications from accidental insertion into the rectum 11. The trocar 207 may optionally include a Veress needle having a blunt, spring-loaded center probe that, in its extended position, prevents the needle tip from injuring tissue, but collapses when sufficient longitudinal force is applied so that the tip can be used to penetrate tissue. Such a needle is potentially useful for preventing accidental injury during penetration of the wall 3 of the rectouterine pouch 19 (e.g., into the rectum 11).

[0148] In some embodiments, the trocar 207 is limited by a stop device to protrude no more than a few millimeters (e.g., no more than about 3 mm, 5 mm, 8 mm, or 10 mm) from the distal end of the inner dilator 205, which is limited by a stop and / or an indicator index. The limitation on protrusion reduces the chance of needle-induced injury, potentially by over-penetrating the outer tissue wall to be dilated and injuring the inner tissue surface. The selected penetration distance (e.g., 5 mm) is sufficient to stretch and pierce the outer tissue wall with tissue pressed against the inner dilator 205 with the trocar 207, while being short enough to prevent piercing any deeper tissue wall beyond the outer tissue. For example, in this article relative to Figure 4 A method of positioning the trocar 207 for penetration is described.

[0149] exist Figure 3C 219, the internal dilator 205 is advanced through the hole opened by the cannula needle 207 until the wide cross section 219 of the distal region of the internal dilator 205 is reached. During advancement, the blunt tip 215 of the internal dilator 205 is first pushed into the hole in the rectouterine recess wall 3 made by the needle 207. Further advancement of the dilator 205 widens the hole in the wall 3 as the tip expands through the tapered region 218 of the dilator 205 between the blunt tip 215 and the wide cross section 219. In some embodiments, the first (distal) dilator step of the stepped dilator 1100 (i.e., the portion of the dilator 1100 that includes the distal tapered region 1121) is used for these operations.

[0150] In some embodiments, the total distance between the wide cross section 219 and the most distal profile of the blunt tip 215 (at the distal port 216) is about 15 mm. Potentially, this distance is short enough to prevent damage to the wall of the rectouterine pouch 19 opposite the wall 3 penetrated by the internal dilator 205 (e.g., short enough to prevent injury to the rectum). However, providing a certain expansion distance allows for a widening slope of the dilator tip, providing a mechanical advantage during insertion, thereby gradually widening the tissue at the puncture. In some embodiments, another dilator tip length is used, such as about 10 mm, 12 mm, 14 mm, 16 mm, or 18 mm.

[0151] In some embodiments, the blunt tip 215 is rounded from a substantially flat distal-most profile with a radius of curvature of approximately 2.5 mm. Although a blunt profile may initially result in a higher resistance to advancement of the internal dilator 205, the blunt tip profile has the potential advantage of reducing the likelihood of damaging the wall of the rectouterine pouch 19 opposite the wall 3 penetrated by the internal dilator 205 (e.g., being short enough to prevent damage to the rectum).

[0152] Optionally, the length of the longest axis of the cross-section 219 is about 20 mm and the length of its shortest axis is about 10 mm. Optionally, the length of the largest axis of the internal dilator 205 at the cross-section 219 is, for example, about 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. Optionally, the length of the shortest axis of the cross-section 219 is, for example, about 5 mm, 7 mm, 8 mm, 10 mm, 11 mm, or 13 mm. Optionally, the length ratio between the longest axis and the shortest axis is, for example, about 1.5, 2, 2.5, 3, or 3.5. In some embodiments, the expansion of one or both of the longest and shortest axes of the cross-section 219 uses the entire available length of the dilator tip. In some embodiments, the proximal expansion across the shortest cross-sectional axis occurs over a distance of, for example, about 2.5 mm, 3 mm, or 4 mm of longitudinal travel and then flattens. Optionally, the proximal expansion in the longest cross-sectional axis occurs over a distance of, for example, about 8 mm, 10 mm, 12 mm, 13 mm, 15 mm, or 18 mm.

[0153] Optionally, the expansion is substantially linear through the longest cross-sectional axis of the tapered region 218, which is the longitudinal distance for a portion of the internal dilator 205 until the expansion leads to the wide cross section 219. Optionally, the expansion is non-linear, for example, the curved arc expands faster and / or slower as the overall circumference of the hole into the rectouterine pouch wall 3 becomes larger. For example, a relatively blunt tip potentially exploits tissue compliance due to elasticity around an initially small entry incision, while a more gradual cross-sectional expansion is employed where inelastic expansion (e.g., by tearing) predominates.

[0154] Optionally, the rate of expansion (slope) gradually increases moving proximally. Potentially, this allows the percentage elongation of the hole circumference as a function of longitudinal advancement to be maintained at a lower initial value than would be produced by a greater linear expansion over the same distance. This can reduce resistance to insertion, thereby potentially reducing the risk of injury. Optionally, linear or nonlinear expansion is employed by the tapered region 213 of the external dilator 203.

[0155] In some embodiments, the needle 207 is retracted before and / or as the internal dilator 205 is advanced, thereby potentially reducing the risk of injury to the opposing wall. In some embodiments, the advancement distance of the internal dilator 205 is controlled by recording the position of the internal dilator 205 as the needle is inserted and comparing that position to a more advanced position. Optionally, a stop is positioned after the initial insertion of the needle 207 and locked in position relative to the patient (e.g., by locking it to a table via a positioning arm) so as to allow a predetermined total advancement distance (e.g., 15 mm) not to be exceeded.

[0156] exist Figure 3D , the outer dilator 203 is shown being advanced longitudinally over the inner dilator 205 until it reaches the wall 3 of the rectouterine pouch 19 (e.g., such that the distal edge 212 of the outer dilator 203 contacts the wall 3). Figure 3E , the outer expander 203 is further advanced until the level of the wide profile 214 of the outer expander 203. It should be noted that Figure 3E The advancement in FIG. 1 shows that the distal edge 212 of the outer dilator 203 is brought to the same longitudinal position as the dilator 203. In some embodiments, the second (proximal) dilation step (i.e., FIG. 11A to FIG. 11E A portion of the dilator 1100, including the proximal tapered region 1117, is used for these operations. In addition to advancing on the internal dilator, the proximal tapered region 1117 follows the distal tapered region 1121 and optionally follows the intermediate isolation region 1119, as described herein with respect to FIG. 11A to FIG. 11E described.

[0157] FIG. 3A to FIG. 3DThe internal dilator 205 is shown inserted first, followed by the external dilator 203 inserted over the internal dilator 205. In some embodiments, the external dilator 203 is optionally used as the first dilator inserted (or inserted together with the internal dilator 205), followed by puncture using the cannula needle 203, dilation with the internal dilator 205 sliding distally from within the external dilator 203, and finally dilation with the external dilator 203 sliding distally over the internal dilator 205. This provides potential advantages, such as the location of the puncture target location for the needle 207, which can be seen through the relatively open lumen of the external dilator 203 when the wall 3 of the rectouterine pouch 19 is transilluminated. Different insertion sequences can also affect the setting of the stop / indicator indexer (e.g., in relation to FIG. 5A to FIG. 5K ), used to determine the relative distances of different expansion portions during insertion and / or expansion.

[0158] Optionally, the distal hole 220 of the outer dilator 203 is sized to appropriately accommodate the wide cross section 219 of the inner dilator 205. The outer circumference at the distal edge 212 can be only slightly larger than the distal hole 220 (that is, optionally, the distal edge 212 is sharp). Optionally, the distal edge 212 is blunt and / or rounded, for example, having an initial wall thickness (or diameter, in the case of a rounded edge) of about 100 μm, 200 μm, 500 μm, or 1 mm.

[0159] In some embodiments, the distance between the distal edge 212 and the wide profile 214 is about 15 mm. In particular, the distance is optionally any distance described with respect to the distance between the distal-most profile of the inner dilator 205 and the wide cross-section 219. Optionally, the two distances are approximately equal. Optionally, the distance of the outer dilator 203 is slightly shorter (e.g., about 0.5 mm, 1 mm, or 1.5 mm shorter), which potentially reduces the possibility of injury due to tissue contact with the distal edge 212. By using a stop and / or an indicator indexer to control the outer dilator 203 relative to the inner dilator 205, for example, as described herein with respect to FIG. 5A to FIG. 5C as described.

