Patent Description:
This disclosure relates to distal tips of surgical tools, such as uterine manipulators, and related methods of operating such surgical tools.

Uterine manipulators are medical instruments that are used for manipulating (e.g., moving or repositioning) a patient's uterus during medical procedures. Such procedures include surgical procedures, such as laparoscopic gynecologic surgery (e.g., total laparoscopic hysterectomy (TLH) surgery). Instruments of this kind often include a proximal portion that remains external to the patient's body during use and a distal portion that is inserted into the patient's body. The proximal portion typically provides for manipulation of the instrument during use. The distal portion often includes a tip that is sized to be inserted into and/or engage the uterus. Generally, the distal portion of the instrument is advanced through the vaginal cavity and into the uterus. With the distal portion inserted within a uterus, the uterus can be manipulated through surgeon-controlled or physician-controlled movements of the proximal portion. Following completion of a procedure, the instrument is removed from the patient's body via the vaginal cavity.

<CIT> describes a uterine manipulator that includes a shaft configured to be inserted into a cervix and a colpotomizer assembly configured to move along the shaft. The shaft includes multiple ruler markings printed along a portion of the shaft. The colpotomizer assembly includes a sleeve that includes a rotatable locking member configured to compress the shaft in a manner that locks the colpotomizer assembly in position along the shaft when the rotatable locking member is depressed against the shaft. The rotatable locking member includes a cam roller configured to compress the shaft when the rotatable locking member is depressed towards the shaft.

In general, this disclosure relates to distal tips of surgical tools (e.g., uterine manipulators) and related methods of operating such surgical tools. In an example embodiment, a uterine manipulator including any of the distal tips disclosed herein can be used for manipulating a patient's uterus during gynecological surgical and/or diagnostic procedures.

A distal tip according to the present invention is set out in claim <NUM>. A surgical tool according to the present invention is set out in claim <NUM>. Further advantageous developments of the present invention are set out in the dependent claims.

Embodiments may provide one or more of the following advantages.

The over-molded design of the expandable member advantageously enables the expandable member to be securely attached to the tip body of the distal tip with only a single seal that is provided by the chemical bond (e.g., an overmolded bond). In contrast, conventional distal tip designs of uterine manipulators often require multiple glue joints for securing a distal expandable member to a shaft. Application of such glue joints is typically difficult to automate and also difficult to carry out in a manual assembly process in a repeatable and reliable manner.

Other aspects, features, and advantages will be apparent from the description, the drawings, and the claims.

<FIG> illustrate a uterine manipulator <NUM> adapted for insertion into a vaginal cavity for use in female pelvic surgical procedures. The uterine manipulator <NUM> is a disposable (e.g., single-use) device. The uterine manipulator <NUM> includes a shaft <NUM> that is configured to extend through a patient's cervix for use in repositioning the patient's uterus and a colpotomizer assembly <NUM> that is disposed about the shaft <NUM> and configured to receive the cervix. The uterine manipulator <NUM> further includes a distal tip <NUM> that is attached to a distal portion <NUM> of the shaft <NUM>, as well as a handle assembly <NUM> that is connected to a proximal portion <NUM> of the shaft <NUM>. The uterine manipulator <NUM> also includes a vaginal occluder <NUM> that surrounds the colpotomizer assembly <NUM> for maintaining pneumoperitoneum within the patient's peritoneal cavity during a surgical procedure.

Referring particularly to <FIG>, the shaft <NUM> of the uterine manipulator <NUM> is formed as a rigid cannula with several portions that have generally curved (e.g., arcuate) shapes. For example, in addition to the distal portion <NUM> to which the distal tip <NUM> is attached and the proximal portion <NUM> that extends into the handle assembly <NUM>, the shaft <NUM> also includes a central portion <NUM> along which the colpotomizer assembly <NUM> is displaceable for engaging the cervix. The shaft <NUM> defines a central lumen <NUM> that allows passage of air between the handle assembly <NUM> and the distal tip <NUM>.

Referring to <FIG>, the central portion <NUM> and parts of the distal and proximal portions <NUM>, <NUM> of the shaft <NUM> are surrounded by a shrink tube <NUM> that provides traction for locking the colpotomizer assembly <NUM> in a desired position along the shaft <NUM>, as will be discussed in more detail below. A set of ruler markings <NUM> are printed across a distal portion of the shrink tube <NUM> and indicate a distance from the fundus of the uterus when the uterine manipulator <NUM> is appropriately, fully inserted into the uterus (e.g., when the distal tip <NUM> is positioned adjacent the fundus, as will be discussed in more detail with respect to <FIG>). The ruler markings <NUM> may be provided in English units or metric units.

Referring again to <FIG>, the portion of the shaft <NUM> that extends between the handle assembly <NUM> and the distal tip <NUM> typically has an arcuate length of about <NUM> to about <NUM> (e.g., about <NUM>). The same portion of the shaft <NUM> typically has a projected length of about <NUM> to about <NUM> (e.g., about <NUM>). A section <NUM> of the proximal portion <NUM> of the shaft <NUM> that extends from the handle assembly <NUM> typically has a radius of curvature of about <NUM> to about <NUM> (e.g., about <NUM>). The central and distal portions <NUM>, <NUM> of the shaft <NUM> typically together have a radius of curvature of about <NUM> to about <NUM> (e.g., about <NUM>). The shaft <NUM> typically has an inner diameter of about <NUM> to about <NUM> (e.g., about <NUM>) and a wall thickness of about <NUM> to about <NUM> (e.g., about <NUM>).

