WO2019034938A1

WO2019034938A1 - Uterine manipulator with a pointer for total laparoscopic hysterectomy

Info

Publication number: WO2019034938A1
Application number: PCT/IB2018/050833
Authority: WO
Inventors: Saliya Ovitigala OVITIGALAGE
Original assignee: Ovitigalage Saliya Ovitigala
Priority date: 2017-08-17
Filing date: 2018-02-12
Publication date: 2019-02-21

Abstract

The present invention relates to a surgical device used in gynaecological surgery and more particularly to a uterine manipulator device and a method of using the device in a total laparoscopic hysterectomy procedure for detaching the cervix and the uterus from the vagina. This manipulator is designed similar to a pair of scissors with a pointer to facilitate the above procedure.

Description

UTERINE MANIPULATOR WITH A POINTER FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

TECHNICAL FIELD

[0001] The present invention relates to a surgical device used in gynecological surgery and more particularly to a uterine manipulator device and a method of using the device in a total laparoscopic hysterectomy procedure for detaching the cervix and the uterus from the vagina.

BACKGROUND ART

[0002] Conventional hysterectomy surgical procedures typically involve one of four approaches. These surgical approaches are Total Abdominal Hysterectomy (TAH), Vaginal Hysterectomy (VH), Total Laparoscopic Hysterectomy (TLH) and Laparoscopic Assisted Vaginal Hysterectomy (LVAH).

[0003] TLH has become more popular amongst surgeons because it is less invasive than TAH. The VH procedure is considered the least invasive approach, however some patients are not suited to VH. This is particularly so where the uterus is large, there has been previous surgery, severe endometriosis and/or adhesions.

[0004] Needless to say, TLH and LAVH should be performed by surgeons having appropriate training and experience with advanced surgical equipment. This usually results in a shorter hospital stay and a shorter recovery period. Consequently, the number of laparoscopic hysterectomies is expected to grow higher, whilst the number of TAH is expected to decrease.

[0005] However, there are currently limitations in TLH. Specifically, securing the uterine arteries and cutting the cardinal ligaments to separate the uterus and the cervix from the vaginal cuff takes a long time. Also, great care needs to be taken to avoid damage to the bladder and ureters.

[0006] Current uterine manipulators used in TLH comprise a colpotomy cup or cylindrical distal ends. During a TLH procedure, the surgeon inserts a cutting tool laparoscopically to cut along the rim of the cervical colpotomy cup of the uterine manipulator. The small area to be incised at the junction of the cervix and the vaginal canal requires a great deal of precision. Compounding this issue is the difficulty in identifying the distal edge of a vaginal manipulator abdominally in order to find the cervix-vaginal junction. While an assistant pushes the uterine manipulator in a cephalad direction, the surgeon uses mostly tactile feedback to assess the cervix-vaginal junction in order to determine where to make the incision. Manipulating the cutting tool from outside of the body, compounded by the high degree of precision required is a difficult task for even the most experienced surgeon. Due to these limitations, the time taken for separation of the uterus from the vagina takes longer than the rest of the procedure.

[0007] Existing uterine manipulators are also limited in terms of the different size of cervix in which they can be used. As noted above, current uterine manipulators have a cylindrical or cup-shaped distal ends which are designed to fit the outer circumferential surface of the cervix. However, this is a common disadvantage in uterine manipulators, for example, the VCare^® uterine manipulator/elevator. As a result of the arrangement of such cup systems, the uterine manipulator is not able to fix to all sizes of cervix, and can therefore lead to difficulty in separating the uterus from the vagina.

[0008] Various other instruments have been developed to assist surgeons in facilitating this surgical procedure. However, the instruments currently available have limitations, particular with regards to the time-consuming step of separation of uterus and cervix from the vagina during a TLH procedure. Accordingly, there is a need to simplify the TLH procedure by overcoming the difficulties associated with separating the uterus and cervix from the vagina, irrespective of the size of the cervix, and therefore reducing the time taken for such surgery.

[0009] It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or in any other country.

