Abstract:
This invention relates to vaginal manipulator tips and related systems and methods. In certain aspects of the invention, a vaginal manipulator tip assembly includes a body and an expandable member secured to the body. The tip assembly can be configured to be inserted into a vagina, and the body can be configured to receive a cervix.

Description:
TECHNICAL FIELD 
       [0001]    This invention relates to vaginal manipulator tips and related systems and methods. 
       BACKGROUND 
       [0002]    Vaginal prolapse is a condition that occurs when the network of muscles, ligaments, and skin in and around a woman&#39;s vagina weaken or break. As a result of the weakened muscles, ligaments, and skin, the vagina prolapses or falls out of its normal position. One type of vaginal prolapse referred to as a vaginal vault prolapse often occurs following a hysterectomy, which involves the removal of the uterus. In vaginal vault prolapse, the top of the vagina gradually falls toward the vaginal opening. This may cause the walls of the vagina to weaken as well. Eventually, the top of the vagina may protrude out of the body through the vaginal opening, effectively turning the vagina inside out. 
         [0003]    Vaginal vault prolapses can be corrected with certain types of surgery, such as laparoscopic surgery. The surgical correction of this condition usually involves a technique called a vaginal vault suspension, in which the surgeon attaches the vagina to strong tissue in the pelvis or to a bone called the sacrum, which is located at the base of the spine. 
       SUMMARY 
       [0004]    In one aspect of the invention, a vaginal manipulator includes a vaginal manipulator shaft and a tip assembly secured to an end region of the vaginal manipulator shaft. The tip assembly includes a body and an expandable member secured to the body. The tip assembly is configured to be inserted into a vagina, and the body of the tip assembly is configured to receive a cervix. 
         [0005]    In an additional aspect of the invention, a vaginal manipulator tip assembly includes a body and an expandable member secured to the body. The tip assembly is configured to be inserted into a vagina, and the body is configured to receive a cervix. 
         [0006]    In a further aspect of the invention a method of correcting a vaginal prolapse includes inserting a vaginal manipulator tip into a vagina of a subject. The vaginal manipulator tip includes an expandable member secured to a body. The method also includes occluding a portion of the vagina by expanding the expandable member of the vaginal manipulator tip in the vagina, using the vaginal manipulator tip to move the vagina to a desired position, and securing the vagina to bone or tissue of the subject. 
         [0007]    In another aspect of the invention, a vaginal manipulator includes a vaginal manipulator shaft including a tip hub that is pivotally connected to an elongate member, and a tip assembly configured to be secured to the tip hub of the vaginal manipulator shaft. The tip assembly includes a body and an expandable member secured to the body, and the tip assembly is configured to be inserted into a vagina. 
         [0008]    Implementations can include one or more of the following features. 
         [0009]    In certain implementations, the expandable member is configured to occlude the vagina when the tip assembly is inserted into the vagina and the expandable member is expanded. 
         [0010]    In some implementations, the expandable member is further configured to create a substantially fluid-tight seal with the vagina when the tip assembly is inserted into the vagina and the expandable member is expanded. 
         [0011]    In certain implementations, the expandable member is configured to inhibit the tip assembly from becoming disengaged from the vagina when the tip assembly is inserted into the vagina and the expandable member is expanded. 
         [0012]    In some implementations, the expandable member is a balloon having a textured outer surface to increase friction between the outer surface of the balloon and the vagina. 
         [0013]    In certain implementations, the expandable member is a balloon. 
         [0014]    In some implementations, the expandable member is a mechanism that is configured to be radially expanded when an axial force is applied to the mechanism. 
         [0015]    In certain implementations, the expandable member is a resilient cone-shaped member. 
         [0016]    In some implementations, the expandable member is mounted between a proximal end and a distal end of the body of the tip assembly. 
         [0017]    In certain implementations, the expandable member is mounted on the proximal end of the body of the tip assembly. 
         [0018]    In some implementations, the tip assembly has a length that is at least 0.5 times a length of the vagina. 
         [0019]    In certain implementations, the length of the tip assembly is greater than or equal to the length of the vagina. 
         [0020]    In some implementations, the body of the tip assembly defines one or more recesses configured to receive at least a portion of the expandable member. 
         [0021]    In certain implementations, the body of the tip assembly defines an annular recess configured to receive a resilient ring of the expandable member. 
         [0022]    In some implementations, the body of the tip assembly defines an annular recess configured to receive substantially the entire expandable member when the expandable member is in an unexpanded configuration. 
         [0023]    In certain implementations, the expandable member is releasably attached to the body. 
         [0024]    In some implementations, the distal end region of the tip is configured to receive the cervix. 
         [0025]    In certain implementations, the distal end region of the body includes at least one member that extends along a longitudinal axis of the body and has an inner surface. The cervix can be received adjacent the inner surface of the at least one member. 