The shaft <NUM> and the shrink tube <NUM> of the uterine manipulator <NUM> are formed (e.g., molded, extruded, drawn, and/or machined) from one or more materials that are biocompatible and capable of withstanding medical device sterilization procedures, such as chemical-based or heat-based sterilization procedures. In some embodiments, the shaft <NUM> may be made of one or more of <NUM> stainless steel, <NUM> stainless steel full hard, various other grades of stainless steel, stainless steels with various other hardness values, glass-filled plastics, and carbon fiber-filled plastics or other materials. Such materials can advantageously provide tactile feedback (e.g., resistance to movement of tissue) to the user of the uterine manipulator <NUM> as the shaft <NUM> is inserted or positioned within the patient. In some embodiments, the shrink tube <NUM> may be made of acrylated olefin or polytetrafluoroethylene (PTFE) and may have a shore durometer of about shore D25 to about shore D60 (e.g., about shore D53). Such a hardness can provide the shrink tube <NUM> with enough traction to lock the colpotomizer assembly <NUM> in a desired position.

Referring to <FIG> and <FIG>, the colpotomizer assembly <NUM> is a displaceable assembly that can be slid along the shaft <NUM> of the uterine manipulator <NUM>. The ability to displace the colpotomizer assembly <NUM> can allow for relatively quick, easy positioning of the distal tip <NUM> of the uterine manipulator <NUM> within the cervix. Once proper placement of the distal tip <NUM> has been visually confirmed, the colpotomizer assembly <NUM> can be advanced along the shaft <NUM> into engagement with the cervix. The colpotomizer assembly <NUM> includes a colpotomizer cup <NUM> adapted to receive the cervix, a sleeve <NUM> that is connected to the colpotomizer cup <NUM> and that can be grasped for moving the colpotomizer assembly <NUM>, and a vaginal occluder <NUM> disposed about a distal region <NUM> of the sleeve <NUM>.

The colpotomizer cup <NUM> includes a generally cylindrical body <NUM>, a base <NUM> that is spaced apart from the body <NUM>, and three projections <NUM> that extend between the body <NUM> and the base <NUM>. The projections <NUM> are spaced substantially equally around the body <NUM> and define three viewing windows <NUM>. The body <NUM> defines a beveled rim <NUM> at a distal edge to provide an anatomical landmark and an incision backstop during use of the uterine manipulator <NUM>. The base <NUM> of the colpotomizer cup <NUM> defines an opening <NUM> that is sized to allow passage of the shaft <NUM>.

The sleeve <NUM> extends proximally from the base <NUM> of the colpotomizer cup <NUM> and has an arcuate shape that generally follows the shape of the central portion <NUM> of the shaft <NUM>. The sleeve <NUM> is formed as a clam shell structure that includes a female portion <NUM> and a male portion <NUM>. The female and male portions <NUM>, <NUM>, respectively, include multiple receptacles <NUM> (e.g., hexagonal or round-shaped receptacles) and multiple pins (e.g., round or cylindrical shaped pins) positioned along peripheral edges and aligned to mate with each other to secure the female and male portions <NUM>, <NUM> together. The female and male portions <NUM>, <NUM> together define a channel <NUM> through which the shaft <NUM> extends.

At a proximal end, the sleeve <NUM> includes a thumb lock <NUM>, opposing receptacles <NUM> (e.g., through openings) that receive the thumb lock <NUM>, opposing projections <NUM> to which the thumb lock <NUM> can be snap fitted, and a guide surface <NUM> that guides a radial position of the sleeve <NUM> about the shaft <NUM> and supports the shaft <NUM> for contact with the thumb lock <NUM>. The thumb lock <NUM>, receptacles <NUM>, projections <NUM>, and guide surface <NUM> together provide a quick, one-handed locking mechanism that allows the colpotomizer assembly <NUM> to be locked into a desired position along the shaft <NUM>.

The thumb lock <NUM> includes a cam roller <NUM> adapted to contact the shrink tube <NUM> surrounding the shaft <NUM> to lock the colpotomizer assembly <NUM> into a selected position along the shaft <NUM>. In particular, the radius of the cam roller <NUM> is variable (e.g., extending radially beyond a minimum circumference of the cam roller <NUM> along certain portions of the cam roller <NUM>), such that the cam roller <NUM> compresses (e.g., digs into) the shrink tube <NUM> as the cam roller <NUM> is rotated towards the shaft <NUM> of the uterine manipulator <NUM>. The thumb lock <NUM> further includes opposing pins <NUM> that extend from the cam roller <NUM> for mounting within the receptacles <NUM>, a jaw <NUM> extending from the cam roller <NUM>, and a lift flange <NUM> extending proximally from the jaw <NUM>. The thumb lock <NUM> is rotatable with respect to the sleeve <NUM> via the arrangement provided by the pins <NUM> and receptacles <NUM>.