SUMMARY OF INVENTION

[0010] The present invention is directed to a uterine manipulator for use in total laparoscopic hysterectomy (TLH), which may at least partially overcome at least one of the abovementioned disadvantages or provide the surgeon with a useful or commercial choice.

[0011] With the foregoing in view, the present invention in a first aspect, a uterine manipulator comprising:

(i) two members connected via pivot means, wherein the first member comprises a proximal end having a finger ring and a distal end to which a uterine sound can be attached, the second member comprises a proximal end having a finger ring and a distal end having a pointer structure, and the pivot means is positioned between the distal and proximal ends of each member;

(ii) a vaginal occluder associated with the first member; and (iii) securing means to secure the first member in a position relative to the second member, such that in use, the pivot means connects the first and second members and allows the first and second members to pivot with respect to each other and the securing means prevents further pivoting once the desired position of the first member with respect to the second member is obtained.

[0012] In a second aspect, the invention provides a method of total laparoscopic hysterectomy, wherein the method comprises utilising a uterine manipulator comprising:

(ii) a vaginal occluder associated with the first member; and

(iii) securing means to secure the first member in a position relative to the second member, such that in use, the pivot means connects the first and second members and allows the first and second members to pivot with respect to each other and the securing means prevents further pivoting once the desired position of the first member with respect to the second member is obtained.

[0013] The first member and second members can be made from any suitable nonconducting material. Preferably, the first and second members are stainless steel.

[0014] In a preferred embodiment, the first member is essentially a linear handle with a finger ring at the proximal end. The distal end is adapted such that a uterine sound can be attached. The uterine sound can be attached to the first member of the uterine manipulator using any known means suitable in the art. In a preferred embodiment, the distal end of the first member has a female internal thread for attaching a uterine sound having a male external thread. Alternatively, the distal end of the first member can have a male external thread for attaching a uterine sound having a female internal thread.

[0015] The uterine sound can be any suitable length. Interchangeability of the uterine sound allows for a suitable length of uterine sound to be selected and used with the uterine manipulator of the present invention, dependent on the anatomy of the patient.

[0016] The second member is essentially a non- linear handle with a finger ring at the proximal end. The distal end has a pointer structure. The pointer is shaped and positioned such that it is visible through the abdomen and acts as a guide to the surgeon as to the position of the junction between the vagina and cervix.

[0017] The distal end of the second member also has a semi-circular structure associated with the pointer structure. In use, the semi-circular structure sits at the cervix-vaginal junction and provides tactile and visual feedback to the surgeon as to the position of the junction and assists in separation of the vagina and uterus.

[0018] Preferably the pivot means allowing the first member and second member to pivot with respect to each other comprises a slip joint. Specifically, the slip joint comprises a hole in one member and a bolt associated with the other member. The first and second members are connected by passing the bolt of one member through the hole in the other member and securing with a nut. In one embodiment, the hole can be in the second member and the bolt associated with the second member. Alternatively, and in a particularly preferred embodiment, the hole can be in the first, linear member, and the bolt can be associated with the second, non-linear member.

[0019] The uterine manipulator further comprises securing means to prevent pivoting of the first member relative to the second member. Whilst in the initial stages of surgery, pivoting of the two members with respect to each other is required for correct positioning of the uterine manipulator in the vaginal and cervical cavity, once the uterine manipulator is in position, it is necessary to secure the two members with respect to each other, essentially locking the pivot means.

[0020] The securing means can comprise complementary angled teeth on each member, positioned between the pivot means and the finger ring, such that the complementary angled teeth interlock in the manner of a ratchet, preventing further movement of each member with respect to each other. In an alternative embodiment, the securing means can comprise a slip joint positioned between the pivot means and the finger rings. In this alternative embodiment, the device thus has two slip joints, one slip joint acting as a pivot means and the second slip joint which is positioned between the pivot means and the finger rings acting as securing means to prevent pivoting once the uterine manipulator is in the desired position.

