Abstract:
A uterine manipulator includes a sound and a body. The sound has a selectively actuatable anchor disposed proximate a distal end and an operating mechanism spaced from the anchor for controlling actuation of the anchor. The body has a passage therethrough adapted to receive the sound passed proximally through the body to a position in which the operating mechanism is accessible proximally of the body and the anchor extends distally.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    Despite decades of commercial availability of a wide variety of transvaginally placed uterine manipulators, the need still exists for more effective and ergonomic surgical instruments to optimize the remote manipulation of a patient&#39;s vaginal, cervical and uterine tissues during modern minimally invasive gynecologic procedures. Naturally occurring openings in the body, like the vagina, urethra, anus and mouth, provide places to engage internal tissues without the requirement of cutting a hole in the patient&#39;s skin. Utilization of the vaginal canal to surgically access the cervix and uterus is routinely part of modern health care. As major gynecologic therapeutic interventions continue to become less invasive using fewer and smaller incisions, without better means for uterine control and mobilization, such procedures will become increasingly difficult to perform and require substantially more operative time, while potentially compromising patient safety and clinical outcomes. Extensive research has led to the invention and development of this new technology for uterine manipulation to address this critical unmet clinical need in women&#39;s health care. 
       DESCRIPTION OF RELATED ART 
       [0002]    Surgeons have been placing medical implements through the vagina in efforts to treat gynecologic maladies for centuries. With the advent of sterile techniques, anesthesia and antibiotics, more advanced surgical interventions were developed. Initially a wide variety of generally cylindrical different size and shape devices, called sounds, were employed to explore and manipulate patients&#39; vaginal canals, cervices and uteri. 
         [0003]    Various purported proprietary product concepts have been developed over time. In 1976, for example, U.S. Pat. No. 3,948,270 described the use of a balloon to anchor a rigid tube within the uterine body to effect uterine fundal elevation and mobility while minimizing the hazard of uterine injury. This invention simply placed a balloon catheter over a rigid tube for insertion through the vagina and cervical canal into the body of the uterus for purposes of uterine injection. No means of engaging the cervix or uterus were provided. 
         [0004]    U.S. Pat. No. 5,209,754 awarded in 1993, described a vaginal cervical retractor used to maneuver and visualize the uterus during surgical examinations and procedures. A balloon on a curved shaft is inserted into the uterine body to communicate with a plastic cup that engages the cervix within the forniceal region of the vagina. The cervical engaging cups were held in place by a hollow tube, which also provides a disc shaped barrier as a vaginal seal. This patent eventually led to the single-patient use, disposable Ahluwalia VCare® Uterine Manipulator product sold by ConMed Corporation (Utica, N.Y.). 
         [0005]    In 1995, U.S. Pat. No. 5,394,863 described a pipe-like optical light guide with a hollow cup to transmit light through the vaginal fornices for surgical and medical procedures. While this invention recognized the utility of providing light to the fornices, it failed to provide a means to actively engage, pivot or manipulate the cervix and uterus. Further, it failed to provide an ergonomic handle to enable surgical control of the specimen. This patent appears to have never led to a commercially available product and the patent was prematurely abandoned. This patent cited eight predecessor patents (U.S. Pat. Nos. 4,449,519; 5,143,054; 5,131,380; 4,337,763; 4,597,383; 4,562,832; 3,945,371; 4,901,708) also involving surgical site illumination. 
         [0006]    Subsequently, in 1996, 1997 and 1998, U.S. Pat. Nos. 5,520,698, 5,643,285 and 5,840,077, respectively, described methods and a uterine manipulation assembly for laparoscopic hysterectomy. This disclosure also provided a cup for cervical engagement located at the end of a hand-controlled device. Movement of this cup was achieved by the counterintuitive side to side rotation of the proximal handle, which is perpendicular to the shaft of the device, leading to up and down movement of the distal cup. This means of moving the distal cup along with the attached cervix has proved to be surprisingly difficult for operating room staff routine implementation. Like the ConMed VCare® product, this technology also used a balloon within the uterine body to hold the device assembly onto the patient. An inflatable vaginal occluder on the shaft of the device assembly is described. This product concept, which uses both single-patient use disposable components and reusable components, led to the development of the KOH Colpotomizer™ used in conjunction with the RUMI® Uterine Manipulator as a product marketed and sold by CooperSurgical, Inc. (Trumbull, Conn.). 
         [0007]    While several more uterine manipulators have been offered as commercial products or described in patent disclosures, they essentially involve non-ergonomic, counterintuitive handles (not co-linear with the device shaft) which function similarly to the RUMI® Manipulator. The ENDOPATH® Uterine Manipulator by Ethicon Endo-Surgery, Inc., (Cincinnati, Ohio) is a fully disposable hand-held device that offers a rotating handle perpendicular to the device shaft to move the distal cervical engagement element up and down through mechanical linkages. This complex plastic device is also secured by a balloon inflated in the uterine body. Other examples of completely reusable uterine manipulator products include the Marina Manipulator (Marina Medical, Sunrise, Fla.) and the Valtchev Manipulator (Conklin Surgical Instruments, Toronto, Canada). Alternative means for engaging the cervix and uterine body are described in European Patent Application # EP 2 116 202 A1 in which a threaded projection is screwed into the cervix and uterus to engage the cervical cup to the patient. Through limitations in effectiveness and ergonomics, none of these previous alternatives truly satisfy the requisite functionality of an optimized uterine manipulator for minimally invasive surgery. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    Briefly stated and in accordance with an embodiment of the invention, a uterine manipulator includes a sound and a body. The sound has a selectively actuatable anchor disposed proximate a distal end and an operating mechanism spaced from the anchor for controlling actuation of the anchor. The body has a passage therethrough adapted to receive the sound passed proximally through the body to a position in which the operating mechanism is accessible proximally of the body and the anchor extends distally. 