[0160] Optionally, the length of the longest axis of the wide cross section 214 is, for example, about 20 mm, 23 mm, 25 mm, 27 mm, 33 mm, or 35 mm. Optionally, the shortest axis of the wide cross section 214 is, for example, about 5 mm, 7 mm, 8 mm, 10 mm, 11 mm, or 13 mm. Optionally, the length ratio between the longest axis and the shortest axis is, for example, about 1.5, 2, 2.5, 3, or 3.5. The sizing instructions also apply to the inclined distal side of the cannula 201, 1010 and the hole 209 and the lumen of the cannula 201, 1010, which are sized to slide on the external dilator 203 in a suitable manner (e.g., with a relative dimensional tolerance of about 1 mm or less). The lumen of the cannula 201, 1010 is sized to accept multiple (usually tubular, sheathed, and / or cylindrical) tools placed side by side, for example, two tools with a diameter of 8 mm or more, and a tool with a diameter of about 5-6 mm or more. In some embodiments, the cross-section of the cannula 201, 1010 and the dilator 203, 205 is (e.g., Figure 2B and 5K ) is generally rectangular with rounded ends (e.g., rounded such that the short sides are formed as substantially arc-shaped portions).

[0161] The rounded head shape has potential advantages for enclosing multiple cylindrical tools side by side because it allows the outermost tool sides to be stacked toward the outside of the cross section while minimizing wasted corner space ("wasted" relative to the interior of the cannula, which is not so important, but relative to creating an incision hole that may be larger than necessary). Rounded corners (relative to sharp corners) also provide potential advantages during insertion because it helps distribute forces that otherwise may tend to concentrate cutting forces on the corners and cause, for example, unpredictable expansion and / or less predictable healing of the incision. Between the arcuate ends, straight segments (used in some embodiments) have the potential advantage of maintaining an outer profile suitable for maintaining full circumferential contact with the surrounding expanded tissue (e.g., maintaining a tension seal) without the need for additional widening, which would create space that does not require the use of cylindrical tools. In some embodiments, a slight outward bend is introduced along the longer sides of the cross section (e.g., less than 1 mm of bend is introduced per 5 mm of circumference), potentially enhancing the tension contact between the dilator and / or cannula and the edge of the hole in the tissue wall they penetrate.

[0162] In the examples shown herein (e.g., Figure 2B , Figure 5K ), the cross-section of the dilator and cannula shown shows mirror symmetry around the major and minor axes. However, in some embodiments, the cross-sectional shape need not have any particular symmetrical arrangement, and may be shaped in other ways (e.g., as an irregular triangle with rounded corners) to accommodate arrangements of different sizes of tools.

[0163] exist Figure 3F In FIG, the vaginal cannula 201 is shown with its most distal edge 211 raised to the level of the wall 3. Figure 3G , the cannula 201 is shown advanced into the rectouterine pouch 19 such that the distal-most edge 211 is generally flat. Figure 3H The cannula 201 is shown with the inner dilator 203 and outer dilator 205 removed. Optionally, the inner dilator 205 can be removed at any time after the outer dilator 203 is in place. Optionally, both dilators 203, 205 are removed together.

[0164] In some embodiments, the lumen cross-section of the cannula 201 is sized to slide appropriately over a cross-section of an outer dilator 203 having the size of the wide cross-section 214. Optionally, advancement of the cannula 201 is performed using the handle 202. Maximum advancement of the cannula 201 relative to the outer dilator 203 is controlled using a stop and / or an indicator indexer.

[0165] In some embodiments, the lumen of the cannula 201 is about 7 cm or other lengths long enough to reach the distance between the most distal position in the rectouterine pouch and the proximal position at or outside the vaginal introitus (e.g., up to about 15 cm). Optionally, a flange 221 is provided at the proximal end of the lumen of the cannula 201. Although the cannula 201 (with handle 202, as described below) is Figure 3F-3I However, it should be understood that in some embodiments, the foregoing description of the sleeve 201 also applies to Fig. 10B Use of sleeve 1010.

[0166] In some embodiments, the handle 202 of the cannula 201 is long enough to extend beyond either of the dilators 203, 205 when the dilators 203, 205 are inserted, and is long enough to provide a gripping area (e.g., a gripping area of ​​about 10 cm; the total length is at least about 37 cm). In some embodiments, the inner dilator 205 is at least long enough to reach its fully inserted position while providing a grip (e.g., an overall length of about 17 cm), and the outer dilator 203 is at least 10 cm long (e.g., an overall length of about 27 cm).

[0167] Reference now Figure 3L , which schematically illustrates a wider view (with reference to FIG. 100 ) of the positioning of the sleeve 201, 1010 according to some specific embodiments of the present invention relative to the anatomical structure of the female lower abdomen / pelvic region. Figure 3H The anatomical structures shown include the uterus 15, vagina 17, bladder 15, rectum 11 and rectouterine pouch 19, also as shown in FIG. Figure 1The handle of the cannula 201, 1010 and optional related devices are not shown in the figure, such as the insufflation seal, which can provide a cannula and / or a cannula needle portion at the vaginal opening, and the cannula needle can be telescopically installed to extend the length of the cannula 201, 1010.

[0168] In some embodiments, the angled distal orifice 209 of the cannula 201, 1010 is angled at an angle between the forward most distal edge portion 211 and the subsequent more proximal edge portion 210. In some embodiments, the longitudinal distance between the distal most edge portion 211 and the proximal most proximal edge portion 210 is approximately 15 mm. In some embodiments, the distance is, for example, approximately 10 mm, 12 mm, 14 mm, 16 mm, or 18 mm. A potential advantage of the inclination of the distal aperture 209 is that it allows the cannula edge to be relatively retracted on the unprotected side of the cannula, which otherwise might be accidentally positioned to scrape the rectum 11. With respect to the most prominent leading end side of the aperture 211: (1) during insufflation, tissue is typically lifted away from the rectum, thereby reducing the risk of contact from this side; and (2) as the robotic arms advance deeper into the peritoneal cavity, where they exit the cannula, they are typically bent through the plane of the leading edge. This potentially prevents the leading edge from contacting delicate internal tissue. The position of the robotic arms can be, for example, Figure 7A-7B Seen in.

[0169] Reference now Fig. 3I , which schematically shows the method according to some specific embodiments of the present invention Figure 3H The cannula structure and the insertion tool. FIG. 7A to FIG. 7B , FIG. 7A to FIG. 7B According to some specific embodiments of the present invention, similar to Fig. 3I The structure of the cannula 201 is shown in Figure 2, with an image of the robotic arm inserted through the cannula 201 (from the viewpoint of the inside of the abdomen where the insufflation is taking place). Fig. 3I and 7A -7B description also applies to Fig. 10B The sleeve 1010 is provided.

[0170] exist Fig. 3I , the lumen of cannula 201 is shown to be occupied by two substantially cylindrical members, e.g., robotic arms 305 (having, e.g., a diameter of about 8.6 mm) and another cylindrical (e.g., tubular) member including tools 307. (e.g., a laparoscopic illumination source, a camera, clamps, cutters, and / or other tools). In some embodiments, the lumen cross-section of cannula 201 is sized to accommodate a plurality of substantially cylindrical members (e.g., robotic arms) each having a diameter of at least about 8 mm, and another tool optionally operated through a tube having a diameter of 2 mm. At least about 5 mm.

[0171] like Fig. 3I As shown, the tool exiting the oblique distal hole 209 of the cannula 201 located in the rectouterine pouch 19 is optionally oriented to curve downward from the hole and enter the rest of the peritoneal cavity where the laparoscopic procedure will be performed (e.g., trimming ligaments in preparation for a hysterectomy). Optionally, this direction can be determined by the instructions herein for FIG. 3F to FIG. 3H This is aided by the angled slots of the distal aperture 209 described.