         [0026]    In some implementations, the inner surface of the at least one member is a curved surface. 
         [0027]    In certain implementations, the distal end region of the body includes a plurality of members that extend circumferentially about the longitudinal axis of the body. The plurality of members define a recess between them that extends along the longitudinal axis of the body. This recess is configured to receive a cervix. 
         [0028]    In some implementations, each of the plurality of members has a curved inner surface. 
         [0029]    In certain implementations, the distal end region of the body defines a recess configured to receive the cervix. 
         [0030]    In some implementations, the recess extends proximally from a distal end surface of the body. 
         [0031]    In certain implementations, the recess has a depth of about 0.5 cm to about 5 cm (e.g., about 3.5 cm). 
         [0032]    In some implementations, the recess has a diameter of about 0.5 cm to about 4.5 cm (e.g., about 3.5 cm). 
         [0033]    In certain implementations, the manipulator shaft includes an elongate member with a proximal end portion and a distal end portion. The manipulator shaft also includes a tip hub connected to the elongate member and is configured to releasably receive and support the tip assembly. 
         [0034]    In some implementations, the tip hub is pivotally connected to the distal end portion of the elongate member. 
         [0035]    In certain implementations, the manipulator shaft includes a grip pivotally connected to the proximal end portion of the elongate member, and the grip is movable relative to the elongate member to control relative movements of the tip hub. 
         [0036]    In some implementations, the elongate member has a curved configuration. 
         [0037]    In certain implementations, the method of correcting vaginal prolapse further includes securing the vagina to the bone or tissue of the subject via a graft. 
         [0038]    In some implementations, securing the vagina to the bone or tissue of the subject includes securing one end region of the graft to the vagina and an opposite end region of the graft to the bone or tissue. 
         [0039]    In certain implementations, the one end region of the graft is sutured to the vagina and the opposite end region of the graft is sutured to the bone or tissue. 
         [0040]    In some implementations, the method includes holding the vaginal manipulator tip adjacent a portion of the vagina being secured to the graft. 
         [0041]    In certain implementations, the graft is a mesh member (e.g., a Y-shaped mesh member). 
         [0042]    In some implementations, the method includes insufflating an abdominal cavity of the subject, wherein the expanded expandable member inhibits insufflation gas from escaping the subject via the vagina. 
         [0043]    In certain implementations, the method includes the vaginal manipulator tip having at least one member that extends circumferentially about a longitudinal axis of the body. The method further includes rotating the vaginal manipulator tip within the vagina to position the at least one member adjacent a portion of the vagina being secured to the bone or tissue. 
         [0044]    In some implementations, the method includes advancing the vaginal manipulator tip into the vagina until a cervix of the subject is received in a recess defined by a distal end portion of the vaginal manipulator tip. 
         [0045]    Implementations can include one or more of the following advantages. 
         [0046]    In certain implementations, the tip assembly is configured to be inserted into a vagina, and the expandable member is configured to occlude the vagina when the tip assembly is inserted into the vagina and the expandable member is expanded. By occluding the vagina, the tip assembly can inhibit insufflation gas from escaping the subject via the vagina during procedures in which the vagina is punctured, such as procedures to correct vaginal prolapse. Preventing insufflation gases from escaping via the patient&#39;s vagina can reduce or prevent the need to replenish the insufflation gas during the procedure. The expandable member can also advantageously prevent the tip assembly from slipping out of the vagina during a treatment. 
         [0047]    In some implementations, the body of the tip assembly defines a recess configured to receive substantially the entire expandable member when the expandable member is in a non-expanded state. This arrangement can facilitate insertion of the tip assembly into a vagina. In particular, because the expandable member is flush with or recessed relative to the outer surface of the body of the tip assembly, the expandable member will typically apply little, if any, frictional force to the vaginal wall as the tip assembly is inserted into the vagina. The flush or recessed arrangement of the expandable member also improves the ease with which the vagina can be manipulated or repositioned within the patient by the tip assembly. 
         [0048]    In certain implementations, the tip assembly is sized to extend along substantially the entire length of the vagina of a patient being treated (e.g., undergoing a vaginal prolapse correction procedure). This configuration can allow all of the sutures used to secure the vagina to a graft, tissue, or bone during the treatment to be placed without having to reposition the manipulator within the vagina. In addition, this configuration increases the ease with which the vagina can be manipulated by the tip assembly. 
         [0049]    In some implementations, the distal end region of the body of the tip assembly is configured to receive a cervix of a patient being treated. This configuration can reduce interference caused by the cervix when repositioning or elevating the patient&#39;s vagina and can thus improve the surgeon&#39;s ability to elevate the vagina to its correct position within the patient. This configuration can also improve the surgeon&#39;s ability to secure a portion of the patient&#39;s vagina that is adjacent to (e.g., that surrounds) the cervix to a graft, tissue, or bone during the procedure. 
