Abstract:
A method of adjusting a uterine manipulator includes inserting a shaft of the uterine manipulator into a cervix, moving a colpotomizer sleeve of the uterine manipulator to a predetermined position along the shaft such that the cervix is received within a colpotomizer cup attached to the colpotomizer sleeve, depressing a rotatable locking member of the colpotomizer sleeve towards the shaft, confirming that the colpotomizer sleeve is accurately located at the predetermined position by visualizing a ruler marking of a plurality of ruler markings printed along the shaft using a magnification lens of the rotatable locking member, and compressing the shaft with the rotatable locking member of the colpotomizer sleeve to lock the colpotomizer sleeve at the predetermined position.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of and claims priority to U.S. application Ser. No. 14/510,251, filed on Oct. 9, 2014, the contents of which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     This disclosure relates to uterine manipulators and related components and methods. 
     BACKGROUND 
     Uterine manipulators are medical instruments that are used for manipulating (e.g., moving or repositioning) a patient&#39;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&#39;s body during use and a distal portion that is inserted into the patient&#39;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&#39;s body via the vaginal cavity. 
     SUMMARY 
     In general, this disclosure relates to uterine manipulators and related components and methods. Such uterine manipulators can be used for manipulating a patient&#39;s uterus during gynecological surgery and/or gynecological diagnostic procedures. 
     In one aspect, a uterine manipulator includes an arcuate shaft configured to be inserted into a cervix and a colpotomizer assembly configured to move along the arcuate shaft. The colpotomizer assembly includes a cup configured to receive the cervix. The cup defines a cup face disposed substantially perpendicular to an axial centerline of the cup and having a centerpoint disposed along the axial centerline of the cup, and an opening spaced apart from the cup face and sized to allow passage of the arcuate shaft. The opening is configured such that, when the arcuate shaft is positioned within the opening, an arcuate centerline of the arcuate shaft is aligned with the centerpoint of the cup face, and the arcuate centerline of the arcuate shaft is offset from the axial centerline of the cup at the opening. 
     In another aspect, a colpotomizer assembly includes a cup configured to receive a cervix. The cup defines a cup face disposed perpendicular to an axial centerline of the cup and having a centerpoint disposed along the axial centerline of the cup and an opening spaced apart from the cup face and sized to allow passage of a shaft. The opening is configured such that, when the shaft is positioned within the opening, an arcuate centerline of the shaft is aligned with the centerpoint of the cup face, and the arcuate centerline of the shaft is offset from the axial centerline of the cup at the opening. 
     In a further aspect, a method of adjusting a uterine manipulator includes moving a colpotomizer cup of the uterine manipulator along a curved shaft of the uterine manipulator in a manner such that a distal face of the colpotomizer cup remains centered on an arch centerline of the curved shaft and an axial centerline of the colpotomizer cup remains offset from the arch centerline of the curved shaft at an opening of the colpotomizer cup that is spaced proximally from the distal face of the colpotomizer cup. 
     In a further aspect, a uterine manipulator includes a shaft configured to be inserted into a cervix. The shaft includes multiple ruler markings printed along a portion of the shaft and a colpotomizer assembly configured to move along 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 a further aspect, a colpotomizer assembly configured to move along a shaft of a uterine manipulator 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 a further aspect, a method of adjusting a uterine manipulator includes moving a colpotomizer sleeve of the uterine manipulator to a predetermined position along a shaft of the uterine manipulator, depressing a rotatable locking member of the colpotomizer sleeve towards the shaft, compressing the shaft with the rotatable locking member of the colpotomizer sleeve to lock the colpotomizer sleeve at the predetermined location, and confirming an accuracy of the position of the colpotomizer sleeve by visualizing a ruler marking printed along the shaft using a magnification lens of the rotatable locking member. 
     In a further aspect, a uterine manipulator includes a shaft configured to be inserted into a cervix, the shaft defining a central lumen that passes air between a proximal portion of the shaft and a distal tip of the shaft. The uterine manipulator further includes an expandable balloon secured to the distal tip of the shaft and a handle secured to the proximal portion of the shaft. The handle includes an integral syringe that is configured to inflate and deflate the expandable balloon by displacing air within the central lumen of the shaft. 
     In a further aspect, a method of deploying a uterine manipulator includes inserting a shaft of the uterine manipulator through a cervix, actuating an integral syringe within a handle that is secured to a proximal portion of the shaft, and inflating an expandable balloon that is secured to a distal tip of the uterine manipulator. 
     Implementations may provide one or more of the following features. 
     In some embodiments, the arcuate shaft includes a proximal portion, a central portion along which the colpotomizer assembly can move, and a distal tip. 
     In certain embodiments, the arcuate shaft is a rigid shaft. 
     In some embodiments, the cup includes a cup body that defines the cup face at a distal end of the cup. 
     In certain embodiments, the cup body is configured to receive the cervix. 
     In some embodiments, the cup body defines multiple viewing windows for visualizing the cervix within the cup body. 
     In certain embodiments, the cup body defines a beveled rim configured to provide an anatomical landmark and an incision backstop. 
     In some embodiments, the cup includes a base defining the opening. 
     In certain embodiments, when the arcuate shaft is disposed within the opening, the arcuate centerline of the arcuate shaft is offset by about 0.065 inch to about 0.085 inch from the axial centerline of the cup at the opening. 
     In some embodiments, the colpotomizer assembly further includes a sleeve connected to the cup and defining a channel configured to receive the arcuate shaft. 
     In certain embodiments, the sleeve includes a locking member configured to lock the colpotomizer assembly at any of multiple different locations along the arcuate shaft. 
     In some embodiments, the colpotomizer assembly further includes a vaginal occluder. 
     In certain embodiments, the uterine manipulator further includes a manipulator handle secured to the arcuate shaft. 