[0021] The vaginal occluder can be any suitable shape and size. For example, the vaginal occluder can be in the shape of a hemisphere, or a spherical cap. Furthermore, the hemisphere or spherical cap can be a solid structure. Alternatively, the hemisphere or spherical cap can be a hollow structure. In a particularly preferred embodiment, the vaginal occluder is a solid hemisphere. [0022] In alternative embodiments, the vaginal occluder is in the shape of a spherical segment.

[0023] Preferably, the vaginal occluder is made of a soft material, such as medical grade silicon. Use of medical grade silicon allows the vaginal occluder to fit into position in most patients without the need to provide different sizes of vaginal occluder to suit different sized anatomies.

[0024] In a preferred embodiment, the vaginal occluder has a hole through which the first member passes. The vaginal occluder acts to prevent leakage of air into the abdomen during the procedure.

[0025] In embodiments where the vaginal occluder is a solid spherical cap or a solid hemisphere, the hole through which the first member passes is preferably a hole through the apex.

[0026] Preferably, the vaginal occluder is not a complete hemisphere, but has a slot adjacent to the second member, to allow for movement of the second member.

[0027] Once inserted into the vaginal and uterine cavity, the pointer structure on the second member allows the surgeon to readily identify the cervix-vaginal junction via the abdomen. Identification of the cervix-vaginal junction is visual (via the abdomen) and also via tactile feedback, thus providing greater accuracy and speed in identifying the cervix-vaginal junction during surgery.

[0028] Advantageously, the pointer guides the direction and level of separation of the uterus from the vagina. As the pointer is visible abdominally at all times, damage to the bladder, ureters, bowel and uterine arteries is minimized.

[0029] Following the first incision at the cervix-vaginal junction, the uterine manipulator can be rotated 360 degrees in either a clockwise or an anti-clockwise direction to separate the uterus.

[0030] Furthermore, the semi-circular structure associated with the pointer lies on the cervix-vaginal junction and an assistant to the surgeon can push the device in a cephalad direction to further assist the surgeon to separate vagina from the uterus.

[0031] The semi-circular structure towards the distal end of the second member enables the uterine manipulator to be used on patients having different cervix sizes. This is in contrast to uterine manipulators currently used, which have a circular cup or cylindrical and can only be used on a limited range of cervix sizes.

[0032] The uterine manipulator can optionally be used with a device for stitching the vaginal cuff. Following removal of the uterus through the vagina, the uterine sound can be replaced with a device for stitching the vaginal cuff, being a vault occluder. Preferably, the vault occluder is a triangular prism-shape structure in combination with a rod adapted to be attached to the first member of the uterine manipulator.

[0033] Preferably, the triangular prism-shape structure of the vault occluder is made of a soft material, such as medical grade silicon, whilst the rod is made from any suitable nonconducting material. Preferably, the rod is stainless steel.

[0034] The vault occluder can be attached to the first member of the uterine manipulator using any known means suitable in the art. In a preferred embodiment, the rod has a male external thread for attaching to the distal end of the first member having a female internal thread. Alternatively, the rod can have a female internal thread for attaching to the distal end of a first member having a male external thread.

[0035] Once the uterine sound has been replaced with the vault occluder, the uterine manipulator is re-inserted into the vagina of the patient and the device is used to pass a needle and to stitch the vaginal cuff. The device also works in combination with the vaginal occluder to maintain a pneumoperitoneum. In an alternative embodiment of the uterine manipulator, vaginal cuff closure can be undertaken without using the vault occluder.

[0036] Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention.

[0037] The reference to any prior art in this specification is not, and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge.

BRIEF DESCRIPTION OF DRAWINGS

[0038] Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention. The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of the Invention in any way. The Detailed Description will make reference to a number of drawings as follows:

[0039] Figure 1A is a left view of an embodiment of a device according to the present invention.

[0040] Figure IB is a detailed side view of the nut and bolt arrangement used as a pivot in the embodiment shown in Figure 1A.

[0041] Figure 1C is a detailed side view of the ratchet of the embodiment shown in Figure 1A.