         [0050]    In certain implementations, the manipulator shaft includes a pivotable tip hub to which the tip assembly can be connected. This gives the surgeon the ability to pivot the tip assembly during treatment. This provides the surgeon with the ability to manipulate the tip assembly within the vagina of a patient, which can facilitate insertion of the tip assembly into the vagina and can facilitate repositioning of the vagina. In addition, the pivotable tip assembly allows the surgeon to bias the vagina toward or away from the graft, tissue, or bone to which the vagina is being secured. This can improve the ability of the surgeon to suture or otherwise secure the vagina to the graft, tissue, or bone. 
         [0051]    Other aspects, features, and advantages of the invention will be apparent from the description and drawings, and from the claims. 
     
    
     
       DESCRIPTION OF DRAWINGS 
         [0052]      FIG. 1  is a side view of a vaginal manipulator. 
           [0053]      FIGS. 2A and 2B  are side views of a tip assembly of the vaginal manipulator of  FIG. 1  with a balloon of the tip assembly deflated and inflated, respectively. 
           [0054]      FIGS. 3A-3C  schematically illustrate a method of using the vaginal manipulator of  FIG. 1  to perform a vaginal prolapse correction procedure, namely a sacral colpopexy procedure. 
           [0055]      FIG. 4  is a side view of a vaginal manipulator tip assembly that includes a balloon positioned at the proximal end of a body of the tip assembly such that the balloon can be held securely between the body of the tip assembly and a tip hub of a vaginal manipulator shaft when the tip assembly is attached to the vaginal manipulator shaft. 
           [0056]      FIG. 5  is a perspective view of a vaginal manipulator tip assembly having a body with a recessed portion that extends proximally from the distal end surface of the body and is configured to receive a cervix. 
           [0057]      FIG. 6  is a cross-sectional view of the vaginal manipulator tip assembly of  FIG. 5  positioned within the vagina of a patient such that the cervix of the patient is received within the recessed portion of the body of the tip assembly. 
           [0058]      FIG. 7  is a perspective view of a vaginal manipulator tip assembly that includes opposed, elongate arcuate walls that form a central recess configured to receive a cervix. 
           [0059]      FIG. 8  is a perspective view of a vaginal manipulator tip assembly that includes a single elongate arcuate wall that forms a recess configured to receive a cervix. 
           [0060]      FIGS. 9A and 9B  are side views of a vaginal manipulator tip assembly with an expandable mechanism in a non-expanded state and an expanded state, respectively. 
           [0061]      FIG. 10  is a side view of a vaginal manipulator that includes a pivotable tip hub to which the tip assembly of  FIGS. 2A and 2B  is secured. 
       
    
    
     DETAILED DESCRIPTION 
       [0062]      FIG. 1  illustrates a vaginal manipulator  100  that includes a vaginal manipulator shaft  102  and a tip assembly  104  releasably secured to a distal end region of the shaft  102 . The tip assembly  104  includes a substantially cylindrical body  106  to which a balloon  108  is secured. Catheter tubing  110  is connected to the balloon  108  to allow the balloon  108  to be inflated and deflated as needed. 
         [0063]    As will be described in greater detail below, the vaginal manipulator  100  can be used to reposition a prolapsed vagina during vaginal prolapse correction procedures, such as sacral colpopexy procedures. To reposition the prolapsed vagina, the user grasps the shaft  102  and inserts the tip assembly  104  assembly into the vagina. By moving the shaft  102 , the tip assembly  104  and the vagina in which the tip assembly  104  is disposed can also be moved. With the tip assembly  104  disposed within the vagina, the balloon  108  can be inflated to create a substantially fluid-tight seal with the vaginal wall. This can help to prevent gases, such as insufflation gases, from escaping the patient via the patient&#39;s vagina. The inflated balloon  108  can also function to grip the vaginal wall to reduce (e.g., prevent) movement of the balloon  108  relative to the surrounding portion of the vagina. This can help to prevent the tip assembly  104  from becoming disengaged from or fall out of the vagina during a procedure. 
         [0064]    The vaginal manipulator shaft  102  includes an elongate, arcuate shaft  112  having a proximal end portion  114  and a distal end portion  116 . A handle  118  is coupled to the proximal end portion  114  of the arcuate shaft  112 . The handle  118  can be integrally formed with the shaft  112  or can be formed as a separate piece and attached to the shaft  112 . A suitable manipulator handle is commercially available from CooperSurgical (Trumbull, Conn.), under the name RUMI Arch™. 