     In some embodiments, the manipulator handle includes an integrated syringe configured to displace air within a central lumen of the arcuate shaft. 
     In certain embodiments, the uterine manipulator further includes an expandable balloon disposed along a distal tip of the arcuate shaft and in fluid communication with the central lumen of the arcuate shaft. 
     In some embodiments, the integrated syringe is configured to deliver air to and withdraw air from the expandable balloon. 
     In certain embodiments, the uterine manipulator further includes an integrated light source mounted to a distal tip of the arcuate shaft. 
     In some embodiments, the manipulator handle includes a power source for powering the integrated light source. 
     In certain embodiments, the uterine manipulator is a single-use device. 
     In some embodiments, the uterine manipulator further includes a shrink tube disposed about the arcuate shaft for facilitating movement of the colpotomizer assembly along the arcuate shaft and locking of the colpotomizer assembly along the shaft. 
     In certain embodiments, the cup body defines a recess configured to receive a cervix. 
     In some embodiments, the opening is configured to receive an arcuate shaft. 
     In certain embodiments, the sleeve includes a locking member configured to lock the colpotomizer assembly at a predetermined location along the shaft. 
     In some embodiments, the colpotomizer cup includes a body that defines the distal face. 
     In certain embodiments, the body defines multiple viewing windows for visualizing the cervix within the body. 
     In some embodiments, at the opening of the colpotomizer cup, the axial centerline of the colpotomizer cup remains offset from the arcuate centerline of the curved shaft by about 0.065 inch to about 0.085 inch. 
     In certain embodiments, moving the colpotomizer cup includes moving a sleeve that is connected to the colpotomizer cup. 
     In some embodiments, the sleeve defines a channel configured to receive the curved shaft. 
     In certain embodiments, the method further includes locking the colpotomizer sleeve at a predetermined location along the curved shaft. 
     In some embodiments, the shaft is a rigid shaft. 
     In certain embodiments, the uterine manipulator further includes a shrink tube that surrounds a portion of the shaft, such that when the rotatable locking member is depressed towards the shaft, the rotatable locking member compresses the shrink tube. 
     In some embodiments, the shrink tube has a hardness of about shore D25 to about shore D60. 
     In certain embodiments, the sleeve defines a channel configured to receive the shaft. 
     In some embodiments, the rotatable locking member includes a lens configured to magnify a ruler marking of the multiple ruler markings when the rotatable locking member is depressed against the shaft. 
     In certain embodiments, the rotatable locking member includes a roller mount that extends from the cam roller, and the sleeve defines a receptacle configured to receive the roller mount of the rotatable locking member. 
     In some embodiments, the sleeve includes opposing projections, and the rotatable locking member includes a jaw configured snap fit onto the opposing projections for securing the rotatable locking member in a locked configuration. 
     In certain embodiments, the rotatable locking member includes a lift flange for rotating the rotatable locking member away from the shaft and into an open configuration. 
     In some embodiments, the multiple ruler markings indicate a distance between a base of a cup of the colpotomizer assembly and a distal end of the shaft. 
     In some embodiments, the colpotomizer assembly further includes a cup configured to receive the cervix and that is attached to the sleeve. 
     In certain embodiments, the cup is configured such that a distal face of the cup remains centered on an arch centerline of the shaft as the colpotomizer assembly is moved along the shaft and such that an axial centerline of the cup remains offset from the arch centerline of the shaft at an opening of the cup that is spaced proximally from the distal face of the cup. 
     In certain embodiments, the uterine manipulator further includes a manipulator handle. 
     In some embodiments, the manipulator handle includes an integrated syringe configured to displace air within a central lumen of the shaft. 
     In certain embodiments, the uterine manipulator further includes an expandable balloon disposed along a distal tip of the shaft and in fluid communication with the central lumen of the shaft. 
     In some embodiments, the sleeve defines a channel that surrounds the shaft. 
     In certain embodiments, the rotatable locking member includes a lens configured to magnify a ruler marking printed along the shaft when the rotatable locking member is depressed against the shaft. 
     In some embodiments, the ruler marking indicates a distance between a base of a cup of the colpotomizer assembly and a distal end of the shaft. 
     In certain embodiments, the rotatable locking member includes a roller mount that extends from the cam roller, and the sleeve defines a receptacle configured to receive the roller mount of the rotatable locking member. 
     In some embodiments, the cup is configured such that a distal face of the cup remains centered on an arch centerline of the shaft as the colpotomizer assembly is moved along the shaft and such that an axial centerline of the cup remains offset from the arch centerline of the shaft at an opening of the cup that is spaced proximally from the distal face of the cup as the cup is moved along the shaft. 
     In certain embodiments, the colpotomizer sleeve defines a channel configured to receive the shaft. 
     In some embodiments, compressing the shaft with the rotatable locking member includes rotating a cam roller of the rotatable locking member into a shrink tube surrounding the shaft. 
     In certain embodiments, depressing the rotatable locking member towards the shaft includes rotating a roller mount of the rotatable locking member within receptacles of the colpotomizer sleeve. 
     In some embodiments, compressing the shaft with the rotatable locking member includes snap fitting a jaw of the rotatable locking member onto opposing projections of the colpotomizer sleeve for securing the rotatable locking member in a locked configuration. 
     In certain embodiments, the method further includes moving a lift flange of the rotatable locking upwards for rotating the rotatable locking member away from the shaft and into an open configuration. 
     In some embodiments, the ruler marking indicates a distance between a base of a colpotomizer cup secured to the colpotomizer sleeve and a distal end of the shaft. 
     In certain embodiments, moving the colpotomizer sleeve along the shaft includes moving a colpotomizer cup configured to receive a cervix and that is attached to the colpotomizer sleeve. 