The thumb lock <NUM> allows the colpotomizer assembly <NUM> to be locked into a desired position using an easy, one-handed technique that can be carried out with the same hand that moves the colpotomizer assembly <NUM> along the shaft <NUM>. When the lift flange <NUM> is pushed downward (e.g., by the user's thumb) towards the shaft <NUM> to place the thumb lock <NUM> in a closed configuration (refer to <FIG>), rotation of the cam roller <NUM> causes the cam roller <NUM> to dig into the shrink tube <NUM>, thereby generating friction that locks the sleeve <NUM> of the colpotomizer assembly <NUM> in position along the shaft <NUM>. Accordingly, the cam roller <NUM> of the thumb lock <NUM> is configured to apply a compressive load to the shaft <NUM>. Such downward force applied to the lift flange <NUM> also causes the jaw <NUM> to snap fit onto the projections <NUM>. When the lift flange <NUM> is pushed upward (e.g., by the user's thumb) away from the shaft <NUM> to place the thumb lock <NUM> in an open configuration (refer to <FIG>), rotation of the cam roller <NUM> releases the shrink tube <NUM>, thereby unlocking the sleeve <NUM> of the colpotomizer assembly <NUM> with respect to the shaft <NUM>. Such upward force applied to the lift flange <NUM> also causes the jaw <NUM> to separate from the projections <NUM>. The thumb lock <NUM> provides the user with the ability to lock the colpotomizer assembly <NUM> at various different positions along the shaft <NUM> of the uterine manipulator <NUM>.

Still referring to <FIG> and <FIG>, the colpotomizer assembly <NUM> of the uterine manipulator <NUM> has a geometry (e.g., provided by the position and size of the opening <NUM> of the base <NUM>) that ensures proper alignment of a cup face <NUM> of the colpotomizer cup <NUM> with respect to the shaft <NUM>. The cup face <NUM> is oriented perpendicular to an axial centerline <NUM> of the colpotomizer cup <NUM>. A centerpoint <NUM> of the cup face <NUM> (located along the axial centerline <NUM> of the colpotomizer cup <NUM>) is maintained along an arch centerline <NUM> of the shaft <NUM> as the colpotomizer assembly <NUM> is slid along the shaft <NUM>. Such alignment of the cup face <NUM> with the arch centerline <NUM> is provided by an offset (e.g., oriented perpendicular to the centerline <NUM>) between the centerline <NUM> of the colpotomizer cup <NUM> and the arch centerline <NUM> of the shaft <NUM>, at the location of the opening <NUM> of the base <NUM> of the colpotomizer cup <NUM>. The offset <NUM> is typically a distance of about <NUM> to about <NUM> (e.g., about <NUM>).

The colpotomizer cup <NUM> is substantially prevented from tilting with respect to the shaft <NUM> by points of contact between the cup <NUM> and the shaft <NUM> at the opening <NUM> of the base <NUM> and points of contact between the guide surface <NUM> and the shaft <NUM> beneath the cam lock <NUM> of the thumb lock <NUM>. Aligning the colpotomizer cup <NUM> with respect to the shaft <NUM> in this manner ensures that an appropriately angled cutting edge is achieved for guiding a cutting of the uterus with an even distribution of tissue when the cervix is received within the colpotomizer cup <NUM>. In other words, this configuration can help to ensure that substantially the same amount of cervical tissue is received in the colpotomizer cup <NUM> about the entire circumference of the shaft <NUM>, and thus can help to ensure that a symmetrical cut is made to the cervix during a surgical procedure, such as a hysterectomy.

The various components of the colpotomizer assembly <NUM> are formed (e.g., molded and/or machined) from one or more materials that are biocompatible. In some embodiments, the colpotomizer cup <NUM> may be made of polyetherimide (PEI), a thermoplastic elastomer (TPE), or other thermoplastics or thermoset materials. In some embodiments, the female and male portions <NUM>, <NUM> of the sleeve <NUM> may be made of acrylonitrile butadiene styrene (ABS), polycarbonate, or other suitable plastics. In some embodiments, certain components of the thumb lock <NUM> (e.g., the cam roller <NUM>, the pins <NUM>, the jaw <NUM>, and the lift flange <NUM>) may be made of polycarbonate. In some embodiments, the colpotomizer cup <NUM> and the sleeve <NUM> are formed (e.g., molded) as separate items that can then be connected together (e.g., via press fit or snap fit). This two-piece construction can allow cup bodies of different sizes (e.g., different diameters) to be used with the same sleeve.

