WO2011140604A1

WO2011140604A1 - A uterine manipulator

Info

Publication number: WO2011140604A1
Application number: PCT/AU2011/000556
Authority: WO
Inventors: Alan Lam
Original assignee: Alan Lam
Priority date: 2010-05-14
Filing date: 2011-05-16
Publication date: 2011-11-17

Abstract

The present disclosure relates to a uterine manipulator which comprises a handle portion, an arm portion, having a proximal end connected to the handle portion and a distal end, and a body portion connected to the distal end of the arm portion. The body portion comprises at a distal end, a hollow uterine tip adapted to be inserted into a patient's uterine cavity via the cervix in use, and at a proximal end, a fitting connector. The body portion further comprises an internal passage providing fluid communication between the fitting connector and the hollow uterine tip. The present disclosure also relates to a vaginal cup for delineation of a patient's cervico-vaginal junction. The vaginal cup is adapted for removable attachment to the body portion of the uterine manipulator, and is of a geometry to prevent loss of pneumoperitoneum following colpotomy. The vaginal cup has a wall defining an opening, a base end and an outer end, where the opening is at the outer end, which is closest to the hollow uterine tip when the vaginal cup is attached to the body portion.

Description

A UTERINE MANIPULATOR

Field of the Invention

The present invention relates to uterine manipulators.

The invention has been developed primarily for use in gynaecological diagnostic and surgical procedures and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use.

Background of the Invention

A uterine manipulator is a surgical instrument used to manipulate the uterus into a desired position in relation to the adjacent organs (such as the ovaries, the bladder, the rectum) during laparoscopic surgery.

In diagnostic laparoscopy, a uterine manipulator is used to help the surgeon visualise the pelvic organs. It may also be used for instillation of saline or dye into the uterine cavity for assessment of tubal patency.

In laparoscopic surgery for removal of uterine fibroids, ovarian cysts, endometriosis, or the uterus (laparoscopic hysterectomy), a uterine manipulator is used to move the uterus forwards (anteversion), backwards (retroversion), or sideways (lateral movement) in order to help the surgeon see the desired target tissue and to reduce the risk of injury to adjacent organs.

Hysterectomy procedures generally involve one of three approaches: (1) vaginal hysterectomy ("VH") (removal of the uterus through the vaginal cavity); (2) abdominal hysterectomy ("TAH") (removal of the uterus through an abdominal incision); (3) laparoscopic hysterectomy. Traditionally, the ratio of abdominal to vaginal hysterectomy is 3 to 1. As vaginal and laparoscopic hysterectomy have been shown to result in less postoperative pain, shorter hospitalization stay and quicker recovery time than abdominal hysterectomy, there has been a trend towards replacing abdominal hysterectomy with the laparoscopic route. Laparoscopic hysterectomy may be classified into 3 types: (1) laparoscopic assisted vaginal hysterectomy (LAVH), (2) laparoscopic sub-total hysterectomy (LSH), (3) laparoscopic total hysterectomy (LTH).

In laparoscopic hysterectomy, surgeons generally use some kind of instrument to help delineate the junction between the cervix and the vagina and to prevent the loss of pneumoperitoneum during the incision into the vagina (colpotomy). This instrument may be separate from the uterine manipulator, or may be part of the uterine manipulator.

The present invention seeks to provide a uterine manipulator which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, or to at least provide an alternative.

It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country. Summary of the Invention

According to a first aspect of the present invention, a uterine manipulator is provided, comprising: a handle portion; an arm portion, having a proximal end connected to the handle portion and a distal end; a body portion connected to the distal end of the arm portion, the body portion comprising at a distal end, a hollow uterine tip adapted to be inserted into a patient's uterine cavity via the cervix in use, and at a proximal end, a fitting connector, the body portion further comprising an internal passage providing fluid communication between the fitting connector and the hollow uterine tip; and a vaginal cup for delineation of the patient's cervico -vaginal junction, the vaginal cup being adapted for removable attachment to the body portion and having a wall defining an opening, a base end and an outer end, the opening being at the outer end, the outer end being closest to the hollow uterine tip when the vaginal cup is attached to the body portion, wherein the vaginal cup is of a geometry to prevent loss of pneumoperitoneum following colpotomy.

Advantageously, in use, the geometry of the vaginal cup allows it to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy.

Advantageously, vaginal cups having different geometries can be removably attached to the uterine manipulator to conform to the cervix, thereby accommodating variations in patient uterine anatomy.

Advantageously, the vaginal cup is removably attached to the body portion such that once surgery has been completed the vaginal cup can be either sterilized for further use or disposed of.

Advantageously, the internal passage allows an irrigation fluid, for example, saline solution for irrigation purposes such as hydrotubation, or a dye liquid for diagnostic purposes such as tubal patency tests (chromotubation), to be communicated between the fitting connector and the hollow uterine tip.

Advantageously, the vaginal cup may be removed when the uterine manipulator is used for purposes where the vaginal cup is not required, for example, during tubal patency tests (chromotubation).

Preferably, the vaginal cup is of a generally frusto-conical geometry, wherein the diameter of the base end is greater than the diameter of the outer end.

Advantageously, the generally frusto-conical geometry of the vaginal cup complements the patient's cervical and vaginal anatomy and facilitates facile introduction of the vaginal cup into the vagina. Insertion is further eased when, for example, the wall of the vaginal cup has a substantially low coefficient of friction. Advantageously, the generally frusto-conical geometry of the vaginal cup complements the patient's cervical and vaginal anatomy and allows the wall of the vaginal cup to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end of the vaginal cup being greater than the diameter of the outer end ensures a good seal with the walls of the vagina in some patients. Preferably, the vaginal cup is of a generally cylindrical geometry, wherein the diameter of the base end is similar to the diameter of the outer end.

Advantageously, the generally cylindrical geometry of the vaginal cup complements the patient's cervical and vaginal anatomy and facilitates facile introduction of the vaginal cup into the vagina. Insertion is further eased when, for example, the wall of the vaginal cup has a substantially low coefficient of friction.