     In some embodiments, the colpotomizer cup is configured such that a distal face of the colpotomizer cup remains centered on an arch centerline of the shaft as the colpotomizer cup is moved along the shaft and such that an axial centerline of the cup remains offset from the arch centerline of the shaft at an opening of the cup that is spaced proximally from the distal face of the cup as the colpotomizer cup is moved along the shaft. 
     In certain embodiments, the moving, the depressing, and the compressing is performed in a one-handed process. 
     In some embodiments, the integral syringe includes a body and a plunger configured to move within the body to displace air. 
     In certain embodiments, a proximal portion of the shaft extends into the body of the plunger. 
     In some embodiments, the plunger includes a button that is slidable along the handle. 
     In certain embodiments, the expandable balloon is inflated when the button is moved distally, and the expandable balloon is deflated when the button is moved proximally. 
     In some embodiments, the integral syringe includes one or more detents that maintain the button in a proximal or a distal position. 
     In certain embodiments, the shaft defines an opening that passes air between the central lumen of the shaft and the expandable balloon. 
     In some embodiments, the handle defines multiple depressions that together provide a grip for grasping the handle. 
     In certain embodiments, the uterine manipulator further includes an integrated light source mounted to the distal tip of the shaft. 
     In some embodiments, the power source includes one or more electrical wires that extend within the central lumen of the shaft from the power source to the integrated light source. 
     In certain embodiments, the integrated light source is an LED. 
     In some embodiments, the uterine manipulator further includes a colpotomizer assembly that is movable along the shaft. 
     In certain embodiments, the colpotomizer assembly includes a cup that is configured to receive a cervix. 
     In some embodiments, the cup is configured such that a distal face of the cup remains centered on an arch centerline of the shaft as the cup is moved along the shaft and such that an axial centerline of the cup remains offset from the arch centerline of the shaft at an opening of the cup that is spaced proximally from the distal face of the cup as the colpotomizer assembly is moved along the shaft. 
     In certain embodiments, the colpotomizer assembly includes a sleeve that is configured to lock the colpotomizer assembly in position along the shaft. 
     In some embodiments, the shaft is a rigid cannula. 
     In certain embodiments, the shaft is a curved shaft. 
     In some embodiments, the method further includes determining a depth of a uterus at which to insert the shaft through the cervix. 
     In certain embodiments, the shaft defines a central lumen that passes air between the integral syringe and the expandable balloon. 
     In some embodiments, actuating the integral syringe includes moving a plunger of the integral syringe distally along the handle to deliver air to the expandable balloon. 
     In certain embodiments, the method includes moving a plunger of the integral syringe proximally along the handle to withdraw air from the expandable balloon, and deflating the expandable balloon. 
     In some embodiments, the shaft defines an opening that passes air between the central lumen of the shaft and the expandable balloon. 
     In certain embodiments, the method further includes grasping the handle along multiple depressions defined by the handle. 
     In some embodiments, the method further includes powering a light source mounted to the distal tip of the shaft. 
     In some embodiments, the method further includes moving a colpotomizer assembly of the uterine manipulator into an operational position. 
     In some embodiments, the method further includes locking the colpotomizer assembly along the shaft at the operational position. 
     Implementations may provide one or more of the following advantages. 
     In some embodiments, a geometry (e.g., provided by the position and size of an opening within a colpotomizer cup base) ensures proper alignment of a cup face with respect to a shaft of the uterine manipulator. In particular, a centerpoint of the cup face is maintained along an arch centerline of the shaft. Such a configuration is imposed by an offset between a centerline of the colpotomizer cup (along which the centerpoint of the cup face lies) and the arch centerline of the shaft, at the position of the opening in the colpotomizer cup base. Such alignment of the colpotomizer cup with respect to the shaft 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. This geometry prevents positioning of the uterine manipulator with a mis-oriented cutting edge, which could lead to undesirable effects following the procedure. 
     In certain embodiments, the uterine manipulator includes a one-handed locking mechanism that allows a colpotomizer assembly to be locked into a desired position along a shaft of the uterine manipulator. The locking mechanism can include a thumb lock that can be actuated with the same hand that moves the colpotomizer assembly along the shaft. The thumb lock provides the user with the ability to easily position and lock the colpotomizer assembly at any of various different positions along the shaft of the uterine manipulator. The thumb lock includes a cam roller that has a variable radius, such that the cam roller can compress (e.g., dig into) a shrink tube as the cam roller is rotated towards the shaft of the uterine manipulator, thereby providing resistance to movement of the colpotomizer assembly along the shaft. The mechanical integrity of the thumb lock may be maintained over multiple (e.g., four) lock-unlock cycles. 
     In some embodiments, a convex lens of the thumb lock magnifies ruler markings printed along the shaft, such that a ruler marking substantially fills a viewing window of the lens. Such magnification assists the user of the uterine manipulator in visualizing the ruler markings to determine an appropriate position of the colpotomizer assembly along the shaft. Proper placement of the uterine manipulator with respect to a fundus of the uterus, as aided by the lens of the thumb lock and the ruler markings along the shaft, can prevent perforation and other damage to the fundus and the distal region of the uterus. Furthermore, the alignment of the lens with the ruler marking and the ability to view placement of the cervix within the colpotomizer cup through viewing windows helps to ensure that the colpotomizer cup is fully forward in the desired position relative to a distal tip of the shaft and relative to the cervix. 
     In certain embodiments, a manipulator handle includes an integral syringe for injecting air into and removing air from a central lumen of a shaft of the uterine manipulator to inflate and deflate an expandable balloon in fluid communication with the central lumen. Button actuation of the syringe can provide the user with a simple, ergonomic, and one-handed mechanism for inflating and deflating the expandable balloon during a surgical procedure. Furthermore, finger depressions positioned along the manipulator handle provide an ergonomic grip for grasping and positioning the uterine manipulator. 