[0172] exist FIG. 7A to FIG. 7B In the figure, the robotic arms 305 include surgical tools 704 positioned at the distal end of each robotic arm 305. The figure shows that the robotic arms 305 enter the insufflated abdominal cavity from the cannula 201 through the inclined distal orifice 209. It is also shown in the figure that the cannula 201 has entered the abdominal cavity through the dilated incision 702.

[0173] Reference now Figure 3J , which is a schematic flow chart outlining the preparation for laparoscopic surgery using a trocar 200 according to some specific embodiments of the present invention. The flow chart shown represents the setup portion of a larger surgery (e.g., a hysterectomy), including the Figures 3A-3I Elements of the method.

[0174] Optionally, at block 110, in some embodiments, a laparoscopically mounted camera is inserted into the peritoneal space, for example from the umbilical cord. Optionally, the camera is provided together with an illumination source. Optionally, a separately mounted illumination source may also be inserted from the umbilical cord.

[0175] At block 112, in some embodiments, the peritoneal space is insufflated, for example by insufflation with CO 2. Insufflation is performed during the procedure to enhance access and / or visibility.

[0176] At block 114, in some embodiments, a sleeve is inserted transvaginally. The sleeve potentially helps maintain insufflation pressure (pseudo-peritoneum) for visualization and / or access during the remainder of the procedure. The sleeve can be provided, for example, as a nylon sleeve (Applied Medical Resources Corporation), or as part of a transanal access platform (Applied Medical Resource Corporation). In some embodiments, the sleeve is inserted at a later stage; for example, at block 122, immediately before the sealing unit.

[0177] At block 116, in some embodiments, a speculum is inserted into the vagina to assist with visualization (alternatively or additionally, using a gripper).

[0178] At block 118, in some embodiments, a uterine manipulator is inserted transvaginally into the uterus. The uterine manipulator can be, for example, a Karl Storz uterine manipulator. The uterine manipulator is used to move the uterus during the procedure, for example, to help provide maneuvering space for other instruments, and / or to help move the uterus away from the rectum to provide greater safety. If a holding hook is used, the holding hook can be removed at this time.

[0179] At block 120, in some embodiments, for example, as described herein with respect to Figures 3A-3G , Figure 3K , Figures 6A-6E and / or Figures 11A-11E As described, dilation and introduction of the cannula are performed. The speculum may be removed during dilation, for example if it begins to interfere with dilation, or afterwards.

[0180] At block 122, in some embodiments, the sealing unit is attached to the cannula 201 (or cannula 1010, for example, as described herein with respect to Figures 10A-10C The sealing unit optionally comprises elements of the system; optionally, incorporating elements specifically adapted for use with cannula 201. Optionally, the uterine manipulator is repositioned to pass through the sealing unit.

[0181] At block 124, in some embodiments, securing is performed.Securing includes securing the cannula and / or the sealing unit to a platform that is fixed relative to the patient (eg, an operating table).

[0182] At block 125, in some embodiments, one or more robotic arms are aligned with the cannula 201, 1010 to prepare for introduction into the cannula 201, 1010, for example, as described herein with respect to Figures 9A-9D or Figures 10C-10J As described.

[0183] At block 126, in some embodiments, for example, by Figure 3H As described, one or more robotic arms and / or other tools are introduced through cannula 201 , 1010 .

[0184] Reference now Figure 3K , Figure 3K is a schematic flow chart showing a method of dilating an access incision and inserting a cannula into the rectouterine pouch according to some specific embodiments of the present invention. Figure 3K The method details Figure 3J The operation of block 120.

[0185] The described method is briefly summarized. Figures 3A-3G Describes Figure 3K Additional details of the operation.

[0186] At block 130, in some embodiments, the inner expander 205 (or, in some embodiments, Figures 11A-11E The stepped dilator 1100 is inserted vaginally to reach the wall 3 of the rectouterine pouch 19 (e.g., as described with respect to Figure 3A At block 132, in some embodiments, the tip of the needle (inserted through the internal dilator 207) is positioned at the entry site where the incision is to be made (e.g., see Figure 4 At block 134, in some embodiments, the rectouterine pouch is punctured (e.g., as described with respect to Figure 3B At block 136, in some embodiments, the rectouterine pouch wall 3 intersects the first dilator (eg, the tip of the inner dilator 205) (eg, as described with respect to Figure 3C Optionally, in some embodiments, the rectouterine pouch wall 3 intersects the first (distal) dilator step 1100. At block 138, in some embodiments, the rectouterine pouch wall 3 intersects the second dilator step 203 (e.g., the outer dilator) (e.g., as described with respect to Figure 3D-3E Optionally, in some embodiments, the rectouterine pouch wall 3 intersects the second (proximal) dilation step of the stepped dilator 1100. At block 140, in some embodiments, the rectouterine pouch wall intersects the sleeve 201, 1010 (e.g., as Figure 3F-3G At block 142, in some embodiments, the dilators 203, 205 and / or the trocar 207 are removed and the flowchart ends.

[0187] Reference now Figure 4 , which schematically illustrates a double verification method for positioning an incision for providing transvaginal access to the rectouterine pouch 19 according to some specific embodiments of the present invention.

[0188] Figure 4 , a schematic diagram of the rectouterine pouch 19 is shown, including the vaginal wall 3 of the rectouterine pouch 19, approached by an internal dilator 205, with a trocar 207 partially extended. Also shown are intraperitoneal insertions (e.g., from the umbilical cord) of a camera 402 and an illumination source 401. The camera 402 and illumination source 401 are shown on the same laparoscopic instrument 400; and optionally, they are provided separately. The camera 402 has an associated field of view 402A, and the illumination source 401 has an associated illumination field 401A.

[0189] In some embodiments, the tip of needle 207 is positioned prior to piercing an area of ​​wall 3, wherein the area is selected based on external observation of light from illumination source 401 that is visible from the outside (e.g., as viewed through a colposcope, optionally using a speculum and / or uterine manipulator to increase visibility). Optionally, the area selected is an area where greater intensity of transmitted illumination light is observed compared to surrounding areas. Such a wall area with good transmitted light may be the thinnest, most easily penetrated portion of wall 3, reachable by needle 207.

[0190] In some embodiments, as the needle 207 is pressed against the wall 3 to puncture the wall, the camera 402 is used to visualize the results. For example, a visible protrusion may initially appear in the camera image at the site of penetration (e.g., a visible deformation on the side of the wall 3 opposite the side contacted by the needle), other tissue deformations, and / or other changes (e.g., a color change due to pressure on the tissue), and then the needle itself may become visible. Optionally, the visualization helps verify that the intended area is being penetrated (e.g., the area being penetrated is suitable for providing intraperitoneal access), and / or helps identify and / or prevent impending rectal punctures or other insertion errors. By communicating throughout the rectal wall 3 using visual signals even before the wall 3 itself has been punctured, complications can potentially be avoided.

[0191] Reference now FIG. 5A to FIG. 5C , which schematically illustrate various stops and / or motion interference devices for use with trocar assembly 200 according to some specific embodiments of the present invention.

[0192] Figure 5A Stop and shoulder type stop devices are shown.In this embodiment, the outer dilator 203 is inserted first, or the outer dilator 203 is inserted together with the inner dilator 205. Figure 5A The view of FIG. 5 has a portion of the outer dilator 203 cut away so that the connection between the inner dilator 205 and the proximal stop 501 can be seen.

[0193] The proximal stop 501 is positioned along the inner dilator 205 so that the surface 501A is aligned with the proximal surface of the outer dilator 203 (at Figure 5A The inner dilator 205 is positioned at a position adjacent to the proximal surface of the outer dilator 203 (e.g., cut away in the middle), at a position where the inner dilator 203 is farthest distal to the outer dilator. The inner dilator 205 should be allowed to move (e.g., the distal-most portion of the inner dilator 205 is 15 mm in front of the distal-most portion of the outer dilator 203). Then, when it is the turn of the outer dilator 203 to be advanced, the distance between the surface 501A and the proximal surface of the outer dilator 203 can be measured to determine the advancement distance. Optionally, another stop device (e.g., Figure 5B and / or Figure 5C A stop device) prevents and / or indicates excessive advancement of the outer expander 203 relative to the distal end of the inner expander 205.