         [0009]    In another embodiment, a uterine manipulator includes a generally straight, elongate body having a longitudinal axis and defining a substantially linear passageway therethrough, terminating at an opening in the cup; a handle on one end of the body having a longitudinal axis substantially co-axial with the longitudinal axis of the body; a cup on an opposite end of the body; and a sound having an elongate shaft receivable in the substantially linear passageway of the elongated body and a distal tip protruding from the opening in the cup. The cup has an opening angled relative to the longitudinal axis of the elongate body. 
         [0010]    This novel product offers compelling effectiveness and ergonomic advantages over other similar pre-existing products. Gynecologic surgeons have repeatedly reported that remote uterine dissection, especially the vaginal cuff separation, remains a significant challenge despite multiple currently available products from other companies. Even with the availability and use of earlier uterine manipulator products, difficulties with cervical and uterine dissections are frequently associated with iatrogenic injuries to patients&#39; bladders, ureters, vaginal vaults and surrounding tissues. Difficulties with this dissection often add substantial time to these operative procedures and are one of the leading causes of the need to convert laparoscopic procedures to more invasive open laparotomies. 
         [0011]    The two main design goals for this invention were to develop a safe and truly effective technology for use under relevant surgical conditions, and then to provide a product that is easily learned and successfully deployed by surgeons and their assistants without requiring exhaustive training. The technology is designed to be more readily installed, intuitively obvious to position, and comfortable to hold. A compelling feature of this invention, to enable ease of installation, is the provision of an isolated slender customized sound which is readily installed through the cervix into the uterus. This compact sound acts as a guide over which the cervical engaging cup can be subsequently passed. The ability to install the sound alone readily enables its installation into the uterus under direct visualization within the vagina. This separate sound also makes its secure engagement to the uterus easy by turning the knurled knob to rotate the anchor. Since known alternative designs provide their uterine insertion elements already attached to the rest of their device, their distal insertion means is burdened with obstructing elements, such as their preinstalled balloons and cervical cups. Non-separated insertion features make device installation difficult to visualize and perform. The transvaginal installation of alternative products is significantly encumbered by having their devices&#39; distal insertion components with unnecessary pre-attached larger diameter features. The provision of a physically separated engagement cup that slides over the installed sound makes the cervical cup installation fast and effective. 
         [0012]    While many previous products reportedly can be used to surgically delineate the vaginal fornices and manipulate the uterus, this innovation simplifies and enhances critical anatomic identification and tissue mobilization in routine and complex minimally invasive gynecologic surgical interventions. This technology can become a cost-effective preferred means for surgeons striving to potentially improve patient outcomes and reduce procedure times. 
         [0013]    This novel technology consists of four primary components, which are further provided in a variety of sizes to accommodate variations in patient anatomy. An ergonomic hand-held cervical engagement device with a custom co-axial handle at its proximal end is connected by an atraumatic shaft incorporating a sliding flexible vaginal occluder to an angled cup to receive the cervix at its distal end. Passageways within this cervical engagement device provide for receipt of additional components and features. To effectively engage and pivot the body of the uterus within the pelvis, an angled shaft (or sound) is provided to pass through the cervical engagement device, through the cervical canal and into the cavity in the body of the uterus, where a rotational anchor can be deployed to secure the shaft to the uterus. Additional options provided with this technology include the provision of light at the distal cervical cup to transilluminate and better visualize tissues of the vaginal fornix area and an energized dissection means to help dissect the uterus from the vagina. 
         [0014]    A ridge on the handle of the cervical engagement device indicates the direction of the angled cervical cup and angled shaft of the sound. By simply rotating the handle, the cervical cup and angled sound rotate to pivot the uterus in the direction of the indicator ridge. When the indicator ridge is oriented up, the body of the uterus is pivoted up (i.e., ante flexed) to provide access for the posterior colpotomy (i.e., vaginal incision) dissection. When the ridge is down, the uterus is retroflexed to enable development of the bladder flap and anterior colpotomy; indicator ridge orientation to either side, enables ipsilateral uterine body pivoting for contra-lateral uterine blood vessel transillumination and dissection, along with colpotomy completion. When the indicator ridge orientation faces the patient&#39;s right side, the uterine body pivots towards the patient&#39;s right side, exposing the left side uterine arteries and veins (and potentially transilluminating them) and distracting these important blood vessels away from the left ureter. By creating further distance between these blood vessels and the adjacent ureter, this simple technique of rotating the coaxial handle to displace the uterus reduces the potential risk of ureteral injury during dissection. By rotating the indicator ridge to the opposite side, this same maneuver can expose the left uterine arteries, move them away from the left ureter and enable completion of the colpotomy. 
         [0015]    For uterine manipulation during, for example, laparoscopic hysterectomy surgery, the components of this technology will have to be provided sterile to the operative field. The cervical engagement devices can be constructed of mostly common surgical plastics with different sized distal cervical cups. For example, distal cervical cups having inside diameters of 30, 35, or 40 mm could accommodate the range of cervical sizes most commonly encountered in hysterectomy surgery. The unique angled sounds offered in this invention can be reusable implements with customized angled shafts constructed of cleanable and resterilizable surgical quality metal; the distal ends of these sounds should have shaft diameters of 5 mm or less to readily pass through the cervical canal and be offered different lengths (e.g., commonly from 6 to 7 to 8 cm) to span the various lengths of patient&#39;s uterine bodies. A reusable, resterilizable metal and fiber optic vaginal illumination device can be employed or the illumination components can be integrated within the cervical engagement device. Likewise, the energy based dissection component can be reusable or single-use and integrated within the cervical engagement device. 
         [0016]    In addition to a passageway for the angled sound, each cervical engagement device can also incorporate a passageway leading from its proximal end to a sealed transparent section in the distal cup. This passageway is parallel to the passageway for the angled sound and can be used to receive and secure a vaginal illumination device. This vaginal illuminator has a fan shaped, metal and fiber optic distal end, a shaft, and a proximal attachment feature. A standard threaded coupler is located at its proximal end to enable connection to a standard surgical light source. Light passes from the light source, through the light bundle, into the proximal end of the vaginal illuminator and out its distal end where it passes through the transparent section in the distal cervical cup. 