     In some embodiments, an integral light source mounted to a distal tip of a shaft of the uterine manipulator can be used to illuminate the vaginal cavity and external orifice of the uterus (cervical os) during insertion of the uterine manipulator. The light source and the distal tip provide an atraumatic surface that allows the uterine manipulator to be inserted in the patient without damaging tissues of the vaginal cavity, cervix, or uterus. The light source can be turned on and off by actuating a button disposed along a distal region of a manipulator handle and optimally positioned for a right-handed or left-handed use. Button actuation of integral light source can provide the user with a simple, ergonomic, and one-handed mechanism for increasing visibility during insertion of the uterine manipulator. 
     In some embodiments, materials (e.g., 304 SS or 304 SS full hard) from which a shaft of the manipulator is constructed can advantageously provide tactile feedback to the user as the shaft is inserted or positioned within the patient. Certain portions of the shaft are covered by a shrink tube that provides lubricity for sliding of a colpotomizer assembly along the shaft and traction for locking the colpotomizer assembly in a desired position. The shrink tube can have a certain hardness that provides the shrink tube with enough traction to securely lock the colpotomizer assembly in the desired position. 
     In certain embodiments, the ability to displace a colpotomizer assembly can allow for quicker and easier positioning of a distal tip of a shaft of the uterine manipulator within the cervix since a procedure can be performed without visual obstruction of the colpotomizer assembly. 
     In certain embodiments, the uterine manipulator can be provided as a disposable (e.g., single-use) surgical device. 
     Other aspects, features, and advantages will be apparent from the description, the drawings, and the claims. 
    
    
     
       DESCRIPTION OF DRAWINGS 
         FIG. 1  is a perspective view of a uterine manipulator including a manipulator handle, a shaft, an expandable balloon, a light source, and a colpotomizer assembly. 
         FIG. 2  is a cross-sectional side view of the uterine manipulator of  FIG. 1 , shown without the colpotomizer assembly. 
         FIG. 3  is a perspective view of a portion of the uterine manipulator of  FIG. 1 , shown with portions of the colpotomizer assembly removed and with the colpotomizer assembly in an unlocked configuration. 
         FIG. 4  is a perspective view of a portion of the uterine manipulator of  FIG. 1 , shown with portions of the colpotomizer assembly removed and with the colpotomizer assembly in a locked configuration. 
         FIG. 5  is a perspective view of a vaginal occluder of the colpotomizer assembly of  FIG. 1 . 
         FIG. 6  is a cross-sectional side view of a portion of the uterine manipulator of  FIG. 1 . 
         FIG. 7  is a front perspective view of the colpotomizer assembly of  FIG. 1 . 
         FIG. 8  is a perspective view of the uterine manipulator of  FIG. 1  provided in a packaging container. 
         FIG. 9  is a cross-sectional side view of a pelvic cavity showing the uterine manipulator of  FIG. 1  in a fully inserted position and with the colpotomizer assembly in a loading position. 
         FIG. 10  is a cross-sectional side view of the pelvic cavity of  FIG. 9 , showing the uterine manipulator of  FIG. 1  in a fully inserted position, with the expandable balloon inflated, and with the colpotomizer assembly unlocked in the loading position. 
         FIG. 11  is a cross-sectional side view of the pelvic cavity of  FIG. 9 , showing the uterine manipulator of  FIG. 1  fully inserted, with the colpotomizer assembly locked in an operational position. 
         FIG. 12  is a cross-sectional side view of the pelvic cavity of  FIG. 9 , showing the uterine manipulator of  FIG. 1  supporting a uterus. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  illustrates a uterine manipulator  100  adapted for insertion into a vaginal cavity for use in female pelvic surgical procedures. The uterine manipulator  100  includes a shaft  102  configured to extend within a cervix for use in repositioning a uterus and a colpotomizer assembly  104  disposed about the shaft  102  and configured to receive the cervix. The uterine manipulator  100  further includes an expandable balloon  106  secured to a distal tip  108  of the shaft  102  and configured to maintain a position of the distal tip  108  within the uterus. A light source  110  is mounted to the distal tip  108  of the shaft  102  and can be used to illuminate the vaginal cavity and external orifice of the uterus (i.e., the cervical os) during insertion of the uterine manipulator  100 . A manipulator handle  112  is connected to a proximal portion  114  of the shaft  102 . 
     Referring to  FIG. 2 , the shaft  102  of the uterine manipulator  100  is formed as a rigid cannula that has a generally curved (e.g., arcuate) shape. The shaft  102  includes the proximal portion  114  that extends into the manipulator handle  112 , a central portion  116  along which the colpotomizer assembly  104  is displaceable for engaging the cervix, and the distal tip  108  configured to extend through the cervix and into the uterus. The central portion  116  and a section of the proximal portion  114  that extends distally from the manipulator handle  112  are covered by a shrink tube  118  that provides lubricity for sliding of the colpotomizer assembly  104  along the shaft  102  and traction for locking the colpotomizer assembly  104  in a desired position along the shaft  102 , as will be discussed in more detail with respect to  FIG. 4 . The shrink tube  118  typically has a thickness of about 0.010 inch to about 0.020 inch (e.g., about 0.014 inch to about 0.018 inch). 
