Tools and methods for vaginal access

Trocar components and methods of use are described, wherein the trocar components are configured to provide access to intraperitoneal space via the rectouterine pouch to surgical tools, which optionally include one or more surgical robot members. The surgical tools are optionally 5 mm or more in diameter. In some embodiments, a cannula part has a lumen sized to provide to a plurality of the surgical tools simultaneous transvaginal access to the intraperitoneal space via the rectouterine pouch. In some embodiments, an incision sized to receive a distal aperture of the cannula is created, optionally using one or two dilators. The dilators are sized to create (optionally starting from a puncture by a needle 2 mm in diameter or less) an oblong aperture. In some embodiments, the oblong aperture is at least twice as wide across a long diameter as across a short diameter.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of intraperitoneal surgery and more particularly, to devices and methods for laparoscopic access to the intraperitoneal space.

Culdoscopy is an endoscopic procedure performed to examine the rectouterine pouch and pelvic viscera by the introduction of a culdoscope through the posterior vaginal wall. The culdoscope may be a modified laparoscope. A trocar is first inserted through the vagina into the posterior cul-de-sac, the space behind the cervix, allowing then the entry of the culdoscope. Due to the position of the patient, intestines fall away from the pelvic organs which can then be inspected. Conditions diagnosable by culdoscopy include tubal adhesions (causing sterility), ectopic pregnancy, and salpingitis. Culdoscopy allows the performance of minor procedures such as tubal sterilization.

SUMMARY OF THE INVENTION

There is provided, in accordance with some embodiments of the present invention. a stepped dilator for use with a trocar kit to provide intraperitoneal access via a body recess, comprising: a dilator body having a longitudinal axis in proximal to distal direction; a first tapered region of the dilator body tapering narrower toward a distal end of the dilator body; a second tapered region of the dilator body tapering narrower in a distal direction, located proximally to the first tapered region, and separated from the first tapered region by an isolating region.

In some embodiments, the isolating region comprises a region of constant cross-section perpendicular to the longitudinal axis extending between the first tapered region and the second tapered region.

In some embodiments, the isolating region comprises a region with no cross-section perpendicular to the longitudinal axis larger in any direction than the largest cross-section perpendicular to the longitudinal axis of the first tapered region.

In some embodiments, the isolating region is at least 3 mm long.

In some embodiments, the isolating region is no more than 20 mm long.

In some embodiments, the isolating region is between 5-15 mm long.

In some embodiments, a whole tapering extent of at least one of the first tapered region and the second tapered region tapers between its smallest cross-sectional area and its largest cross-sectional area perpendicular to the longitudinal axis over a longitudinal distance of 15 mm or less.

In some embodiments, through the tapering extent of at least one of the first tapered region and the second tapered region, a diameter of the stepped dilator perpendicular to the longitudinal axis increases by at least 7.5 mm.

In some embodiments, a cross-section with the largest cross-sectional area of the first tapered region perpendicular to the longitudinal axis has at least one axis of about 10 mm or longer.

In some embodiments, a distal tip of the first tapered region comprises a front surface aperture of 4 mm2 or less, and expands in a distal direction from the front surface aperture through a radius of curvature of at least 2.5 mm.

In some embodiments, the front surface aperture is an aperture of an inner lumen sized to allow partial advancement of a trocar needle having a diameter less than or equal to about 2 mm in a longitudinal direction through the aperture.

In some embodiments, the cross-section of the first tapered region having the largest cross-sectional area perpendicular to the longitudinal axis has at least one axis of about 7.5 mm or less.

There is provided, in accordance with some embodiments of the present invention: a kit comprising the stepped dilator described above, along with a handle and a trocar needle; wherein the stepped dilator and handle together define a lumen sized to accept passage the trocar needle from a proximal end of the handle to a distal tip of the stepped dilator.

In some embodiments, the trocar needle is provided with a handle extending at least 5 cm past a proximal end of the handle when a distal tip of the trocar needle is advanced 5 mm past the distal tip of the stepped dilator.

In some embodiments, the trocar needle is provided with a dull-tipped, inner, spring-loaded stylet to act as a Veress needle having an extended position and a collapsed position; wherein the stylet comprises a blunt end extending past a sharp tip of the trocar needle in the extended position and preventing the sharp tip from injuring tissue; and wherein the stylet moves to the collapsed position upon sufficient longitudinal force being exerted so that it no longer extends pas the sharp tip, allowing the sharp tip can operate to penetrate tissue.

In some embodiments, provided with a stopper device is configured to resist advancing the distal tip of the trocar needle more than 5 mm beyond the distal tip of the stepped dilator.

In some embodiments, a cross-section with the largest cross-sectional area of the second tapered region perpendicular to the longitudinal axis has at least one axis of about 21 mm or longer.

There is provided, in accordance with some embodiments of the present invention. a cannula to provide intraperitoneal access across a wall of a body recess, wherein a cross-section of an inner lumen of the cannula transverse to a longitudinal axis of the cannula has a long and a short axis; and wherein the long axis is at least twice as long as the short axis.

In some embodiments, the short cross-section axis is between 5 mm and 10 mm.

In some embodiments, the long cross-section axis is between 10 mm and 30 mm.

In some embodiments, a lumenal wall defining the transverse cross-section of the cannula comprises straight sections on opposite sides of the transverse cross-section.

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

In some embodiments, the cannula is at least 5 cm long.

In some embodiments, an edge defining an aperture at a distal end of the cannula comprises a first edge portion extending along one side of the aperture, and a second edge portion extending along another side of the aperture, wherein the first edge portion extends along a side more distal along the longitudinal axis than the second edge portion.

In some embodiments, the first and second edge portions extend along opposite sides of the aperture.

In some embodiments, the first edge portion and the second edge portion extend along the long cross-section axis.

In some embodiments, the cannula comprises a handle extending at least 10 cm from a proximal end of the cannula.

There is provided, in accordance with some embodiments of the present invention. a cannula for use with a trocar to provide intraperitoneal access via a body recess, wherein an edge defining an aperture at a distal end of the cannula comprises a first edge portion extending along one side of the aperture, and a second edge portion extending along another side of the aperture, wherein the first edge portion extends along a side more distal along the longitudinal axis than the second edge portion.

In some embodiments, the first edge portion is positioned at least 5 mm more distally than the second edge portion.

In some embodiments, the first edge portion and the second edge portion each comprise respective a straight portion.

There is provided, in accordance with some embodiments of the present invention. a method of using a cannula to provide intraperitoneal access to a body cavity via a body recess, comprising: inserting a distal end of the cannula into a dilated aperture of a rectouterine pouch via transvaginal access; wherein an edge defining an aperture at the distal end of the cannula comprises a first edge portion extending along one side of the aperture, and a second edge portion extending along an opposite side of the aperture, and the first edge portion is positioned more distally along the cannula and from the dilated aperture than the second edge portion; and wherein the cannula is inserted so that the aperture at the distal end of the cannula is oriented to open toward the side of the second edge portion and facing toward a rectum adjacent to the rectouterine pouch.

In some embodiments, the method comprises inserting a flexible robotic arm through the cannula and into the rectouterine pouch, so that it exits the aperture in a direction oriented away from the rectum.

In some embodiments, the inserting a distal end of the cannula into the rectouterine pouch comprises sliding the cannula over an outer dilator; the outer dilator has a tapered distal insertion end sized and shaped to fittingly slide over an inner dilator having a tapered distal insertion end with a rounded tip; the cannula slides fittingly over the outer dilator; and at least the outer dilator is inserted into the rectouterine pouch via transvaginal access.

In some embodiments, the method comprises sliding the cannula over the outer dilator while the inner dilator remains within the outer dilator.

In some embodiments, the inserting a distal end of the cannula into the rectouterine pouch comprises sliding the cannula over a stepped dilator; the stepped dilator has a tapered distal insertion end with a rounded tip, a second tapered region, and an isolating region between the second tapered region and the tapered distal insertion end; the cannula slides fittingly over the stepped dilator; and the dilator is inserted into the rectouterine pouch via transvaginal access.

In some embodiments, the rounded tip has a hole sized to pass a trocar needle having a diameter less than or equal to about 2 mm.

There is provided, in accordance with some embodiments of the present invention. a kit for providing intraperitoneal access via a body recess, comprising: a cannula, wherein a transverse cross-section of an inner lumen of the cannula transverse to a longitudinal axis of the cannula has a long axis long enough to allow simultaneous insertion of at least two cylindrical members, each at least 8 mm in diameter; a stepped dilator having a dilator body with: a first tapered region of the dilator body tapering narrower toward a distal end of the dilator body, and a second tapered region of the dilator body tapering narrower in a distal direction, located proximally to the first tapered region, and separated from the first tapered region by an isolating region; and a trocar needle provided with a handle region extending past a proximal end of the inner dilator when a distal tip of the trocar needle is advanced to the distal tip of the inner dilator.

In some embodiments, the long axis of the cannula inner lumen transverse cross-section is at least 21 mm.

In some embodiments, the cannula has a short cross-sectional axis; and wherein the long cross-sectional axis is at least twice as long as the short cross-sectional axis.

In some embodiments, the kit comprises an arm sheath for a plurality of robotic arms, sized to fit within the cannula, having a minimum diameter of about 10 mm, and a maximum diameter of at least twice the minimum diameter.

There is provided, in accordance with some embodiments of the present invention. a method of gaining intraperitoneal access via a body recess, comprising: inserting a first stage of a stepped dilator into a rectouterine pouch to widen an aperture in a wall of the rectouterine pouch; and inserting a second stage of the stepped dilator into the rectouterine pouch to widen the aperture; wherein the first and second stages of the stepped dilator each comprise a region which tapers narrower in a distal direction, and wherein the first and second stages of the dilator are separated by an isolating region at least 3 mm long.

In some embodiments, the method is preceded by: inserting the stepped dilator transvaginally to the wall of the rectouterine pouch; and advancing a trocar needle from within the stepped dilator to produce the aperture in the wall of the rectouterine pouch.

In some embodiments, an inner lumen of the cannula has at least one cross-sectional axis of at least 20 mm.

In some embodiments, the inner lumen of the cannula has at least one cross-sectional axis of less than about 12 mm.

There is provided, in accordance with some embodiments of the present invention. a method of gaining intraperitoneal access via a body recess, comprising: inserting a camera to an intraperitoneal space with a wall of a rectouterine pouch in a field of view of the camera; illuminating the wall of the rectouterine pouch using an intraperitoneally positioned illumination device; selecting a position for an aperture in the wall of the rectouterine pouch, based on light from the illumination device visible from outside the rectouterine pouch; advancing a trocar needle from outside the rectouterine pouch to press against the selected position in the wall of the rectouterine pouch; verifying the position of the trocar needle, based on one or more images from the camera within the intraperitoneal space; and piercing the rectouterine pouch to from the aperture, using the trocar needle.

There is provided, in accordance with some embodiments of the present invention. a kit for setting a position of a robotic arm system along a longitudinal axis of a cannula inserted to a body orifice, wherein the robotic arm system comprises a motor unit and at least one robotic arm extending, when positioned, distally from the motor unit along the longitudinal axis, the kit comprising: the cannula, including a cannula body configured for insertion to the body orifice; a mounting block, configured for attachment to the cannula; and an assembly attached to the mounting block and comprising a spacing arm and an aligning arm, and movable between a stowed position and a deployed position; wherein the deployed position of the assembly places elements of the aligning arm where they indicate a predetermined position along the longitudinal axis.