         [0065]    The arcuate shaft  112  and the handle  118  of the vaginal manipulator shaft  102  can be formed, e.g., molded and/or machined, from materials that are biocompatible and capable of withstanding heat-based medical device sterilization procedures (e.g., autoclave, steam autoclave, or dry heat oven) so that the vaginal manipulator shaft  102  can be sterilized and re-used after a treatment. Suitable materials that are capable of withstanding medical device sterilization procedures include metals, such as stainless steel and aluminum, and polymers, such as polyoxymethylene (POM) commonly known under the DuPont™ brand name Deirin®. 
         [0066]      FIGS. 2A and 2B  illustrate the tip assembly  104  of the vaginal manipulator  100  detached from the vaginal manipulator shaft  102  with the balloon  108  in a deflated state and an inflated state, respectively. Referring first to  FIG. 2A , the body  106  of the tip assembly  104  has an annular recess  119  configured to receive substantially the entire ring-shaped or donut-shaped balloon  108  when the balloon  108  is deflated. This can facilitate insertion of the tip assembly  104  into a vagina by limiting the resistance or friction experienced by the balloon  108  contacting the vaginal walls during insertion. For similar reasons, this configuration can increase the ease with which the vagina can be manipulated or repositioned using the tip assembly  104 . 
         [0067]    The inner surface of the balloon  108  (i.e., the surface that forms the inner diameter of the donut-shaped balloon  108 ) is secured to a reduced diameter portion  121  of the body  106 . In certain implementations, the balloon  108  is secured to the reduced diameter portion  121  of the body by a friction fit. In such implementations, the donut-shaped balloon  108  is formed of a resilient (e.g., elastic) material and has an inner diameter that, in a relaxed (i.e., unstretched) state, is less than the outer diameter of the reduced diameter portion  121  of the body  106 . As a result, the balloon  108 , when positioned around the reduced diameter portion  121  of the body  106  is stretched and secured to the body  106 . The friction between the inner surface of the balloon  108  and the outer surface of the reduced diameter portion  121  of the body  106  in combination with end surfaces  123  and  125  of the body  106 , which abut the proximal and distal ends of the balloon  108 , limit movement of the balloon  108  relative to the body  106 . As an alternative to or in addition to this stretch fit arrangement of the balloon  108 , the inner surface of the balloon  108  can be bonded (e.g., thermally bonded or adhesively bonded using biocompatible adhesive) to the outer surface of the reduced diameter portion  121  of the body  106 . 
         [0068]    The inflation catheter or tube  110  is affixed to the balloon  108  and is in fluid communication with an interior of the balloon  108 . The free end of the inflation tube  110  can be connected to a fluid source (e.g., a gas source or liquid source) and the fluid source can be operated to inflate the balloon  108 . Any of various fluid sources, such as syringes and pumps, can be used to inflate the balloon  108 . 
         [0069]    The balloon  108  can be formed of any of various materials that permit the balloon  108  to form a substantially fluid-tight seal with the walls of a vagina when the balloon  108  is inserted into the vagina and inflated. Examples of suitable materials include high flexural modulus elastomers, such as thermo-plastic elastomers, silicone, polyethylene (PE), polyethylene terephthalate (PTE), and polyvinyl chloride. Other examples of suitable materials from which the balloon  108  can be formed include polyether-block-amide (e.g., Pebax®), nylon 12 (e.g., Vestamid®), and polyurethane elastomers (e.g., Tecothane®) 
         [0070]    The body  106  of the tip assembly  104  has a length that is at least 0.5 times (e.g., at least about 0.75 times, at least about 1.0 times) the length of the vagina in which it is to be used. In some implementations, the body  106  has a length of about 5 cm to about 15 cm (e.g., about 8 cm to about 13 cm, about 13 cm). The body  106  also has a diameter that approximately matches the diameter of the vagina in which the tip assembly  104  is to be inserted. In certain implementations, the body  106  has a diameter of about 3 cm to about 6 cm (e.g., about 4 cm). The diameter of the reduced diameter portion  121  is typically about 0.1 cm to about 1.0 cm less than the diameter of adjacent larger diameter regions of the body  106 . The body  106  has a rounded distal end region that generally conforms to the top region of a vagina. The rounded end region extends proximally about 1 cm to about 3 cm (e.g., about 1 cm) from the distal end of the tip assembly  104 . 
         [0071]    The body  106  of the tip assembly  104  can be formed, e.g., molded and/or machined, from polyoxymethylene. Alternatively or additionally, other biocompatible rigid thermoplastic or thermoset materials, such as polycarbonate (Lexan®) and acrylonitrile butadiene styrene (ABS), can be used to form the body  106  of the tip assembly  104 . Typically the body  106  has a color that differs substantially from flesh (e.g., vaginal tissue) such that the body  106  can provide a distinct variance in color next to flesh and when flesh is stretched around the body  106 . This can help a surgeon to distinguish the tip assembly  104  from the patient&#39;s flesh during surgical procedures. 