     The shaft  102  of the uterine manipulator  100  defines a central lumen  120  that allows passage of air between the manipulator handle  112  and the expandable balloon  106 . The central lumen  120  of the shaft  102  also allows passage of one or more electrical wires  117  from a power source  115  (e.g., a battery) disposed within the manipulator handle  112  to the light source  110  secured to the distal tip  108  of the shaft  102 . The shaft  102  also defines an opening  122  located along the distal tip  108  that allows passage of air between the central lumen  120  and the expandable balloon  106  for inflating and deflating the expandable balloon  106 . The shaft  102  further includes a set of ruler markings  124  (shown in  FIGS. 1 and 3 ) printed across the shrink tube  118  along the central portion  116  and that indicate a distance from the fundus of the uterus when the uterine manipulator  100  is appropriately, fully inserted into the uterus (e.g., when the distal tip  108  of the shaft  102  is positioned adjacent the fundus, as will be discussed in more detail with respect to  FIG. 8 ). The ruler markings  124  may be provided in English units (e.g., inches) or S.I. units (e.g., mm or cm). 
     The shaft  102  (e.g., including the section of the proximal portion  114  extending from the manipulator handle  112 , the central portion  116 , and the distal tip  108 ) typically has a length of about 11.0 inches to about 12.0 inches (e.g., about 11.4 inches to about 11.7 inches. The section of the proximal portion  114  extending from the manipulator handle  112  typically has a radius of curvature of about 5.0 inches to about 7.0 inches (e.g., about 6.0 inches). The central portion  116  of the shaft  102  typically has a radius of curvature of about 5.50 inches to about 7.00 inches (e.g., about 6.00 inches to about 6.25 inches). The distal tip  108  of the shaft  102  typically has a length of about 0.50 inch to about 0.60 inch (e.g., about 0.55 inch to about 0.56 inch). The shaft  102  typically has an inner diameter of about 0.100 inch to about 0.150 inch (e.g., about 0.128 inch to about 0.134 inch) and a wall thickness of about 0.020 inch to about 0.040 inch (e.g., about 0.027 inch to about 0.029 inch). 
     The expandable balloon  106  is secured at opposite ends to the distal tip  108  of the shaft  102 . The balloon  106  can be secured to the shaft  102  via chemical bonding and compressive capture via the shrink tube. The expandable balloon  106  surrounds the opening  122  along the distal tip  108  and accordingly is in fluid communication with the central lumen  120  of the shaft  102 . The expandable balloon  106  can be rapidly inflated and rapidly deflated by syringe actuation that occurs at the manipulator handle  112 . The expandable balloon  106  typically has a length of about 1.2 inches to about 1.8 inches (e.g., about 1.4 inches to about 1.6 inches). In a fully inflated state, the expandable balloon  106  typically has a maximum diameter of about 0.60 inch to about 0.80 inch (e.g., about 0.66 inch to about 0.68 inch). 
     Still referring to  FIG. 2 , the light source  110  can be secured to the distal tip  108  of the shaft  102  via crimping or chemical bonding and is typically provided as a light-emitting diode (LED). The light source  110 , together with the distal tip  108 , forms an atraumatic surface that allows the uterine manipulator  100  to be inserted in the patient without damaging tissues of the vaginal cavity, cervix, or uterus. The light source  110  can be turned on and off by actuating a button  119  (e.g., a push button or a slidable button) that is disposed along the manipulator handle  112  and that is electrically coupled to the power source disposed within the manipulator handle  112 . The button may generally be disposed along a distal region of the manipulator handle  112  and may be optimally positioned for a right-handed or left-handed user (e.g., a surgeon) of the uterine manipulator  100 . Button actuation of the integral light source  110  can provide the user of the uterine manipulator  100  with a simple, ergonomic, and one-handed mechanism for increasing visibility during insertion of the uterine manipulator. The light source  110  can receive power via the one or more electrical wires that extend within the central lumen  120  between the power source and the light source  110 . The light source  110  typically operates (e.g., emits light) at a power dissipation of about 100 mW to about 140 mW (e.g., about 108 mW to about 132 mW). 
     Referring now to  FIGS. 1 and 2 , the manipulator handle  112  is formed as a clam shell structure that includes a female portion  126  and a male portion  128 . The female and male portions  126 ,  128 , respectively, include multiple receptacles  130  (e.g., hexagonal shaped receptacles) and multiple pins (e.g., round or cylindrical shaped pins) positioned along peripheral edges and aligned to mate with each other to hold the female and male portions  126 ,  128  together. The manipulator handle  112  includes finger depressions  132 ,  134 ,  136  that provide a grip to allow the user of the uterine manipulator  100  to ergonomically grip the manipulator handle  112 . The manipulator handle  112  further includes an integral syringe  138  for injecting air into and removing air from the central lumen  120  of the shaft  102  to inflate and deflate the expandable balloon  106  in fluid communication with the central lumen  120 . A body  140  of the syringe  138  extends distally from the manipulator handle  112  and surrounds an end of the proximal portion  114  of the shaft  102 , such that the shaft  102 , surrounded by the shrink tube  118  along its proximal portion  114 , terminates within the body  140  of the syringe  138 . The syringe  138  further includes a plunger  142  that can be actuated (e.g., slid proximally and distally) via a slidable button  144  to inject air into and remove air from the central lumen  120  of the shaft  102 . The syringe  138  further includes one or more internal detents in contact with a bottom surface of the button  144  that serve to secure the button  144  in a proximal or distal position upon the button  144  being slid past the detents. Button actuation of the integral syringe  138  can provide the user of the uterine manipulator  100  with a simple, ergonomic, and one-handed mechanism for inflating and deflating the expandable balloon  106  during a surgical procedure. 