In some embodiments, the mounting block attaches to the cannula by connecting to an access device having a lumen sized to fittingly accept the cannula therewithin.

In some embodiments, the spacing arm and the aligning arm deploy by hinging around a plurality of stopped hinges, each stopped hinge defining at least a stopped deployed position, and a stopped stowed position.

In some embodiments, the kit further comprises: the motor unit and the 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 a distal end of the at least one robotic arm aligns with a distal end of the cannula when the at least one robotic arm is inserted to the cannula, and a stopper portion of the aligning arm contacts a stopper-receiving portion of the motor unit to prevent longitudinal advance of the motor unit.

In some embodiments, the kit comprises an arm sheath with a lumen sized to accept the at least one robotic arm, and an outer surface sized to fit within the cannula.

There is provided, in accordance with some embodiments of the present disclosure, an inner dilator for use with a trocar kit to provide intraperitoneal access via a body recess, having a distal insertion end tapered over a longitudinal distance of 15 mm or less between a distal tip and a fully dilating cross-section of the inner dilator, wherein: the fully dilating cross-section of the inner dilator has at least one axis of about 10 mm or longer; the distal tip of the insertion end comprises a front surface aperture of 4 mm2or less, and the distal tip of the insertion end expands in a direction along the taper from the front surface aperture through a radius of curvature of at least 2.5 mm; and the front surface aperture is an aperture of an inner lumen sized to allow partial advancement of a trocar needle having a diameter less than or equal to about 2 mm in a longitudinal direction through the aperture.

In some embodiments, the fully dilating cross-section of the inner dilator has at least one axis of about 7.5 mm or less.

There is provided, in accordance with some embodiments of the present disclosure, a kit comprising the inner dilator described above, along with the trocar needle, wherein the inner dilator is at least 17 cm long, and the trocar needle is provided with a handle extending at least 5 cm past a proximal end of the inner dilator when a distal tip of the trocar needle is advanced 5 mm past the distal tip of the inner dilator.

In some embodiments, the trocar needle is provided with a dull-tipped, inner, spring-loaded stylet to act as a Veress needle, wherein the stylet, in its extended position prevents a sharp tip of the needle from injuring tissue, but collapses upon sufficient longitudinal force being exerted so that the sharp tip can operate to penetrate tissue.

In some embodiments, provided with a stopper device is configured to resist advancing the distal tip of the trocar needle more than 5 mm beyond the distal tip of the inner dilator.

There is provided, in accordance with some embodiments of the present disclosure, a kit comprising the inner dilator described above, along with an outer dilator, wherein the outer dilator has a distal insertion end tapered over a longitudinal distance of 15 mm or less between a distal opening and a fully dilating cross-section of the outer dilator, wherein the fully dilating cross-section of the inner dilator has at least one axis of about 21 mm or longer.

In some embodiments, the distal opening has an inner lumen sized to fittingly enclose the fully dilating cross-section of the inner dilator.

In some embodiments, the kit is provided with a stopper configured to resist advancing the distal tip of the outer dilator more than 15 mm beyond the distal tip of the inner dilator.

There is provided, in accordance with some embodiments of the present disclosure, a trocar kit for providing intraperitoneal access via a body recess, comprising: a cannula, wherein a transverse cross-section of an inner lumen of the cannula transverse to a longitudinal axis of the cannula has a long axis long enough to allow simultaneous insertion of at least two cylindrical members, each at least 8 mm in diameter; an inner dilator at least long enough to leave an external handling region of about 10 cm while inserted fully into a body aperture 7 cm long, and having a distal insertion end tapered over a longitudinal distance short enough to reach a complete first-stage dilation within 15 mm or less of movement between a distal tip of 4 mm2area or less and a fully dilating cross-section of the inner dilator, wherein the fully dilating cross-section of the inner dilator has at least one axis about half as long as the long axis of the cannula cross-section; a trocar needle provided with a handle region extending past a proximal end of the inner dilator when a distal tip of the trocar needle is advanced to the distal tip of the inner dilator; and an outer dilator, wherein the outer dilator has a distal insertion end tapered over a longitudinal distance of 15 mm or less between a distal opening sized to fittingly surround the fully dilating cross-section of the inner dilator, and a fully dilating cross-section of the outer dilator, wherein the fully dilating cross-section of the outer dilator is sized to be fittingly surrounded by the inner lumen of the cannula.

In some embodiments, the long cross-sectional axis of the cannula inner lumen is at least 21 mm.

In some embodiments, the cannula has a short cross-sectional axis; and wherein the long cross-sectional axis is at least twice as long as the short cross-sectional axis.

There is provided, in accordance with some embodiments of the present disclosure, a trocar kit for providing intraperitoneal access via a body recess, comprising: an inner dilator, an outer dilator, and a cannula; wherein: the outer dilator is sized and shaped to fittingly insert over the inner dilator; the cannula is sized and shaped to fittingly insert over the outer dilator; the inner dilator is provided with a rounded distal tip having a hole sized for the longitudinal pass of a trocar needle portion having a diameter less than or equal to about 2 mm; and an inner lumen of the cannula has at least one cross-sectional axis of at least 20 mm; and wherein the inner lumen of the cannula has at least one cross-sectional axis of less than about 12 mm.

In some embodiments, the inner dilator and the outer dilator are each tapered from a respective narrower distal insertion end to a respective full-size cross-section within 15 mm along a longitudinal axis.

There is provided, in accordance with some embodiments of the present disclosure, a method of gaining intraperitoneal access via a body recess, comprising: inserting an inner dilator transvaginally to a wall of a rectouterine pouch; advancing a trocar needle from within the inner dilator to produce an aperture in the wall of the rectouterine pouch; inserting the inner dilator no more than 15 mm into the rectouterine pouch to widen the aperture; inserting an outer dilator no more than 15 mm into the rectouterine pouch by sliding the outer dilator over the inner dilator and across the aperture while the aperture is held open by the inner dilator; and inserting a distal end of a cannula into the rectouterine pouch by sliding the cannula over the outer dilator and across the aperture while the aperture is held open by the outer dilator; wherein an inner lumen of the cannula has at least one cross-sectional axis of at least 20 mm.

In some embodiments, the inner lumen of the cannula has at least one cross-sectional axis of less than about 12 mm.

There is provided, in accordance with some embodiments of the present disclosure, a method of gaining intraperitoneal access via a body recess, comprising: inserting a camera to an intraperitoneal space with a wall of a rectouterine pouch in a field of view of the camera; illuminating the wall of the rectouterine pouch using an intraperitoneally positioned illumination device; selecting a position for an aperture in the wall of the rectouterine pouch, based on light from the illumination device visible from outside the rectouterine pouch; advancing a trocar needle from outside the rectouterine pouch to press against the selected position in the wall of the rectouterine pouch; verifying the position of the trocar needle, based on one or more images from the camera within the intraperitoneal space; and piercing the rectouterine pouch to from the aperture, using the trocar needle.

There is provided, in accordance with some embodiments of the present disclosure, a kit for setting a longitudinal position of a robotic arm system along a longitudinal axis of a cannula inserted to a body orifice, wherein the robotic arm system comprises a motor unit and at least one robotic arm extending distally from the motor unit along the longitudinal axis, the kit comprising: a cannula, including a cannula body configured for insertion to the body orifice and a cannula handle extending proximally along a longitudinal axis of the cannula; a mounting block, including a block body and a clamp configured to clamp the cannula handle at a selected longitudinal position relative to the block body; and a motor unit stopper, including a longitudinally extended member attached to the block body, and movable between: a first position extending a predetermined length from the block body to a proximal end of the motor unit stopper, and a second position; wherein the proximal end of the motor stopper unit in the first position is positioned to contact and prevent longitudinal advance of the motor unit upon insertion of the at least one robotic arm to the cannula, thereby defining a predetermined longitudinal position of the robotic arm system relative to the cannula; and wherein the second position of the motor unit stopper removes the motor unit stopper proximal end from a position preventing the longitudinal advance of the motor unit from the predetermined longitudinal position.

In some embodiments, the motor unit stopper is attached to the block body by a hinge, the first position comprises orientation of the motor unit stopper along the longitudinal axis of the cannula, and movement between the first position and the second position comprises rotation of the motor unit stopper on the hinge.

In some embodiments, the motor unit stopper is movable between the first position and the second position without disturbing the position of either the cannula or the motor unit when the at least one robotic arm is inserted to the cannula.

In some embodiments, the kit further comprises: the motor unit and the 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 a distal end of the at least one robotic arm aligns with a distal end of the cannula when the at least one robotic arm is inserted to the cannula, and the motor unit stopper contacts the stopper-receiving portion of the motor unit to prevent longitudinal advance of the motor unit.

In some embodiments, the kit comprises a plurality of extenders, each comprising a tube with a lumenal cross-section sized to receive a robotic arm having a cross-sectional axis of at least 7 mm, and a length sized to extend longitudinally from the proximal end of the stopper to a position distal to the longitudinal position of the block body.

In some embodiments, the block body is slotted to receive the plurality of extenders at a position and orientation allowing guidance of robotic arms along the longitudinal axis to an aperture of the cannula body.

There is provided, in accordance with some embodiments of the present disclosure, a kit comprising an inner dilator having a distal tip sized to partially dilate an incision, and an outer dilator sized to slide distally over the inner dilator to further dilate the incision with a distal tip of the outer dilator, wherein: the overall dilation of the inner and outer dilators is at least enough to allow simultaneous insertion of at least two cylindrical members each having a diameter of at least about 8 mm, while a longitudinal distance along each of the inner and outer dilators over which dilation occurs is less than about 20 mm; at least one of the inner dilator and the outer dilator are marked near a proximal end to indicate a relative position at which the two dilators are positioned, including at least a mark indicating alignment of the distal ends of the two dilators, and a mark indicating a longitudinal position difference of one dilator relative to the other of the longitudinal distance over which dilation occurs.

In some embodiments, both the inner and outer dilators are marked with a distance scale indicating distance along each dilator to its distal end.

In some embodiments, the distance scales of the inner and outer dilators are numerically aligned when the distal ends of each are aligned.

In some embodiments, the kit comprises an indicating indexer configured to change the force needed to translate the inner and outer dilators longitudinally over one another, depending on the relative longitudinal positions of the inner and outer dilators.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of intraperitoneal surgery and more particularly, to devices and methods for laparoscopic access to the intraperitoneal space.

Overview

A broad aspect of some embodiments of the present invention relates to trocar components (provided individually and/or in kits) configured to provide access to intraperitoneal space via the rectouterine pouch for surgical tools, optionally including one or more surgical robot members (herein, “robotic arms”). Compared, for example, to umbilicus entry to the intraperitoneal space, rectouterine pouch access to the peritoneal space provides potential advantages for reduced invasiveness, reduced patient trauma, reduced visible scarring, and/or speed of the operation.

An aspect of some embodiments of the present invention relates to a cannula having a lumen with an oblong cross-section, and configured to simultaneously accept two or more substantially cylindrical tools extending side-by-side along the lumen.