         [0017]    The vaginal illuminator is an option that can be used at the surgeon&#39;s discretion with this technology for the provision of transillumination light delivered through the distal cervical cup. Using light to transilluminate or pass through targeted tissues is a common practice in minimally invasive surgery. Vaginal illumination is commonly employed in many routine gynecologic diagnostic and therapeutic interventions. When using commercially available alternative uterine manipulation products, it is frequently difficult to localize the vaginal fornices during laparoscopic hysterectomy. During this critical dissection, many very skilled and experienced surgeons have described the sense of getting lost deep in this pelvic anatomy. In accordance with an aspect of this invention, transillumination via the fiber optic vaginal illuminator through the transparent seal of the distal cervical cup can make identifying the cervical cup edges and the targeted fornices much easier. This transillumination technique may allow the surgical team to identify internal tissue structures, such as blood vessels, that lie within solid tissue planes. With this lighting option, important internal tissue elements can be differentiated through direct video imaging. 
         [0018]    The resection or removal of the uterus requires the cervical region of the uterus to be dissected free or amputated from its attachments at the upper forniceal area of the vagina. This dissection is typically approached from one of two directions: “from below” or “from above.” If the surgeon stands down between the patient&#39;s legs and passes dissecting instruments from outside towards the inside up through the vagina, as in a vaginal hysterectomy, this dissection is considered to be “from below.” When dissecting is performed using the instruments placed “from above,” the instruments are oriented in the preferred direction from the inside of the peritoneal cavity towards the vagina, as in traditional open surgery or in total laparoscopic hysterectomy, the surgeon can stay at the patient&#39;s side adjacent to the abdomen. By providing this new technology that also provides an energized dissection function, this unique approach facilitates the benefits and convenience of providing the dissection coming in from below along with the safety and ergonomics of viewing the dissection from the above, laparoscopic perspective. Thus, this technology provides for direct dissection of the vaginal cuff up through the vagina, while simultaneously viewing and performing laparoscopic surgery from above. 
         [0019]    Extensive product development, including bench top and cadaver testing and related clinical evaluations, affirm the relative effectiveness, safety and durability of this new technology. The cervical engagement device with its angled sound along with the optional vaginal illuminator and integrated energized dissection features provide a compellingly improved alternative technology that has been favorably received by reviewing surgeons for enhanced uterine manipulation during minimally invasive gynecologic procedures. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0020]    While the novel aspects of the invention will be described with particularity in the appended claims, the invention itself together with further objects and advantages thereof may be more readily understood by reference to the following detailed description of the presently preferred embodiments of the invention taken in conjunction with the accompanying drawing in which: 
           [0021]      FIG. 1  is a perspective view of an instrument in accordance with an aspect of the invention as presented for use; 
           [0022]      FIG. 2  is an exploded perspective view of the instrument of  FIG. 1  illustrating the subsystems of the preferred embodiment; 
           [0023]      FIG. 2A  is a rear perspective view of the device subsystem of  FIG. 2   
           [0024]      FIG. 3  is an orthogonal cross sectional view along lines  3 - 3  of the instrument of  FIG. 1 ; 
           [0025]      FIG. 4  is an exploded perspective view of a device subsystem of the invention of  FIG. 1  illustrating the components and assembly of said subsystem; 
           [0026]      FIG. 5  is an overhead perspective view of a sound subsystem of the preferred embodiment of the instrument of  FIG. 1 ; 
           [0027]      FIG. 6  is an underside perspective view of the sound subsystem presented in  FIG. 5 ; 
           [0028]      FIG. 7  is an exploded perspective view of the sound subsystem presented in  FIG. 5  illustrating the components and assembly of said subsystem; 
           [0029]      FIG. 8  is an orthogonal cross sectional view along lines  8 - 8  of the sound subsystem presented in  FIG. 5  illustrating the components and operational characteristics of said subsystem; 
           [0030]      FIG. 9  is an orthogonal cross sectional view along lines  3 - 3  of the instrument presented in  FIG. 1  demonstrating the introduction of the sound subsystem first detailed in  FIG. 5  into the distal end of the device subsystem of  FIG. 4 ; 
           [0031]      FIG. 10  is again an orthogonal cross sectional view along lines  3 - 3  of the instrument presented in  FIG. 1  demonstrating the progression, first initiated in  FIG. 9 , of the sound subsystem into the device subsystem; 
           [0032]      FIG. 11  is yet again an orthogonal sectional view along lines  3 - 3  of the instrument presented in  FIG. 1  detailing the final stage of integration, advanced from  FIG. 10 , of the sound subsystem into the device subsystem; 
           [0033]      FIG. 12  is a perspective view of a light wand subsystem of the preferred embodiment of the instrument of  FIG. 1 ; 
           [0034]      FIG. 13  is an orthogonal cross sectional view taken along lines  13 - 13  of  FIG. 12  illustrating the components and assembly of said subsystem; 
           [0035]      FIG. 14  is an exploded perspective view of the light wand subsystem presented in  FIG. 12  illustrating the components and assembly of said subsystem; 
           [0036]      FIG. 15  is an orthogonal cross sectional view along lines  15 - 15  of the instrument presented in  FIG. 1  demonstrating the introduction of the light wand subsystem first detailed in  FIG. 12  into the proximal end of the device subsystem of  FIG. 4 ; 
           [0037]      FIG. 16  is again an orthogonal cross sectional view along lines  15 - 15  of the instrument presented in  FIG. 1  demonstrating the progression, first initiated in  FIG. 15 , of the light wand subsystem into the device subsystem; 
           [0038]      FIG. 17  is yet again an orthogonal sectional view along lines  15 - 15  of the invention presented in  FIG. 1  detailing the final stage of integration, advanced from  FIG. 16 , of the sound subsystem into the device subsystem; 
           [0039]      FIG. 18  is an orthogonal side view of the human anatomy taken along the midline, also known as a sagittal view, showing the sound subsystem of  FIG. 5 , as presented in its preferred method of intravaginal use, passing first through a cervix and into a uterus; 
           [0040]      FIG. 19  is an enlarged detail view of the proximal end of the sound subsystem shown in  FIG. 18  illustrating the operation of said subsystem in the preferred method of use; 
           [0041]      FIG. 20  is an enlarged detail view of the distal end of the sound subsystem shown in  FIG. 18  illustrating the operation of said subsystem in the preferred method of use; 
           [0042]      FIG. 21  is, again, an anatomical sagittal view illustrating the device subsystem of  FIG. 4  being manipulated and positioned onto the sound subsystem of  FIG. 5  and advanced into a vaginal canal; 
           [0043]      FIG. 22  is, again, an anatomical sagittal view showing the device and sound subsystems shown in  FIG. 21  fully integrated wherein an occluder is approaching the vaginal opening and the device subsystem is contacting vaginal fornices; 
           [0044]      FIG. 23  is an anatomical sagittal view showing the device of  FIG. 4  wherein the occluder is fully advanced into the vaginal canal; 
           [0045]      FIG. 23A  is an orthogonal section view of the human anatomy taken along the front, also known as an anterior or coronal view, illustrating the rotation of the device within the vaginal canal and the subsequent displacement of the uterus relative to the surrounding anatomy to distance the uterine artery from the ureter; 
           [0046]      FIG. 24  is an anatomical sagittal view illustrating the system of  FIG. 1  fully emplaced within the field of surgical use such that the light wand of  FIG. 12  is introduced proximally through the device of  FIG. 4  and introducing light through the vaginal fornices; 
           [0047]      FIG. 25  is an exploded perspective view of an additional embodiment of the instrument wherein a light pipe and cautery wand are integrated within said invention. 