         [0072]    As shown in  FIG. 2B , when the balloon  108  is inflated, its diameter exceeds the maximum diameter of the body  106 . In certain implementations, the diameter of the inflated balloon  108  is about 0.25 cm to about 4.0 cm greater than the maximum diameter of the body  106 . The balloon  108  can, for example, have an outer diameter of about 3.5 cm to about 10 cm. Due to the size of the inflated balloon  108 , when the tip assembly  104  is positioned within a vagina and the balloon  108  is inflated, the balloon  108  can create a fluid-tight seal with the walls of the patient&#39;s vagina. 
         [0073]    The tip assembly  104  can be connected to the vaginal manipulator shaft  102  through an opening in the proximal end  120  of the body  106  of the tip assembly  104 . A tip hub at the distal end  116  of the vaginal manipulator shaft  102  includes a pair of spaced apart flats which extend upwardly from a first surface of a base of the tip hub. The tip hub can be inserted into a counter-bore hole at the proximal end  120  of the tip assembly  104  and into a position in which the spaced apart flats engage a rectangular aperture in the proximal end  120  of the tip assembly  104 . The tip hub also includes a hole for receiving a proximal end of a rod  124  designed to connect with the vaginal manipulator shaft  102 . Further information regarding suitable mechanism for securing the tip assembly  104  to the vaginal manipulator shaft  102  can be found in U.S. Patent Application Publication No. 2010/0106163, which is incorporated by reference herein. 
         [0074]      FIGS. 3A-3C  schematically illustrate a method of using the vaginal manipulator  100  to reposition a patient&#39;s prolapsed vagina  350  during a vaginal prolapse correction procedure, namely a sacral colpopexy procedure. In this case, the patient previously underwent a hysterectomy procedure and, as a result, no longer has a uterus or cervix. Referring to  FIG. 3A , the surgeon first grasps the shaft  102  of the vaginal manipulator  100  and inserts the tip assembly  104  into the prolapsed vagina  350 . While inserting the tip assembly  104  into the vagina  350 , the balloon  108  of the tip assembly  104  is in a deflated state such that the balloon  108  sits entirely or almost entirely within the recess  119  of the body  106  and does not substantially resist insertion of the tip assembly  104 . 
         [0075]    With the balloon  108  in the deflated state, the user continues to advance the tip assembly  104  into the vagina  350 . The distal end region of the advancing tip assembly  104  eventually contacts the upper portion of the vagina  350 , which has prolapsed into the vaginal cavity. As a result, advancement of the tip assembly  104  pushes the upper portion of the vagina  350  upward into the patient. The tip assembly  104  is advanced until the vagina  350  has been repositioned or raised to its proper location inside the patient, as shown in  FIG. 3B . 
         [0076]    Referring to  FIG. 3C , after repositioning the vagina  350  as desired, a fluid source (e.g., a syringe or pump) is connected to the inflation tube  110  and operated to inflate the balloon  108 . Prior to or after repositioning the vagina  350  and inflating the balloon  108 , an abdominal cavity  352  of the patient is insufflated with insufflation gas (e.g., CO 2 ), and desired surgical instruments, including a laparoscope, are inserted into the abdominal cavity  352  of the patient. The insufflation of the abdominal cavity  352  improves accessibility to and visibility of the female pelvic organs for the surgeon. 
         [0077]    The outer surface of the vagina  350  is then secured to a sacrum  354  of the patient via a Y-shaped graft  356 . To secure the vagina  350  to the sacrum  354 , the surgeon first sutures two branches of the Y-shaped graft  356 , which can be made of synthetic material (e.g., polypropylene or polyester) or a natural material (e.g., fascia or dermis), to the anterior and posterior fascia of the vagina  350  using laparoscopic instruments. While suturing the Y-shaped graft  356  to the vagina  350 , the tip assembly  104  of the vaginal manipulator  100  can help the surgeon to properly position the sutures within the vaginal tissue. The tip assembly  104  of the vaginal manipulator  100  can also be used in a manner similar to a thimble to provide a back-stop to aid in driving the needle and suture materials through the vaginal wall. Due to the length of the tip assembly  104 , a portion of the tip assembly  104  typically sits adjacent the portion of the vagina  350  being sutured at all times. As a result, it is not typically necessary to move the tip assembly  104  relative to the vagina  350  during the suturing process. 
         [0078]    The punctures created in the vagina  350  during this suturing process may cause insufflation gas to leak from the abdominal cavity  352  into the vaginal cavity of the patient. However, the inflated balloon  108  of the tip assembly  104  substantially prevents the insufflation gas from escaping the patient via the vagina  350  and thus helps to ensure that pneumoperitoneum is maintained. This can help to ensure that visibility within the abdominal cavity  352  of the patient remains adequate for the surgeon to complete the surgical procedure the procedure. 