[0194] Figure 5B A leaf spring based stopper and / or motion interference device is shown. The device includes a bracket 504 connected to the distal end of the outer expander 203, which in turn supports a leaf spring 505 configured to press down on the body of the inner expander 205. Optionally, the interaction is configured to be sufficient to prevent the inner expander 205 from sliding freely relative to the outer expander 203 (e.g., due to gravity).

[0195] Optionally, the inner dilator 205 includes a receiving shape 505A (hidden by the leaf spring 505) that is positioned to contact the leaf spring 505 and interfere with further longitudinal movement of the outer dilator 203 relative to the inner dilator 205. A stop device can be used to prevent over-expansion. One or both of the inner dilator 205 and the outer dilator 203 are advanced relative to each other. There can be multiple different receiving shapes 505A, allowing different positions to be noted. Although referred to as a "stop", Figure 5B The stop device may optionally be constructed with a shape and / or surface friction that interferes with the resistance, rather than completely preventing further longitudinal movement. In such an embodiment, Figure 5B The stop device may alternatively be described as an "indicator indexer". Optionally, the indicator indexer indicates relative dilator position (as indicated by audible and / or tactile feedback) by a position that resists further longitudinal movement and / or a position where the two dilators snap into place.

[0196] Interference occurs at one or more relative longitudinal positions of the two dilators 203, 205, for example, when the distal-most portions of the two dilators are aligned, such as Figure 3E As shown. The receiving shape 505A may include, for example, an insert portion into which the leaf spring 505 falls when the two portions are aligned. Additionally or alternatively, the receiving shape 505A includes a raised portion. In this case, the inner cavity of the external dilator 203 can be shaped to pass through the raised portion of the receiving shape 505A until the leaf spring 505 encounters it. Alternatively, the inner cavity of the external dilator 203 can be shaped to prevent the receiving shape from passing, so that it also serves as a type of stop and shoulder arrangement. It should be understood that although the device is shown with respect to two nested dilators, the device can alternatively or additionally be implemented between the sleeve and the dilator.

[0197] Figure 5C203, 205. The inner expander 205 may be provided with a receiving shape (not shown) somewhere along its length, the receiving shape including notches and / or protrusions, i.e., portions that contact the leaf springs 503 at a certain relative longitudinal position of the two expanders 203, 205; for example, Figure 3E As shown, when the distal ends of the two dilators are aligned. Figure 5C The leaf spring device is placed at any suitable location along the body of the outer expander 203, but is preferably placed in a position that remains outside the body cavity during use. Multiple such devices can be provided on the outer expander 203, and / or multiple receiving shapes can be provided on the inner expander 205. Optionally, a leaf spring device is provided on the inner expander 205, and an appropriate receiving shape is provided on the outer expander.

[0198] In some embodiments, the stopper and / or motion interference device replaces the leaf spring with another mechanism. For example, in some embodiments, a plunger (e.g., as described with respect to FIG. 8A to FIG. 8B The plunger presses downward to hold two nested components in relative position (e.g., two dilators; a dilator and a cannula), and / or to indicate that a particular relative position has been reached, by friction and / or by interference between the plunger and one or more stop / indicator index shapes - and / or by releasing such interference and / or friction.

[0199] Reference now FIG. 5D to FIG. 5F , which schematically shows the needle 207 and the needle handle 511 according to some specific embodiments of the present invention, and the needle passes through the dilator handle 510.

[0200] exist Figure 5D , the needle 207 is shown partially inserted into the hollow body of the dilator handle 510. The dilator handle 510 can optionally be used as a handle for the internal dilator 205; and the dilator handle 510 can be used as a handle for the internal dilator 205. For example, by threading or other connection means. The proximal end 512 of the needle 207 is suitable for attachment to, for example, Fig. 5F As shown in Figure 5E In some embodiments, for example, as described with respect to Figure 5G to Figure 5I As depicted, the relative lengths of the needle 207 and dilator handle 510 (as well as the relative position of the handle 511 on the needle 207 ) are configured to help control the maximum distance that the needle 207 can be distally advanced relative to the inner dilator 205 .

[0201] Reference now Figure 5G to Figure 5I, which schematically illustrate a device for controlling the relative positioning of the inner dilator 205, the outer dilator 205 and the needle 207 according to some specific embodiments of the present invention. FIG. 8A to FIG. 8B , these figures illustrate the dimensional features of the outer expander 203 and the inner expander 205 according to some specific embodiments of the present invention.

[0202] exist Figure 5G and FIG. 8A to FIG. 8B , the external dilator 203 is shown to be provided with an integrated graduated window 515. The graduated window 515 optionally includes at least one reference mark along a longitudinal window formed on a portion of the external dilator 203 (e.g., cut into the proximal end). In some embodiments, the external dilator 203 is used to define a reference position that allows the current position of the wall 3 of the rectouterine pouch 19 to be inferred. Being too blunt to penetrate the wall 3, the most distal end is usually stopped against the wall 3. This can be verified, for example, by observation using a speculum.

[0203] In some embodiments, a distance scale (e.g., in centimeters from the distal end) is marked on one or both of the inner dilator 205 and the outer dilator 203, for example, scale 811 on the outer dilator 203 and scale 813 on the inner dilator 203. FIG. 8A to FIG. 8B ).

[0204] FIG. 8A to FIG. 8BAlso shown is a ball stop 815, which is an example of an indicator indexer. In some embodiments, the ball stop 815 includes a spring-loaded ball bearing configured to protrude outward from near the proximal end of the inner expander 205 under elastic pressure. The inner cavity of the outer expander 203 is sized so that it can be pushed up and then slid forward along the ball stop 815. During this movement, the ball of the ball stop 815 is pushed inward. It acts (by continuing to squeeze outward) to center the outer expander 203 on the inner expander 205, and optionally resists the spontaneous relative movement (sliding) of the two expanders (e.g., due to the weight of the outer expander 205). When the outer expander 203 is fully advanced, the ball stop 815 is released from the proximal side of the outer expander 203, potentially causing a tactile and / or audible click, and / or causing a change in the mechanical manipulation of the expanders 203, 205, which indicates to the user that the outer expander 203 has been fully advanced. Optionally, the outer dilator 203 includes one or more notches and / or ridges along its lumen at locations thereof that alter the force of the ball stop 815 to interfere with the relative longitudinal translation of the dilators 203, 205. It should be understood that the ball stop 815 may alternatively be provided at locations on the outer dilator 203 (and optionally, its ridges and / or notches) where the device slidably interacts with the inner dilator 205. Optionally, an indicator index is provided for indicating and / or controlling the relative longitudinal position of other paired elements of the trocar set; for example, between the inner dilator 205 and the needle 207, and / or between the outer dilator 203 and the cannula 201, 1010. In some embodiments, a ball stop is provided that, when locked, controls the relative movement between the stepped dilator 1100 and the cannula 201, 1010. In some embodiments, a stop is provided that, when locked, controls the sleeve 1010 and the access device 1001 ( Fig. 10A ) relative motion between them.

[0205] exist Figure 8B , the ball stop 815 is shown still compressed by the outer expander 203. Fig. 8A Once the ball stop 815 is not compressed, the ball is pressed outwardly to the full extent of its travel, resulting in increased resistance (when contacting the proximal surface 817 of the outer expander 203), thereby accidentally pushing the inner expander 205 distally relative to the outer expander 203.