In some embodiments, a cannula part is provided which has sufficient longitudinal length to extend between a wall of the rectouterine pouch and a position near to the entrance to the vagina, for example, about 7-15 cm long. Optionally, an intravaginal length of cannulation is selectably extended (e.g., between from 7 up to about 15 cm) by use of the cannula together with an additional part; for example, a trocar part, with which it may be telescopically mated. Alternatively, in some embodiments, a selection of different cannula lengths is provided (e.g., in a length range of from 7 to 15 cm, for example, at least three cannulas in this range; and optionally cannulas of sizes in about 1 cm or 2 cm length increments from each other). This provides a potential advantage for avoiding a possibility of pinching between two telescoping cannula portions.

Optionally, the cannula lumen cross-section is sized to provide simultaneous, side-by-side intraperitoneal access to two substantially cylindrical (e.g., tubular) tools having a diameter of about 8.6 mm. In some embodiments, the substantially cylindrical tools comprise tube-shaped robotic arms. The cannula lumen cross-section, in some embodiments, has a longest axis at least twice as long as a shortest axis. Optionally, the cannula cross-section is sized so that there is also room for a third tool having a cross-section with a maximum axis length of about 6 mm or less. Compared to a circular cross-section sized to pass two or more such cylindrical tools, such an oblong cross-section provides a potential advantage for allowing a smaller overall cannula perimeter, with a correspondingly smaller incision needed to accept the cannula.

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

Optionally, the cannula is constructed from stainless steel or another material which can be sterilized and re-sterilized to surgical use standards. Optionally, the cannula is disposable and provided in a sterilized condition.

An aspect of some embodiments of the present invention relates to geometries of dilators configured to achieve incision dilation while advancing to longitudinal distances kept short and/or controlled to avoid trauma to delicate tissues near the rectouterine pouch; and to methods of dilation adjusted for the geometries of the dilators.

A significant potential complication of opening a rectouterine pouch incision to the intraperitoneal space is damage to the rectum. The damage may be due for example, to over-penetration causing puncture, scraping, and/or crushing during initial puncture and/or dilation of the incision. In some embodiments, a constraint on maximum longitudinal advance is set by the width of the rectouterine pouch, and a need to reduce the potential for accidental damage to nearby internal organs, for example, the rectum.

In some embodiments of the invention, features of a trocar kit and/or its method of use potentially act to reduce a risk of injury due to over-penetration during cannulization. In particular, target insertion depth (e.g., minimum depth at full dilation) is kept low in some embodiments (e.g., dilation of up to about 7.5-15 mm occurs over about 10-20 mm of longitudinal insertion depth, for example, 13 mm, 15 mm, 17 mm, 19 mm, or 20 mm). In some embodiments, dilation occurs over about up to 30 mm, 40 mm, or 50 mm of insertion depth.

Overall insertion depth by a dilator after dilation itself is complete is optionally somewhat larger than this (e.g., up to about 2-5.5 cm). However, application of potentially injurious force is particularly likely during a dilating phase in which the expanding portion of the dilator is being advanced through an incision—since this is the phase of dilator operation during which overcoming resistance by use of additional force is expected and normal.

Optionally, insertion in a dilating phase of operation to an excessive depth is treated as itself having a higher risk of causing injury (e.g., due to the internal proximity of delicate tissues) than the elevation of maximum peak insertion force that may result from the lowered mechanical advantage of a shortened dilation depth.

In some embodiments, dilators are provided as a pair of dilators. In some embodiments, the pair of dilators comprises a first dilator and a second dilator, wherein the first dilator is smaller in cross-section than the second dilator. Optionally, the first dilator is provided as an “inner” dilator relative to the second, larger and “outer” dilator. The inner and outer dilators are configured to slide longitudinally relative to one another.

In some embodiments, a dilator is provided as a single dilator which dilates using a stepwise plurality of staged dilator expansions (e.g., two or three).

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

The amount of widening over the travel of the dilator stage is optionally itself in the range of about 7.5-15 mm, for example, about 7.5 mm, 10 mm, 12 mm, 12.5 mm, or 15 mm. This fairly rapid rate of dilation as a function of longitudinal advance accepts loss of mechanical advantage in exchange for a reduced required insertion depth to complete dilation. Total insertion depth during dilation can be about the length of a single step (optionally plus a few millimeters past the expanding part of the dilator, e.g., plus 5-10 millimeters) when a plurality of dilators are used; wherein a subsequent dilator is inserted over the previous dilator. When a single (stepwise expanding) dilator is used, insertion depth during dilation may be the sum of the lengths of the individual dilation stages; plus an optional isolating region between the dilation steps having a length of, for example, about 5-15 mm; and optionally plus a few more millimeters (e.g., 5-10 mm) past the expanding part of the dilator. For example, the total insertion depth may be about 50 mm. In some embodiments, the isolating region is at least 3 mm long. Additionally or alternatively, the isolating region is less than about 20 mm long.

Related to this, the inventors have realized that mechanical properties of the pouch wall tissue related to resisting dilation (e.g., resistance to tearing and/or stretching) are potentially more permissive of a lowered mechanical advantage than the mechanical properties of the walls of other intraperitoneal access positions, for example, the mechanical properties of the skin, fat, and/or muscle layers of the umbilical region. This has allowed use of a dilator design which has reduced mechanical advantage (is blunter), in exchange for such potential advantages as a shorter dilator insertion depth and/or a smaller number of dilation steps.

Dividing the dilation into stages (e.g., by using a plurality of dilators and/or a plurality of isolated dilation steps) potentially gives greater control over dilation by providing a stopping point mid-dilation. This potentially reduces a chance of uncontrolled tearing during dilation, and/or allows inspection of initial dilation to ensure that there is no unexpected damage (e.g., excessive bleeding) which might be aggravated by further dilation.

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 needle can be extended. Optionally, the distal-most portion curves proximally, widening in both width and height through a radius of at least about 2.5 mm, then expanding primarily in width to form a wide oblong cross-section about 15 mm proximal to the distal-most portion (or another distance, for example in the range of about 10-20 mm).

In some embodiments, the second dilator and/or dilator step has a distal-most portion defining a lumen sized to fittingly slide over the first dilator. The outer perimeter of the distal-most cross-section is only slightly larger than the oblong cross-section at the proximal end of the expanding cross-section region of the first dilator. From there, the second dilator's cross-section also expands going proximally for about 15 mm (or another distance, for example in the range of about 10-20 mm). The maximum of the further expansion is by about, for example, about 5 mm,7.5, mm, 10 mm, or 12.5 mm. Optionally, there is a larger expansion along one axis of the incision cross-section than along another axis; for example, there may be a relative factor of expansion of about 1:1.5, 1:2, or 1:3.

In some embodiments, the cannula is sized to fittingly slide over the second dilator to reach a position with its distal aperture inserted within the rectouterine pouch.

In some embodiments, the trocar needle used with the first dilator is provided together with a holder and/or handle which are sized so that the maximum distal advance of the trocar needle is limited by interference between the handle and/or the holder. In some embodiments, the dilators are provided with a stopper and/or indicating indexer which allow tracking of their relative position, and/or resist, indicate, and/or prevent over-advancement of one dilator relative to the other.

Optionally, the dilator, dilators, handle, holder, and/or trocar needle are constructed from stainless steel or another suitable material which can be sterilized and re-sterilized to surgical use standards (e.g., by autoclaving). Optionally, one or more of these parts is disposable and provided in a sterilized condition.

An aspect of some embodiments of the present invention relates to dilator safety performance maintained and/or enhanced by feedback features and/or methods which help monitor dilator advancement.

In some embodiments, a potential for loss of control of position (e.g., sudden accidental over-advancement as tissue gives way, and/or as the end of the expanding region of the dilator is reached) is reduced by moving each dilator with respect to a fixed (e.g., clamped to the patient table) reference. For example, the first dilator is moved with reference to its initial position and/or an already inserted needle; and/or the second dilator is moved relative to the inserted position of the first dilator. Monitoring of position relative to a fixed reference position potentially encourages a user of the dilators to ease back on force when nearing a dilator's target position.

In some embodiments, a stopper arrangement changes (e.g., increases) a sliding resistance between two components in relative motion as a target dilator advancement limit is approached and/or reached. The change may indicate reaching a target position to a user, and/or mechanically resist advance beyond the target position.

An aspect of some embodiments of the present invention relates to methods of cannulizing a rectouterine pouch wall while monitoring the penetration using information communicated across the rectouterine wall. In some embodiments, initial rectouterine pouch penetration (e.g., using a trocar needle) is visualized from using a camera and/or light source already inserted to the intraperitoneal space from another location, for example, the umbilical. Upon needle contact, a region of indentation may be interiorly observed before actual puncture. Alternatively or additionally, transillumination of the rectouterine pouch wall by an intraperitoneally located light source is observed from outside the pouch in order to help position a needle used for initial penetration. The method has a potential advantage insofar as the rectouterine wall is located both in a difficult region to directly access (due to its position deep within the vagina), and nearby sensitive internal structures which could lead to surgical complications if damaged during cannulization. Dual inside-to-outside and outside-to-inside needle position verification allows seeing from the outside (by the illumination) that the targeted port position (aimed at by a needle which is to create an initial opening) is in a reasonable location relative to internal structures which are to be targeted/avoided, and then confirming that the actual port position which the needle will create really is at the position aimed at.

It is noted that the method described with respect to the rectouterine pouch may be adapted to cannulization of other areas, wherein a first introduction of a camera and light source is from a first port into an intrabody space, and cannulization is to be performed to create another port in a region which perhaps provides some advantage (e.g., better suited to receive a larger incision which is needed for larger tools, and/or provides a preferred direction and/or position of access by the tools), but may also be at greater risk of complication during its creation (e.g., because it is in a region which is more difficult to target externally, and/or because it is associated with certain safety risks if performed incorrectly). More generally, in some embodiments, where a plurality of ports are to be used, second and subsequent ports may be opened under two-sided observation after camera and lighting are established within a first port.

An aspect of some embodiments of the present invention relates to achieving dependable and preferably rapid initial positioning of robotic arms relative to a cannulated surgical access-way. The cannula helps to provide access to a region of surgical activity which is not only internal, but also positioned at the end of a restrictive tunnel. The robotic arms themselves may be articulated along their length in such a way that the result of a commanded motion is different depending on exactly what their starting position is relative to the potential restrictions on motion presented by the cannula and/or the geometry of the internal body space in which they are operated.

Two parameters of particular importance are the distance of longitudinal advance of one or more robotic arms through the lumen of the cannula, and the angle of approach of the one more robotic arms. An incorrect distance of longitudinal advance potentially leads to unexpectedly restricted motion (e.g., because an articulated arm portion has not advanced out of the cannula as much as expected), or even injury (e.g., a collision with body tissue due to over-advancing). An incorrect angle of approach potentially leads to torquing of the robotic arms and/or cannula due to mutual interference as the robotic arms advance. In some more extreme cases, this could lead to difficulty with robotic arm advance, and/or to disturbance of the cannula position. Even if the alignment is correct enough to achieve safe robotic arm introduction to the region of surgical activity, robotic arms may not perform fully as expected, because of lateral interference forces. Such forces are potentially hard to judge by visual inspection to allow correction or compensation.