Advantageously, the generally cylindrical geometry of the vaginal cup complements the patient's cervical and vaginal anatomy and allows the wall of the vaginal cup to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end of the vaginal cup being similar to the diameter of the outer end ensures a good seal with the walls of the vagina in some patients.

Preferably, the vaginal cup comprises a guiding edge disposed adjacent to the opening for delineating the patient's cervico -vaginal junction in use.

Advantageously, in use, the guiding edge outlines the cervico-vaginal junction for precise incisions into the vaginal fornices.

Preferably, the vaginal cup further comprises two generally opposed cut-out sections disposed at the outer end such that the guiding edge comprises two generally opposed guiding edge lips adapted to delineate only the patient's anterior and posterior fornices of the cervico-vaginal junction.

Advantageously, when the vaginal cup is pressed against the patient's cervix, in use, only the anterior and posterior vaginal fornices will be visibly delineated by the guiding edge. As such, a surgeon will know precisely where to make the initial incisions into the anterior and posterior vaginal fornices such that the lateral vaginal fornices may be avoided. The aim of the two generally opposed cut-out sections is to shield the ascending branches of the uterine vessels and the ureters from being inadvertently drawn into the surgical field. Once the anterior and/or posterior colpotomy incision have been made, the surgeon may then cut the lateral vaginal fornices using the opening of the vaginal cup as a template to define the path the surgeon needs to follow with the cutting instrument, for example, using an electrical hook, a coagulating shear or a pair of scissors. Advantageously, in use, the vaginal cup is adapted to fit over the patient's cervix and provide a means to displace the cervix from the ureters laterally, the urinary bladder anteriorly, and the rectum posteriorly, thereby defining the colpotomy incision required for surgically removing the cervix and uterus. Preferably, the two generally opposed cut-out sections are substantially U-shaped.

Preferably, the body portion has a longitudinal axis and an external thread and the vaginal cup has a complementary internal thread adapted to meshingly receive the external thread of the body portion such that, in use, the vaginal cup can be accurately adjusted to a longitudinal position relative to the body portion that complements the patient's uterine anatomy.

Advantageously, the longitudinal position of the vaginal cup relative to the body portion can be adjusted according to the patient's uterine anatomy, thereby accommodating variations patient uterine anatomy.

Preferably, the body portion further comprises a lock adapted to releasably secure the vaginal cup at the longitudinal position.

Advantageously, the lock allows the longitudinal position of the vaginal cup relative to the body portion to be adjusted to suit the patient's uterine anatomy and then secured in place, thereby preventing the vaginal cup from moving or detaching from the uterine manipulator in use, such as during surgery.

Preferably, the lock comprises an internal thread that is complementary to and adapted to meshingly receive the external thread of the body portion.

Advantageously, the longitudinal position of the lock can be accurately adjusted relative to the body portion.

Preferably, the lock is shaped to enable a tight cervical seal to be formed against a patient's cervix, in use, when the uterine manipulator is used without the vaginal cup.

Advantageously, the lock is, for example, cone-shaped, such that the lock may further function, for example, during tubal patency tests (chromotubation), as a seal when the lock is applied against a patient's cervix to provide the tight cervical seal to prevent the egress of dye liquid from the cervix. Preferably, the arm portion of the uterine manipulator is shaped such that the handle portion is offset from the longitudinal axis of the body portion.

Advantageously, the shape of the arm portion of the uterine manipulator allows the surgeon to achieve facile insertion of the uterine manipulator into the vagina for both retro verted and ante verted uteri.

Advantageously, the shape of the arm portion also enables the surgeon to move the patient's uterus more easily in the anterior, posterior and lateral planes.

Preferably, the fitting connector is adapted for removably attaching a fluid connector.

Preferably, the fluid connector is a hose barb for releasably engaging a fluid supply tube.

Advantageously, the hose barb allows a fluid supply tube carrying a fluid, such as an irrigation fluid, to be tightly fitted to the fitting connector to prevent the fluid supply tube from detaching in use.

Preferably the vaginal cup is of a colour that distinguishes it from blood or body tissue.

Advantageously, a vaginal cup coloured blue, for example, will be visually distinguishable from blood or tissue during, for example, laparoscopic surgery, thereby aiding the surgeon in distinguishing the vaginal cup from the surrounding tissue or blood.

Preferably, the handle portion further comprises a lug adapted for removably attaching the uterine manipulator to an adjustable arm.

Advantageously, the attachment of the uterine manipulator via the lug to the adjustable arm allows the uterine manipulator to be used by the surgeon unaided. For example, the adjustable arm, which is also desirably attached to, for example, an external support, may be moved or angled to allow the uterine manipulator to be moved to a plurality of desired positions.

Preferably, the hollow uterine tip is removable from the body portion.

Advantageously, the hollow uterine tip may be removably attached to the body portion of the uterine manipulator such that the hollow uterine tip and the uterine manipulator can be subjected to separate treatments, (e.g. sterilization) or can be disposed of separately.

Advantageously, hollow uterine tips having different geometries can be removably attached to the uterine manipulator, thereby accommodating variations in patient uterine anatomy.

According to a second aspect of the present invention, a vaginal cup for delineation of a patient's cervico -vaginal junction is provided, the vaginal cup being adapted for removable attachment to a uterine manipulator, comprising: a wall defining an opening, a base end and an outer end, the opening being at the outer end, the outer end being closest to the cervico-vaginal junction in use, wherein the vaginal cup is of a geometry to prevent loss of pneumoperitoneum following colpotomy.

Advantageously, vaginal cups having different geometries can be removably attached to the uterine manipulator to conform to the patient's cervix, thereby accommodating variations in patient uterine anatomy.

Advantageously, the vaginal cup can be removed from the uterine manipulator after surgery and either sterilized for further use or disposed of.

Advantageously, the generally frusto-conical geometry of the vaginal cup complements the patient's cervical and vaginal anatomy and facilitates facile introduction of the vaginal cup into the vagina. Insertion is further eased when, for example, the wall of the vaginal cup has a substantially low coefficient of friction.