         [0079]    Still referring to  FIG. 3C , once the two branches of the Y-shaped graft  356  have been secured to the vagina  350 , the third branch of the Y-shaped graft  356  is sutured to the sacrum  354  to suspend the vagina  350  in the desired position. This is done using laparoscopic instruments that are positioned in the abdominal cavity  352  and thus have access to the outer wall of the vagina  350  and the sacrum  354 . Once the suturing is completed, the insufflation gas is released from the abdominal cavity  352 , and the balloon  108  is deflated. The vaginal manipulator  100  and the various laparoscopic surgical instruments are then removed from the patient. 
         [0080]    While certain implementations have been described, other implementations are possible. 
         [0081]    While  FIGS. 3A-3C  illustrate a sacral colpopexy procedure during which the vagina  350  of a patient is secured to the sacrum  354  of the patient, the vagina  350  can alternatively or additionally be attached via the graft  356  or a differently sized and/or shaped graft to other tissue or bone to correct the vaginal prolapse. For example, the vagina  350  can be secured to strong tissue in the pelvis of the patient. Alternatively or additionally, the vagina  350  can be secured to the uterosacral and/or scarospinous ligaments as well as other portions of the boney or ligamentous pelvic structure. During such procedures, the vaginal manipulator  100  is used in generally the same way to reposition the vagina and assist in the suturing process. 
         [0082]    In addition, as an alternative to using a graft to secure the patient&#39;s vagina to bone or tissue, the vagina can be directly secured to the bone or tissue in certain cases. 
         [0083]    While the body  106  of the tip assembly  104  has been described as having the annular recess  119  in which the balloon  108  is disposed, alternative tip assemblies include bodies with no such annular recess. As shown in  FIG. 4 , for example, a tip assembly  404  includes a cylindrical body  406  having a substantially constant diameter along its length. A balloon  408  is secured to a proximal end  420  region of the body  406 . In certain implementations, the inner surface of the balloon  408  is secured to a thin rod  424  in the proximal end  420  of the body  406  by friction fit. In such implementations, the donut-shaped balloon  408  is formed of a resilient material and has an inner diameter that, in a relaxed state, is less than the outer diameter of the rod  424 . This rod  424  also fits into a hole in the vaginal manipulator shaft  102  that secures the tip assembly  404  to the vaginal manipulator shaft  102 . As a result, the balloon  408  is further secured between a tip hub at the distal end region  116  of the vaginal manipulator shaft  102  and a rectangular aperture in the proximal end region  420  of the tip assembly  404 . As an alternative or in addition to this stretch fit arrangement of the balloon  408 , the inner surface of the balloon  408  can be bonded (e.g., thermally bonded or adhesively bonded using biocompatible adhesive) to the outer surface of the rod  424  and/or to the proximal end surface of the body  406 . The tip assembly  404  can be connected to the vaginal manipulator shaft  102  and used in the same manner as the vaginal manipulator  100  described above. 
         [0084]    While the vaginal manipulators above have been described as being used to reposition the vagina of a patient whose uterus was previously removed, vaginal manipulators can similarly be used to reposition vaginas in patients who still have their uterus or cervix. Such manipulators can include tip assemblies that are specially configured to accommodate the cervix of the patient during the procedure.  FIG. 5  illustrates an example of one such vaginal manipulator tip assembly  504 . As shown in  FIG. 5 , a distal end region  522  of a body  506  of the tip assembly  504  defines a recess  530  that extends proximally from a distal end surface of the body  506  and is configured to receive a cervix. The recess  530  has a diameter of about 0.5 cm to about 4.5 cm (e.g., about 3.5 cm) and/or a depth (measured along the longitudinal axis of the body) of about 0.5 cm to about 5.0 cm (e.g., about 3.5 cm). The body  506  of the tip assembly  504  can otherwise have dimensions similar to the body  106  of the tip assembly  104  described above and can be formed of any of the materials described above with respect to the body  106  of the tip assembly  104  described above. 
         [0085]    A balloon  508  is secured to the body  506  of the tip assembly  504 . A resilient ring  528  of the balloon  508  is secured within an annular recess  519  of the body  506 . The resilient ring  528  and the annular recess  519  are configured so that the annular recess  519  receives the resilient ring  528  of the balloon  508  by friction fit. In particular, the inner diameter of the resilient ring  528 , when the balloon  508  is in a relaxed (i.e., unstretched) state, is less than the outer diameter of the portion of the body  506  forming the annular recess  519 . As a result, the resilient ring  528 , when positioned around the annular recess  519 , is stretched and the balloon  508  is secured to the body  506 . The depth of the annular recess  519  can be further configured to be greater than the thickness of the resilient ring  528  of the balloon  508 , further securing the resilient ring  528  in the annular recess  519  and restricting the balloon  508  from being able to move proximally or distally along the body  506  of the tip assembly  504 . As an alternative to or in addition to this stretch fit arrangement of the balloon  508 , the resilient ring  528  of the balloon  508  can be bonded (e.g., thermally bonded or adhesively bonded using biocompatible adhesive) to the portion of the body  506  forming the annular recess  519 . 