           [0048]      FIG. 26  is an orthogonal cross sectional view along lines  26 - 26  of the embodiment presented in  FIG. 25  demonstrating the integration of the light pipe and cautery wand; and 
           [0049]      FIG. 27  is an anatomical sagittal view depicting an energized cautery wand of  FIG. 25 , presented in its preferred method of use, separating the uterus from the vagina as in a traditional colpotomy; 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0050]    While the invention has been described in connection with certain presently preferred embodiments thereof, those skilled in the art will recognize that many modifications and changes may be made without departing from the broad scope of the invention, which is intended to be defined solely by the appended claims. 
         [0051]    Referring to  FIG. 1 , a perspective view of a uterine manipulator  10  is shown, comprised of a sound  20  and a light wand  30  accepted within and housed by a device  40 . The sound  20  and light wand  30  are generally manufactured such that they are reusable and preferably comprised of rigid, sterilizable, and cleanable materials such as stainless steels and the like. The device  40  is typically disposable and generally comprised of sterilizable molded polymers. 
         [0052]    Evident in the device  40  are a proximally located textured handle  41  imparting a tactile surface for ease of physical manipulation of manipulator  10  and device  40 , an indicator ridge  42  to delineate manipulator  10  orientation within a surgical field, a centrally situated shaft or body  43  providing support to and visual indication of insertion depth for the manipulator  10 , a distally positioned occluder  50  to maintain intra-peritoneal gas pressure within the surgical field, and a distally sited cup  60  for cervical engagement. 
         [0053]      FIG. 2  shows an exploded perspective view of the uterine manipulator  10  with the sound  20  and light wand  30  removed from the device  40 . The sound  20  is received through the distal end of the device  40  while the light wand  30  is received through the proximal end of the device  40 . 
         [0054]    The sound  20  is inserted distally through a sound port  61 , which is a substantially linear passageway formed through the device body, such that a cervical stop  21  rests firmly against a stop ledge  62  provided in the cup  60 . When inserted fully into the sound port  61 , an anchor nut  22  protrudes from textured handle  41  as opposed wedge stops  23   a  engage with a latch  44 . 
         [0055]    The light wand  30  is insertable proximally into the device  40  through a wand port  45 , in the textured handle  41 , best shown in  FIG. 2A , until a winged snap  31  engages with receiving edges  46  of the wand port  45 . A wand fan  32  mates adjacent to a window  70  within the cup  60 . 
         [0056]      FIG. 2A  is a proximal view of the device  40  and highlights a latch port  49  through which the latch  44  and the sound  20  subsystem shown in  FIG. 2  protrude from the textured handle  41  and the wand port  45  through which the light wand  30  is introduced and engages with receiving edges  46 . 
         [0057]      FIG. 3  is an orthogonal section view taken along sectioned lines  3 - 3  of the uterine manipulator  10  of  FIG. 1  showing the positions of the assembled sound  20  and light wand  30  within the device  40 . In the illustrated orientation, the sound  20  is located vertically above the light wand  30 . The cervical stop  21  of the sound  20  is engaged with the stop ledge  62  in the cup  60  and the wand fan  32  is nested adjacent to the window  70  within the cup  60 . 
         [0058]    Shown in  FIG. 4  is an exploded perspective view of the device  40 . The device  40  is purposefully meant to be supplied as a sterile, one-time use product. A left handle  47  and a right handle  48  are assembled to capture tabs  44   a  of the latch  44  within left receptacles  47 A of the left handle  47  and symmetrically opposed right receptacles (not shown) of the right handle  48 . The left handle  47  and right handle  48  are typically made from an opaque medical grade plastic and produced from an injection molding process and assembled and retained via a mechanical force fit, ultrasonic welding process, or adhesives. The latch  44  is preferably made from a formed stainless steel sheet, but can be made from a resilient medical grade polymer. 
         [0059]    The occluder  50  is slid over the shaft  43  such that a bore  51  of the occluder  50  engages with ridges  43   a  of the device  40  and creates an airtight seal around the shaft  43 . In an embodiment, the occluder  50  can be slid back and forth and positioned along the shaft  43  as dictated by the surgical procedure. The occluder  50  is made of a transparent or translucent molded flexible polymer such as medical-grade silicone. 