Advantageously, the generally frusto-conical geometry of the vaginal cup complements the patient's cervical and vaginal anatomy and allows the wall of the vaginal cup to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end of the vaginal cup being greater than the diameter of the outer end ensures a good seal with the walls of the vagina in some patients.

Preferably, the vaginal cup is of a generally cylindrical geometry, wherein the diameter of the base end is similar to the diameter of the outer end.

Advantageously, in use, the guiding edge outlines the cervico -vaginal junctions for precise incisions into the vaginal fornices.

Advantageously, when the vaginal cup is pressed against the patient's cervix, in use, only the anterior and posterior vaginal fornices will be visibly delineated by the guiding edge. As such, a surgeon will know precisely where to make the initial incisions into the anterior and posterior vaginal fornices such that the lateral vaginal fornices may be avoided. The aim of the two generally opposed cut-out sections is to shield the ascending branches of the uterine vessels and the ureters from being inadvertently drawn into the surgical field. Once the anterior and/or posterior colpotomy incision have been made, the surgeon may then cut the lateral vaginal fornices using the opening of the vaginal cup as a template to define the path the surgeon needs to follow with the cutting instrument, for example, using an electrical hook, a coagulating shear or a pair of scissors.

Advantageously, in use, the vaginal cup is adapted to fit over the patient's cervix and provide a means to displace the cervix from the ureters laterally, the urinary bladder anteriorly, and the rectum posteriorly, thereby defining the colpotomy incision required for surgically removing the cervix and uterus.

Preferably, the two generally opposed cut-out sections are substantially U-shaped.

Preferably, the vaginal cup further comprises an internal thread adapted to meshingly receive a complementary external thread of the uterine manipulator such that, in use, the vaginal cup can be accurately adjusted to a longitudinal position relative to the uterine manipulator to complement the patient's uterine anatomy.

Advantageously, the longitudinal position of the vaginal cup relative to the uterine manipulator can be adjusted according to the patient's uterine anatomy, thereby accommodating variations in patient uterine anatomy.

Advantageously, a vaginal cup coloured blue, for example, will be visually distinguishable from blood or tissue during laparoscopic surgery thereby aiding the surgeon in distinguishing the vaginal cup from the surrounding tissue or blood.

Other aspects of the invention are also disclosed. Brief Description of the Drawings

Notwithstanding any other forms which may fall within the scope of the present invention, a preferred embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

Fig. 1 is a side view of a uterine manipulator in accordance with a preferred embodiment of the present invention;

Fig. 2 is side view of a vaginal cup removably attached to a body portion of the uterine manipulator of Fig. 1; Fig. 3 is a perspective view of the vaginal cup of Fig. 2;

Fig. 4 is a side view of the vaginal cup of Figs. 2 and 3; and

Fig. 5 is an end view of the vaginal cup of Figs. 2 to 4.

Detailed Description of Specific Embodiments It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

With reference to Figs. 1 and 2, a uterine manipulator 10 is disclosed which comprises a handle portion 15; an arm portion 20 having a proximal end connected to the handle portion 15 and a distal end; a body portion, generally indicated by the numeral 25, connected to the distal end of the arm portion 20, the body portion 25 comprising at a distal end a hollow uterine tip 30 that is adapted to be inserted into a patient's uterus (not shown) via the cervix (not shown), in use; and at a proximal end a fitting connector 35, the body portion 25 further comprising an internal passage (not shown) providing fluid communication between the fitting connector 35 and the hollow uterine tip 30; and a vaginal cup, generally indicated by the reference numeral 40, the vaginal cup 40 being adapted for removable attachment to the body portion 25.

As shown in Figs. 3 and 4, the vaginal cup 40 comprises a wall 45 defining an opening 50, a base end 55 and an outer end 60, the opening 50 being at the outer end 60 of the vaginal cup 40, the outer end 60 of the vaginal cup 40 being closest to the hollow uterine tip 30 when the vaginal cup 40 is attached to the body portion 25 of the uterine manipulator 10 as shown in Fig. 2. In this embodiment, the vaginal cup 40 is of a suitable geometry to prevent loss of pneumoperitoneum (for instance, carbon dioxide) in use, such as during surgery, namely, following colpotomy. Preferably, the wall 45 of the vaginal cup 40 is designed to have a low coefficient of friction by, for example, having smooth surfaces such that facile vaginal insertion of the vaginal cup 40 is enabled.

In this embodiment, and as shown in Figs. 3 and 4, the vaginal cup 40 is of a generally frusto-conical geometry, wherein the diameter of the base end 55 is greater than the diameter of the outer end 60 such that the geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina (not shown). In another embodiment, the vaginal cup 40 is of a generally cylindrical geometry, wherein the diameter of the base end 55 is similar to the diameter of the outer end 60 such that the geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina. It will be appreciated therefore, that in other embodiments, the vaginal cup 40 may be of any suitable geometry that complements the patient's cervical and vaginal anatomy, thereby accommodating variations in patient uterine anatomy.

In this embodiment, the vaginal cup 40 is of a diameter that is adapted to fit over the patient's cervix. It will be appreciated therefore, that one or more additional vaginal cups 40 having, for example, suitable diameters, can be removably attached to the uterine manipulator 10 to conform to the patient's cervix, thereby accommodating variations in patient uterine anatomy. The different diameters of the vaginal cup 40 relative to the cervix can be selected according to the patient's uterine anatomy, rather than a one-size fits all approach. This is important, for example, to avoid inadvertently pushing the patient's ureters (not shown) closer to the vaginal cup 40 during colpotomy with an ill-fitting vaginal cup 40.