These concerns potentially applies to one or both of robotic arm movements fully under the direct guidance of a surgeon, and robotic arm movements which are at least partially under automatic control. Moreover, it can be difficult to judge the angle of approach and initial distance of longitudinal advance required for intended device operation, potentially leading to an iterative and/or painstaking setup period before the surgery can begin.

In some embodiments of the present invention, apparatus elements attached to the cannula are deployed to provide indications of where a robotic arm device should be placed. In some embodiments, these elements include spacing devices and/or guides which, once deployed, provide clear indications of whether robotic arm-cannula alignment is correct, and/or help to prevent incorrect alignments.

Reference is now made toFIG. 1, which is a schematic representation of portions of a human female pelvic anatomy, referenced by descriptions herein according to some embodiments of the present disclosure.

Referenced in particular by descriptions herein is rectouterine pouch19, including a portion of rectouterine pouch wall3accessible from vagina17. Also shown inFIG. 1are bladder15, uterus13, and rectum11. As shown, uterus13is in an anteverted position (i.e., tilted forward toward the bladder). In a significant number of patients, uterus13may be retroverted (i.e., tilted posteriorly), or in another position. In some embodiments, a retroverted uterus can be manipulated into a position which improves intraperitoneal access through the rectouterine pouch3; for example, by use of a uterine manipulator.

Reference is now made toFIG. 2A, which schematically represents a kit of trocar components200, according to some embodiments of the present disclosure.

In some embodiments, the trocar components200are sized and shaped to open an intraperitoneal aperture in the rectouterine pouch19, transvaginally via vagina17.

In some embodiments, trocar components200comprise a trocar needle207, an inner dilator205, an outer dilator203, and/or a cannula201,1010. The components are optionally sized and shaped to be nested one within the next in the order listed. Optionally, a distance of longitudinal advancement of trocar components200along one another is indicated and/or limited by use of a stopper and/or indicating indexer, for example, leaf spring device503or another device, for example as described in relation toFIGS. 5A-5Cherein.

Reference is now made toFIG. 2B, which schematically represents distal portions of components in the kit of trocar components200, according to some embodiments of the present disclosure. Reference is also made toFIGS. 3A-3H, which schematically represent a method of using trocar components200to establish intraperitoneal access through rectouterine pouch wall3or another body wall, according to some embodiments of the present disclosure.

WhileFIGS. 3A-3Hillustrate a two-dilator expansion procedure, it is to be understood that more dilators (e.g., three, four, five, or more) are optionally used. Using more dilators is optionally coupled to steeper-sloped dilator tip designs (i.e., less expansion per mm of advance), which can help to reduce resistance to insertion. Optionally, only one dilator is used (for example as described in relation toFIGS. 6A-6Eherein). The inventors have found that two dilators, each expanding along a longitudinal distance of about 15 mm, are apparently enough to reach a fully dilated size of about 30 mm×10 mm, without undue use of insertion force and/or elevated risk of patient injury. In particular, 15 mm appears to be a safe distance of direct penetration through a vaginal wall3into rectouterine pouch19, which does not carry a significant risk of accidental injury to the adjacent rectum19.

InFIG. 3A, a distal end of inner dilator205is shown advanced to wall3of rectouterine pouch19, e.g., with blunt tip215positioned in contact with wall3. The advance is made transvaginally, in some embodiments. Vagina17is not shown in the sequence ofFIGS. 3A-3H, but may be understood to surround distal portions of the trocar components near the rectouterine pouch wall3.

InFIG. 3B, a sharp tip217of trocar needle207is advanced out of a distal port216of inner dilator205sufficiently to puncture wall3and enter rectouterine pouch19.

Optionally, trocar needle207is no more than 2 mm in diameter (distal port216is sized large enough to pass trocar needle207; for example, distal port216may be about 2.1 mm in diameter to pass a trocar needle207having a 2 mm diameter). Potentially, this limitation on diameter helps to reduce a risk of serious complications developing in the case of accidental penetration into rectum11. Optionally, trocar needle207comprises a Veress needle having a blunt, spring-loaded center stylet which in its extended position prevents the sharp tip of the needle from injuring tissue, but collapses upon sufficient longitudinal force being exerted so that the sharp tip can operate to penetrate tissue. Such a needle potentially serves to prevent unintended injury (e.g., penetration to the rectum11) during penetration of the wall3of the rectouterine pouch19.

In some embodiments, trocar needle207is restrained by a stopper device from protruding more than a few millimeters (e.g., no more than about 3 mm, 5 mm, 8 mm, or 10 mm) from the distal tip of inner dilator205by a stopper and/or indicating indexer. Potentially, the restriction on protrusion reduces opportunity for the needle cause injury by over-penetrating the outer tissue wall to be dilated and injuring an internal tissue surface. A penetration distance chosen, e.g., 5 mm, may be enough to stretch and puncture with the trocar needle207an outer tissue wall having tissue pressed against the inner dilator205, while being short enough that puncture of any deeper tissue layer beyond the outer tissue wall is prevented. A method of positioning trocar needle207for penetration is described, for example, in relation toFIG. 4, herein.

In the position ofFIG. 3C, inner dilator205is advanced through the hole opened by trocar needle207, up to about the wide cross-section219of the distal region of inner dilator205. During the advance, blunt tip215of inner dilator205is first pushed into the hole in wall3made by needle207. Further advance of dilator205widens the hole in wall3according to the expansion of the tip through tapering region218of dilator205between blunt tip215and wide cross-section219. In some embodiments, a first (distal) dilating stage of stepped dilator1100(that is, a portion of dilator1100comprising distal tapering region1121) is used for these operations.

In some embodiments, the overall distance between wide cross-section219and the distal-most profile of blunt tip215(at distal port216) is about 15 mm. Potentially, this distance is short enough to prevent injury to the wall of the rectouterine pouch19opposite to the wall3which inner dilator205penetrates (e.g., short enough to prevent injury to the rectum). However, providing some distance of expansion allows the widening slope of the dilator tip to provide mechanical advantage during insertion, so that tissue at the puncture is widened gradually. In some embodiments, another dilator tip length is used, for example about 10 mm, 12 mm, 14 mm, 16 mm, or 18 mm.

In some embodiments, blunt tip215rounds back from a substantially flat distal-most profile with a radius of curvature of about 2.5 mm. While a blunt profile potentially results in initially higher resistance to the advance of inner dilator205, the blunt tip profile has the potential advantage of reducing a likelihood of injury to the wall of the rectouterine pouch19opposite to the wall3which inner dilator205penetrates (e.g., short enough to prevent injury to the rectum).

Optionally, cross-section219is about 20 mm across its longest axis, and about 10 mm across its shortest axis. Optionally, the largest axis of the inner dilator205at cross-section219is about, for example, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. Optionally, the shortest axis of cross-section219is, for example, about 5 mm, 7 mm, 8 mm, 10 mm, 11 mm or 13 mm. Optionally, the 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 axis and the shortest axis of cross-section219uses the whole available length of the dilator tip. In some embodiments, proximal-going 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, then levels out. Optionally, proximal-going expansion across 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.

Optionally, the expansion of the longest cross-sectional axis through tapering region218is substantially linear as a function of longitudinal distance for a portion of inner dilator205leading up to wide cross-section219. Optionally the expansion is non-linear, e.g., curved to expand faster and/or slower as the overall perimeter of the entry hole into wall3grows larger. For example, a relatively blunt tip potentially takes advantage of tissue compliance due to elasticity around an initially small entrance incision, while a more gradual cross-section expansion is used where non-elastic expansion (e.g., by tearing) dominates.

Optionally, there is a gradual increase in expansion rate (slope) moving still further proximally. Potentially, this allows percentage stretch of a hole perimeter as a function of longitudinal advance is maintained at a lower initial value than would be produced by a more linear expansion over the same distance. This may reduce resistance to insertion, potentially reducing a risk of trauma. Optionally, either linear or non-linear expansion is used through tapering region213of outer dilator203.

In some embodiments, needle207is retracted before and/or as inner dilator205is advanced, potentially reducing a risk of injury to the opposite wall. In some embodiments, the distance of advance of inner dilator205is controlled by recording the position of inner dilator205upon needle penetration, and comparing that position to more advanced positions. Optionally, a stopper is positioned after initial penetration by needle207and locked into place relative to the patient (e.g., locked to the table by a positioning arm) so that no more than a predetermined total advance distance (e.g., 15 mm) is allowed.

InFIG. 3D, outer dilator203is shown longitudinally advanced over inner dilator205until it reaches wall3of rectouterine pouch19(e.g., so that distal edge212of outer dilator203contacts wall3). InFIG. 3E, outer dilator203is advanced further, up to the level of the wide profile214of outer dilator203. It is noted that the advance inFIG. 3Eshows the distal edge212of outer dilator203brought to the same longitudinal position as the distal-most profile of inner dilator205. In some embodiments, a second (proximal) dilating stage of stepped dilator1100(that is, a portion of dilator1100ofFIGS. 11A-11Ecomprising proximal tapering region1117) is used for these operations; except that instead of advancing over an inner dilator, the proximal tapering region1117follows after distal tapering region1121, and optionally after an intervening isolating region1119, as described herein in relation toFIGS. 11A-11E.

FIGS. 3A-3Dshow first insertion of inner dilator205, then outer dilator203over inner dilator205. In some embodiments, outer dilator203is optionally used as the first inserted dilator (or insertion along with inner dilator205), followed by puncture using trocar needle203, dilation with the inner dilator205sliding distally from within outer dilator203, and finally dilation with outer dilator203sliding distally over inner dilator205. This provides a potential advantage, for example, in the location of a puncture target location for needle207, which can be seen through the relatively open lumen of outer dilator203upon transillumination of the wall3of the rectouterine pouch19. The difference in insertion order can also affect the arrangement of stoppers/indicating indexers (for example as described in relation toFIGS. 5A-5I) used to determine the relative distances of the different dilation components during insertion and/or dilation.

Optionally, the distal aperture220of outer dilator203is sized to fittingly accommodate the wide cross-section219of inner dilator205. The outer perimeter at distal edge212may be just slightly larger than distal aperture220(i.e., distal edge212is optionally sharp). Optionally, distal edge212is blunt and/or rounded, for example, with an initial wall thickness (or diameter, in the case of a rounded edge) of, for example, about 100 μm, 200 μm, 500 μm, or 1 mm.

In some embodiments, the distance between distal edge212and wide profile214is about 15 mm. In particular, the distance is optionally any distance described in relation to the distance between the distal-most profile of inner dilator205and wide cross-section219. Optionally, these two distances are about equal. Optionally, the distance for outer dilator203is slightly shorter (e.g., about 0.5 mm, 1 mm, or 1.5 mm shorter), which potentially reduces a possibility of injury due to tissue contact with distal edge212. Optionally, a distance of advance of outer dilator203relative to inner dilator205is controlled by use of a stopper and/or indicating indexer, for example as described in relation toFIGS. 5A-5Cherein.