         [0086]      FIG. 6  is an anterior cross-sectional view of the tip assembly  504  with the tip assembly  504  fully inserted into a vagina  650  of a patient. As shown, a cervix  658  of the patient has been received in the recess  530  of the tip assembly  504 . This allows the tip assembly  504  to be maneuvered in a way to restore the prolapsed vagina  650  to its original or desired position without the cervix  658  hindering the movement of the tip assembly  504 . The length of the tip assembly  504  can help reduce or minimize the need for repositioning of the tip assembly  504  during the procedure. The balloon  508  can be inflated via an inflation tube  510 . The balloon  508  is shown in its expanded configuration, occluding the vagina  650  to prevent insufflating gas from escaping the patient via the vagina  650 . 
         [0087]    While the bodies of the tip assemblies described above are generally cylindrical, tip assemblies having bodies of various other shapes can be used. Referring to  FIG. 7 , for example, a tip assembly  704  includes a body  706  having a proximal portion  703  and two opposed arcuate members  732 ,  734  that extend distally from the proximal portion  703 . The arcuate members  732 ,  734  extend circumferentially about the longitudinal axis of the body  706  and have curved inner surfaces. A recess  730  sized to receive a cervix is formed between the two members  732 ,  734 . 
         [0088]    A balloon  708  is secured to the proximal portion  703  of the body  706 . In particular, a resilient ring  728  of the balloon  708  is secured within an annular recess  719  formed in a proximal end region  120  of the body  706 . The annular recess  719  is configured to receive the resilient ring  728  of the balloon  708  by friction fit. The balloon  708  can alternatively or additionally be secured to the body  706  using any of the various attachment techniques described above with respect to the balloons and bodies of other tip assemblies described herein. 
         [0089]    The tip assembly  704  can be used in much the same way as the tip assembly  504  described above with respect to  FIGS. 5 and 6 . For example, the tip assembly  704  can be inserted into a prolapsed vagina, and the distal end of the tip assembly  704  can be used to push and reposition the prolapsed vagina into a desired location or orientation in the patient. As the distal end of the tip assembly  704  approaches the cervix of the patient, the recess  730  between the arcuate members  732 ,  734  receives the cervix. This allows a surgeon to fully advance the tip assembly  704  until the vagina is properly relocated. The surgeon can then, if necessary, rotate the tip assembly  704  such that the arcuate members  732 ,  734  sit adjacent the portion of the vagina being sutured. The opposing members  732 ,  734  allow for the surgeon to suture both anterior and posterior fascia of the outer vaginal wall once positioned. This can be advantageous in saving time and effort on the part of the surgeon. The balloon  708  can be inflated via an inflation tube  710  to occlude the vagina to prevent insufflation gas from escaping the patient via the patient&#39;s vagina. 
         [0090]      FIG. 8  illustrates a tip assembly  804  that is similar to the tip assembly  704  described above. However, the tip assembly  804  includes only a single arcuate member  832  that extends distally from a proximal portion  803  of a body  806  of the tip assembly  804 . The member  832  extends circumferentially about a longitudinal axis of the body  806  and has a curved inner surface. During vaginal prolapse correction procedures in patients that still have their cervix, the cervix can be received in a recess  830  formed by the member  832 . The cervix can be received in the recess  830  by maneuvering the member  832  between the cervix and the vaginal wall. This can help the operator manipulate the vagina even as it approaches the cervix and provide a brace against which sutures can be applied along the entirety of the vaginal wall. In addition, due to the relatively small volume occupied by the single member  832  of the body  806 , the tip assembly  804  can be inserted into and guided through the patient&#39;s vagina relatively easily. 