In this embodiment, as shown in Figs 3 and 4, the outer end 60 of the vaginal cup 40 comprises a guiding edge 61 adjacent to the opening 50 such that, in use, the guiding edge 61 may be used for delineating the patient's cervico-vaginal junction (not shown). In use, the guiding edge 61 outlines the cervico-vaginal junction for precise incisions into the vaginal fornices (not shown). In this embodiment, the vaginal cup 40 further comprises two generally opposed cut-out sections 65 disposed at the outer end 60, that extend substantially down from the guiding edge 61 and along the wall 45 of the vaginal cup 40, terminating at a specified distance 65' from the guiding edge 61, as shown in Fig. 4, such that the guiding edge 61 comprises two generally opposed guiding edge lips 61 ' adapted to delineate only the patient's anterior and posterior fornices (not shown) of the cervico-vaginal junction. In use, when the vaginal cup 40 is pressed against the patient's cervix, only the anterior and posterior vaginal fornices will be visibly delineated by the guiding edge 61. As such, a surgeon will know precisely where to make the initial incisions into the anterior and posterior vaginal fornices such that the lateral vaginal fornices (not shown) may be avoided. The aim of the two generally opposed cut-out sections 65 is to shield the ascending branches of the uterine vessels and the ureters from being inadvertently drawn into the surgical field. Once the anterior and/or posterior colpotomy incision have been made, the surgeon may then cut the lateral vaginal fornices using the opening 50 of the vaginal cup 40 as a template to define the path the surgeon needs to follow with the cutting instrument, for example, using an electrical hook, a coagulating shear or a pair of scissors. It will therefore be appreciated that the specified distance 65' may be any suitable distance to allow the two generally opposed cut-out sections 65 to shield the ascending branches of the uterine vessels and the ureters. In this embodiment, the two generally opposed cut-out sections 65 are substantially U-shaped. However, it will be appreciated that the two generally opposed cut-out sections 65 may be any suitably defined void able to act as shields during initial incisions. In other embodiments, the two generally opposed guiding edge lips 61 ' may also comprise radiused corners (not shown) that function to reduce or eliminate the risk of damage to patient tissue, for example, the inside of the vagina, when the uterine manipulator 10 is in use.

In this embodiment, the vaginal cup 40 comprises a female attachment means 70 adapted to fit a complementary male attachment means designated as 75 in Fig. 1 on the body portion 25 such that the vaginal cup 40 may be removably attached to the body portion 25. In this embodiment, the body portion 25 has a longitudinal axis and an external thread (not shown) and the vaginal cup 40 has a complementary internal thread (not shown) adapted to meshingly receive the external thread of the body portion 25 such that, in use, the vaginal cup 40 can be accurately adjusted to a longitudinal position relative to the body portion 25 that complements the patient's uterine anatomy. In other embodiments, the vaginal cup 40 may be removably attached to the body portion 25 using any one of a number of complementary attachment means including, but not limited to, any one of the following: a bayonet fitting, a push fitting, a luer lock fitting.

In this embodiment, as shown in Figs. 1 and 2, the body portion 25 further comprises a lock 80 adapted to releasably secure the vaginal cup 40 at the longitudinal position relative to the body portion 25. Preferably, the lock 80 comprises an internal thread (not shown) that is complementary to and adapted to meshingly receive the external thread of the body portion 25. In this embodiment, the lock 80 is shaped to enable a tight cervical seal to be formed against the patient's cervix, in use, when the uterine manipulator 10 is used without the vaginal cup 40. Preferably, the lock 80 further comprises a surface 81 adapted to be pushed against the patient's cervix in use, to form the tight cervical seal.

Referring once again to Fig. 1, in a preferred embodiment, the arm portion 20 of the uterine manipulator 10 is generally curvilinear such that the handle portion 15 is offset from the longitudinal axis of the body portion 25. It will be appreciated, however, that the shape of the arm portion 20 is not limited to the curvilinear form and that any other suitable form may be possible within the scope of the present invention.

In this embodiment, the fitting connector 35 is adapted for removably attaching a fluid connector (not shown) adapted for releasably engaging a fluid supply tube (not shown). In a preferred embodiment, the fluid connector is a hose barb (not shown) comprising one or more ridges disposed about the outer surface of the hose barb. In other embodiments, the fluid connector may be any other suitable types of fluid connectors within the scope of the present invention.

In this embodiment, the vaginal cup 40 is of a colour, for example, blue or green, that will be visually distinguishable from blood or tissue during, for example, laparoscopic surgery thereby aiding the surgeon in distinguishing the vaginal cup 40 from the surrounding tissue or blood.

In this embodiment, the handle portion 15 further comprises a lug 85 adapted for removably attaching the uterine manipulator 10 to an adjustable arm (not shown) such that the uterine manipulator 10 may be used by the surgeon unaided. For example, the adjustable arm, which is also desirably attached to, for example, an external support, may be moved or angled to allow the uterine manipulator 10 to be moved to a plurality of desired positions.

In this embodiment, the various components of the uterine manipulator 10, including the handle portion 15, the arm portion 20, the body portion 25, the vaginal cup 40 and the hollow uterine tip 30 are preferably made from a material that is biocompatible and of medical grade such as a medical grade metal, including for example, but not limited to, any one or more of the following: 316 stainless steel or titanium, or a medical grade polymer including, for example, but not limited to, any one or more of the following: silicone, polyethylene or polyetheretherketone. Referring once again to Figs. 2 to 4, in this embodiment, the vaginal cup 40 delineates the patient's cervico-vaginal junction, in use. In a preferred embodiment, the vaginal cup 40 is available in both the generally frusto-conical geometry and the generally cylindrical geometry such that the vaginal cup 40 of the most suitable geometry may be chosen to complement the patient's cervical and vaginal anatomy to enable facile introduction of the vaginal cup 40 into the vagina. Furthermore, the vaginal cup 40 of most suitable geometry may be further chosen to complement the patient's cervical and vaginal anatomy such that the wall 45 of the vaginal cup 40 acts as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. In some patients, the diameter of the base end 55 of the vaginal cup 40 being greater than the diameter of the outer end 60 ensures that a good seal is maintained between the wall 45 of the vaginal cup 40 and the walls of the vagina. In other patients, the diameter of the base end 55 of the vaginal cup 40 being similar to the diameter of the outer end 60 ensures that a good seal is maintained between the wall 45 of the vaginal cup 40 and the walls of the vagina. The interchangeable nature of the vaginal cup 40 ensures that the vaginal cup 40 with the most suitable geometry and diameter to complement the patient's uterine anatomy may be used.