Optionally, the longest axis of wide cross-section214is, for example, about 20 mm, 23 mm, 25 mm, 27 mm, 33 mm, or 35 mm. Optionally, the shortest axis of wide cross-section214is, for example, about 5 mm, 7 mm, 8 mm, 10 mm, 11 mm, or 13 mm. Optionally, the ratio between the longest axis and the shortest axis is, for example, about 1.5, 2 2.5, 3, or 3.5. The dimensional descriptions apply as well to slanted distal aperture209of cannula201,1010and the internal lumen of cannula201,1010which is sized to slide over outer dilator203in a fitting association (e.g., with a relative size tolerance of about 1 mm or less). The internal lumen of cannula201,1010is sized to accept a plurality of (typically tubular, tube-sheathed and/or cylindrical) tools positioned side-by side, for example, two tools of 8 mm diameter or more and one tool of about 5-6 mm diameter or more. In some embodiments, the cross-sections of the cannula201,1010and dilators203,205are (for example as shown inFIGS. 2B and 5K) substantially rectangular with rounded ends (e.g., rounded so that the short sides are formed as sections of substantially circular arcs).

A rounded-end shape has a potential advantage for enclosing a plurality of side-by-side cylindrical tools, since it allows packing of the outermost tool sides toward the outside of the cross-section, while minimizing wasted corner space (the “waste” is not so much with respect to the cannula interior as it is with respect to the creation of a potentially larger-than-necessary incision hole). Round corners (as opposed to sharp corners) also provide a potential advantage during insertion, by helping to distribute forces which might otherwise tend to focus cutting toward the corners and lead, e.g. to less predictable dilation and/or incisions which heal more unpredictably. Between the arced ends, a straight line section (used in some embodiments) has the potential advantage of maintaining an outer profile suitable for staying in full peripheral contact with the dilated tissue surrounding it (e.g., to maintain a tension seal), without extra widening which would create space that the cylindrical tools within do not need to use. In some embodiments, there is a slight outward bowing introduced along the longer sides of the cross-sections (e.g., less than 1 mm of bowing per 5 mm of perimeter), potentially enhancing tension contacts between the dilators and/or cannula and the aperture edges of the tissue wall they penetrate.

In the examples illustrated herein (e.g.,FIGS. 2B, 5K), the cross-sections of the dilators and cannula shown display mirror symmetry around both a long axis and a short axis. However, the cross-sectional shape, in some embodiments, need not have any particular symmetry arrangement, and can be otherwise shaped (e.g., as a round-cornered irregular triangle) to suit the accommodation of different-sized arrangements of tools.

InFIG. 3F, vaginal cannula201is shown with its distal-most edge211brought up to the position of wall3. InFIG. 3G, cannula201is shown advanced into the rectouterine pouch19, so that distal-most edge211is about even with the distal-most portion of outer dilator203.FIG. 3Hshows cannula201with inner dilator203and outer dilator205removed. Optionally, inner dilator205is removed at any time after outer dilator203is in place. Optionally, the two dilators203,205are removed together.

In some embodiments, an inner lumen cross-section of cannula201is sized to fittingly slide over section of outer dilator203having the size of wide cross-section214. Optionally advance of cannula201is performed by use of a handle202. Optionally, the maximum advance of cannula201relative to outer dilator203is controlled by the use of a stopper and/or indicating indexer.

In some embodiments, the lumen of cannula201is about 7 cm, or another length long enough to reach between a distal-most position within the rectouterine pouch, and a proximal position at or outside the vaginal orifice (e.g., up to about 15 cm). Optionally, a flange221is provided at a proximal end of the lumen of cannula201. While cannula201(with a handle202, as next described) is shown inFIG. 3F-3I, it should be understood that the foregoing descriptions of cannula201also apply, in some embodiments, to the use of cannula1010ofFIG. 10B.

Handle202of cannula201is long enough, in some embodiments, to extend past either of the dilators203,205while they are inserted, and enough past to provide a grasping region (e.g., a grasping region of about 10 cm; overall length is optionally at least about 37 cm). In some embodiments, inner dilator205is at least long enough to reach its fully inserted position while providing a handle (e.g., about 17 cm overall), and outer dilator203is at least 10 cm longer again (e.g., about 27 cm overall).

Reference is now made toFIG. 3L, which schematically represents a wider view (compared toFIG. 3H) of the positioning of cannula201,1010relative to anatomical structures of a female lower abdomen/pelvic region, according to some embodiments of the present disclosure. Among the anatomical structures shown are the uterus15, vagina17, bladder15, rectum11, and rectouterine pouch19, also shown as inFIG. 1. Not shown is the handle of cannula201,1010, and optional associated devices such as insufflation sealing which may be provided for, e.g., at the vaginal orifice, and/or a trocar part which may be telescopically fitted to extend the length of cannula201,1010.

In some embodiments, slanted distal aperture209of cannula201,1010is slanted at an angle between a leading distal-most edge portion211, and a following, more proximal edge portion210. The longitudinal distance between distal-most edge portion211and proximal-most edge portion210, in some embodiments, is about 15 mm. In some embodiments, the distance is, for example, about 10 mm, 12 mm, 14 mm, 16 mm, or 18 mm. A potential advantage of the slanting of distal aperture209is to allow the cannula edge to be relatively retracted on an unprotected side of the cannula which could otherwise be accidentally positioned to scrape the rectum11. As for the more-protruding leading-edge side of the aperture211: (1) upon insufflation, tissue is generally lifted away from the rectum, reducing contact risk posed by this side, and (2) the robotic arms, where they exit the cannula, will generally be curved across the plane of the leading edge as they reach deeper into the peritoneal space. This potentially prevents contact of the leading edge with delicate internal tissues. Robotic arm positions can be seen, for example, inFIGS. 7A-7B, herein.

Reference is now made toFIG. 3I, which schematically represents the cannula configuration ofFIG. 3H, along with inserted tools, according to some embodiments of the present disclosure. Reference is also made toFIGS. 7A-7B, which are images (from a viewpoint inside an insufflated abdomen) of robotic arms inserted through the cannula201in a configuration similar to that ofFIG. 3I, according to some embodiments of the present disclosure. Descriptions in relation toFIGS. 3I and 7A-7Bof cannula201also apply to cannula1010ofFIG. 10B.

InFIG. 3I, the lumen of cannula201is shown occupied by two substantially cylindrical members, for example, robotic arms305(having diameter, for example, of about 8.6 mm), and another cylindrical (e.g., tubular) member comprising a tool307(for example, a laparoscopic illuminator, camera, clamp, cutter, and/or another tool). In some embodiments, the lumenal cross section of cannula201is sized to accommodate a plurality of substantially cylindrical members (e.g., robotic arms) each having a diameter of at least about 8 mm, and optionally another tool operated through a tube having a diameter of at least about 5 mm.

As shown inFIG. 3I, tools exiting the slanted distal aperture209of cannula201positioned within rectouterine pouch19are optionally oriented to curve downward from the aperture, into the rest of the peritoneal space where operations of a laparoscopic procedure are to be performed (for example, clipping ligaments in preparation for hysterectomy. Optionally, this orientation is assisted by the angled slot of distal aperture209described in relation toFIGS. 3F-3H, herein.

InFIGS. 7A-7B, robotic arms305include surgical tools704positioned on a distal end of each robotic arm305. The robotic arms305are shown entering into an insufflated abdominal cavity from cannula201through slanted distal aperture209. Also illustrated in the image is the dilated incision702through which cannula201has entered the abdominal cavity. Reference is now made toFIG. 3J, which is a schematic flowchart outlining preparation for a laparoscopic procedure using trocar200, according to some embodiments of the present disclosure. The procedure shown represents a setup portion of a larger procedure (for example, a hysterectomy), including elements of the method described in relation toFIGS. 3A-3I.

Optionally, at block110, in some embodiments, a laparoscopically mounted camera is inserted into the peritoneal space, for example from the umbilical. Optionally, the camera is provided together with an illumination source. Optionally, a separately mounted illumination source is also inserted from the umbilical.

At block112, in some embodiments, the peritoneal space is insufflated, e.g., by inflating with CO2. Insufflation is performed to enhance access and/or visibility during the procedure.

At block114, in some embodiments, a sleeve is inserted transvaginally. The sleeve potentially helps to maintain insufflation pressure (pseudo-peritoneum) used for visualization and/or access during the rest of the procedure. The sleeve may be provided, for example, as an Alexis® nylon sleeve (Applied Medical Resources Corporation), or as part of a GelPOINT® path transanal access platform (Applied Medical Resource Corporation). In some embodiments, the sleeve is inserted at a later stage; for example just before attachment of a sealing unit at block122.

At block116, in some embodiments, a speculum is inserted to the vagina to assist in visualization (optionally or additionally, a tenaculum is used).

At block118, in some embodiments, a uterine manipulator is inserted transvaginally to the uterus. The uterine manipulator may 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 room for other instruments, and/or to help move the uterus away from the rectum to provide increased safety. If a tenaculum was used, the tenaculum may be removed at this point.

At block120, in some embodiments, dilation and cannula introduction is performed, for example, as described in relation toFIGS. 3A-3G,FIG. 3K,FIGS. 6A-6E, and/orFIGS. 11A-11Eherein. The speculum may be removed during dilation, for example if it begins to interfere with dilation, or afterward.

At block122, in some embodiments, a sealing unit is attached to cannula201(or cannula1010, for example as described in relation toFIGS. 10A-10C, herein). The sealing unit optionally comprises elements of a GelPOINT® system; optionally in combination with elements specifically adapted for use with cannula201. Optionally, the uterine manipulator is re-positioned to pass through the sealing unit.

At block124in some embodiments, fixation is performed. Fixation comprises securing of the cannula and/or sealing unit to a platform which is stationary relative to the patient (e.g., an operating table).

At block125, in some embodiments, one or more robotic arms are aligned to cannula201,1010in preparation for introduction into cannula201,1010, for example as described in relation toFIGS. 9A-9DorFIGS. 10C-10J, herein.

At block126, in some embodiments, one or more robotic arms and/or other tools are introduced through the cannula201,1010, for example as described in relation toFIG. 3Hherein.

Reference is now made toFIG. 3K, which is a schematic flowchart representing a method of dilating and cannulating an access incision into a rectouterine pouch, according to some embodiments of the present disclosure. In some embodiments, the method ofFIG. 3Kdetails operations of block120ofFIG. 3J.

The method is outlined briefly. Additional details for the operations ofFIG. 3Kare described in relation toFIGS. 3A-3G, herein.

At block130, in some embodiments, inner dilator205(alternatively, in some embodiments, stepped dilator1100ofFIGS. 11A-11E) is inserted transvaginally to reach a wall3of the rectouterine pouch19(for example as described in relation toFIG. 3A). At block132, in some embodiments, a tip of a needle (inserted through inner dilator207) is located at the site where an access incision is to be made (for example, as detailed in relation toFIG. 4). At block134, in some embodiments, the rectouterine pouch is punctured (for example, as described in relation toFIG. 3B). At block136, in some embodiments, the pouch wall3is crossed with the first dilator stage, for example, a tip of inner dilator205(for example as described in relation toFIG. 3C). Alternatively, in some embodiments, pouch wall3is crossed with a first (distal) dilating stage of stepped dilator1100. At block138, in some embodiments, the pouch wall3is crossed with a second dilator stage, for example, the outer dilator203(for example, as described in relation toFIGS. 3D-3E). Alternatively, in some embodiments, pouch wall3is crossed with a second (proximal) dilating stage of stepped dilator1100. At block140, in some embodiments, the pouch wall is crossed with cannula201,1010(for example, as described in relation toFIGS. 3F-3G). At block142, in some embodiments, the dilators203,205and/or trocar needle207are removed, and the flowchart ends.