         [0060]    The window  70  is disposed in the cup  60  such that a front face  71  of the window  70  is flush with a distal face  63  of the cup  60 . The joint between the cup  60  and window  70  is preferably hermetic to prevent the introduction of bodily fluids in proximity to the heat intense areas of a wand fan  32  of the light wand  30 , and can be accomplished via mechanical press fits, gasketing, or adhesive fillers. The window  70  is produced via injection molding processes and is made of a heat resistant transparent material such as polyetherimide (commercially available from GE Plastics under the trade name Ultem®) or from other high performance transparent acrylics. The cup  60  is similarly made from an injection molded, but opaque heat resistant plastic such as Ultem®. The device  40  can be manufactured and offered with a variety of cups  60  to accommodate a variety of cervical sizes. For convenience in identification, the respective cups  60  may be marked with the appropriate nomenclature via a marking  65  provided on the cup  60 . 
         [0061]    The assembled cup  60  with window  70  are inserted over a head  43   b  of the body  43  such that the window  70  is positioned coplanar with, but opposite from, the indicator ridge  42  of the device  40 . The cup  60  is preferably fixedly and permanently attached to the shaft  43  during a surgical procedure, for example, via a mechanical force fit or with the aid of adhesives. 
         [0062]    Referring to  FIGS. 5 through 8 , the sound  20 , a subsystem of the uterine manipulator  10 , is detailed. The sound  20 , as described, is preferably meant to be supplied as a sterile, cleanable, and reusable product that is used to probe and couple to the uterine structures. Additional operational characteristics of the sound  20  are explained below. 
         [0063]      FIG. 5  is an overhead perspective view of the sound  20  initially detailed in  FIG. 2 . The sound  20  is centrally comprised of a substantially cylindrical keyed shaft  24 , which distally supports an angled shaft  25  and a rotational anchor  26 . A guide shaft  23 , and anchor nut  22 , and a cap  28  are disposed proximally on the sound  20 . It should be noted that due to variations in the human anatomy, different sizes of devices may be required from one surgical case to the next. The sound  20  can be manufactured and offered with a variety of angled shafts  25  to accommodate the array of anatomical differences. For convenience in identification, the respective angled shafts  25  may be marked with the appropriate nomenclature via a marking  21 A provided on the cervical stop  21 . Additionally, to aid in orientation of the insertion of the sound  20  into device  40  and provide for verification of the orientation of the rotational anchor  26 , a marking  23 N may be applied to the guide shaft  23 . 
         [0064]    A clockwise rotation  22 C of the anchor nut  22 , as viewed from the anchor nut  22  end of the sound  20 , will cause a drive screw  29  and attached drive wire  27 , more readily viewed in  FIG. 6 , to retract and induce a pulling force on an anchor barrel  80  housed within rotational anchor  26 . This pulling will cause the rotational anchor  26  to follow rotation direction  26 C, pivoting about a pivot point, and move perpendicular to the angled shaft  25 . Conversely rotating the anchor nut  22  in the opposite direction will impart a pushing force on the anchor barrel  80 , causing the rotational anchor  26  to return to its original position aligned with the angled shaft  25 . 
         [0065]      FIG. 6  is an underside perspective view of the sound  20  of  FIG. 5 . From this perspective, proximally, the drive screw  29  is shown. As described above, the drive screw  29  is engaged with the anchor nut  22  to push or pull the drive wire  27  which engages with and directs the rotational anchor  26 . The drive wire  27  emanating from the drive screw  29  is delivered through the guide shaft  23  via a wire channel  23 B, retained by retaining tabs  23 C and allowed cleaning access via cleaning troughs  23 D. The wire  27  also passes through the keyed shaft  24  via a wire channel  24 A, where it is retained by retaining tabs  24 B and allowed cleaning access via cleaning troughs  24   c . Lastly, the wire also passes through the angled shaft  25  via a wire channel  25 A, where it is retained by retaining tabs  25 B and allowed cleaning access via cleaning troughs  25 C. At the distal end of the wire channel  25 A, the wire  27  connects to the rotational anchor  26 . Again, a clockwise rotation  22 C of the anchor nut  22 , as viewed from the anchor nut  22  end of the sound  20 , will cause the drive screw  29  and its attached drive wire  27  to retract in pull direction  27 A and induce a pulling force on the anchor barrel  80  housed within rotational anchor  26  and cause the rotational anchor  26  to follow rotation direction  26   c  and move perpendicular to the angled shaft  25 . Conversely rotating the anchor nut  22  in the opposite direction will return the rotational anchor  26  to its original position parallel to the angled shaft  25 . Of course, using a reverse threaded anchor nut  22  could provide for opposite actuation between the perpendicular and aligned positions. 
         [0066]      FIG. 7  is an exploded perspective view of the sound  20  of  FIG. 5  wherein the components and assembly order are detailed. The keyed shaft  24  preferably is manufactured from a rigid sterilizable material, such as stainless steel, and is connected to the angled shaft  25  via a distal boss  24 D which is inserted into a receptacle housing  25 D. The angled shaft  25  preferably is also of a non-corrosive, biocompatible material similar to the keyed shaft  24 . The assembled keyed shaft  24  and angled shaft  25  are further assembled to the guide shaft  23  wherein a proximal boss  24 E is retained in a receiving bore  23 E. The guide shaft  23  is also favorably selected from similar non-corrosive, biocompatible material. In a preferred embodiment, the keyed shaft  24 , angled shaft  25 , and the guide shaft  23  are permanently joined to form a unitary boss, e.g., via a welding or brazing process, although they may be coupled via other means. 
         [0067]    The drive wire  27  is a common non-corrosive, biocompatible material such as stainless steel wire and is inserted into a wire bore  29   a  of the drive screw  29  and permanently attached via welding or brazing. The drive screw is typically made from a commercial stainless steel with a common industrial thread  29   b.    