[0206] exist Figure 5H, the inner dilator 205 is shown partially inserted into the outer dilator 203. The graduated markings 517 on the inner dilator 205 allow for monitoring of the distal advancement of the inner dilator 205 relative to the outer dilator 203, for example, even with a distal position of the outer dilator 203 (in preparation for the dilation needle) and / or a position a few millimeters (e.g., 15 mm) distally ahead of the outer dilator 205 during initial dilation.

[0207] Also in Figure 5H , the needle 207 is shown still only partially advanced relative to the handle 510 and the dilators 203, 205. In some embodiments, the dilator handle 510 fits (e.g., screws into) a socket in the inner dilator 205, holding it a predetermined distance from the distal end of the inner dilator 205.

[0208] exist Fig.5I In the illustration, the relative position of the components is shown immediately after the needle 207 pierces the wall 3 of the rectouterine pouch 19.

[0209] As can be seen from the relative positions of the graduated window 515 and the marking 517, the distal end of the inner dilator 205 has moved forward, even as has the distal end of the outer dilator 203. The handle 511 has been pushed forward so that it abuts the proximal end of the dilator handle 510, preventing further advancement of the needle 207. The lengths of the needle 207, the inner dilator 203, and the dilator handle 510 are set so that the needle 207 now extends a predetermined amount from the front of the inner dilator 203, falling within a distance sufficient to penetrate the wall 3 of the rectouterine pouch 19, but avoiding the risk of also penetrating the wall of the rectum 11.

[0210] Optionally, the distal-most end of the inner dilator 205 is longitudinally offset (e.g., away) from the distal-most end of the outer dilator 203 by a certain distance to control the maximum advancement of the needle 207. Optionally, the maximum advancement of the needle 207 is performed prior to the advance through the wall 3 relative to the "advance" operation performed on the inner dilator 205. This provides the potential advantage of allowing the relative positions of the markings of the window 515 and the ruler 517 to indicate in detail the advancement distance of the needle.

[0211] During dilation, in some embodiments, distal advancement of the outer dilator 203 relative to the inner dilator 205 may disrupt the longitudinal frame of reference initially established by the outer dilator 203. In some embodiments, by advancing the inner dilator 205 into the rectouterine pouch, the inner dilator 205 is clamped in place, thereby maintaining the frame of reference.

[0212] Reference now Figure 5K , which shows an example of manufacturing a dilation and cannula kit according to some specific embodiments of the present invention, which includes, for example, FIG. 3A to FIG. 3I and FIG. 5D to FIG. 5I Items are to scale and shown along their overall length, with the exception of needle 207, which is truncated on the right hand side (sharp distal end). The illustration from top to bottom is:

[0213] Needle 207, including handle 511;

[0214] A cannula 201 , comprising a handle 202 and an angled distal aperture 209 , comprising a proximal edge portion 210 and a distal-most edge portion 211 .

[0215] The outer dilator 203 includes a graduated window 515 , a distal edge 212 , a tapered region 213 , and a wide profile 214 proximal to the tapered region 213 .

[0216] An inner dilator 205 comprising a distal port 216 in a blunt tip 215 , a tapered region 218 , and a wide cross section 219 proximal to the tapered region 218 .

[0217] • A dilator handle 510 that can be optionally attached (eg, threadably attached) to the inner dilator 205 to serve as a proximal handle thereof.

[0218] Reference now FIG. 6A to FIG. 6E , which schematically illustrate dilation using a single dilator trocar kit according to some specific embodiments of the present invention.

[0219] Fig. 6A A schematic diagram of a body cavity (e.g., vagina 17) and an access device 601 that may be used, for example, to help maintain insufflation pressure is shown. Figure 6B , a uterine manipulator 603 (shown not fully inserted) is optionally added, potentially allowing manipulation to increase visibility of the trocar target area (which may be the wall 3 of the rectouterine pouch 19, not shown). Figure 6C In the embodiment of the present invention, a cannula 605 (optionally constructed as described herein with respect to cannula 201 or cannula 1010) is inserted into the target area. Cannula 605 includes a handle 605A to allow manipulation of the lumen area of ​​cannula 605.

[0220] exist Fig.6D 607A is optionally used to insert the dilator 607 into the cannula 605. The tip of the dilator 607 is optionally shaped to start at the cutting tip from its most distal longitudinal position. Alternatively, the tip of the dilator 607 is blunt (e.g., its shape is similar to the shape of the internal dilator 205). Optionally, the dilator 607 allows the distal end of the cannula needle to pass through the hole. Optionally, the initial puncture is performed separately by a needle, for example, the dilator 607 is inserted into the lumen of the catheter 605 (not shown), and the dilator 607 is subsequently inserted.

[0221] In some embodiments, the tip of the dilator 607 expands to any suitable cross-sectional size; for example, the tip of the dilator 607 can expand to any suitable cross-sectional size. Optionally, the longitudinal distance between the distal-most position and the maximum expanded tip cross-section is about 15 mm or any other suitable distance; for example, any cross-section described relative to the wide cross-section 219. For example, as described with respect to the dilator tips of dilators 203, 205. A single step expansion at the same maximum dilator tip distance may be simpler from a component replacement and operation perspective relative to using two or more dilators. However, there are potential trade-offs, namely increased penetration length (e.g., if the expansion angle is maintained) and / or increased penetration resistance (e.g., if the expansion angle is increased).

[0222] exist Fig. 6E , the tip of the dilator 607 is shown as being maximally advanced, and dilation is complete. To complete the trocar procedure, the cannula 605 can now be advanced through the dilated hole, and the dilator 607 removed.

[0223] Reference now Figure 5J , which is a flow chart schematically outlining a method according to some embodiments of the present invention that uses indicators to transitionally establish and maintain a known insertion depth of a trocar 207, dilator 203, 205 and / or cannula 201, 1010 parts.

[0224] At box 551, in some embodiments, a first dilator (e.g., internal dilator 205) is inserted into position with its blunt tip against the outer wall of the rectouterine pouch. The position can be set, for example, by direct visualization (e.g., using a speculum), or by indicating where insertion resistance is encountered and / or indirectly (e.g., by using a speculum). By shining a light into the dilator lumen and monitoring the light spot projected through the rectouterine pouch wall (e.g., the location where the light spot reaches its smallest, most clearly defined shape) using a camera located in the peritoneal cavity. Optionally, the first dilator is held in a clamped position, for example, in position. By a clamping arm mounted on a table. Optionally, at box 552, the penetration depth relative to the natural orifice is recorded, providing a total vaginal length (TVL), which can be used separately from the transition method for establishing the position of the trocar assembly, and / or verifying the set insertion depth by the delivery method.

[0225] At block 553, in some embodiments, for example, the trocar 207 is inserted into the dilator 205 via the retainer 210. With respect to the dimensions of the retainer 210 itself, which are sized to enable insertion to a predetermined longitudinal position relative to the first dilator, the number of visible shafts of the trocar 207 optionally indicates where the needle tip is located relative to the distal end of the first dilator. This can be used to control the distance that the trocar 207 is advanced, and can also be controlled in conjunction with a stop (e.g., a shoulder stop) to prevent over-advancement of the trocar 207. Optionally, the needle remains in place at least until the first dilator is advanced over it.

[0226] At box 555, in some embodiments, a second dilator (e.g., an external dilator 203) is advanced over the first dilator until a portion of the second dilator (e.g., its proximal end or a graduation mark) is appropriately aligned with a portion of the second dilator (e.g., a graduation mark on a scale). If a graduation scale is used, it can be on one or both of the first and second dilators. For the purpose of describing the method, it is assumed that the distal ends of the first dilator and the second dilator are aligned with each other at an alignment position; therefore, the distal ends of the first dilator and the second dilator are aligned with each other. Optionally, they are offset by some known amount. Additionally or alternatively, the insertion depth of the second dilator relative to the total length of the vagina is used to longitudinally locate and / or verify the position of the second dilator.

[0227] At this stage, the longitudinal positions of the distal ends of the first and second dilators are known relative to the longitudinal direction of the rectouterine pouch wall to be dilated. Alternatively, either dilator may be advanced or retracted relative to the other in any suitable order, and their positions relative to the rectouterine pouch wall will remain known as long as the order of movement and their distances are tracked.