         [0091]    While the vaginal manipulator tip assemblies described above include balloons that can be inflated to create a substantially fluid-tight seal in a patient&#39;s vagina, other types of expandable members can be used for this purpose. In certain implementations, as shown in  FIGS. 9A and 9B , for example, a vaginal manipulator tip assembly  904  includes an expandable mechanism  908  that is secured to a body  906  of the tip assembly  904 . In an unexpanded state, as shown in  FIG. 9A , an annular recess  919  formed in the body  906  receives substantially the entire expandable mechanism  908 . The expandable mechanism  908  includes multiple first spokes  911  configured longitudinally and attached to the body  906  near a distal end  925  of the annular recess  919 . A flexible biocompatible membrane  930  is attached to and surrounds the multiple spokes  911 . Each first spoke  911  has a second corresponding spoke  913 . The second spoke  913  is connected at its distal end to the first spoke  911  between the proximal and distal ends of the first spoke  911 . The second spokes  913  are connected at their proximal ends to a ring  915  fitted around a reduced diameter portion  921  of the body  906 . When expanded, as shown in  FIG. 9B , the ring  915  is pushed distally up the reduced diameter portion  921  of the body  906 . The ring  915  can, for example, be moved distally along the reduced diameter portion  921  of the body  906  by pushing a rigid wire that is attached to the ring  915  and extends proximally such that the wire is accessible to the surgeon during use. Pushing the ring  915  distally causes the distal ends of the second spokes  913  radially away from the body  906 , forcing the proximal ends of the first spokes  911  radially outward. This expands the flexible cover of the expandable mechanism  908 , creating a fluid-tight seal. 
         [0092]    Any of various other types of expandable mechanisms can similarly be used with the tip assemblies described herein. For example, a mechanical iris, a coiled flat or wire spring, expanding bellows, or Chinese lantern-type supporting structures can be used for this purpose. 
         [0093]    Other types of expandable members can alternatively or additionally be used with the tip assemblies described herein. For example, a flexible cone-shaped member can be secured around the body of a tip assembly. The outer diameter of a proximal end region of the cone-shaped member would be slightly larger than a vaginal canal of a patient while the outer diameter of the distal end region would be smaller than the vaginal canal. The cone-shaped member is formed of one or more flexible thermoplastic or thermoset materials, such as polyethylene, silicone, polyvinylchloride, and thermoplastic elastomers (TPEs). As the tip assembly is inserted into the vagina, the smaller distal end of the cone-shaped member readily passes through the vagina. As the larger proximal end region of the cone-shaped member reaches the vagina, it creates a substantially fluid-tight seal with the vaginal walls. 
         [0094]    Multiple different sized vaginal manipulator tip assemblies of any of the various different types described above can be provided in a kit. The kit can also include the vaginal manipulator shaft. Prior to treatment, the surgeon can select the tip assembly that most closely matches the size of the vagina to be treated and can then use that tip assembly during the vaginal prolapse correction procedure. Selecting a tip assembly that closely matches the patient&#39;s vagina size improves the ability of the surgeon to manipulate or reposition the patient&#39;s vagina after the tip assembly has been inserted into the vagina. Selecting a tip assembly having a length that is substantially equal to the length of the patient&#39;s vagina also helps to ensure that the tip assembly will be positioned adjacent each of the regions of the vagina to be sutured during the procedure and can thus facilitate the suturing process. 
         [0095]    While the tip assemblies above have been described as being attached to the arcuate vaginal manipulator shaft  102 , the tip assemblies can alternatively be used with other types of vaginal manipulator shafts. Referring to  FIG. 10 , for example, the tip assembly  104  described above is shown attached to an articulate shaft  1000 . The shaft  1000  has a pivotable joint  1060  in its distal end region  1016 . The pivotable distal end region  1016  can help in positioning the tip assembly  104  within the vaginal canal, and also in manipulating the vagina with the tip assembly  104 . The tip assembly  104  is pivotally controlled by a connecting structure  1062  that operatively couples a tip hub  1070  to a grip  1066  such that movement of the grip  1066  relative to a frame  1064  causes a corresponding movement of the tip hub  1070  relative to the frame  1064 . The connecting structure  1062  can, for example, be a wire. A locking mechanism  1068  is operable to fix the grip  1066  against movement relative to the frame  1064 . 
         [0096]    While the vaginal manipulators above have been described as being used during laparoscopic surgical procedures to correct vaginal prolapse, the vaginal manipulators can be used in a similar manner during open surgical procedures (e.g., laparotomy procedures) to correct vaginal prolapse. 
         [0097]    While the vaginal prolapse correction procedures described above involve the surgeon grasping and maneuvering the shaft of the vaginal manipulator in order to reposition the patient&#39;s vagina, an automated device, such as a robotic arm, can alternatively be used to grasp and maneuver the vaginal manipulator shaft in order to reposition the patient&#39;s vagina. 
         [0098]    While the vaginal manipulators above have been described as being used during vaginal prolapse correction procedures, the vaginal manipulators can be used for other types of procedures, such as laparoscopic procedures, including hysterectomy, removal of the adnexa, treatment of endometriosis, and other gynecologic diagnostic and therapeutic procedures. These manipulators can also be used for gynecologic procedures done at laparotomy. 
         [0099]    Other implementations are within the scope of the following claims.