[0042] Figure 2 is a right view of the embodiment of Figure 1A.

[0043] Figure 3 shows three different views of the first member of the embodiment of Figure 1.

[0044] Figure 4A is a side view of the second member of the embodiment of Figure 1.

[0045] Figure 4B is a detailed side view of the finger ring of the second member shown in Figure 4A.

[0046] Figure 4C is a detailed view of the ratchet of the second member shown in Figure 4A.

[0047] Figure 4D is a detailed view of the nut and bolt arrangement used as a pivot with the second member shown in Figure 4A.

[0048] Figure 4E is a detailed view of the pointer of the second member shown in Figure 4A.

[0049] Figure 5A is a top view of the hemispherical vaginal occlusion cup of the embodiment shown in Figure 1.

[0050] Figure 5B is a side view of the hemispherical vaginal occlusion cup of Figure 5A.

[0051] Figure 5C is a perspective view of the hemispherical vaginal occlusion cup of Figure 5A.

[0052] Figure 6A is a side view of a uterine sound of the embodiment shown in Figure 1.

[0053] Figure 6B is a perspective view of the uterine sound of Figure 6A. [0054] Figure 6C is a bottom view of the uterine sound of Figure 6A.

[0055] Figure 6D is a side view of the threaded portion of the uterine sound of Figure 6A.

[0056] Figure 7 shows various views of the pointer of the embodiment shown in Figure 1.

[0057] Figure 8 shows various views of a device for use with the embodiment of Figure 1 when stitching the vaginal cuff.

[0058] Figure 9 is a diagram showing the device of the embodiment of Figure 1 positioned within the vagina and uterine cavity.

[0059] Figure 10 is an alternative view of the device of the embodiment of Figure 1 positioned within the vagina and uterine cavity.

[0060] Figure 11 is a side view of the first member of the embodiment of Figure 1 after removal of the uterus and the uterine sound replaced with the device of Figure 8 for assisting with stitching the vaginal cuff.

[0061] Figure 12 is a diagram showing the first member of Figure 11 positioned within the vagina.

[0062] Figure 13 is a perspective view of the pivot means of an alternative embodiment of a device according to the present invention.

[0063] Figure 14 is a side view of the embodiment of the device of Figure 13 with an alternative vaginal occlusion cup.

[0064] Figure 15 is a perspective view of the embodiment of the device of Figure 14.

[0065] Figure 16 is an alternative perspective view of the embodiment of the device of Figure 14.

DESCRIPTION OF EMBODIMENTS

[0066] Referring to Figure 1A, there is shown a uterine manipulator 10 according to one embodiment of the invention. The uterine manipulator 10 has a first member 12, a second member 14, a uterine sound 16, a hemispherical vaginal occluder 18, a pointer 20, pivot means 22, securing means 24 and finger rings, 26 and 26' .

[0067] A detailed view of the pivot means 22 is shown in Figure IB. The pivot means 22 comprises a hole 28 in the first member and a bolt 30 associated with the second member. The bolt 30 is secured in the hole 28 with a nut 32.

[0068] The uterine manipulator also has angled teeth 34 positioned on each member between the pivot means 22 and the finger rings 26 and 26'. The angled teeth 34 are shown in detail in Figure 1C. In use, the angled teeth 34 on each member essentially interlock, and act as a ratchet to secure the position of the first member 12 with respect to the second member 14, thus preventing pivoting or other relative movement.

[0069] An alternative view of the uterine manipulator 10 of Figure 1A is shown in Figure 2. Like features are numbered similarly.

[0070] Three different views of the first member 12 of the uterine manipulator 10 of Figure 1 (without a uterine sound attached) are shown in Figure 3. Specifically, the first member 12 comprises a finger ring 26, angled teeth 34 (part of the securing means), and a hole 28 (part of the pivot means 22).

[0071] The distal end of the first member 12 has a female internal thread such that the uterine sound 16 having a male external thread can be attached. The hole 28 in the central portion of the first member 28 is part of the pivot means 22. The hole 28 facilitates a sliding movement of the second member 14 with respect to the first member, and the members 12, 14 can be locked in position with a bolt 30 and nut 32 associated with the second member 14 (see Figure 4).