[0228] For example, at box 557, in some embodiments, the first dilator is advanced into the rectouterine pouch while the second dilator remains fixed (e.g., clamped). Optionally, the relative movement is monitored by observing the movement of the scale marks at the proximal end of the dilator. At box 559, for example, when the first dilator is sufficiently advanced (e.g., 15 mm) to achieve full first stage expansion, the second dilator is advanced (e.g., until the original relative alignment of the two is restored). Additionally or alternatively, the varying insertion depth is controlled / monitored relative to the total length of the vagina.

[0229] Additionally or alternatively (at block 558 and / or block 560 ), the headway distance is controlled by reference to the TVL determined at block 552 .

[0230] At block 561, the first dilator (and trocar 207, if not already removed) may be removed from the position. And the second dilator may remain as a longitudinal positioning reference to position cannula 201 at block 563. Optionally, cannula 201 has a handle that is long enough to support a scale and / or reference mark that aligns with some visible portion of the second cannula (scale mark, distal end or indicator mark) when cannula 201 is in place. Additionally or alternatively, the insertion depth of the cannula is controlled / monitored relative to the total length of the vagina.

[0231] At block 565, the second dilator is removed.Cannula 201 is now positioned across the rectal wall and at a known longitudinal depth relative to the rectal wall.

[0232] Optionally, FIG. 11A to FIG. 11E The stepped dilator 1100 is used by the method, wherein Fig. 6E Insertion optionally occurs in two stages, one in the distal tapered region 1121 and the proximal tapered region 1117, optionally with a pause between the two stages, by allowing the physician to sense the change in insertion resistance as the distal tapered region 1121 transitions to the isolation region 1119.

[0233] Casing fixation and robotic alignment Casing free positioning alignment system

[0234] Reference now Figures 9A-9D , Figures 9A-9D Included are views showing an instrument holder 900 for cannula 201 and its use configuration, wherein the instrument holder 900 includes a motor unit stop 902 for setting an initial robot arm position according to some embodiments of the present invention.

[0235] Fig. 9A The instrument interior support 900 is schematically shown and includes a mounting block 901 and a stop arm 902. In some embodiments, the stop arm 902 is hinged on a hinge 904 to rotate relative to the mounting block 901 to different orientations.

[0236] Fig. 9B The cannula 201 and associated handle 202 are shown mounted to a mounting block 901. In some embodiments, mounting includes positioning the proximal end of the handle 202 in a well-defined position relative to the mounting block 901; for example, flush with a hole 903 of an inner cavity in a frame 901 that is sized and shaped to accommodate the handle 202. The cannula 201 can optionally be secured relative to the frame 901 by tightening the handle 905.

[0237] Fig. 9CAn overall mounting arm assembly 910 is shown including a workbench mounting block 911 (e.g., configured with a clamp and tensioning handle support for securely attaching to a workbench or other stable surface) and an articulated arm 912 extending distally from the mounting block 911 and secured to the distal end of the mounting block 901.

[0238] Fig.9D An instrument holder 900 is shown having a motor unit stop 902 configured to set the initial working distance of a motor unit 930. The motor unit stop 902 is sized so that when positioned to protrude horizontally from the mounting block 901, its distal end marks the distance of the motor. The unit 930 should be positioned so that when the cannula 201 is positioned relative to the mounting block 901, as shown in FIG. Fig. 9B As shown (the bushing is not in Fig.9D 920 ) with its arm (which itself has a well-known predetermined length) reaching a defined (and safe) initial distal-most position within cannula 201 (e.g., at the distal end of the cannula). Robotic arm 305 (not shown) passes distally from motor unit 930 within extender 920. Extender 920 comprises a tube having a lumen size designed to allow robotic arm 305 to pass therethrough, e.g., a lumen of at least 7 mm, 8 mm, 9 mm, or 10 mm. Extender 920 may be aligned (e.g., set at Fig. 9B ) to guide the robotic arm 305 to the sleeve 201.

[0239] A kit including a cannula 201 and handle 202 and an instrument holder 900 with a motor unit stop 902 (optionally including an extender 920 and / or a motor unit 930 and associated arm 305) may facilitate a quick, reproducible initial setup by appropriately positioning its components at marked predetermined locations, providing a defined initial relationship between the distal end of the cannula 201 and the distal end of the robotic arm 305, e.g., alignment of the two ends.

[0240] To allow the robotic arm to initiate movement in the distal direction, the motor unit stop 902 is allowed to swing out of the horizontal position (e.g., downward) so that the motor unit 930 can be advanced distally without interference. Preferably, the motor unit stop 902 is attached to the mounting block 901 and is configured to allow transition between a first position that prevents the motor unit 930 from advancing and a second position that allows the motor unit 930 to advance; the second position prevents the motor unit 930 from advancing. The connection does not necessarily have to be by a hinge (e.g., the stop block 902 can be telescopic, slidable within the block 901, or otherwise movable) without interfering with the position of the two sides of the structure (e.g., without interfering with the position of the sleeve 201 or the motor unit 930). A hinge has a potential advantage by allowing a reproducible longitudinal stop position to be obtained when the stop is oriented in a horizontal position (oriented to the longitudinal axis of the sleeve), and an immediate transition to a non-stop position without requiring much effort. A longitudinal force causes the stop 902 to slide, or a torque is applied to the fastener to release the stop 902.

[0241] Locking alignment system

[0242] Reference now FIG. 10A to FIG. 10E , FIG. 10A to FIG. 10E Schematically illustrates a folded instrument holder 1000 for a cannula 1010 and its configuration according to some specific embodiments of the present invention, which is used in setting an initial robotic arm position relative to the cannula 1010. Also refer to FIG. 10F to FIG. 10J , which schematically illustrates components of a folding instrument holder 1000 according to some specific embodiments of the present invention. FIG. 12A to FIG. 12C , which schematically illustrates a duckbill gasket 1050 for sealing access to a proximal aperture of access device 1001, according to some embodiments of the present invention.

[0243] Fig. 10A An access device 1001 is shown which is configured for insertion into a gel seal 1003 (e.g., in FIG. 10B to FIG. 10C In use, the gel seal 1003 is positioned at the entrance to the vagina to provide protected access. Thus, during surgery, the elements to the right of the gel seal 1003 will be positioned inside the vagina, while the elements to the left will be positioned outside the vagina.

[0244] The cross-seal area 1001A of the access device 1001 is flanged on either side and is located within the gel membrane of the gel seal 1003. In some embodiments, the outer (proximal) side 1001B of the access device 1001 (also referred to herein as the "trocar") is provided with a mounting tab 1002. The lumen 1004 of the access device 1001 is sized to allow for the insertion of a stepped dilator 1100 (e.g., Fig. 10B ), or optionally another expander / expander system, such as a two-piece expander including an inner expander 205 and an outer expander 203. Fig. 10B Also shown assembled with the stepped dilator 1100 are the needle handle 511 of the needle 207 and the dilator handle 510 .

[0245] The lumen 1004 of the access device 1001 is also sized to allow the cannula 1010 to be inserted over the stepped dilator 1100 (or other dilation system). In some embodiments, when inserted into the lumen 1004, the cannula 1010 is properly received by the access device 1001 and optionally locked thereto. In some embodiments, the cannula 1010 includes a body having an elongated (e.g., elliptical) cross-section with an inclined distal aperture 209, e.g., relative to the Figure 3L As described, and having a flange 221 on its proximal side. In some embodiments, flange 221 comprises a receiving recess of ball detent 1006 provided on access device 1001, which controls the relative movement between sleeve 1010 and access device 1001 when locked.