Reference is now made toFIG. 4, which schematically represents a dual-verification method of locating an incision for providing transvaginal access to a rectouterine pouch19, according to some embodiments of the present disclosure.

Shown inFIG. 4is a schematic representation of rectouterine pouch19, including a vaginal wall3of the rectouterine pouch19, approached by an inner dilator205, with a trocar needle207partially extended. Also shown are an intraperitoneally inserted (e.g., from the umbilical) camera402and an illumination source401. Camera402and illumination source401are shown on the same laparoscopic instrument400; optionally they are separately provided. Camera402has an associated field of view402A, while illumination source401has an associated illumination field401A.

In some embodiments, the tip of needle207is positioned before puncture against a region of wall3, wherein the region selected based on external observation of light from illuminator401visible from outside (e.g., as viewed transvaginally, optionally using the speculum and/or uterine manipulator to increase visibility). Optionally, the region selected is a region through which trans-illumination light intensity is observed to be relatively large compared to surrounding regions. Such well trans-illuminated wall areas are potentially among the thinnest, most easily penetrated portions of wall3accessible to needle207.

In some embodiments, as needle207is pressed against wall3to puncture it, camera402is used to visualize the results. In the camera images, for example, there may be initially a protrusion, other tissue distortion, and/or other change (e.g., a color change due to pressure on the tissue) visible at the site of penetration (e.g., a distortion visible from a side of wall3opposite a side contacting the needle), and afterwards the needle itself may become visible. Optionally, the visualization helps to verify that the intended region is being penetrated (e.g., that the region being penetrated is suitable to provide intraperitoneal access), and/or to help identify and/or prevent imminent rectal puncture or another insertion mistake. By using visual cues that communicate across the rectouterine wall3, even before the wall3itself has been punctured, complications may potentially be avoided.

Reference is now made toFIGS. 5A-5C, which schematically represent different stopper and/or movement interference devices for use with trocar components200, according to some embodiments of the present disclosure.

FIG. 5Aillustrates a stopper-and-shoulder type of stopper device. In this embodiment, outer dilator203is inserted first, or along with inner dilator205. The view ofFIG. 5Acuts away a portion of outer dilator203so that the connection between inner dilator205and proximal stopper501can be seen.

Proximal stopper501is positioned along inner dilator205at a position where surface501A is brought into abutment with a proximal surface (cut-away inFIG. 5A) of outer dilator203at the position where inner dilator203is as far distal relative to outer dilator205as it should be allowed to go (e.g., with a distal-most portion of inner dilator205positioned 15 mm in advance of a distal-most portion of outer dilator203). Then, when it is the turn of outer dilator203to be advanced, the distance between surface501A and the proximal surface of outer dilator203can be measured to determine the advance distance. Optionally another stopper device (for example, that ofFIGS. 5B and/or 5C) prevents and/or indicates distal over-advancement of outer dilator203relative to inner dilator205.

FIG. 5Billustrates a leaf-spring based stopper and/or motion interference device. The device comprises a bracket504attached to a distal portion of outer dilator203, which in turn supports a leaf spring505configured to press down onto the body of inner dilator205. This interaction optionally is set to a force sufficient to retard free sliding (e.g., due to gravity) of the inner dilator205relative to the outer dilator203.

Optionally, inner dilator205comprises a receiving shape505A (hidden by leaf spring505) which is positioned to contact leaf spring505and interfere with further longitudinal movement of outer dilator203relative to inner dilator205. The stopper device may be used to prevent over-advancement of either or both of inner dilator205and outer dilator203with respect to one another. There may be a plurality of different receiving shapes505A, allowing different positioned to be noted. Though referred to as a “stopper”, the stopper device ofFIG. 5Bis optionally configured using shapes and/or surface friction that interfere to resist, rather than completely prevent further longitudinal motion. The stopper device ofFIG. 5Bin such embodiments may be alternatively described as an indicating indexer. Optionally, the indicating indexer indicates relative dilator positions by the positions from which further longitudinal movement is resisted, and/or positions at which the two dilators click into place (as indicated through audible and/or tactile feedback).

The interfering occurs at one or more relative longitudinal positions of the two dilators203,205, for example, when the two are positioned with their distal-most portions in alignment, as shown inFIG. 3E. Receiving shape505A may comprise, for example, an inset portion into which leaf spring505falls when the two parts are aligned. Additionally or alternatively, receiving shape505A comprises a raised portion. In this case, a lumen of outer dilator203may be shaped to pass over the raised portion of receiving shape505A until leaf spring505encounters it. Alternatively, lumen of outer dilator203may be shaped to prevent passage of the receiving shape, so that it also acts as a type of stopper-and-shoulder arrangement. It should be understood that although the device is illustrated with respect to two nested dilators, it may alternatively or additionally be implemented between a cannula and a dilator.

FIG. 5Crepresents a different leaf-spring based stopper device. In this example, there are optionally provided be a plurality of leaf springs503mounted to the body of outer dilator203. Somewhere along its length, inner dilator205has a receiving shape (not shown), which comprise an indentation and/or a raised portion that contacts leaf spring503at a certain relative longitudinal position of the two dilators203,205; for example, when the two are positioned with their distal-most portions in alignment, as shown inFIG. 3E. The leaf spring device ofFIG. 5Ccan be placed in any suitable location along the body of outer dilator203, but preferably in a location that remains outside body cavities during use. There may be a plurality of such devices provided on outer dilator203, and/or a plurality of receiving shapes provided on inner dilator205. Optionally, the leaf spring device is provided on inner dilator205, and the outer dilator provided with the appropriate receiving shape(s).

In some embodiments, a stopper and/or motion interference device replaces the leaf spring with another mechanism. For example, in some embodiments, a plunger is provided (e.g., a spring-loaded pressing member such as a ball bearing, for example as described in relation toFIGS. 8A-8B). The plunger presses down to hold two nested parts in relative position (e.g., two dilators; dilator and cannula), and/or indicate that a particular relative position has been reached, by force of friction and/or by interference between the plunger and one or more stopper/indicating indexing shapes—and/or by release of such interference and/or friction.

Reference is now made toFIGS. 5D-5F, which schematically illustrate a needle207, needle-passing dilator handle510, and needle handle511, according to some embodiments of the present disclosure.

InFIG. 5D, needle207is shown partially inserted within the hollow body of dilator handle510. Optionally, dilator handle510serves as a handle for inner dilator205; e.g., attached via a screw thread or other attachment means. Proximal end512of needle207is adapted to attach to needle handle511ofFIG. 5E, for example as shown inFIG. 5F. In some embodiments, the relative lengths of needle207and dilator handle510(and the relative position of handle511on needle207) are configured to help control the maximum distance of distal advance of needle207relative to inner dilator205, for example as described in relation toFIGS. 5G-5I.

Reference is now made toFIGS. 5G-5I, which schematically illustrate devices for controlling the relative positioning of inner dilator205, outer dilator205, and needle207according to some embodiments of the present disclosure. Reference is also made toFIGS. 8A-8B, which illustrate scale features of outer dilator203and inner dilator205, according to some embodiments of the present disclosure.

InFIG. 5GandFIGS. 8A-8B, outer dilator203is shown provided with an integrated scale window515. Scale window515optionally comprises at least one reference mark alongside a longitudinal window formed in a portion (e.g., cut into a proximal end) of outer dilator203. In some embodiments, outer dilator203is used to define a reference position allowing inference of the current position of the wall3of rectouterine pouch19. Outer dilator can be inserted as far as it will easily pass. Since it is too blunt to puncture wall3, it will normally be brought to a halt with its distal-most end abutting wall3. This can be verified by viewing using a speculum, for example.

In some embodiments, a distance scale is marked (e.g., in centimeters from the distal end) on one or both of the inner dilator205and outer dilator203, for example, scale811of the outer dilator203, and scale813of the inner dilator205(FIGS. 8A-8B).

Also illustrated inFIGS. 8A-8Bis ball-stop device815, which is an example of an indicating indexer. In some embodiments, ball stop device815comprises a spring-loaded ball bearing, configured to protrude outwards from near a proximal end of inner dilator205under elastic pressure. The lumen of outer dilator203is sized so that it can be pushed over and then slide forward along ball-stop device815. The ball of ball-stop device815is pushed inward during this motion. It acts (by continuing to press outward) to help center outer dilator203over inner dilator205, and optionally to resist spontaneous relative translation (sliding) of the two dilators (e.g., due to the weight of outer dilator205). Upon sufficient advance of outer dilator203, ball-stop device815is freed from the proximal side of outer dilator203, potentially inducing a tactile and/or audible click, and/or causing changes to the mechanical handling of the dilators203,205which indicate to a user that outer dilator203has been fully advanced. Optionally, outer dilator203comprises one or more indentations and/or bumps along its lumen at positions which change the force with which the ball-stop device815interferes with relative longitudinal translation of the dilators203,205. It should be understood that the ball-stop device815may alternately be provided on the outer dilator203at a position where it interacts while sliding with the inner dilator205(and optionally bumps and/or indentations thereof). An indicating indexer is optionally provided for indication and/or control of relative longitudinal positions of other pairs of elements of the trocar kit; for example, between inner dilator205and needle207, and/or between outer dilator203and cannula201,1010. In some embodiments, a ball stop is provided which controls relative motion between stepped dilator1100and cannula201,1010when locked. In some embodiments, a ball stop is provided which controls relative motion between cannula1010and an access device1001(FIG. 10A) when locked.

InFIG. 8B, the ball stop device815is shown still compressed by outer dilator203. InFIG. 8A, the ball stop device is free of compression. Once the ball-stop device815is free of compression, the ball is pressed outward to the full extent of its travel, resulting in an increased resistance (upon contacting a proximal surface817of outer dilator203) to accidentally pushing inner dilator205distally relative to dilator203.

InFIG. 5H, inner dilator205is shown partially inserted into outer dilator203. Scale markings517on inner dilator205allow monitoring of the distal advance of inner dilator205relative to outer dilator203, e.g., to a position distally even with the distal end of outer dilator203(in preparation for needle puncture), and/or to a position a few millimeters (e.g., 15 mm) distally in advance of outer dilator205during initial dilation.

Also inFIG. 5H, needle207is shown still only partially advanced with respect to handle510and the dilators203,205. In some embodiments, dilator handle510fits (e.g., screws into) to a socket in inner dilator205, holding it at a predetermined distance from the distal end of inner dilator205.

InFIG. 5I, the relative positions of components shown is as may occur immediately after needle207punctures the wall3of the rectouterine pouch19.

The distal-most end of inner dilator205has been brought forward even with the distal-most end of outer dilator203, as monitored from the relative positions of scale window515and markings517. Handle511has been pushed forward so that it abuts a proximal end of dilator handle510, preventing further advancement of needle207. Lengths of needle207, inner dilator203, and dilator handle510are set so that needle207now protrudes from the front of inner dilator203by a predetermined amount which has been determined to fall within the range of distances which are enough to penetrate a wall3of a rectouterine pouch19, but avoid risk of also penetration a wall of the rectum11.