Referring to <FIG>, the vaginal occluder <NUM> includes a tubular body <NUM> with a generally frustoconical exterior shape profile that is mounted about the distal region <NUM> of the sleeve <NUM>. The vaginal occluder <NUM> further includes annular-shaped flanges <NUM> that extend radially from the tubular body <NUM>. The flanges <NUM> have a variable diameter that gradually decreases in the distal direction. For example, the proximal-most flange 198a typically has a diameter of about <NUM> to about <NUM> (e.g., about <NUM>), while the distal-most flange 198b typically has a diameter of about <NUM> to about <NUM> (e.g., about <NUM>). The vaginal occluder <NUM> is a flexible structure that seals against the wall of the vaginal cavity to help maintain pneumoperitoneum during an operation. In some embodiments, the vaginal occluder <NUM> may be made of medical grade silicone, polyvinyl chloride (PVC), or a TPE.

Still referring to <FIG>, the handle assembly <NUM> includes a handle <NUM> that is formed as a clam shell structure including a female portion <NUM> and a male portion <NUM>. The female and male portions <NUM>, <NUM>, respectively, include multiple receptacles <NUM> (e.g., hexagonal shaped receptacles) and multiple pins (e.g., round or cylindrical shaped pins) positioned along interior walls and aligned to mate with each other to hold the female and male portions <NUM>, <NUM> together. The female and male portions <NUM>, <NUM> of the handle <NUM> also define multiple gripping features in the form of ridges <NUM> that enable the user of the uterine manipulator <NUM> to ergonomically grip the handle <NUM>. The handle <NUM> is formed (e.g., molded and/or machined) of one or more materials that are biocompatible and capable of withstanding medical device sterilization procedures, such as chemical-based or heat-based sterilization procedures. For example, in some embodiments, the handle <NUM> is made of polycarbonate or ABS.

In addition to the handle <NUM>, the handle assembly <NUM> further includes a fluid line <NUM> (e.g., a tubular conduit) for injecting air into and removing air from the central lumen <NUM> of the shaft <NUM> to expand and collapse an expandable member <NUM> of the distal tip <NUM> that is in fluid communication with the central lumen <NUM>. The fluid line <NUM> is securely connected to the proximal portion <NUM> of the shaft <NUM> with a fitting <NUM> (e.g., a barb fitting). The fluid line <NUM> is equipped with a connector <NUM> for attachment to a fluid source (e.g., an air source) and a clamp <NUM> for closing off the fluid line <NUM> to maintain a desired air pressure within the expandable member <NUM>, which is located at the distal portion <NUM> of the shaft <NUM>.

Referring to <FIG>, the distal tip <NUM> is securely connected to the distal portion <NUM> of the shaft <NUM>. Referring particularly to <FIG>, the distal tip <NUM> includes a rigid, elongate tip body <NUM> and an expandable member <NUM> that is attached to the tip body <NUM>. In some embodiments, the tip body <NUM> is typically formed as an injection-molded structure that therefore defines injection features <NUM>, <NUM>, <NUM>. Example materials from which the tip body <NUM> may be molded include one or more of polybutylene terephthalate (PBT), nylon, and polycarbonate. The tip body <NUM> includes an end portion <NUM> that defines an attachment surface <NUM> to which the expandable member <NUM> is bonded and an insertion shaft <NUM> that extends from the end portion <NUM> into the central lumen <NUM> of the shaft <NUM>. The end portion <NUM> includes a support body <NUM> with a substantially cylindrical shape and a round cap <NUM> with a substantially hemispherical (e.g., dome) shape that is located distal to the support body <NUM>.

The insertion shaft <NUM> includes a central rod <NUM> and several circumferential features that extend around a majority of a circumference of the central rod <NUM>. For example, the insertion shaft <NUM> further includes a distal shoulder <NUM> located adjacent the end portion <NUM>, a wall section <NUM> that extends axially from the distal shoulder <NUM>, and a proximal base <NUM> that is axially spaced apart from the wall section <NUM>. The distal shoulder <NUM> and the proximal base <NUM> are sized to form circumferential slip fits with an inner surface of the shaft <NUM> That is, an outer diameter of the distal shoulder <NUM> and the proximal base <NUM> are slightly less than the inner diameter of the shaft <NUM>. The wall section <NUM> is recessed radially with respect to the distal shoulder <NUM> and the proximal base <NUM> such that the wall section <NUM> does not contribute to the slip fit. Furthermore, the distal shoulder <NUM> provides an abutment surface against which the distal portion <NUM> of the shaft <NUM> is abutted in a non-hermetically sealed configuration.

The distal shoulder <NUM> and the wall section <NUM> together define two elongate gaps on opposite sides of the insertion shaft <NUM> that form distal fluid channels <NUM>, while the proximal base <NUM> defines two elongate gaps that form proximal fluid channels <NUM>. The fluid channels <NUM>, <NUM> provide openings in the circumferential slip fits between the inner surface of the shaft <NUM> and the insertion shaft <NUM> to permit fluid flowing within the shaft <NUM> from the handle assembly <NUM> to exit the shaft <NUM> at the distal shoulder <NUM> of the insertion rod <NUM>. The distal fluid channels <NUM> are angularly offset from the proximal fluid channels <NUM> to define part of the fluid path that opens at both ends of the insertion shaft <NUM>. For example, fluid can flow distally through the proximal fluid channels <NUM>, along the central rod <NUM>, and through the distal fluid channels <NUM> to flow out of the shaft <NUM> along the distal shoulder <NUM>. Fluid flowing out of the shaft <NUM> is contained by and causes expansion of the expandable member <NUM>.