         [0068]    The assembled drive wire  27  and drive screw  29  are delivered through the previously assembled guide shaft  23 , keyed shaft  24 , angled shaft  25  by communicating the drive wire  27  through the wire channel  23 B, wire channel  24 A, and wire channel  25 A, correspondingly, such that a guide surface  29 C of the drive screw  29  is in contact with a drive channel  23 F, more effectively conveyed in  FIG. 8 , of the guide shaft  23 . The anchor nut  22 , which also can be made from a commercial, non-corrosive, biocompatible material such as stainless steel, contains an internal thread  22 A that mates with thread  29 B of drive screw  29  and external knurling  22 B to aid in digital manipulation in typical wet, slippery surgical cases. The anchor nut  22  is threaded onto the drive screw  29 , over a retaining shaft  23 G of the guide shaft  23  and secured with the cap  28  by inserting a cap pin  90  through a pin bore  28 A in the cap  28  and through a subsequent pin bore  23 H in the proximal end of the retaining shaft  23 G of the guide shaft  23 . The cap  28  and cap pin  90  may be of a commercial, non-corrosive, biocompatible material such as stainless steel. 
         [0069]    The free end of the drive wire  27  is passed through a wire hole  81  in the anchor barrel  80  and secured flush via welding or brazing. The anchor barrel  80 , which can be made from stainless steel and is in all aspects similar to a common dowel pin, protrudes from the angled shaft  25  in proximity to a link receptacle  25 E. The anchor barrel  80  is guided into a barrel bore  26 A of rotational anchor  26  such that the anchor barrel  80  rests central to the rotational anchor  26 . 
         [0070]    A dowel pin  100  is pressed into and through a dowel bore  25 F of the angled shaft and through a shaft bore  111  of an anchor link  110  waiting in the link receptacle  25 E of the angled shaft  25 . The anchor link  110  is typically fabricated from a rigid material such as stainless steel and provides a means to allow the rotational anchor  26  to pivot while remaining attached to the angled shaft  25 . A link bore  26   b  of the rotational anchor  26  is positioned concentric to an anchor bore  112  of the anchor link  110  and a dowel pin  100  is pressed through to retain the rotational anchor  26  while still allowing rotation. 
         [0071]      FIG. 8  is an orthogonal cross sectional view of the sound  20  taken along lines  8 - 8  of  FIG. 5  further illustrating the sound  20 . As described above, the rotational anchor  26  is held by both the anchor barrel  80 , which is fixedly attached to the drive wire  27 , and the anchor link  110 , which is secured by the dowel pin  100 , relative to the angled shaft  25 . The anchor link  110  is secured to the angled shaft by the dowel pin  100 . The angled shaft  25  is oriented and secured to the keyed shaft  24  which is subsequently oriented and secured to the guide shaft  23 , which houses the drive screw  29  in the drive channel  23 F. The thread  29 B of the drive screw  29  mates with the internal thread  22 A of the anchor nut  22  and is secured to the retaining shaft  23 G of the guide shaft  23  via the cap pin  90  which is pressed through the cap  28  and subsequently through the guide shaft  23 . The drive wire  27  is fed through the angled shaft  25 , the keyed shaft  24 , and the guide shaft  23  and securely fastened within the wire bore  29 A of the drive screw  29 . Again, as arranged in the Figures, clockwise rotation  22 C of the anchor nut  22 , as viewed from the anchor nut  22  end of the sound  20 , will cause the drive screw  29  and its attached drive wire  27  to retract in pull direction  27 A and induce a pulling force on the anchor barrel  80  housed within rotational anchor  26  to cause the rotational anchor  26  to follow rotation direction  26 C and move perpendicular to the angled shaft  25 . Conversely rotating the anchor nut  22  in the opposite direction will return the rotational anchor  26  to its original position aligned with the angled shaft  25 . 
         [0072]    In reference to  FIGS. 9 through 11 , the steps of engaging the sound  20  within the device  40  are detailed. The sound  20  distally enters the device  40  through the cup  60 , transits the shaft  43  via a passageway in the shaft, engaging the latch  44 , and exits the textured handle  41 . 
         [0073]      FIG. 9  shows the sound  20  as it enters the device  40  through the sound port  61  of the cup  60 . The keyed shaft  24  is housed within the shaft  43  and the anchor nut  22  protrudes from the textured handle  41  via the latch port  49 . 
         [0074]      FIG. 10  illustrates the insertion progression of the sound  20  through the device  40  wherein the sound is advanced in direction  120  such that the activation wedge  23 J of the guide shaft  23  engages the ramp  44 B forcing the latch  44  to flex in direction  44 C providing physical resistance and subsequent tactile feedback of sound  20  engagement with the latch  44  of device  40 . 
         [0075]      FIG. 11  illustrates the next sequence of advancing the sound  20  through the device  40 . Therein the sound  20  has further advanced through the device  40  in direction  120  such that, distally, the cervical stop  21  of the sound  20  rests firmly against stop ledge  62  in the cup  60 , and proximally, the activation wedge  23 J of the guide shaft  23  has cleared the ramp  44 B of the latch  44 . The latch  44  returns to its normal position through direction  44 D and latch catch  23 K rests within latch recess  44 E such that a shaft stop  23 M interfaces with a sound stop  44 F, physically locking the sound  20  within the device  40 . In this position, inadvertent decoupling of the subsystems while in use is prevented. Removal of the sound  20  from the device  40  is accomplished by simply lifting the latch  44  to disengage the latch  44  by allowing the latch recess  44 E to clear the latch catch  23 K so that sound  20  may be extracted from the distal end of device  40 . 
         [0076]    The light wand  30  subsystem is detailed in  FIGS. 12 through 14 . Generally, the light wand  30  is used to transilluminate the vaginal fornices during dissection to help visualize the internal structure of the area being dissected. Vascular structures are highlighted with the use of the light wand  30  and can help the surgeon choose satisfactory areas to perform the dissection to reduce bleeding. In one embodiment, the light wand  30  is intended to be a rigid, cleanable, and reusable component that is selectively received in and removed from the device  40 . It preferably is made from robust sterilizable materials like medical grade stainless steels. In other embodiments, the light wand  30  may be fixed in the device  40 . 