Optionally, the distal-most end of inner dilator205remains longitudinally offset from (e.g, distal to) the distal-most end of outer dilator203by some distance to control the maximum advance of needle207. Optionally, maximum advance of needle207relative to inner dilator205is performed first, before advance to penetrate wall3. This provides a potential advantage for allowing marked relative positions of window515and scale517to indicate the distance of needle advance in detail.

During dilation, in some embodiments, distal advance of outer dilator203relative to inner dilator205potentially disrupts the longitudinal frame of reference that outer dilator203initially establishes. In some embodiments, the frame of reference is maintained by clamping inner dilator205into place once it has advanced into the rectouterine pouch.

Reference is now made toFIG. 5K, which illustrates a manufactured example of a dilation and cannulation kit comprising members described and illustrated in, for example,FIGS. 3A-3I and 5D-5I, according to some embodiments of the present disclosure. Items are to scale with each other, and shown along their total length, with the exception of needle207, which has been truncated on the right hand (sharpened, distal) side. Illustrated, from top to bottom, are:Needle207including handle511,Cannula201, including handle202and slanted distal aperture209, comprising proximal edge portion210and distal-most edge portion211.Outer dilator203, including scale window515, distal edge212, tapering region213, and the wide profile214at the proximal side of tapering region213.Inner dilator205, including distal port216positioned in blunt tip215, tapering region218, and the wide cross-section219at the proximal side of tapering region218.Dilator handle510, which may optionally be attached to (e.g., screwingly attached to) inner dilator205to serve as a proximal-side handle thereof.

Reference is now made toFIGS. 6A-6E, which schematically represent dilation using a single dilator trocar kit, according to some embodiments of the present disclosure.

FIG. 6Ashows a schematic representation of a body cavity (e.g., a vagina17), together with an access device601which is optionally used, e.g., to help maintain insufflation pressure. InFIG. 6B, a uterine manipulator603is optionally added (shown incompletely inserted), potentially allowing maneuvering to increase visibility of the trocar target region (which may be a wall3of a rectouterine pouch19, not shown). InFIG. 6C, cannula605(optionally constructed as described herein in relation to cannula201or cannula1010) is inserted to the target region. Cannula605comprises a handle605A to allow maneuvering of the lumen region of the cannula605.

InFIG. 6D, a dilator607is being inserted to cannula605, optionally using handle607A. The tip of dilator607is optionally shaped to begin at its distal-most longitudinal position with a cutting tip. Alternatively, the tip of dilator607is blunted (shaped, for example, like that of inner dilator205). Optionally, dilator607allows for passage distally of a trocar needle via an aperture. Optionally, initial puncture is made separately by a needle, e.g., passed into the lumen of cannula605(not shown), and dilator607inserted afterward.

In some embodiments, the tip of dilator607expands to any appropriate cross-sectional size; for example, any cross-section described in relation to wide cross-section219. Optionally, the longitudinal distance between distal-most position and the tip cross-section of greatest expansion is about 15 mm or any other suitable distance; for example, as descried in relation to dilator tips of dilators203,205. Relative to use of two or more dilators, one-step dilation over the same maximum dilator tip distance is potentially simpler from the point of view of component exchanges and manipulations. There is a potential tradeoff, however, of increased penetration length (e.g., if expansion angle is maintained), and/or (e.g., if expansion angle is increased) of increased resistance to penetration.

InFIG. 6E, the tip of dilator607is shown maximally advanced, with dilation complete. To complete trocarization, the cannula605may now be advanced through the dilated aperture, and the dilator607removed.

Reference is now made toFIG. 5J, which is a flowchart schematically outlining a method of using indicators to transitively establish and maintain known insertion depths of the trocar needle207, dilator203,205, and/or cannula201,1010parts, according to some embodiments of the present disclosure.

At block551, in some embodiments, a first dilator (e.g., inner dilator205) is brought into position with its blunt tip against the outer wall of the rectouterine pouch. This position may be established, for example, by direct visualization (e.g., using a speculum), by noting where insertion resistance is encountered, and/or indirectly, e.g., by shining a light through the dilator lumen, and monitoring the projected light spot (e.g., the position where the spot reaches its smallest, most sharply defined shape) through the rectouterine pouch wall using a camera positioned inside the intraperitoneal space. Optionally, the first dilator is held clamped in position, e.g., by a table-attached clamping arm. Optionally, at block552, the depth of penetration relative to the natural orifice opening is noted, providing a total vaginal length (TVL) which may be used separately from the transitive method of establishing trocar component positions, and/or to verify insertion depths set by the transitive method.

At block553, in some embodiments, a trocar needle207is inserted into dilator205, e.g., via holder210. Insofar as holder210is itself sized to insert to a predetermined longitudinal position relative to the first dilator, the amount of visible shaft of trocar needle207optionally provides an indication of where the needle tip is positioned relative to the distal end of the first dilator. This can be used to control an advancing distance of trocar needle207, optionally along with a stopper device (such as a shoulder stopper) that prevents over-advancement of the trocar needle207. Optionally, the needle remains in place at least until the first dilator is advanced over it.

At block555, in some embodiments, a second dilator (e.g., outer dilator203) is advanced over the first dilator until a part of the second dilator (e.g., its proximal end, or an index mark) it is suitably aligned to a part of the second dilator (e.g., an index marking on a scale). If an index scale is used, it may be on either or both of the first and second dilator. For the sake of description of the method, the distal ends of the first and second dilators are assumed to be aligned to one another in the aligned position; optionally, they are offset by some known amount. Additionally or alternatively, the insertion depth of the second dilator relative to the total vaginal length is used to longitudinally position and/or verify the position of the second dilator.

At this stage, the longitudinal positions of the distal ends of the first dilator and second dilator are both known relative to that of the rectouterine pouch wall which is to be dilated. Optionally, either dilator can be advanced or retracted relative to the other in any suitable sequence, and so long as the sequence of movements and their distances are tracked, their positions relative to the rectouterine pouch wall will remain known.

For example, at block557, in some embodiments, the first dilator is advanced into the rectouterine pouch while the second dilator remains fixed (e.g., clamped). The relative motion is optionally monitored by looking at scale marking motions on the proximal ends of the dilators. At block559, e.g., once the first dilator is sufficiently advanced (for example, 15 mm) to achieve a full first-stage dilation, the second dilator is advanced (e.g., until the original relative alignment of the two is restored). Additionally or alternatively, the changing insertion depths are controlled/monitored relative to the total vaginal length.

Additionally or alternatively (at blocks558and/or560), advancing distance is controlled by making reference to the TVL determined at block552.

From this position, at block561, the first dilator (and trocar needle207, if not yet withdrawn) may be removed; and the second dilator may remain as a longitudinal positioning reference for positioning the cannula201at block563. Optionally, the cannula201has a handle which is long enough to support a scale and/or reference mark that aligns with some visible part of the second dilator (a scale mark, distal end, or indicator mark) when the cannula201is in place. Additionally or alternatively, the cannula insertion depth is controlled/monitored relative to the total vaginal length.

At block565, the second dilator is removed. Cannula201is now positioned crossing the rectouterine wall, and at a known longitudinal depth relative to the rectouterine wall.

Optionally, the stepped dilator1100ofFIGS. 11A-11Eis used by this method, with the insertion ofFIG. 6Eoptionally occurring in two stages, one for each of distal tapering region1121, and proximal tapering region1117, optionally with a pause between the two stages enabled by allowing the physician to sense a change in insertion resistance upon transitioning from distal tapering region1121to isolating region1119.

Cannula Fixation and Robot Alignment to Cannula

Free-Positioned Alignment System

Reference is now made toFIGS. 9A-9D, which comprise views representing an instrument holder900for cannula201and its configuration for use, wherein instrument holder900includes a motor unit stopper902for use in setting an initial robotic arm position, according to some embodiments of the present disclosure.

FIG. 9Aschematically shows an in instrument holder900, comprising a mounting block901and a stopper arm902. In some embodiments, stopper arm902is hinged upon hinge904to rotate to different orientations relative to mounting block901.

FIG. 9Bshows cannula201and associated handle202mounted to mounting block901. Mounting, in some embodiments, comprises positioning a proximal end of handle202in a well-defined position relative to mounting block901; for example, flush with an aperture903of a lumen within block901sized and shaped to receive handle202. Fixation of cannula201relative to block901is optionally assured by tightening a tightening handle905.

FIG. 9Cshows an overall mounting arm assembly910, comprising a table-mounting block911(configured, e.g., with clamps and tightening handles supporting firm attachment to a table or other stabilizing surface), and jointed arm912extending distally from the mounting block911to attachment at its distal side to mounting block901.

FIG. 9Dshows the instrument holder900with motor unit stopper902configured to set an initial working distance of motor unit930. Motor unit stopper902is sized so that when positioned to horizontally protrude from block901, its distal end marks the distance at which motor unit930should be set so that its arms (which themselves have a well-known predetermined length) reach a defined (and safe) initial distal-most position within cannula201(e.g., at the distal end of the cannula) when cannula201positioned relative to mounting block901as shown inFIG. 9B(the cannula is not shown inFIG. 9D). Robotic arms305(not seen) pass distally from motor unit930within extenders920. Extenders920comprise tubes having a lumen sized to pass the robotic arms305thereinto, for example, a lumen of, for example, at least 7 mm, 8 mm, 9 mm, or 10 mm. Extenders920may be aligned (e.g., set within slots921ofFIG. 9B) to guide the robotic arms305to cannula201.

By appropriate positioning of its parts at marked and predetermined positions, a kit comprising cannula201and handle202, and instrument holder900with motor unit stopper902(optionally including extenders920and/or motor unit930and associated arms305) potentially helps to achieve a rapid, reproducible initial setup providing a well-determined initial relationship between the distal end of cannula201, and the distal ends of robotic arms305, for example, an alignment of the two ends.

To allow initiation of robotic arm movement in a distal direction, motor unit stopper902is allowed to swing away from the horizontal position (e.g., downward), so that motor unit930can advance distally without interference. Preferably, attachment of motor unit stopper902to block901is configured to allow conversion between a first position that prevents advance of motor unit930, and a second position that allows it; without disturbing the position of structures on either side of it—for example, without disturbing positions of the cannula201or the motor unit930. The attachment is not necessarily by a hinge (for example, stopper902may be telescoping, slideable within block901, or otherwise moveable). A hinge provides a potential advantage by allowing a reproducible longitudinal stopper position to be obtained when the stopper is oriented in the horizontal (oriented to the longitudinal axis of the cannula) position, together with ready conversion to a non-stopping position without having to exert either longitudinal force to slide the stopper902, or torque on a fastener to release the stopper902.

Lock-Positioned Alignment System

Reference is now made toFIGS. 10A-10E, which schematically illustrate views representing a collapsing instrument holder1000for cannula1010and its configuration for use in setting an initial robotic arm position relative to cannula1010, according to some embodiments of the present disclosure. Reference is also made toFIGS. 10F-10J, which schematically represent components of collapsing instrument holder1000, according to some embodiments of the present disclosure. Further reference is made toFIGS. 12A-12C, which schematically represent a duck-bill gasket1050used to seal access to the proximal aperture of access device1001, according to some embodiments of the present disclosure.