[0072] The first member 12 also has angled teeth 34 towards its proximal end (the finger ring 26) which act co-operatively with angled teeth on the second member 14 to lock the first member 12 and the second member 14 in position and prevent pivoting or other relative movement.

[0073] A side view of the second member 14 of the uterine manipulator 10 of Figure 1 is shown in Figure 4A. Specifically, the second member 14 comprises a finger ring 26', angled teeth 34 (part of the securing means), a bolt 30 and a nut 32 (part of the pivot means 22) and a pointer 20.

[0074] Various regions of the second member 14 are shown in detail in Figures 4B-4E, namely, the finger ring 26' is detailed in Figure 4B, the angled teeth 34 in figure 4C, the bolt 30 and nut 32 in Figure 4D and the pointer 20 in Figure 4E. [0075] The pointer 20 is associated with a semi-circular structure 36 at the distal end of the second member 14. In use, the pointer 20 provides a visual cue through the abdomen of the position of the cervix-vaginal junction, whilst the semi-circular structure 36 is positioned at the cervix-vaginal junction and provides tactile feedback to the surgeon as to the position of the junction and assists in separation of the vagina and uterus.

[0076] As shown in Figure 4A, the second member 14 is essentially a handle with a 'V shaped section towards its proximal end (the finger ring 26'). The pointer 20 at the distal end acts as a guide for the colpotomy procedure. A bolt 30 is fixed to the second member 14 and passes through the hole 28 in first member 12 of the device. The pivot position of the first member 12 with respect to the second member 14 is then fixed with a nut 32. The second member 14 also has angled teeth 34 towards its proximal end which act co-operatively with angled teeth on the first member 12 to lock the first member 12 and the second member 14 in position and prevent pivoting or other relative movement.

[0077] The hemispherical vaginal occluder 18 of the uterine manipulator 10 of Figure 1 is shown in Figures 5A-5C. The hemispherical vaginal occluder 18 has a cylindrical hole 38 through its centre, and a slot 40 in the surface, such that the occluder 18 does not form a complete hemisphere. In use, a uterine sound (not shown) is passed through the hole 38 and the slot 40 allows for pivoting movement of the second member (not shown), whilst the occluder 18 prevents leakage of air into the abdomen during the procedure.

[0078] Various views and details of a uterine sound 16 for use with the uterine manipulator 10 of Figure 1 are shown in Figures 6A-6D. Specifically, the uterine sound 16 has a blunt end 42, which in use, is positioned in the uterus and mobilises the uterus at the end of the procedure. The uterine sound 16 also has a male threaded portion 44 which screws into a complementary female threaded portion on the first member 12 of the uterine manipulator 10.

[0079] Figure 7 shows various views of the pointer 20 of the uterine manipulator 10 of Figure 1. The pointer 20 is associated with a semi-circular structure 36. In use, the semi-circular structure 36 sits at the cervix-vaginal junction and provides tactile feedback to the surgeon as to the position of the junction and assists in separation of the vagina and uterus. The semi-circular structure 36 enables the uterine manipulator 10 to be used on patients having different cervix sizes.

[0080] Figure 8 shows various views of a vault occluder 46 for use with the uterine manipulator 10 of Figure 1. Specifically, following removal of the uterus, the uterine sound 16 of the uterine manipulator 10 of Figure 1 is removed and replaced with the vault occluder 46. The vault occluder 46 is a triangular prism- shape structure with a male threaded portion 48 which screws into a complementary female threaded portion on the first member 12 of the uterine manipulator 10 (similarly to the uterine sound 16 which it is replacing). The vault occluder 46 is used to pass a needle and to stitch the vaginal cuff.