Referring once again to Figs. 1 and 2, in this embodiment, the lock 80 is adapted to releasably secure the vaginal cup 40 at the longitudinal position relative to the body portion 25 by acting as a stopper, such that the vaginal cup 40 may be prevented from moving or detaching from the uterine manipulator 10 in use, such as during surgery. In this embodiment, the lock 80 is, for example, cone-shaped, such that the lock 80 may further function, for example, during tubal patency tests (chromotubation), as a seal when the external surface 81 is applied against the patient's cervix to provide the tight cervical seal to prevent the egress of dye liquid from the cervix.

In this embodiment, the general curvilinear geometry of the arm portion 20 offsets the handle portion 15 from the longitudinal axis of the body portion 25 and affords the surgeon increased range of motion in the sagittal plane. This, in turn allows facile insertion of the uterine manipulator 10 into the vagina for both retro verted and anteverted uteri. For example, when used with an anteverted uterus, the positioning of the body portion 25 in a plane lower than that of the handle portion 15 affords the surgeon added range of motion of the handle portion 15 in the downward direction. Conversely, when the uterine manipulator 10 is used with a retro verted uterus, the positioning of the body portion 25 in a plane higher than that of the handle portion 15 affords the surgeon added range of motion of the handle portion 15 in the upward direction.

In this embodiment, the internal passage allows an irrigation fluid, for example, saline solution for irrigation purposes such as hydrotubation, or a dye liquid for diagnostic purposes such as tubal patency tests (chromotubation), to be communicated between the fitting connector 35 and the hollow uterine tip 30. In use, connection of the fitting connector 35 to the fluid supply tube ensures that corresponding fluid may be communicated to the internal passage. Furthermore, connection of fitting connector 35 to the hose barb adapted for releasably engaging the fluid supply tube allows the fluid supply tube to be tightly fitted to the fitting connector 35 to prevent the fluid supply tube from detaching in use. The plurality of ridges disposed on the external surface of the hose barb functions to afford increased friction during the removal of the fluid supply tube from the hose barb, preventing the fluid supply tube from easily detaching from the hose barb during use. In a preferred embodiment, the hose barb further comprises a locking mechanism (not shown) which allows the hose barb to be locked to the fitting connecter 35. It will be appreciated that the locking mechanism may take the form of any one of a number of locking mechanisms, including but not limited to any one or more of the following: a luer lock fitting, a bayonet fitting, a screw thread fitting or a push fitting. In this embodiment, the locking mechanism is a luer lock fitting.

In this embodiment, the hollow uterine tip 30 may be of varying length, diameter and/or geometry to accommodate the variation in the size and disposition of the patient's uterus and external cervical os (not shown), which may differ according to the patient's uterine anatomy. In this embodiment, the hollow uterine tip 30 is removable from the body portion 25 such that differently sized hollow uterine tips 30 may be removably attached to the distal end of the body portion 25 via any suitable method. For example, the hollow uterine tip 30 may be attached using any one of a number of complementary attachment methods including, but not limited to any one of the following: a bayonet fitting, a screw thread fitting, a push fitting, a luer lock fitting. In this embodiment, the hollow uterine tip 30 is removably attached to the distal end of the body portion 25 via a screw thread fitting. Preferably, the hollow uterine tip 30 comprises a collar 31 adapted to afford a user, for example, the surgeon's assistant a better grip on the hollow uterine tip 30 when attaching or removing the hollow uterine tip 30 from the distal end of the body portion 25.

A first advantage of at least some of the above embodiments is patient safety. In use, the geometry of the vaginal cup 40 allows it to act as a seal within the vagina to prevent a loss of pneumoperitoneum (loss of carbon dioxide) from within the peritoneal cavity following colpotomy, in use.

Advantageously, vaginal cups 40 having different geometries can be removably attached to the uterine manipulator 10 to conform to the cervix, thereby accommodating variations in patient uterine anatomy.

Advantageously, the generally frusto-conical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end 55 of the vaginal cup 40 being greater than the diameter of the outer end 60 ensures a good seal with the walls of the vagina in some patients.

Advantageously, the generally cylindrical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end 55 of the vaginal cup 40 being similar to the diameter of the outer end 60 ensures a good seal with the walls of the vagina in some patients.

Advantageously, in use, the guiding edge 61 outlines the cervico-vaginal junction for precise incisions into the vaginal fornices.

Advantageously, when the vaginal cup 40 is pressed against the patient's cervix, in use, only the anterior and posterior vaginal fornices will be visibly delineated by the guiding edge 61. As such, the surgeon will know precisely where to make the initial incisions into the anterior and posterior vaginal fornices such that the lateral vaginal fornices may be avoided. The aim of the two generally opposed cut-out sections 65 is to shield the ascending branches of the uterine vessels and the ureters from being inadvertently drawn into the surgical field. Once the anterior and/or posterior colpotomy incision have been made, the surgeon may then cut the lateral vaginal fornices using the opening 50 of the vaginal cup 40 as a template to define the path the surgeon needs to follow with the cutting instrument, for example, an electrical hook, a coagulating shear or a pair of scissors.

Advantageously, in use, the vaginal cup 40 is adapted to fit over the patient's cervix and provide a means to displace the cervix from the ureters laterally, the urinary bladder anteriorly, and the rectum posteriorly, thereby defining the colpotomy incision required for surgically removing the cervix and uterus.

A second advantage of at least some of the above embodiments is user convenience. The vaginal cup 40 is removably attached to the body portion 25 such that once surgery has been completed the vaginal cup 40 can be either sterilized for further use or disposed of.

Advantageously, the internal passage allows an irrigation fluid, for example, saline solution for irrigation purposes such as hydrotubation, or a dye liquid for diagnostic purposes such as tubal patency tests (chromotubation), to be communicated between the fitting connector 35 and the hollow uterine tip 30.