     The shaft  102 , the expandable balloon  106 , the manipulator handle  112 , and the shrink tube  118  of the uterine manipulator  100  can be formed (e.g., molded and/or machined) from one or more materials that are biocompatible and capable of withstanding medical device sterilization procedures, such as chemical-based methods or heat-based methods. In some embodiments, the shaft  102  (e.g., including the proximal portion  114 , the central portion  116 , and the distal tip  108 ) can be made of 304 SS and/or 304 SS full hard. Such materials can advantageously provide tactile feedback (e.g., resistance to movement of tissue) to the user of the uterine manipulator  100  as the shaft  102  is inserted or positioned within the patient. In some embodiments, the expandable balloon  106  can be made of silicone, polyvinyl chloride (PVC) or a thermal plastics rubber elastomer (TPRE). In some embodiments, the manipulator handle  112  can be made of polycarbonate or Acrylonitrile butadiene styrene (ABS). In some embodiments, the shrink tube  118  can be made of acrylated olefin and can have a shore durometer of about shore D25 to about shore D60. Such a hardness can provide the shrink tube  118  with enough traction to lock the colpotomizer assembly  104  in a desired location, as will be discussed in more detail with respect to  FIGS. 3 and 4 . While certain examples of materials from which the shaft  102 , the expandable balloon  106 , the manipulator handle  112 , and the shrink tube  118  can be formed have been provided, it should be understood that a variety of other materials can alternately be used to form these components. 
     Referring to  FIGS. 1 and 3 , the colpotomizer assembly  104  is a displaceable assembly that may be slid along the shaft  102  of the uterine manipulator  100 . The ability to displace the colpotomizer assembly  104  can allow for quicker and easier positioning of the distal tip  108  of the shaft  102  within the cervix since this procedure can be performed without the visual obstruction of the colpotomizer assembly  104 . Then, once proper placement of the distal tip  108  is visually confirmed, the colpotomizer assembly  104  can be advanced along the shaft  102  into engagement with the cervix. The colpotomizer assembly  104  includes a colpotomizer cup  146  adapted to receive the cervix, a sleeve  148  that is connected to the colpotomizer cup  146  and that can be grasped for moving the colpotomizer assembly  104 , and a vaginal occluder  150  disposed about a distal cuff  196  of the sleeve  148 . 
     Referring particularly to  FIG. 3 , the colpotomizer cup  146  includes an annular body  152 , a rim  154  located at a distal end  156  of the body  152 , and a base  158  located at a proximal end  160  of the body  152 . The rim  154  is beveled to permit anatomical landmark and incision backstop during use of the uterine manipulator  100 . The body  152  includes three projections  162  that extend to the base  158  and define three viewing windows  164 . The base  158  of the colpotomizer cup  146  defines an opening  166  sized to allow passage of the shaft  102 . As shown in  FIG. 6 , a wall of the opening  166  defines a cylindrical profile through which the shaft  102  passes. Referring again to  FIG. 3 , the sleeve  148  extends proximally from the base  158  of the colpotomizer cup  146  and has an arcuate shape that generally follows the shape of the central portion  116  of the shaft  102 . The sleeve  148  is formed as a clam shell structure that includes a female portion  168  and a male portion  170  (shown in  FIG. 1 ). The female and male portions  168 ,  170 , respectively, include multiple receptacles  172  (e.g., hexagonal 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  168 ,  170  together. The female and male portions  168 ,  170  together define a channel  111  through which the shaft  102  extends. 
     At a proximal end  174  of the sleeve  148 , the sleeve  148  includes a thumb lock  176 , opposing receptacles  178  that receive the thumb lock  176 , opposing projections  180  to which the thumb lock  176  can be snap fitted, and a guide surface  182  that appropriately guides the sleeve  148  along the shaft  102  and supports the shaft  102  for contact with the thumb lock  176 . The thumb lock  176 , receptacles  178 , projections  180 , and guide surface  182  together provide a quick, one-handed locking mechanism that allows the colpotomizer assembly  104  to be locked into a desired position along the shaft  102 . 
     Referring to  FIGS. 3 and 4 , the thumb lock  176  includes a cam roller  184  adapted to contact the shrink tube  118  surrounding the shaft  102  to lock the colpotomizer assembly  104  into a selected position along the shaft  102 . In particular, the radius of the cam roller  184  is variable (e.g., extending radially beyond a minimum circumference of the cam roller  184  along certain portions of the cam roller  184 ), such that the cam roller  184  compresses (e.g., digs into) the shrink tube  188  as the cam roller  184  is rotated towards the shaft  102  of the uterine manipulator  100 . The thumb lock  176  further includes a roller mount  186  adjacent the cam roller  184 , a jaw  188  extending from the cam roller  184 , a lens  190  disposed atop the jaw  188 , and a lift flange  192  extending proximally from the jaw  188 . The lens  190  is a convex lens that magnifies the ruler markings  124  printed along the shaft  102 . The focal point of the lens  190  is selected such that a ruler marking  124  substantially fills the viewing window of the lens  190 . Such magnification assists the user of the uterine manipulator  100  in visualizing the ruler markings  124  to determine the position of the colpotomizer assembly  104  along the shaft  102 . The roller mount  186  is adapted to extend into and rotate within the receptacles  178 . 
     The thumb lock  176  allows the colpotomizer assembly  104  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  104  along the shaft  102 . When the lens  190  or the lift flange  192  is pushed downward (e.g., by the user&#39;s thumb) towards the shaft  102  to place the thumb lock  176  in a closed configuration (shown in  FIG. 4 ), rotation of the roller mount  186  and associated rotation of the cam roller  184  causes the cam roller  184  to dig into the shrink tube  118 , thereby generating friction that locks the sleeve  148  of the colpotomizer assembly  104  in position along the shaft  102 . The cam roller  184  of the thumb lock  176  is configured to apply a compressive load of up to about 5 lb to about 10 lb (e.g., about 7 lb to about 8 lb) on the shaft  102 . Such downward force applied to the lens  190  or to the lift flange  192  also causes the jaw  188  to snap fit onto the projections  180 . When the lift flange  192  is pushed upward (e.g., by the user&#39;s thumb) away from the shaft  102  to place the thumb lock  176  in an open configuration (shown in  FIG. 3 ), rotation of the roller mount  186  and associated rotation of the cam roller  184  causes the cam roller  184  to release the shrink tube  118 , thereby unlocking the sleeve  148  of the colpotomizer assembly  104  with respect to the shaft  102 . Such upward force applied to the lift flange  192  also causes the jaw  188  to separate from the projections  180 . The thumb lock  176  provides the user with the ability to lock the colpotomizer assembly  104  at various different positions along the shaft  102  of the uterine manipulator  100 . 