         [0077]      FIG. 12  is a perspective view of the light wand  30  detailing the components used in the assembly of said subsystem. Distally oriented to the subsystem is the wand fan  32 , comprised of an upper half  32 A and a lower half  32 B, which are coupled to the fan coupler  33 . When, as in the illustrated embodiment, the light wand is selectively received in and removable from the device, the fan coupler  33  or any other component of the light wand  30  may be permanently inscribed with a marking  33 A to provide the surgeon a visual cue to aid in the insertion of the light wand  30  into the device  40 . A wand shaft  34  is connected to the fan coupler  33 , and a winged snap  31  is attached over the wand shaft  34  in a majoritively proximal location. An input adapter  35  is attached proximally to the wand shaft and is used to provide a mating thread for attachment to many commercially available fiber optic light sources such as a Karl Storz Xenon 300 manufactured by Karl Storz GmbH &amp; Co. KG, Tuttlingen, Germany. 
         [0078]      FIG. 13  is an orthogonal section view taken along lines  13 - 13  of  FIG. 12  further indicating the component structure of the light wand  30 . As illustrated, an optical bundle  36  is centrally housed within the wand shaft  34 . The proximal end of the bundle mates flush with an input face  35 A of the input adapter  35 . The bundle funnels through the fan coupler  33  and the distal end is flush with an exit face  32 C of the wand fan  32 . 
         [0079]      FIG. 14  is an exploded perspective view of the light wand  30  that illustrates the components and assembly of said subsystem. Distally oriented to the subsystem is the wand fan  32 , comprised of the upper half  32 A and the lower half  32 B, which are coupled to the fan coupler  33  for example, via a welding, brazing, or adhesive process. The upper half  32 A and lower half  32 B of wand fan  32  and the fan coupler are typically manufactured from a rigid biocompatible material such as stainless steel or the like. The fan coupler  33  is fixedly joined to a similarly biocompatible wand shaft  34 , preferably by a welding, brazing or adhesive process. Proximally, a winged snap  31  is fixed to the wand shaft  34 , preferably by a welding, brazing or adhesive process. The input adapter  35 , preferably made from stainless steel, is fixed to the proximal end of the wand shaft  34  and completes the external structure of the light wand  30  subsystem. 
         [0080]    The optical bundle  36  is packed within the wand shaft  34 , and made flush with the input face  35 A of the input adapter  35  and the exit face  32 C of the wand fan  32 . The optical bundle  36  is most typically comprised of a group of tightly packed optical fibers that are polished at each end to maintain optical efficiency and prevent light loss. The optical bundle  36  may be secured within the light wand  30  using optical adhesives. 
         [0081]      FIGS. 15 through 17  are orthogonal section views taken along lines  15 - 15  of  FIG. 1  and are useful to detail the introduction of the light wand  30  subsystem into the device  40  subsystem. For clarity, the sound  20  subsystem is not shown. The light wand  30  is intended to pass through the device  40  and rest in proximity to the window  70  of the cup  60  such that optical efficiency is maintained and light loss is avoided as light emitted from the exit face  32 C passes through the window. 
         [0082]    In  FIG. 15 , the light wand  30  has been introduced wand fan  32 -first into the wand port  45 , which is a passageway extending through the device  40 , along direction  37  shown in  FIG. 16 , such that the wand fan  32  is disposed in the fan cavity  64  of the cup  60 . 
         [0083]    In a successive step illustrated in  FIG. 16 , the light wand  30  progresses further into the device  40  via direction  37  until the winged snap  31  interfaces with the receiving edges  46  of the wand port  45 . By forcing the light wand  30  into the wand port  45 , or by depressing finger grooves  31 A, spring arms  31 B compress in direction  31 C allowing ramp tips  31 D to engage with the receiving edges  46  and further compress the spring arms  31 B to allow the winged snap  31  access into the wand port  45 . 
         [0084]      FIG. 17  shows that continued insertion of the light wand  30  into the device  40  causes the wand fan  32  to stop against the window  70  such that the exit face  32 C of the wand fan  32  is adjacent to, and preferably in intimate contact with, a rear face  72  of the window  70 . The exit face  32 C&#39;s contact with, or adjacency to, the rear face  72  ensures maximum light transmissivity and minimizes optical losses. Also in this position, the ramp tips  31 D clear the receiving edges  46  of the wand port  45  allowing the spring arms  31 B to return to their normal position through direction  31 E and subsequently capturing the winged snap  31  within the wand port  45  by the nesting of receiving troughs  31 F inside the receiving edges  46  of the wand port  45 . The light wand  30  is retained in the device  40  until the spring arms  31 B are compressed to unlatch the receiving troughs  31 F from the receiving edges  46 . 
         [0085]      FIGS. 18 through 24  employ a variety of orthogonal anatomical views, also known as sagittal views, and enlarged detail views, to highlight the preferred use of the uterine manipulation system  10  in a surgical field. The uterine manipulation device  10  is used to provide support for, retention of, and dissection assistance with processes associated with hysterectomies. 
         [0086]      FIG. 18  is an orthogonal, midline anatomical view, also known as a sagittal view, showing a retractor  160  maintaining an opening and line of sight into a vaginal canal  130 . As illustrated, the sound  20  is inserted through the vaginal canal  130  such that the cervical stop  21  rests against an external cervical os  140  and the angled shaft  25  enters the uterus  150 . The sound  20  is used to probe the cervix and retain the uterus  150  for removal after a uterine dissection. The rotational anchor  26  described above is actuated to its perpendicular position to serve these purposes. Although the invention utilizes the novel rotational anchor  26  illustrated and described previously, other anchors could be used. Any selectively actuatable device that can be readily inserted into the uterus and then expanded, including a conventional device, may be used. 
         [0087]      FIG. 19  is an enlarged detail view of the proximal end of  FIG. 18  showing the method of engagement of the sound  20 . Specifically, the anchor nut  22  is moved in a clockwise rotation  22 C, as viewed from proximal end, while the orientation of the sound  20  is maintained in relation to the anatomy. The result of this rotation is shown in  FIG. 20 . More specifically,  FIG. 20  shows that the rotational anchor  26  is moved in the rotation direction  26 C such that the rotational anchor  26  is deployed and anchor fingers  26 D engage the endometrial lining  151  of the uterus  150 . The anchor nut  22  activated in  FIG. 19  deploys the rotational anchor  26  such that it is, for the most part, perpendicular to the angled shaft  25 . In this perpendicular position, the rotational anchor  26  with the anchor fingers  26 D, the uterus is held securely and readily extracted when desired. Likewise, rotating the anchor nut  22  in a counterclockwise direction will return the rotational anchor  26  to its original position parallel to the angled shaft  25  and allow for the ready release of the extricated uterine tissue. 