[0246] In some embodiments, after positioning the sleeve 1010, a double seal "duckbill" gasket 1050 (eg, Fig. 10C and Figures 12A-12C 1001. When nothing is inserted into the cannula 1010, the first sealing member 1050A of the gasket 1050 is usually sealed (the two opposite sides are pushed together). Figures 10D-10E 1050B is formed so that it seals around the robot guide 1032. The sealing members 1050A and 1050B are made of a soft elastic material, such as silicone rubber. In some embodiments, the gasket body 1050C includes a rigid polymer or metal material that provides support for the sealing members 1050A and 1050B to help maintain the overall shape of the gasket 1050. In some embodiments, each of the sealing members 1050A and 1050B is formed so as to have a major axis and a minor axis, and the length of the major axis is at least twice the length of the minor axis.

[0247] In some embodiments, the placement of the above elements generally corresponds to Figure 3J The operations of box 120 (expanding and introducing the cannula) and box 122 (sealing unit) are described below.

[0248] In some embodiments, corresponding to Figure 3J The fixing of the operation of block 124 includes attaching the mounting protrusion 1002 to the mounting block 1020. The mounting block 1020 itself can be fixed to a platform fixed relative to the patient, such as an operating table. In some embodiments, the attachment includes inserting the mounting protrusion 1002 into the receiving hole 1061 ( Fig.10J ). In some embodiments, a notch 1005 or another shape on the mounting protrusion 1002 engages the lock within the receiving hole 1061. Optionally, the button 1021 is pressed to assist and / or activate the engagement and / or release of the mounting protrusion 1002 from the lock.

[0249] The mounting block 1020 is a component of the instrument support 1000. The instrument support 1000 is attached to the mounting block 1020 and also includes a spacer arm 1024 and an alignment arm 1030. In some embodiments, the spacer arm 1024 is attached to the mounting block 1020 by a hinge 1022 and an alignment arm 1030 that stops. The arm 1030 is in turn attached to the spacer arm 1024 by a hinge 1028 that stops. In some embodiments, the spacer arm 1024 is telescopic (reversibly extendable and retractable). Optionally, the release and / or locking of the telescopic is controlled by a button 1026 or other control member.

[0250] exist Figures 10D-10E Further shown in FIG. 1 is the use of detent hinges 1022 , 1028 and button 1026 to position the spacing arm 1024 and the alignment arm 1030 .

[0251] In some embodiments of the invention, cannula 1010 is used to provide intraperitoneal access to one or more robotic arms, for example, as described with respect to Fig. 3I and Figure 7A-7B As described in the Overview, these robotic arms can be positioned so that they begin with a well-known longitudinal travel distance through the cannula 1010 and at a well-known approach angle (typically one that is axially aligned with the cannula 1010).

[0252] exist Figures 10D-10E , the spacer arm 1024 and the alignment arm 1030 comprise an assembly that is shown fully deployed (in the deployed position) to help set the starting position for introducing the robotic arm into the cannula 1010. In some embodiments, this includes:

[0253] · Move the spacer arm 1024 from its vertical downward stowed position (eg Fig. 10C90° to the horizontal extended position.

[0254] • Extend the spacer arm 1024 to set the spacing distance by pressing the button 1026 and pulling to expose the telescoping arm portion 1024A.

[0255] • Place the alignment arm 130 from its stowed position against the spacing arm 1024 (eg Fig. 10C ) to the vertical extended position.

[0256] Optionally, after the robotic arm is correctly positioned, the spacer arm 1024 and the alignment arm 1030 are returned to their stowed positions. A potential advantage of storage after use is that they do not interfere with further movement of the robotic arm (eg, deeper entry into the peritoneal cavity).

[0257] Figures 10F-10J These components are shown in more detail. Figures 10F-10H The spacer arm 1024 is shown in a retracted (unextended) configuration. The locked hinges 1022 and 1028 can be seen, including details of their alternative embodiments. For example, in the case of the locked hinge 1022, each (optionally, four) protrusions 1063 are spaced around the circumference of the locked hinge 1022. Each protrusion 1063 extends into a corresponding recess of the plate 1022A. The protrusions 1063 are fixed to the block 1020 in the direction ( Fig.10J ), while the plate 1022A is fixed to the spacer arm 1024. Thus, as long as the protrusion 1063 engages the notch of the plate 1022A, the spacer arm 1024 is fixed in orientation. When the button 1062 is actuated, the protrusion 1063 is recessed from its notch, thereby allowing the spacer arm 1024 to rotate freely. Alternatively, once the notch is removed, the protrusion 1063 is held in place by the plate 1022A, so that the button 1022A can be released while the spacer arm 1024 continues to move freely.

[0258] Once the spacer arm 1024 is deployed a full 90°, the notch of plate 1022A and the tab 1063 realign, allowing the tab 1063 to spring back into place, thereby locking the spacer arm 1024 in the new orientation. This mechanism has the potential advantages of (1) allowing only one orientation of deployment of the spacer arm 1024, and (2) being strong enough to hold the weight of the horizontal deployment of the spacer arm 1024 and alignment arm 1030 without collapsing.

[0259] In some embodiments, the stop hinge 1028 includes a similar mechanism including a protrusion 1065, a button 1067, and a notched plate 1066. The notched plate 1066 is again secured to the spacing arm 1024 while securing the protrusion 1065 in the direction of the alignment arm 1030.

[0260] exist Figures 10D-10EIn the fully extended position, the horizontal rod 1068 of the alignment arm 1030 ( Fig.10I ) is used to set the height that the robot arm should horizontally pass through when aligning the sleeve 1010 so as to be flush with the longitudinal axis of the sleeve 1010. Similarly, the robot arm should pass through the space between the vertical rods 1064 so as to approach the sleeve 1010 along the central longitudinal axis of the sleeve 1010. In addition, in some embodiments, when a certain designated portion ("stop receiving portion") of the motor unit or other housing of the robot arm to be positioned is pressed against the active portion of the alignment arm 1030, the motor unit or other housing is in place, i.e., as a stop, for example, pressing on the vertically extending main rod 1069 of the alignment arm 1030.

[0261] Now back to Figures 10D-10E In some embodiments, before being delivered into the cannula 1010 (e.g., before performing Figure 3J In the operation of block 126 of the embodiment of the present invention, the robotic arm 305 sheath (e.g., two round arms) is placed side by side using the arm sheath 1032. In some embodiments, the arm sheath 1032 has an inner lumen size designed to allow at least two robotic arms having a minimum outer diameter of about 8.6 mm to pass therethrough. In some embodiments, for example, the minimum diameter of the lumen of the arm sheath 1032 is about 9 mm, 10 mm, or 11 mm.

[0262] A potential advantage of the sheath 1032 is to ensure that the robotic arm is straight and, in addition, to ensure that a portion of the robotic arm does not accidentally get caught during entry and passage through the cannula 1010. In addition, in some embodiments, a gasket 1034 is provided that includes: a mounting hole for each of the two robotic arms through which they can pass. The gasket 1034 is suitably attached to the proximal end of the arm sheath 1032 to serve as another protective seal. Optionally, the arm sheath 1032 is made of stainless steel. Optionally, the gasket 1034 is made of a flexible polymer such as silicone rubber.

[0263] Stepped expander

[0264] Reference now Figures 11A-11E , which schematically shows a stepped dilator 1100, a dilator handle 510 and a trocar 207 according to some specific embodiments of the present invention.

[0265] In some embodiments, the dilator handle 510 and the trocar 207 are substantially similar to each other, for example, Figure 5D-5F , Figure 5H , Fig.5I and Figure 5K as described.

[0266] In some embodiments, the stepped dilator 1100 includes distal and proximal tapered regions 1121 and 1117 along the distal working end 1115 of a single dilator. Fig. 11B , Fig. 11C In some embodiments, the shapes of the distal and proximal tapered regions 1121, 1117 are substantially as described with respect to the embodiments of the tapered regions 213 and 218 of the two dilator combinations, such as those described herein with respect to Figure 2A-3I and Figure 5K However, for the sake of clarity, some specific details of the shape of the tapered region are repeated here.