With the insertion shaft <NUM> disposed in the shaft <NUM> and with the shaft <NUM> positioned against the distal shoulder <NUM>, mechanical interlocks <NUM> in the form of crimps may be applied to the shaft <NUM> at an axial location that is distal to the proximal base <NUM>. The mechanical interlocks <NUM> are located on opposite sides of the shaft <NUM> and interfere with (e.g., dig into) the insertion shaft <NUM> to secure the distal tip <NUM> to the shaft <NUM>. The mechanical interlocks <NUM> are circumferentially offset from the proximal fluid channels <NUM> so as not to block fluid from flowing distally through the proximal fluid channels <NUM>.

Referring particularly to <FIG>, the expandable member <NUM> is attached to the tip body <NUM> of the distal tip <NUM> at a chemical bond <NUM> along the attachment surface <NUM>. Accordingly, the chemical bond <NUM>, and hence, a distal portion <NUM> of the expandable member <NUM> have a substantially hemispherical (e.g., dome) shape. The expandable member <NUM> includes a central portion <NUM> that extends from the distal portion <NUM>, and the expandable member <NUM> terminates at a proximal end region <NUM>. The central portion <NUM> and the proximal end region <NUM>, together with the insertion shaft <NUM>, define a substantially annular interior region <NUM> of the expandable member <NUM> in which the distal portion <NUM> of the shaft <NUM> is inserted. Accordingly, the expandable member <NUM> is arranged over the distal portion <NUM> of the insertion shaft <NUM> and has a substantially U-shaped cross-sectional profile, as shown in <FIG>, <FIG>.

Referring particularly to <FIG>, an adhesive (e.g., glue) is applied circumferentially between the distal portion <NUM> of the shaft <NUM> and the proximal end region <NUM> to form a joint <NUM> (e.g., a glue joint) that in part secures the expandable member <NUM> to the shaft <NUM>. Referring to <FIG>, the shrink tube <NUM> surrounds the proximal end region <NUM> and part of the central portion <NUM> of the expandable member <NUM> to further secure the expandable member <NUM> to the shaft <NUM>. Placement of the shrink tube <NUM> around the expandable member <NUM> imparts a circumferential distal shoulder <NUM> to the shrink tube <NUM>.

The expandable member <NUM> is an over-molded structure that is made of an elastomer material. Accordingly, the chemical bond <NUM> is an over-molded bond that is created during manufacture of the uterine manipulator <NUM> as the expandable member <NUM> is formed onto the tip body <NUM> of the distal tip <NUM>. Due to its material formulation, the expandable member <NUM> forms an inflatable balloon <NUM> that inflates radially into an expanded configuration along the central portion <NUM> when air that exits the shaft <NUM> at the distal shoulder <NUM> is captured between the expandable member <NUM> and an exterior surface of the shaft <NUM>. The expandable member <NUM> can be deflated upon withdrawal of air at the fluid line <NUM> of the handle assembly <NUM>. A smooth surface of the expandable member <NUM> that snuggly covers the end portion <NUM> of the tip body <NUM> and the dome shape of the end portion <NUM> together provide the distal tip <NUM> with an atraumatic profile that allows the uterine manipulator <NUM> to be inserted into the patient without damaging tissues of the vaginal cavity, cervix, or uterus.

In some embodiments, the expandable member <NUM> is made of a medical grade silicone material. In other embodiments, the expandable member <NUM> may be made of one or more other materials, such as PVC or an elastomeric material (e.g., a TPE). The over-molded design of the expandable member <NUM> advantageously enables the expandable member <NUM> to be securely attached to the tip body <NUM> of the distal tip <NUM> with only a single seal that is provided by the chemical bond <NUM>. Furthermore, the chemical bond <NUM> can withstand a higher pressure than can the expandable member <NUM>, such that the chemical bond <NUM> does not contribute to failure at the distal tip <NUM>. For example, in some embodiments, the chemical bond <NUM> can withstand a pressure in a range of about <NUM> kPa to about <NUM> kPa, while the expandable member <NUM> has a burst pressure in a range of about <NUM> kPa to about <NUM> kPa. In contrast, conventional distal tip designs of uterine manipulators often require multiple glue joints for securing a distal expandable member to a shaft. Application of such glue joints is typically difficult to automate and also difficult to carry out in a manual assembly process in a repeatable and reliable manner. Therefore, glue joints are common failure points (e.g., leak points) for conventional balloon tip designs.

In some embodiments, the tip body <NUM> of the distal tip <NUM> has a total length of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the end portion <NUM> of the tip body <NUM> (e.g., defining a maximum width of the tip body <NUM>) typically has a maximum diameter of about <NUM> to about <NUM> (e.g., about <NUM>) and a length of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the distal shoulder <NUM> and the proximal base <NUM> have a diameter of about <NUM> to about <NUM> (e.g., about <NUM>), which is sized to provide the slip fit with the inner surface of the distal portion <NUM> of the shaft <NUM>. In some embodiments, the distal shoulder <NUM> has an axial length of about <NUM> to about <NUM> (e.g., about <NUM>).