Advantageously, the vaginal cup 40 may be removed when the uterine manipulator 10 is used for purposes where the vaginal cup 40 is not required, for example, during tubal patency tests (chromotubation).

Advantageously, the generally frusto-conical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and facilitates facile introduction of the vaginal cup 40 into the vagina. Insertion is further eased when, for example, the wall 45 of the vaginal cup 40 has a substantially low coefficient of friction.

Advantageously, the generally cylindrical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and facilitates facile introduction of the vaginal cup 40 into the vagina. Insertion is further eased when, for example, the wall 45 of the vaginal cup has a substantially low coefficient of friction. Advantageously, the longitudinal position of the vaginal cup 40 relative to the body portion 25 can be adjusted according to the patient's uterine anatomy, thereby accommodating variations in patient uterine anatomy.

Advantageously, the lock 80 allows the longitudinal position of the vaginal cup 40 relative to the body portion 25 to be adjusted to suit the patient's uterine anatomy and then secured in place, thereby preventing the vaginal cup 40 from moving or detaching from the uterine manipulator 10 in use, such as during surgery.

Advantageously, the longitudinal position of the lock 80 can be accurately adjusted relative to the body portion 25.

Advantageously, the lock 80 is, for example, cone-shaped, such that the lock 80 may further function, for example, during tubal patency tests (chromotubation), as a seal when the lock 80 is applied against the patient's cervix to provide a tight cervical seal to prevent the egress of dye liquid from the cervix.

Advantageously, the shape of the arm portion 20 of the uterine manipulator 10 allows the surgeon to achieve facile insertion of the uterine manipulator 10 into the vagina for both retroverted and anteverted uteri.

Advantageously, the shape of the arm portion 20 also enables the surgeon to move the patient's uterus more easily in the anterior, posterior and lateral planes.

Advantageously, the hose barb allows a fluid supply tube carrying a fluid, such as an irrigation fluid, to be tightly fitted to the fitting connector 35 to prevent the fluid supply tube from detaching in use.

Advantageously, a vaginal cup 40 coloured blue, for example, will be visually distinguishable from blood or tissue during, for example, laparoscopic surgery thereby aiding the surgeon in distinguishing the vaginal cup 40 from the surrounding tissue or blood.

Advantageously, the attachment of the uterine manipulator 10 via the lug 85 to the adjustable arm allows the uterine manipulator 10 to be used by the surgeon unaided. For example, the adjustable arm, which is also desirably attached to, for example, an external support, may be moved or angled to allow the uterine manipulator 10 to be moved to a plurality of desired positions. Advantageously, the hollow uterine tip 30 may be removably attached to the body portion 25 of the uterine manipulator 10 such that the hollow uterine tip 30 and the uterine manipulator 10 can be subjected to separate treatments, (e.g. sterilization) or can be disposed of separately. Advantageously, hollow uterine tips 30 having different geometries can be removably attached to the uterine manipulator 10, thereby accommodating variations in patient uterine anatomy.

According to a second embodiment, with reference to Figs. 2 to 5, a vaginal cup 40 for delineation of a patient's vagino -cervical junction is shown in use, the vaginal cup 40 being adapted for removable attachment to a uterine manipulator 10, such as that described above. The vaginal cup 40 of this embodiment comprises: a wall 45 defining an opening 50, a base end 55 and an outer end 60, the opening 50 being at the outer end 60 of the vaginal cup 40, the outer end 60 of the vaginal cup 40 being closest to the patient's vagino -cervical junction in use, wherein the vaginal cup 40 is of a suitable geometry to prevent loss of pneumoperitoneum (for instance, carbon dioxide) in use, such as during surgery, namely, following colpotomy. Preferably, the wall 45 of the vaginal cup 40 is designed to have a low coefficient of friction by, for example, having a smooth surface such that facile vaginal insertion of the vaginal cup 40 is enabled. In this embodiment, and as shown in Figs. 3 and 4, the vaginal cup 40 is of a generally frusto-conical geometry, wherein the diameter of the base end 55 is greater than the diameter of the outer end 60 such that the geometry of the wall 45 of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the vaginal cup 40 to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. In another embodiment, the vaginal cup 40 is of a generally cylindrical geometry, wherein the diameter of the base end 55 is similar to the diameter of the outer end 60 such that the geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina. It will be appreciated therefore, that in other embodiments, the vaginal cup 40 may be of any suitable geometry that complements the patient's cervical and vaginal anatomy, thereby accommodating variations in patient uterine anatomy. In this embodiment, the vaginal cup 40 is of a diameter that is adapted to fit over the patient's cervix. It will be appreciated therefore, that one or more additional vaginal cups 40 having for example, suitable diameters, can be removably attached to the uterine manipulator 10 to conform to the patient's cervix, thereby accommodating variations in patient uterine anatomy. The different diameters of the vaginal cup 40 relative to the cervix can be selected according to the patient's uterine anatomy, rather than using a one-size fits all approach. This is important to avoid inadvertently pushing the patient's ureters closer to the vaginal cup 40 during colpotomy with an ill- fitting vaginal cup 40.