[0267] In some embodiments, the distal (first) tapered region 1121 has a blunt distal-most portion. The distal-most portion optionally has a port through which the trocar 207 can extend. Optionally, the distal-most portion curves proximally, widens in width and height by a radius of about 2.5 mm, and then expands primarily in width to form a wide elliptical cross-section of about 15 mm near the distal-most portion (or another distance), for example in the range of about 10-20 mm.

[0268] In some embodiments, the non-expanded isolation region 1119 extends longitudinally between the distal and proximal tapered regions. Preferably, the isolation region 1119 is long enough to allow the physician to sense a reduction in insertion resistance when passing the proximal side of the distal tapered region 1121 during insertion, and responsively reduces the insertion force, thereby pausing expansion. This distance is optionally in the range of about 5-15 mm. In some embodiments, the isolation region 1119 has a constant cross-section extending proximally from the distal side of the isolation region 1119 until reaching the distal side of the proximal tapered region 1117. Alternatively, in some embodiments, the isolation region 1119A (FIG. 11) includes a contraction (e.g., a tapering contraction) of the proximal cross-section relative to the distal tapered region 1121, which potentially acts as a relief, which allows the surgeon to enhance the feeling of reduced insertion resistance. This contraction may also allow the surgeon to detect by feel the difference between an initial expansion, after which the expanded tissue perimeter remains elastic (tending to cause the expanded opening to re-collapse), and an expansion that has caused a tear, thereby potentially reducing the tendency of the expanded opening to apply inward force to the expander.

[0269] In some embodiments, the proximal (second) tapered region 1117 has a distal-most cross-section originating from the most proximal portion of the isolation region 1119. The cross-section of the second dilator expands proximally therefrom by about 15 mm (or another distance, e.g., in the range of about 10-20 mm). The maximum value of further expansion is, for example, about 5 mm, 7.5 mm, 10 mm, or 12.5 mm of expansion. Optionally, the expansion along one axis of the cutout cross-section is greater than the expansion along another axis; for example, there may be a relative expansion coefficient of about 1:1.5, 1:2, or 1:3.

[0270] In some embodiments, the body 1111 of the expander 1100 is made of a sterilizable and resterilizable (e.g., autoclave compatible) material, such as stainless steel. Optionally, an insertion region 1113 is provided on one or both sides of the body 1111. This potentially reduces the weight of the expander 1100 (e.g., in embodiments where the body 1111 is made of solid metal).

[0271] In some embodiments, the overall length of the dilator 1100 without the handle 510 is at least 17 cm. In some embodiments, the threaded region 1102A is threaded to receive the threads of the handle 510. The length of the handle 510 is optionally at least 20 cm.

[0272] General Concepts

[0273] As used herein, with respect to an amount or value, the term "about" means "within +10%.

[0274] The terms "include", "including", "having" and their combinations mean: "including but not limited to".

[0275] The term "consisting of" means "including and limited to."

[0276] The term "consisting essentially of" means that the composition, method or structure may include other ingredients, steps and / or parts, but the other ingredients, steps and / or parts do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0277] As used herein, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0278] The words "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." Any embodiment described as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0279] The word “optionally” is used herein to mean “provided in some embodiments and not provided in other embodiments.” Any particular embodiment may include multiple “optional” features, unless such features are in conflict.

[0280] As used herein, the term "method" refers to manners, means, techniques and processes for accomplishing a given task, including but not limited to known manners, means or those readily developed from known manners, means, techniques and processes, as well as techniques and procedures implemented by practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine.

[0281] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating the clinical or visual symptoms of a condition, or substantially preventing the appearance of clinical or visual symptoms of a condition.

[0282] Throughout this application, embodiments of the present invention may be presented with reference to a range format. It should be understood that the description of the range format is only for the purpose of convenience and brevity, and should not be interpreted as an inflexible limitation on the scope of the present invention. Therefore, the description of the range should be considered to have clearly disclosed all possible sub-ranges and each numerical value within the range. For example, a description of a range such as "from 1 to 6" should be considered to have specifically disclosed sub-ranges, such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc.; and single numbers within the range, such as 1, 2, 3, 4, 5 and 6. Regardless of the breadth of the range, it is applicable.

[0283] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers represented by these other such ranges), it is intended that any number (fractional or integer) be included within the range. Unless the context clearly dictates otherwise, the indicated range limitations (including the range limitations) are intended to be inclusive. The phrases "range / range between" refer to the range between a first indicated number and a second indicated number, and "range / range from" refer to the range from the first indicated number "to," "up to," "until," or "through" the second indicated number (or another such range indicating term), are used interchangeably herein and include the first and second indicated numbers and all fractions and integers therebetween.

[0284] Although the present invention has been described in conjunction with specific embodiments of the present invention, it is apparent that many substitutions, modifications and variations will be apparent to those skilled in the art. Therefore, it should be considered that the present invention encompasses all such substitutions, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0285] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as each individual publication, patent or patent application is specifically and individually indicated to be incorporated herein by reference. In addition, the citation or identification of any reference in this application should not be construed as an admission that the reference can be used as prior art for the present invention. To the extent that this section heading is used, it should not be construed as a necessary limitation.

[0286] It should be understood that, for the sake of clarity, specific features described in the context of different embodiments of the present disclosure may also be provided in combination in a single embodiment. Conversely, for the sake of brevity, various features described in the context of a single embodiment may also be provided individually or in any suitable sub-combination or as appropriate in any other described embodiment of the present invention. Specific features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment is inoperable without those elements.

Claims

1. A surgical system for providing abdominal access via a body recess, comprising: a. Step dilator (1100), comprising: a dilator body having a longitudinal axis in a proximal to distal direction; a first tapered region (1121) of the dilator body that gradually narrows toward a distal end of the dilator body, the first tapered region (1121) having a blunt distal-most portion having a port; a second tapered region (1117) of the dilator body, which tapers in the distal direction, is positioned proximal to the first tapered region and is separated from the first tapered region by an isolating intermediate region, the length of the isolating intermediate region being at least 3 mm; and b. a trocar (207) passing through a port of the distal-most portion of the first tapered region (1121) of the dilator body of the stepped dilator such that the tip (217) of the needle (207) extends from the port; and c. a cannula disposed above the stepped dilator (1100), wherein a cross-section of the lumen of the cannula (1010) transverse to the longitudinal axis of the cannula has a major axis and a minor axis; and wherein the length of the major axis is at least twice that of the minor axis, The sleeve has a distal orifice (209) which is inclined relative to the longitudinal axis of the sleeve, and the edge of the orifice includes a first edge portion (211) and a second edge portion (210), the first edge portion (211) having a straight section, the first edge portion (211) extending along one side of the orifice, and the second edge portion (210) extending along the other side of the orifice, wherein the first edge portion (211) extends along a side farther than the second edge portion on the longitudinal axis of the sleeve, and each of the first edge portion and the second edge portion extends along the long axis.

2. The surgical system according to claim 1, characterized in that: The sleeve is slidably disposed over the stepped dilator.

3. The surgical system according to claim 1, characterized in that: The sleeve is fitted and slidably disposed over the stepped dilator.

4. The surgical system according to any one of claims 1 to 3, characterized in that: Also included is an access device (1001) defining a lumen that cooperatively retains the cannula (1010) locked thereto.

5. The surgical system according to any one of claims 1 to 3, characterized in that: The cannula is secured to an operating table such that the cannula is fixedly held relative to the operating table.

6. The surgical system according to any one of claims 1 to 3, characterized in that: The invention is configured to be used together with a robotic arm system, the robotic arm system comprising a motor unit and at least one robotic arm (305), the surgical system being configured to set the position of the robotic arm along the longitudinal axis of the cannula (1010) when the at least one robotic arm (305) extends distally from the motor unit along the longitudinal axis of the cannula (1010), the surgical system further comprising: A mounting block (1020) attached to the sleeve (1010); and an assembly attached to the mounting block and comprising a spacing arm (1024) and an alignment arm (1030) and movable between a stowed position and a deployed position; Therein, the deployed position of the assembly places the elements of the alignment arm (1030) indicative of a predetermined position along the longitudinal axis of the cannula.

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