     As shown in  FIG. 5 , the vaginal occluder  150  includes a main body  194  that can be mounted concentrically about the distal cuff  196  of the sleeve  148 , an expandable balloon cuff  198 , and a balloon cuff catheter tube  101 . The balloon cuff catheter tube  101  is affixed to the balloon cuff  198  and communicates fluid to the balloon cuff  198  when inflation is desired. 
     Referring to  FIGS. 6 and 7 , the colpotomizer assembly  104  of the uterine manipulator  100  has a geometry (e.g., provided by the position and size of the opening  166  of the base  158 ) that ensures proper alignment of the cup face  103  with respect to the shaft  102 . The cup face  103  is oriented perpendicular (e.g., normal) to an axial centerline  109  of the colpotomizer cup  146 . A centerpoint  105  of the cup face  103  (located along the axial centerline  109  of the colpotomizer cup  146 ) is maintained along an arch centerline  107  of the shaft  102  as the colpotomizer assembly  104  is slid along the shaft  102 . Such alignment of the cup face  103  with the arch centerline  107  is provided by an offset  113  between the centerline  109  of the colpotomizer cup  146  and the arch centerline  107  of the shaft  102 , at the location of the opening  166  of the base  158  of the colpotomizer cup  146 . The offset  113  is typically a distance of about 0.065 inch to about 0.085 inch (e.g., about 0.071 inch to about 0.081 inch). The colpotomizer cup  146  is substantially prevented from tilting with respect to the shaft  102  by points of contact between the cup  146  and the shaft  102  at the opening  166  of the base  158  and the roller mount  182  and cam lock  184  of the thumb lock  176 . Aligning the colpotomizer cup  146  with respect to the shaft  102  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  146 . In other words, this configuration can help to ensure that substantially the same amount of cervical tissue is received in the colpotomizer cup  146  about the entire circumference of the shaft  102 , and can thus 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  104  can be formed (e.g., molded and/or machined) from one or more materials that are biocompatible. In some embodiments, the colpotomizer cup  146  can be made of polyetherimide (PEI). In some embodiments, the female and male portions  168 ,  170  of the sleeve  148  can be made of acrylonitrile butadiene styrene (ABS). In some embodiments, certain components of the thumb lock  176  (e.g., the cam roller  184 , the roller mount  186 , the jaw  188 , and the lift flange  192 ) can be made of polycarbonate. In some embodiments, the various components of the vaginal occluder  150  can be made of medical grade silicone. In some embodiments, the colpotomizer cup  146  and the sleeve  148  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 assembly can allow cup bodies of different sizes (e.g., different diameters) to be used with the same sleeve. While certain examples of materials with which the components of the colpotomizer assembly  104  can be formed have been described, it should be understood that other materials can alternately be used to form these components. 
     Referring to  FIG. 8 , in some embodiments, the uterine manipulator  100  is provided as a disposable (e.g., single-use) surgical device that is housed in a packaging container  200 . The packaging container  200  provides an easy-to-open structure that allows for secure, space-saving transport and storage of the uterine manipulator  100 . The packaging container  200  includes a base  202  that houses the uterine manipulator  100  and a cover  204  that can be peeled from the base  202  to open the packaging container  200 . The base  202  of the packaging container  200  has a shape that generally follows the shape of the uterine manipulator  100 . The base  202  of the packaging container  200  includes spaced apart posts  206  that secure the shaft  102  of uterine manipulator  100  in a stable position. The packaging container  200  can be transparent, translucent, or opaque and can be made of one or more materials that are biocompatible. For example, the packaging container  200  can be made of Ethylene-vinyl acetate. 
     The uterine manipulator  100  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  100  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  146  of the colpotomizer assembly  104  should be placed during the surgical procedure. In other words, the depth of the uterus corresponds to an operational position of the colpotomizer cup  146  for carrying out the procedure. As discussed above with respect to  FIGS. 2-4 , the ruler markings  124  along the shaft  102  of the uterine manipulator  100  indicate a distance from the fundus to the base  158  of the colpotomizer cup  146  when the uterine manipulator  100  is appropriately, fully inserted within the patient. The ruler markings  124  along the shaft  102  compensate for an arc length of the colpotomizer assembly  104 , thereby reflecting an accurate depth placement of the colpotomizer cup  146 . Proper placement of the uterine manipulator  100  with respect to the fundus, as aided by the lens  190  of the thumb lock  176  and the ruler markings  124  along the shaft  102 , can prevent perforation and other damage to the fundus and the distal region of the uterus. 
       FIGS. 9-12  illustrate a method of using the uterine manipulator  100 . Referring particularly to  FIG. 8 , once prepared, the patient&#39;s peritoneal cavity  300  is inflated with a gas (e.g., CO 2 ) to facilitate accessibility and visibility of the female pelvic organs and surgical instruments (e.g., a laparoscope  314 ) as the instruments are inserted through the abdominal wall  302  and into the peritoneal cavity  300 . The colpotomizer assembly  104 , while in an unlocked configuration, is slid proximally along the shaft  102  until the colpotomizer assembly  104  reaches a loading position (e.g., a position where the proximal end  174  of the sleeve  148  is positioned along the proximal portion  114  of the shaft  102 ). The button  119  located along the manipulator handle  112  for controlling the light source  110  is actuated (e.g., depressed or slid) to turn on the light source  110 . Next, the uterine manipulator  100 , with the colpotomizer assembly  104  in the loading position and with the light source  110  turned on, is inserted into the vaginal cavity  304 . Light emitted from the light source  110  improves visibility of the vaginal cavity  304  as the uterine manipulator  100  is inserted. In some cases, the colpotomizer assembly  104  is locked in the loading position prior to insertion into the vaginal cavity  304 . In other instances, the colpotomizer assembly  104  remains unlocked in the loading position during insertion into the vaginal cavity  304 . 