In this embodiment, as shown in Figs 3 and 4, the outer end 60 of the vaginal cup 40 comprises a guiding edge 61 adjacent to the opening 50 such that, in use, the guiding edge may be used for delineating the patient's cervico-vaginal junction. In use, the guiding edge 61 outlines the cervico-vaginal junction for precise incisions into the vaginal fornices. In this embodiment, the vaginal cup 40 further comprises two generally opposed cut-out sections 65 disposed at the outer end 60, that extend substantially down from the guiding edge 61 and along the wall 45 of the vaginal cup 40, terminating at a specified distance 65' from the guiding edge 61, as shown in Fig. 4, such that the guiding edge 61 comprises two generally opposed guiding edge lips 61 ' adapted to delineate only the patient's anterior and posterior fornices of the cervico-vaginal junction. In use, when the vaginal cup 40 is pressed against the patient's cervix, only the anterior and posterior vaginal fornices will be visibly delineated by the guiding edge lips 61 '. As such, a surgeon will know precisely where to make the initial incisions into the anterior and posterior vaginal fornices such that the lateral vaginal fornices may be avoided. The aim of the two generally opposed cut- out sections 65 is to shield the ascending branches of the uterine vessels and the ureters from being inadvertently drawn into the surgical field. Once the anterior and/or posterior colpotomy incision have been made, the surgeon may then cut the lateral vaginal fornices using the opening 50 of the vaginal cup 40 as a template to define the path the surgeon needs to follow with the cutting instrument, for example, an electrical hook, a coagulating shear or a pair of scissors. It will therefore be appreciated that the specified distance 6 ' may be any suitable distance to allow the two generally opposed cut-out sections 65 to shield the ascending branches of the uterine vessels and the ureters. In this embodiment, the two generally opposed cut-out sections 65 are substantially U-shaped. However, it will be appreciated that the two generally opposed cut-out sections 65 may be any suitably defined void in the wall 45 of the vaginal cup 40 to enable them to act as shields during initial incisions. In other embodiments, the guiding edge lips 61 ' may also comprise radiused corners that function to reduce or eliminate the risk of damage to patient tissue, for example, the inside of the vagina, when the uterine manipulator 10 is in use.

In this embodiment, the vaginal cup 40 further comprises a female attachment means 70 adapted to complement the uterine manipulator 10 such that the vaginal cup 40 may be removably attached to the uterine manipulator 10. For example, the female attachment 70 may be adapted to complement the uterine manipulator 10 shown in Fig. 1 at a male attachment designated 75. In this embodiment, the uterine manipulator 10 has a longitudinal axis and an external thread (not shown) and the vaginal cup 40 has a complementary internal thread (not shown) adapted to meshingly receive the external thread such that, in use, the vaginal cup 40 can be accurately adjusted to a longitudinal position relative to the uterine manipulator 10 that complements the patient's uterine cavity. In other embodiments, the vaginal cup 40 may be removably attached to the body portion 25 using any one of a number of complementary attachment means including, but not limited to, any one of the following: a bayonet fitting, a push fitting, a luer lock fitting. In this embodiment, the vaginal cup 40 is of a colour, for example, blue or green, that will be visually distinguishable from blood or tissue during, for example, laparoscopic surgery thereby aiding the surgeon in distinguishing the vaginal cup 40 from the surrounding tissue or blood. Preferably, the vaginal cup 40 is made from a material that is biocompatible and of medical grade such as a medical grade metal, including for example, but not limited to, any one or more of the following: 316 stainless steel or titanium, or a medical grade polymer including, for example, but not limited to any one or more of the following: silicone, polyethylene or polyetheretherketone.

Referring once again to Figs. 2 to 4, in this embodiment, the vaginal cup 40 delineates the patient's cervico-vaginal junction, in use. In a preferred embodiment, the vaginal cup 40 is available in both the generally frusto-conical geometry and the generally cylindrical geometry such that the vaginal cup 40 of the most suitable geometry may be chosen to complement the patient's cervical and vaginal anatomy to enable facile introduction of the vaginal cup 40 into the vagina. Furthermore, the vaginal cup 40 of most suitable geometry may be further chosen to complement the patient's cervical and vaginal anatomy such that it acts as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. In some patients, the diameter of the base end 55 of the vaginal cup 40 being greater than the diameter of the outer end 60 ensures that a good seal is maintained between the wall 45 of the vaginal cup 40 and the walls of the vagina. In other patients, the diameter of the base end 55 of the vaginal cup 40 being similar to the diameter of the outer end 60 ensures that a good seal is maintained between the wall 45 of the vaginal cup 40 and the walls of the vagina. The interchangeable nature of the vaginal cup 40 ensures that the vaginal cup 40 with the most suitable geometry and diameter to complement the patient's uterine anatomy may be used.

A first advantage of at least some of the above embodiments is patient safety. In use, the geometry of the vaginal cup 40 allows it to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy, in use.

Advantageously, vaginal cups 40 having different geometries can be removably attached to the uterine manipulator 10 to conform to the patient's cervix, thereby accommodating variations in patient uterine anatomy.

Advantageously, the generally frusto-conical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end 55 of the vaginal cup being greater than the diameter of the outer end 60 ensures a good seal with the walls of the vagina in some patients.

Advantageously, the generally cylindrical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and allows the wall 45 of the vaginal cup 40 to act as a seal within the vagina to prevent a loss of pneumoperitoneum (for instance, carbon dioxide) from within the peritoneal cavity following colpotomy. The diameter of the base end 55 of the vaginal cup being similar to the diameter of the outer end 60 ensures a good seal with the walls of the vagina in some patients.

Advantageously, in use, the guiding edge 61 outlines the cervico-vaginal junctions for precise incisions into the vaginal fornices. Advantageously, when the vaginal cup 40 is pressed against the patient's cervix, in use, only the anterior and posterior vaginal fornices will be visibly delineated by the guiding edge 61. As such, the surgeon will know precisely where to make the initial incisions into the anterior and posterior vaginal fornices such that the lateral vaginal fornices may be avoided. The aim of the two generally opposed cut-out sections 65 is to shield the ascending branches of the uterine vessels and the ureters from being inadvertently drawn into the surgical field. Once the anterior and/or posterior colpotomy incision have been made, the surgeon may then cut the lateral vaginal fornices using the opening 50 of the vaginal cup 40 as a template to define the path the surgeon needs to follow with the cutting instrument, for example, an electrical hook, a coagulating shear or a pair of scissors.

Advantageously, in use, the vaginal cup 40 is adapted to fit over the patient's cervix and provide a means to displace the cervix from the ureters laterally, the urinary bladder anteriorly, and the rectum posteriorly, thereby defining the colpotomy incision required for surgically removing the cervix and uterus. A second advantage of at least some of the above embodiments is user convenience. The vaginal cup 40 can be removed from the uterine manipulator 10 after surgery and either sterilized for further use or disposed of.