FIG. 10Ashows an access device1001, shaped for insertion into a gel seal1003(in a position indicated, for example, inFIGS. 10B-10C). In use, gel seal1003is positioned at the vaginal entrance to provide protected access; thus, elements positioned to the right of gel seal1003would be positioned intra-vaginally during a procedure, and elements positioned to the left would be positioned extra-vaginally.

Trans-seal region1001A of access device1001is flanged on either side, and seats within the gel membrane of gel seal1003. External (proximal) side1001B of access device1001(also referred to herein as a “trocar”), in some embodiments, is provided with a mounting projection1002. Lumen1004of access device1001is sized to allow insertion of stepped dilator1100(e.g., as shown inFIG. 10B), or optionally another dilator/dilator system, for example, a two-piece dilator comprising inner dilator205and outer dilator203. Also shown inFIG. 10Bassembled together with stepped dilator1100are needle handle511of needle207and dilator handle510.

Lumen1004of access device1001is also sized to allow insertion of a cannula1010over stepped dilator1100(or other dilatory system). When inserted to lumen1004, in some embodiments, cannula1010is fittingly contained by access device1001, and optionally locked thereto. Cannula1010, in some embodiments, comprises a body with an elongated (e.g., oval) cross-section, having a slanted distal aperture209, for example as described in relation toFIG. 3L, and a flange221at its proximal side. In some embodiments, flange221includes a receiving indentation for a ball stop1006provided on access device1001which controls relative motion between cannula1010and access device1001when locked.

In some embodiments, a two-seal “duck bill” gasket1050(shown inFIG. 10C, andFIGS. 12A-12C) is inserted into the proximal aperture of access device1001after positioning of cannula1010. A first sealing member1050A of gasket1050is normally sealed (two opposite sides pushed together) when there is nothing inserted into cannula1010. Upon insertion of robotic arm guide1032(explained further in relation toFIGS. 10D-10E), first sealing member1050A is forced open, while a second sealing member1050B, which is normally open, is shaped so that it seals around the robotic arm guide1032. The sealing members1050A,1050B are made of a soft elastic material, for example, a silicone rubber. In some embodiments, gasket body1050C comprises a rigid polymer or metal material that provides support to sealing members1050A,1050B to help maintain the overall shape of gasket1050. In some embodiments, each of the sealing members1050A,1050B is shaped so that it has a long axis and a short axis, with the long axis being at least twice as long as the short axis.

The placement of the above-described elements generally corresponds, in some embodiments, to the operations of block120(dilate and introduce cannula) and block122(sealing unit) ofFIG. 3J.

Fixation corresponding to operation of block124ofFIG. 3J, in some embodiments, comprises attaching mounting projection1002to mounting block1020. Mounting block1020may itself be affixed, for example, to a platform stationary relative to the patient, such as an operating table. In some embodiments, attachment comprises insertion of mounting projection1002into a receiving aperture1061(shown inFIG. 10J) of mounting block1020. In some embodiments, notch1005or another shape on mounting projection1002engages to a lock within receiving aperture1061. Optionally, button1021is pressed to assist and/or activate engagement and/or release of mounting projection1002from the lock.

Mounting block1020is a component of instrument holder1000. Attached to mounting block1020, instrument holder1000additionally comprises spacing arm1024and aligning arm1030. In some embodiments, spacing arm1024is attached to mounting block1020by stopped hinge1022, and aligning arm1030is in turn attached to spacing arm1024by stopped hinge1028. In some embodiments, spacing arm1024is telescoping (reversibly extendible and retractable). Optionally, release and/or locking of telescoping is controlled by a button1026or other control member.

The use of stopped hinges1022,1028and button1026to position spacing arm1024and aligning arm1030are further illustrated inFIGS. 10D-10E.

In some embodiments of the invention, cannula1010is used to provide intraperitoneal access to one or more robotic arms, for example robotic arms305as described, for example, in relation toFIGS. 3I and 7A-7B. As also described in the Overview herein, it is a potential advantage to be able to position these robotic arms so that they begin at a well-known distance of longitudinal advance through cannula1010, and at a well-known angle of approach (generally an angle of approach axially aligned with cannula1010).

InFIGS. 10D-10E, spacing arm1024and aligning arm1030comprise an assembly shown fully deployed (in a deployed position) in order to help set a starting position for robotic arms being introduced into cannula1010. In some embodiments, this comprises:Rotating spacing arm102490° from its vertically downward stowed position (seen inFIG. 10C) to a horizontal deployment position.Extending spacing arm1024to set the spacing distance by pressing on button1026, and pulling to expose telescoping arm portion1024A.Rotating aligning arm1030from its stowed position against spacing arm1024(as inFIG. 10C) to a vertical deployment position.

Optionally, spacing arm1024and aligning arm1030are returned to their stowed positions after use to position robotic arms correctly. A potential advantage of post-use stowing is so that they do not interfere with further movements of the robotic arms (e.g., advancing deeper into the intraperitoneal cavity).

FIGS. 10F-10Jillustrate these components in more detail.FIGS. 10F-10Hshow spacing arm1024in a collapsed (unextended) configuration. Stopped hinges1022,1028can be seen, including details of an optional embodiment thereof. For example, in the case of stopped hinge1022, each of (optionally four) projections1063is spaced around a circumference of stopped hinge1022. Each projection1063extends into a respective notch of plate1022A. The projections1063are fixed to the orientation of block1020(FIG. 10J), while plate1022A is affixed to spacing arm1024. Accordingly, as long as the projections1063engage the notches of plate1022A, spacing arm1024is fixed in orientation. Upon actuating button1062, projections1063are recessed out of their notches, allowing spacing arm1024to rotate freely. Optionally, the projections1063are held in place by plate1022A once the notches are moved out of alignment with them, so that button1022A can be released while spacing arm1024continues to move freely.

Once spacing arm1024is deployed by a full 90°, the notches of plate1022A and projections1063come back into alignment, allowing projections1063to spring back into place, locking spacing arm1024in a new orientation. This mechanism has potential advantages of (1) only allowing one deployed orientation of spacing arm1024, and (2) being strong enough to hold the horizontally deployed weight of spacing arm1024and aligning arm1030without collapsing.

Stopped hinge1028, in some embodiments, comprises a similar mechanism, comprising projections1065, button1067, and notched plate1066. Notched plate1066is again affixed to spacing arm1024, while the projections1065are fixed to the orientation of aligning arm1030.

In the fully deployed position ofFIGS. 10D-10E, horizontal bar1068(FIG. 101) of aligning arm1030acts to set an elevation across which robotic arms should be horizontally passed while aiming at cannula1010in order to be level with the longitudinal axis of cannula1010. Similarly, the robotic arms should pass through the space between vertical bars1064in order to approach cannula1010along its central longitudinal axis. Furthermore, in some embodiments, a motor unit or other housing holding a robotic arm which is being positioned is in position when some designated portion of it (a “stopper-receiving portion”) is pressed up against a portion of aligning arm1030that acts as a stopper, for example, pressed against the vertically extending main bar1069of aligning arm1030.

Returning now toFIGS. 10D-10E: in some embodiments, robotic arms305are sheathed (e.g., two round arms side-by-side) using arm sheath1032before being passed into cannula1010(e.g., in performing the operations of block126ofFIG. 3J). In some embodiments, arm sheath1032has an inner lumen sized 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, a minimum diameter of the inner lumen of arm sheath1032is about 9 mm, 10 mm, or 11 mm.

A potential advantage of sheath1032is to ensure that the arms are straight, and moreover to ensure that no part of them will be accidentally snagged during passage into and through cannula1010. In some embodiments, moreover, there is provided a gasket1034, comprising a fitted hole for each of two robotic arms that may be passed therethrough. Gasket1034fittingly attaches to a proximal end of arm sheath1032, to act as another protective seal. Optionally, arm sheath1032is constructed from stainless steel. Optionally gasket1034is manufactured from a flexible polymer such as a silicone rubber.

Stepped Dilator

Reference is now made toFIGS. 11A-11E, which schematically represent a stepped dilator1100, dilator handle510, and trocar needle207, according to some embodiments of the present disclosure. Reference

In some embodiments, stepped dilator1100comprises, along a distal working end1115of a single dilator, distal and proximal tapering regions1121and1117(FIGS. 11B, 11C). Distal and proximal tapering regions1121,1117are, in some embodiments, substantially shaped as described for embodiments of tapering regions213and218of the two-dilator combination which is described herein, for example, in relation toFIGS. 2A-3I and 5K. Nevertheless, some specific details of tapering region shapes are repeated here for clarity.

In some embodiments, distal (first) tapering region1121has a blunted distal-most portion. The distal-most portion optionally has a port through which a trocar needle207can be extended. Optionally, the distal-most portion curves proximally, widening in both width and height through a radius of about 2.5 mm, then expanding primarily in width to form a wide oblong cross-section about 15 mm proximal to the distal-most portion (or another distance, for example in the range of about 10-20 mm).

In some embodiments, a non-dilating isolating region1119extends longitudinally between the distal and proximal tapering regions. Preferably, isolating region1119is long enough to allow an inserting physician to sense a reduction in insertion resistance upon passing the proximal side of distal tapering region1121, and reduce insertion force in response, so that dilation is paused. This distance is optionally in the range of about 5-15 mm. In some embodiments, isolating region1119is of a constant cross-section extending proximally from the distal side of isolating region1119until reaching the distal side of proximal tapering region1117. Alternatively, isolating region1119A (FIG. 11C), in some embodiments, comprises a constriction (e.g., a tapering constriction) relative to the proximal-side cross-section of distal tapering region1121, which potentially acts as a detente that accentuates for a physician the sensation of reduced insertion resistance. The constriction may also allow a physician to detect by feel a difference between an initial dilation after which the dilated tissue perimeter retains elasticity (tending to re-collapse the dilated opening), and a dilation where a tear has been induced, potentially reducing the tendency of the dilated opening to exert inward force on the dilator.

In some embodiments, proximal (second) tapering region1117has a distal-most cross-section arising from the proximal-most portion of isolating region1119. From there, the second dilator's cross-section expands going proximally for about 15 mm (or another distance, for example in the range of about 10-20 mm). The maximum of the further expansion is an expansion by about, for example, about 5 mm,7.5, mm, 10 mm, or 12.5 mm. Optionally, there is a larger expansion along one axis of the incision cross-section than along another axis; for example, there may be a relative factor of expansion of about 1:1.5, 1:2, or 1:3.

In some embodiments, a body1111of dilator1100is constructed of a sterilizable and re-sterilizable (e.g., autoclave compatible) material, e.g. stainless steel. Optionally, an inset region1113is provided on one or both sides of body1111. This potentially reduces weight of dilator1100(e.g., in embodiments where body1111is constructed of a solid piece of metal).

In some embodiments, dilator1100is at least 17 cm in overall length without handle510. In some embodiments, threaded region1102A is threaded to accept a thread of handle510. Handle510is optionally at least 20 cm long.

General

As used herein with reference to quantity or value, the term “about” means “within ±10% of”.

The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “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.

The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment may include a plurality of “optional” features except insofar as such features conflict.

Throughout this application, embodiments of this disclosure may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges 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.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.