In some embodiments, the distal fluid channels <NUM> (e.g., defined by the distal shoulder <NUM> and the wall section <NUM>) have a length of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the proximal fluid channels <NUM> have a length of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the two distal fluid channels <NUM> are spaced about <NUM> degrees apart from each other. In some embodiments, the two proximal fluid channels <NUM> are spaced apart from each other by about <NUM> degrees to about <NUM> degrees (e.g., about <NUM> degrees).

In some embodiments, the expandable member <NUM> has a thickness of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the expandable member <NUM> has a total length of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the inflatable balloon <NUM> has a generally doughnut-shaped profile. In some embodiments, the inflatable balloon <NUM> has a maximum diameter (e.g., oriented perpendicular to the central axis <NUM> of the tip body <NUM>) of about <NUM> to about <NUM> (e.g., about <NUM>). In some embodiments, the balloon <NUM> has an axial length of about <NUM> to about <NUM> (e.g., about <NUM>).

The uterine manipulator <NUM> may be used in a number of procedures that require manipulation of the uterus, including surgical procedures, such as hysterectomies. In one example, the uterine manipulator <NUM> is used in a total laparoscopic hysterectomy (TLH) surgery. A patient is prepared for TLH surgery according to know procedures. Such procedures can include determining a depth of the uterus (e.g., as measured from the fundus of the uterus to the cervical os) using a sounding device or an ultrasound technique. For example, a sounding device that has ruler markings along its length may be inserted into the patient until a distal end is positioned adjacent the fundus of uterus according to visual confirmation of the depth reading at the cervix. The ruler marking located at the depth of the uterus (i.e., at the proximal end of the cervix) indicates the location where the colpotomizer cup <NUM> of the colpotomizer assembly <NUM> should be placed during the surgical procedure. In other words, the depth of the uterus corresponds to an operational position of the colpotomizer cup <NUM> for carrying out the procedure.

<FIG> illustrate a method of using the uterine manipulator <NUM>. Referring particularly to <FIG>, once prepared, the patient's peritoneal cavity <NUM> is inflated with a gas (e.g., CO<NUM>) to facilitate accessibility and visibility of the female pelvic organs and surgical instruments (e.g., a laparoscope <NUM>) as the instruments are inserted through the abdominal wall <NUM> and into the peritoneal cavity <NUM>. The colpotomizer assembly <NUM>, while in an unlocked configuration, is slid proximally along the shaft <NUM> until the colpotomizer assembly <NUM> reaches a loading position (e.g., a position where the proximal end of the sleeve <NUM> is positioned along the proximal portion <NUM> of the shaft <NUM>). The uterine manipulator <NUM> is then inserted into the vaginal cavity <NUM>. In some cases, the colpotomizer assembly <NUM> is locked in the loading position prior to insertion into the vaginal cavity <NUM>. In other instances, the colpotomizer assembly <NUM> remains unlocked in the loading position during insertion into the vaginal cavity <NUM>.

Referring to <FIG>, the uterine manipulator <NUM> is moved distally within the vaginal cavity <NUM> until the distal tip <NUM> of the shaft <NUM> is positioned adjacent the fundus <NUM> of the uterus. A fluid (e.g., air) is then supplied to the fluid line <NUM> within the handle <NUM> to inflate the balloon <NUM> such that the balloon <NUM> engages an interior surface of the uterus <NUM>. In some cases, fluid may be withdrawn through the fluid line <NUM> to deflate the balloon <NUM> if it is determined that the uterine manipulator <NUM> needs to be repositioned. Leaving the colpotomizer assembly <NUM> in the loading position during insertion of the uterine manipulator <NUM> can allow for a relatively unobstructed view of the cervix <NUM> to help ensure proper placement of the distal tip <NUM>.

Referring to <FIG>, the colpotomizer assembly <NUM> (still in the unlocked configuration) is advanced distally from the loading position until the ruler markings <NUM> indicate that the base <NUM> of the colpotomizer cup <NUM> is positioned at an operational position (i.e., at a distance from the distal tip <NUM> that is approximately equal to the depth of the uterus <NUM> as determined from the sounding device). The viewing windows <NUM> of the colpotomizer cup <NUM> can provide for additional visual confirmation of placement. In the operational position, the cervix <NUM> is positioned within the body <NUM> of the colpotomizer cup <NUM> and abuts the base <NUM> of the colpotomizer cup <NUM>. The ability to view placement of the cervix <NUM> within the colpotomizer cup <NUM> through the viewing windows <NUM> helps to ensure that the colpotomizer cup <NUM> is fully forward in the desired position relative to the distal tip <NUM> of the shaft <NUM> and relative to the cervix <NUM>. In this position, the colpotomizer cup <NUM> provides an anatomical landmark at the base of the uterus <NUM> (e.g., indicating a location of an apex of the cervix <NUM>) and an incision backstop (e.g., an edge that defines where the uterus <NUM> should be cut). Furthermore, the cup face <NUM> of the colpotomizer cup <NUM> is centered on the arch centerline <NUM> of the shaft <NUM>, ensuring a proper angular position of the colpotomizer cup <NUM> with respect to the shaft <NUM> for providing a desirable or suitable cutting guide.