Advantageously, the generally cylindrical geometry of the vaginal cup 40 complements the patient's cervical and vaginal anatomy and facilitates facile introduction of the vaginal cup 40 into the vagina. Insertion is further eased when, for example, the wall 45 of the vaginal cup 40 has a substantially low coefficient of friction.

Advantageously, the longitudinal position of the vaginal cup 40 relative to the uterine manipulator 10 can be adjusted according to the patient's uterine anatomy, thereby accommodating variations in patient uterine anatomy.

Advantageously, a vaginal cup 40 coloured blue, for example, will be visually distinguishable from blood or tissue during laparoscopic surgery, thereby aiding the surgeon in distinguishing the vaginal cup 40 from the surrounding tissue or blood.

Interpretation Embodiments:

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

Specific Details

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Terminology

In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "forward", "rearward", "radially", "peripherally", "upwardly", "downwardly", and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

Different Instances of Objects

As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

Comprising and Including

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention. Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

Scope of Invention

Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.

Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Industrial Applicability

It is apparent from the above, that the arrangements described are applicable to the medical device industries.

Claims

Claims The claims defining the invention are as follows:

1. A uterine manipulator, comprising: a handle portion; an arm portion, having a proximal end connected to the handle portion and a distal end; a body portion connected to the distal end of the arm portion, the body portion comprising at a distal end, a hollow uterine tip and adapted to be inserted into a patient's uterine cavity via the cervix in use, and at a proximal end, a fitting connector, the body portion further comprising an internal passage providing fluid communication between the fitting connector and the hollow uterine tip; and a vaginal cup for delineation of the patient's cervico -vaginal junction, the vaginal cup being adapted for removable attachment to the body portion and having a wall defining an opening, a base end and an outer end, the opening being at the outer end, the outer end being closest to the hollow uterine tip when the vaginal cup is attached to the body portion, wherein the vaginal cup is of a geometry to prevent loss of pneumoperitoneum following colpotomy.

2. A uterine manipulator as defined in claim 1, wherein the vaginal cup is of a generally frusto-conical geometry, wherein the diameter of the base end is greater than the diameter of the outer end.

3. A uterine manipulator as defined in claim 1, wherein the vaginal cup is of a generally cylindrical geometry, wherein the diameter of the base end is similar to the diameter of the outer end.

4. A uterine manipulator as defined in claim 1, wherein the vaginal cup comprises a guiding edge disposed adjacent to the opening for delineating the patient's cervico- vaginal junction in use.

5. A uterine manipulator as defined in claim 1, wherein the vaginal cup further comprises two generally opposed cut-out sections disposed at the outer end such that the guiding edge comprises two generally opposed guiding edge lips adapted to delineate only the patient's anterior and posterior fornices of the cervico -vaginal junction.

6. A uterine manipulator as defined in claim 5, wherein the two generally opposed cutout sections are substantially U-shaped.

7. A uterine manipulator as defined in claim 1, wherein the body portion has a longitudinal axis and an external thread and the vaginal cup has a complementary internal thread adapted to meshingly receive the external thread of the body portion such that, in use, the vaginal cup can be accurately adjusted to a longitudinal position relative to the body portion that complements the patient's uterine anatomy.

8. A uterine manipulator as defined in claim 7, wherein the body portion further comprises a lock adapted to releasably secure the vaginal cup at the longitudinal position.

9. A uterine manipulator as defined in claim 8, wherein the lock comprises an internal thread that is complementary to and adapted to meshingly receive the external thread of the body portion.

10. A uterine manipulator as defined in claim 9, wherein the lock is shaped to enable a tight cervical seal to be formed against a patient's cervix, in use, when the uterine manipulator is used without the vaginal cup.

11. A uterine manipulator as defined in claim 7, wherein the arm portion of the uterine manipulator is shaped such that the handle portion is offset from the longitudinal axis of the body portion.

12. A uterine manipulator as defined in claim 1, wherein the fitting connector is adapted for removably attaching a fluid connector.

13. A uterine manipulator as defined in claim 12, wherein the fluid connector is a hose barb for releasably engaging a fluid supply tube.

14. A uterine manipulator as defined in claim 1, wherein the vaginal cup is of a colour that distinguishes it from blood or body tissue.

15. A uterine manipulator as defined in claim 1, wherein the handle portion further comprises a lug adapted for removably attaching the uterine manipulator to an adjustable arm.

16. A uterine manipulator as defined in claim 1, wherein the hollow uterine tip is removable from the body portion.

17. A vaginal cup for delineation of a patient's cervico-vaginal junction, the vaginal cup being adapted for removable attachment to a uterine manipulator, comprising: a wall defining an opening, a base end and an outer end, the opening being at the outer end, the outer end being closest to the cervico-vaginal junction in use, wherein the vaginal cup is of a geometry to prevent loss of pneumoperitoneum following colpotomy.

18. A vaginal cup as defined in claim 17, being of a generally frusto-conical geometry, wherein the diameter of the base end is greater than the diameter of the outer end.

19. A vaginal cup as defined in claim 17, being of a generally cylindrical geometry, wherein the diameter of the base end is similar to the diameter of the outer end.

20. A vaginal cup as defined in claim 17, comprising a guiding edge disposed adjacent to the opening for delineating the patient's cervico-vaginal junction in use.

21. A vaginal cup as defined in claim 17, further comprising two generally opposed cutout sections disposed at the outer end such that the guiding edge comprises two generally opposed guiding edge lips adapted to delineate only the patient's anterior and posterior fornices of the cervico-vaginal junction.

22. A vaginal cup as defined in claim 21, wherein the two generally opposed cut-out sections are substantially U-shaped.

23. A vaginal cup as defined in claim 17, further comprising an internal thread adapted to meshingly receive a complementary external thread of the uterine manipulator such that, in use, the vaginal cup can be accurately adjusted to a longitudinal position relative to the uterine manipulator to complement the patient's uterine anatomy.

24. A vaginal cup as defined in claim 17, being of a colour that distinguishes it from blood or body tissue.

25. A uterine manipulator substantially as herein described with reference to the accompanying figures.

26. A vaginal cup substantially as herein described with reference to the accompanying figures.