     Referring to  FIG. 10 , the uterine manipulator  100  is moved distally within the vaginal cavity  304  until the distal tip  108  of the shaft  102  is positioned adjacent the fundus  308  of the uterus. The slidable button  144  of the syringe  138  is then slid distally (as shown in  FIG. 2 ) to inflate the expandable balloon  106  such that the expandable balloon  106  engages an interior surface of the uterus  306 . In some cases, the slidable button  144  may be slid proximally to deflate the expandable balloon  106  if it is determined that the uterine manipulator  100  needs to be repositioned. Leaving the colpotomizer assembly  104  in the loading position during insertion of the uterine manipulator  100  can allow for a relatively unobstructed view of the cervix  310  to help ensure proper placement of the distal tip  108  of the shaft  102 . 
     Referring to  FIG. 11 , the colpotomizer assembly  104  (still in the unlocked configuration) is advanced distally from the loading position until the ruler markings  124  (as visualized through the lens  190 ) indicate that the base  158  of the colpotomizer cup  146  is positioned at an operational position (i.e., at a distance from the distal tip  108  that is approximately equal to the depth of the uterus  306  as determined from the sounding device). The viewing windows  164  of the colpotomizer cup  146  can provide for additional visual confirmation of placement. In the operational position, the cervix  310  is positioned within the body  152  of the colpotomizer cup  146  and abuts the base  158  of the colpotomizer cup  146 . The alignment of the lens  190  with the ruler marking  124  and the ability to view placement of the cervix  310  within the colpotomizer cup  146  through the viewing windows  164  helps to ensure that the colpotomizer cup  146  is fully forward in the desired position relative to the distal tip  108  of the shaft  102  and relative to the cervix  310 . In this position, the colpotomizer cup  146  provides an anatomical landmark at the base of the uterus  306  (e.g., indicating a location of an apex of the cervix  310 ) and an incision backstop (e.g., an edge that defines where the uterus  306  should be cut). Furthermore, the cup face  103  of the colpotomizer cup  146  is centered on the arch centerline  107  of the shaft  102 , ensuring a proper angular position of the colpotomizer cup  146  with respect to the shaft  102  for providing a desirable or suitable cutting guide. 
     With the colpotomizer assembly  104  positioned as desired, the jaw  188  of the thumb lock  176  is then depressed to lock the colpotomizer assembly  104  at the operational position. The jaw  188  can be depressed using the same hand that advances the colpotomizer assembly  104  within the vaginal cavity  304 , such that distal movement and locking of the colpotomizer assembly  104  can be performed in a one-handed operation. If necessary, the lift flange  192  of the thumb lock  176  can be pushed upwards to unlock the colpotomizer assembly  104  for repositioning along the shaft  102 . In some implementations, the mechanical integrity of the thumb lock  176  may be maintained over multiple (e.g., four) lock-unlock cycles. 
     Referring to  FIG. 12 , once the colpotomizer assembly  104  is locked in the desired operational position along the shaft  102 , the vaginal occluder  150  can be inflated (e.g., with a sterile, water-based fluid) to seal a distal region of the vaginal cavity  304 , thereby maintaining pneumoperitoneum. The vaginal occluder  150  inhibits (e.g., prevents) the escape of gas used to inflate the peritoneal cavity  300  during and following the first of any colpotomy incisions. 
     A surgeon can then manipulate or move the uterus  306  into a desired position to perform surgical procedures that include cutting around the base of the uterus  306 . As discussed above, the offset  113  (located at the opening  166  in the base  158  of the colpotomizer cup  146 ) between the centerline  109  of the colpotomizer cup  146  and the arch centerline  107  of the shaft  102  ensures that the centerpoint  105  of the cup face  103  is located along the arch centerline  107  of the shaft  102 . Such a configuration prevents undesired tilting of the colpotomizer cup  146  relative to the shaft  102 , such that cutting along the cup face  103  results in a symmetrical cut of the uterus  306  with an even distribution of tissue within the colpotomizer cup  146 . After the uterus  306  is completely incised such that the uterus  306  is totally free in the peritoneal cavity  300  and held only by the uterine manipulator  100 , then the uterine manipulator  100 , along with the supported uterus  306 , is removed through the vaginal cavity  304 . The uterine manipulator  100  can be disposed of following the surgery. 
     While certain embodiments have been described above, other embodiments are possible. 
     For example, while the locking mechanism of the colpotomizer assembly  104  is described as being located at the proximal end  174  of the sleeve  148 , 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 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  104  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  100  has been described as including the integral syringe  138 , in some embodiments, a uterine manipulator may not include an integral syringe. For example, in some embodiments, a syringe may alternatively be secured externally to a proximal end of a manipulator handle of a uterine manipulator. 
     While the uterine manipulator  100  has been described as including the integrated light source  110 , in some embodiments, a uterine manipulator may not include an integrated light source. For example, in some embodiments, a uterine manipulator may be used with a separate or external light source. In other examples, a uterine manipulator may be used without a light source. 
     While the uterine manipulator  100  has been described as disposable, in some embodiments, the uterine manipulator  100  may be reusable (e.g., sterilizable).