         [0088]      FIG. 21  shows the sound  20  in position such that the actuated rotational anchor  26  is nested in the uterus  150 . Also in this Figure, the device  40  is introduced into the vaginal canal along direction  131  with the sound disposed in the sound port. The retractor  160  may be used as a guide to aid in insertion of the device  40 . 
         [0089]      FIG. 22  is a sagittal view depicting the device  40  further inserted into the vaginal canal  130  until the cup  60  meets and envelops the cervix  170 , resting in the vaginal fornix  132 . 
         [0090]      FIG. 23  is yet another sagittal view showing the device  40  fully connected with the sound  20 . Also in this Figure, the occluder  50  is advanced into the vaginal canal  130  in direction  52  so as to seal the vaginal canal  130  to maintain intra-peritoneum pressure. 
         [0091]      FIG. 23A  is a frontal anatomical section, or a coronal view, illustrating the rotation of the device  40  along direction  121 , i.e., about the longitudinal axis of the device  40 , within the vaginal canal  130 . Because the cup  60  contacting the cervix  170  is angled relative to the longitudinal axis of the device, such rotation imparts a right lateral displacement  153  of the uterus  150  (from the patient&#39;s perspective) creating a margin of safety between a left ureter  220 , and a left uterine artery  152  in preparation for a left lateral colpotomy. Rotating device  40  in the opposite direction would consequently provide for a left lateral displacement of the uterus  150  (from the patient&#39;s perspective) a right lateral colpotomy. 
         [0092]      FIG. 24  is a sagittal view wherein the device  40  has been rotated substantially 180-degrees in direction  121 , i.e., about the longitudinal axis of the device  40 , to reposition the uterus  150  in retroflexion. In this position, additional surfaces of the uterus are readily accessible to a surgeon. As should be appreciated from  FIGS. 23A and 24 , the uterine manipulator  10  of the present invention allows for repositioning of the uterus  150  in any desirable position through rotation about a single axis, which is the longitudinal axis of the device. During rotation, a positive pressure is maintained between the cup  160  and the uterus  150 , but the cup  60  will rotate relative to the uterus  150 . The sound  20  also will rotate relative to the uterus  150 , as it is fixed relative to the cup  60 . The rotational anchor  26  preferably has smooth surfaces, to facilitate this relative movement and prevent injury within the uterus  150 . 
         [0093]      FIG. 24  also illustrates the incorporation of the light wand  30  into the device  40 . Light  180  is passed through the system via the light wand  30  to illuminate the vaginal fornix  132  through the abdominal cavity  190  to aid in the colpotomy. 
         [0094]      FIG. 25  is an exploded perspective view of an embodiment incorporating an integrated light pipe  200 , similar to the light wand  30 , and cautery wand  210 . The light pipe  200  is permanently captured between the assembled left handle  47  and right handle  48  such that the proximal face  201  is flush with the entry port  203  of the adapter halves  204 , that when assembled serve as the connection point for most commercial light sources. The light pipe  200  proceeds through the shaft  43  and cup  60  until the distal face  202  is flush with and sealed tightly within a light port  205  of the cup  60 . The light pipe  200  is typically molded from optically clear polymers such as medical grade polymethyl methacrylate (PMMA) acrylic whose end faces are highly polished to provide for maximum light transmissivity. In other embodiments, a powered light source may be provided to emit light proximate the cup  60 . For example, a Light Emitting Diode could be provided in the cup  60  or a battery-operated light source could be provided, with batteries disposed in the device  40 . 
         [0095]    The cautery wand  210  is similar to the likes of commercially available wands such as the E1551G Blade Electrode from ValleyLab of Boulder, Colo., and is simply inserted through a wand port  211 , traverses the shaft  43  and exits an electrode port  212  in the cup  60 . Any known cautery may be used. 
         [0096]      FIG. 26  is an assembled orthogonal section view taken along lines  26 - 26  of  FIG. 25  illustrating the integration of the light pipe  200  within the textured handle  41  of the device  40  where the light pipe  200  is fixedly located coplanar and adjacent to the sound  20  such that the proximal face  201  is flush with the entry port  203  and, similarly, the distal face  202  is flush with the light port  205 . Situated immediately below the light pipe  200  is the cautery wand  210  that is readily inserted through the wand port  211 , traverses a wand channel  215 , and exits the electrode port  212  through the cup  60 . The cautery wand is movable in the wand channel  215 , allowing linear motion in direction  216 , thereby making a cautery tip  213  protuberate only at the surgeon&#39;s discretion or when surgical conditions dictate. 
         [0097]      FIG. 27  is a sagittal view in which the cautery wand  210  is installed in the device  40  such that a wand tip  213  exits the cup  60 . With the wand tip  213  energized, an incision  214  is made between the uterus  150  and vagina  133  while the rotational anchor  26  of sound  20  retains the uterus  150  in relation to the cup  60  of device  40 . 
         [0098]    Those of ordinary skill in the art will understand that modifications can be made to the foregoing embodiments. For example, although the sound, light wand and cautery wand are provided as items that are selectively inserted and removed from the device, any or all of them may be fixed as integral parts of the device. Moreover, the device may have additional passageways formed therethrough. For example, the device may include a cannula passageway adapted for receiving conventional surgical ports or other instruments. 
         [0099]    The foregoing embodiments of the present invention are provided as exemplary embodiments and are presently best modes for carrying out the invention. Modifications of these embodiments will be readily apparent to those of ordinary skill in the art. The invention is not intended to be limited by the foregoing embodiments, but instead is intended to be limited only by the appended claims.