With the colpotomizer assembly <NUM> positioned as desired, the jaw <NUM> of the thumb lock <NUM> is then depressed to lock the colpotomizer assembly <NUM> at the operational position. The jaw <NUM> can be depressed using the same hand that advances the colpotomizer assembly <NUM> within the vaginal cavity <NUM>, such that distal movement and locking of the colpotomizer assembly <NUM> can be performed in a one-handed operation. If necessary, the lift flange <NUM> of the thumb lock <NUM> can be pushed upwards to unlock the colpotomizer assembly <NUM> for repositioning along the shaft <NUM>. In some implementations, the mechanical integrity of the thumb lock <NUM> may be maintained over multiple (e.g., four) lock-unlock cycles. With the colpotomizer assembly <NUM> locked in the desired operational position along the shaft <NUM>, the vaginal occluder <NUM> seals a distal region of the vaginal cavity <NUM>, thereby maintaining pneumoperitoneum. In this manner, the vaginal occluder <NUM> prevents the escape of gas used to inflate the peritoneal cavity <NUM> during and following the first of any colpotomy incisions.

A surgeon can then manipulate or move the uterus <NUM> into a desired position to perform surgical procedures that include cutting around the base of the uterus <NUM>. After the uterus <NUM> is completely incised such that the uterus <NUM> is totally free in the peritoneal cavity <NUM> and held only by the uterine manipulator <NUM>, then the balloon <NUM> is deflated, and the uterine manipulator <NUM> is withdrawn from the patient through the vaginal cavity <NUM>. The uterus <NUM> is subsequently removed from the patient according to conventional protocols. The uterine manipulator <NUM> can be disposed of following the surgery.

While the uterine manipulator <NUM> has been described and illustrated with respect to certain dimensions, sizes, shapes, arrangements, materials, components, and methods, in some embodiments, a uterine manipulator that is otherwise substantially similar in construction and function to the uterine manipulator <NUM> may include one or more different dimensions, sizes, shapes, arrangements, configurations, materials, and components, or may be utilized according to different methods.

For example, while the distal tip <NUM> has been described and illustrated as having a substantially dome-shaped distal region, in some embodiments, a uterine manipulator may include a distal tip that is otherwise substantially similar in construction and function to the distal tip <NUM>, except that the distal tip has a different shape, such as a conical shape or a cylindrical shape.

While the body of the distal tip <NUM> has been described as a rigid member, in some embodiments, a uterine manipulator may include a distal tip that is otherwise substantially similar in construction and function to the distal tip <NUM>, except that the distal tip alternatively has a flexible body to which the expandable member is attached.

While the distal tip <NUM> has been described and illustrated as being attached to the distal portion <NUM> of the shaft <NUM> with mechanical interlocks <NUM> in the form of crimps, in some embodiments, a uterine manipulator may include a distal tip that is otherwise substantially similar in construction and function to the distal tip <NUM>, except that the distal tip is formed to be attached to the distal portion <NUM> of the shaft <NUM> with a different fastening or coupling feature, such as a threaded profile, an expandable barb, or a clip.

While the distal tip <NUM> has been described and illustrated as including an expandable member <NUM> that is secured at a proximal end <NUM> to the distal portion <NUM> of the shaft <NUM> with a glue joint <NUM>, in some embodiments, a uterine manipulator with a distal tip that is otherwise substantially similar in construction and function to the distal tip <NUM> may alternatively include an expandable member that is secured at a proximal end to the shaft with a different type of fastener, joint, or joining mechanism, such as ultrasonic welding, spin welding, heat staking, or threading.

Furthermore, in some embodiments, the thumb lock <NUM> of the colpotomizer assembly <NUM> may be equipped with a lens (e.g., a convex lens) adjacent the lift flange <NUM> that magnifies the ruler markings <NUM> printed along the shaft <NUM>. The focal point of the lens may be selected such that a ruler marking <NUM> substantially fills the viewing window of the lens. Such magnification can assist the user of the uterine manipulator <NUM> in visualizing the ruler markings <NUM> to determine the position of the colpotomizer assembly <NUM> along the shaft <NUM>.

<FIG> illustrate an elongate tip body <NUM> of a distal tip <NUM> of a uterine manipulator <NUM>. The distal tip <NUM> is substantially similar in construction and function to the distal tip <NUM>, except that the distal tip <NUM> includes a through channel <NUM> for delivering fluid to a patient's uterus. Accordingly, the distal tip <NUM> includes the expandable member <NUM> (omitted from <FIG> for clarity) and is equipped with a fluid line <NUM>. The fluid line <NUM> extends within a shaft of the uterine manipulator <NUM> from a handle assembly of the uterine manipulator <NUM> to the through channel <NUM>. Within the handle assembly, a proximal end of the fluid line <NUM> is connectable to a fluid source for providing the fluid. The uterine manipulator <NUM> may be otherwise substantially similar in construction and function to the uterine manipulator <NUM>. In some examples, the uterine manipulator <NUM> may be utilized to deliver fluid to the uterus during a chromopertubation procedure or another procedure. In some embodiments, the distal tip <NUM> may be included as part of a different surgical tool that is not a uterine manipulator.

<FIG> illustrates a distal tip <NUM> of a uterine manipulator <NUM>. The distal tip <NUM> is substantially similar in construction and function to the distal tip <NUM>, except that an expandable member <NUM> of the distal tip <NUM> is initially provided in an inverted shape. Accordingly, the distal tip <NUM> includes the elongate tip body <NUM> of the distal tip <NUM>, and the expandable member <NUM> is securely attached to the end portion <NUM> of the tip body <NUM> along a chemical bond <NUM>, while a central portion <NUM> and a proximal end region <NUM> of the expandable member <NUM> are positioned inside-out above the end portion <NUM> to form an inverted configuration.

The inverted configuration improves ease of access to the insertion shaft <NUM> of the tip body <NUM> and the distal portion <NUM> of the shaft <NUM> of the uterine manipulator <NUM> to facilitate mechanical attachment of the distal tip <NUM> to the shaft <NUM> using a mechanical interlocking feature (e.g., such as the mechanical interlocks <NUM> or another type of fastening feature). Once the insertion shaft <NUM> is securely positioned within the shaft <NUM>, then the central portion <NUM> and proximal end region <NUM> of the expandable member <NUM> can be rolled downward (e.g., proximally) over the distal end <NUM> of the shaft <NUM> and secured to the shaft <NUM> with a glue joint, and the shrink tube <NUM> may be placed over a portion of the expandable member <NUM>, as discussed above with respect to the uterine expandable member <NUM> of the distal tip <NUM>. Therefore, aside from the distal tip <NUM>, the uterine manipulator <NUM> may be otherwise substantially similar in construction and function to the uterine manipulator <NUM>.

<FIG> illustrates a distal tip <NUM> of a uterine manipulator <NUM>. The distal tip <NUM> is similar in construction and function to the distal tip <NUM>, except that the distal tip <NUM> has a generally tapered (e.g., conical) distal end region. As described above with respect to the distal tip <NUM>, the distal end region of the distal tip <NUM> forms a smooth, atraumatic surface. The distal tip <NUM> includes an elongate tip body <NUM> that is designed to form a slip fit with an inner surface of the shaft <NUM> of the uterine manipulator <NUM> and an over-molded expandable member <NUM> that is securely attached to an end portion <NUM> of the tip body <NUM> along a chemical bond <NUM>. The uterine manipulator <NUM> may be otherwise substantially similar in construction and function to the uterine manipulator <NUM>.

A uterine manipulator that is similar in construction and function to the uterine manipulator <NUM> may also include modifications to components other than the distal tip <NUM>. For example, while the uterine manipulator <NUM> has been described as including the fluid line <NUM> that can be coupled to a fluid source, in some embodiments, a uterine manipulator may alternatively include an integral syringe.

While the locking mechanism of the colpotomizer assembly <NUM> is described as being located at the proximal end of the sleeve <NUM>, in other embodiments, a locking mechanism may be located a different location (e.g., at an intermediate location) along a length of a colpotomizer assembly.

While a specific configuration of a one-handed cam-based locking mechanism has been described, other alternative types of locking mechanisms can be used. In certain embodiments, for example, a uterine manipulator may include a different type of one-handed cam-based locking mechanism. Such example locking mechanisms may include a screen door mechanism, a Touhy Borst mechanism, or a sheet metal skive capture mechanism.

While the colpotomizer assembly <NUM> has been described as including a one-handed locking mechanism, in some embodiments, a uterine manipulator may include a colpotomizer assembly that has a two-handed locking mechanism.

While the uterine manipulator <NUM> has been described as disposable, in some embodiments, the uterine manipulator <NUM> may be designed to be reusable (e.g., sterilizable).

Claim 1:
A distal tip (<NUM>; <NUM>; <NUM>; <NUM>) for a surgical tool (<NUM>; <NUM>; <NUM>; <NUM>), the distal tip comprising:
a tip body (<NUM>; <NUM>; <NUM>) comprising:
an end portion (<NUM>; <NUM>) defining an attachment surface (<NUM>), and
an elongate member (<NUM>) configured to be inserted within a tubular shaft (<NUM>) of the surgical tool and defining a recessed channel (<NUM>) that terminates at the end portion, wherein the elongate member of the tip body defines an annular sidewall (<NUM>, <NUM>) that is sized to form a slip fit with an inner surface of the tubular shaft, wherein the annular sidewall forms an abutment surface against which a distal portion (<NUM>) of the tubular shaft is positioned at an end of the recessed channel; and
an expandable member (<NUM>; <NUM>; <NUM>) extending around the tip body, being secured to the attachment surface with a chemical bond (<NUM>; <NUM>; <NUM>), and being adjustable between:
an expanded configuration in which at least a portion (<NUM>; <NUM>) of the expandable member extends radially outward from the tip body, and
a collapsed configuration in which at least the portion of the expandable member is oriented substantially parallel to the tip body.