[0081] Figures 9 and 10 are alternative view diagrams showing the uterine manipulator 10 of Figure 1 positioned within the vagina 50 and uterine cavity 52 as it would be during use. The uterine sound 16 is positioned within the uterine cavity 52, the pointer 20 and associated semicircular structure 36 are positioned at the cervix-vaginal junction and the hemispherical vaginal occluder 18 is positioned within the vagina 50. The first member 12 of the manipulator 10 is positioned through a hole 38 in the occluder 18 and the second member 14 is positioned within the slot 40 in the occluder 18.

[0082] Figure 11 is a side view of the first member 12 of a uterine manipulator 10 of Figure 1, wherein the uterine sound 16 has been replaced with a vault occluder 46 as shown in Figure 8. During surgery, following removal of the uterus, the uterine sound 16 is replaced with the vault occluder 46. The vault occluder 46 assists with passage of a needle to the surgeon and with stitching the vaginal cuff. The vault occluder 46 also works in combination with the vaginal occluder 18 to maintain a pneumoperitoneum.

[0083] Figure 12 is a diagram showing the first member 12 of Figure 11 positioned within the vagina.

[0084] Figure 13 is a perspective view showing details of a pivot means 54 of an alternative embodiment of a uterine manipulator 10. In this embodiment, the pivot means 54 comprises two slip joints 56 and 56' instead of a ratchet mechanism. The two slip joints 56 and 56' operate cooperatively during use to allow the surgeon to position the uterine manipulator and adjust according to the patient's anatomy. The slip joints 56 and 56' are thus an alternative to a ratchet mechanism.

[0085] Figure 14 is a side view of an alternative embodiment of a uterine manipulator 10. The uterine manipulator 10 comprises a linear first member 12 with a finger ring 26, a non-linear second member 14 with a finger ring 26', a vaginal occluder 18, and pivot means 54 comprising two slip joints 56 and 56'. Both members 12 and 14 push through holes in the vaginal occluder 18. In this alternative embodiment, the distal end of the second member 14 can be separated from the pointer 20 (not shown) and semicircular structure 36 (not shown) to facilitate insertion of the vaginal occluder 18. The vaginal occluder 18 is made of medical grade silicon and can be fitted with different size collars in order to fit different sized vaginas. In the embodiment shown in Figure 14, the uterine manipulator 10 does not have a vault occluder 46.

[0086] A perspective view of the uterine manipulator 10 of Figure 14 is shown in Figure 15.

[0087] A further alternative perspective view of the uterine manipulator 10 of Figure 14 is shown in Figure 16.

[0088] The main disadvantage of uterine manipulators currently in use, is the difficulty in abdominally identifying the cervix-vaginal junction, particularly in obese patients. Unlike uterine manipulators currently in use, the pointer of the device of the present invention can be moved in a vertical direction and thereby helps to easily identify the cervix-vaginal junction. In addition, after the first incision, the pointer acts as a guide to separate the vagina from the cervix.

[0089] Another disadvantage of uterine manipulators currently in use, is that they are not easy to use on patients with a large cervix. Current uterine manipulators have a cylindrical or cup-shaped distal end, which does not necessarily fit over all sizes of cervix. The semi-circular structure at the distal end of the uterine manipulator of the present invention is able to slide around the cervix as the manipulator is rotated through 360 degrees, irrespective of the size of the cervix. Consequently, a colpotomy can be performed safely and in a shorter period of time.

[0090] The uterine manipulator allows for fixing the uterus and the uterine cervix, mobilizing and allowing a satisfactory exposure of anatomical structures. This leads to the surgical procedure being performed in a more secure manner, and within a shorter period of time, compared to using current uterine manipulators.

[0091] The procedure is carried out by positioning the uterine manipulator such that the pointer demarcates the cervix-vaginal junction. The vaginal occluder prevents leakage of the pneumoperitoneum.

[0092] Once colpotomy is completed, the uterus is removed through the vagina with the uterine manipulator. Thereafter, the uterine sound and second member are removed from the uterine manipulator and replaced with a vault occluder and the manipulator is re-inserted into the vaginal cavity. The vault occluder serves two functions in the procedure. Firstly, the needle that is used to stitch the vaginal vault is nicked to the vault occluder and pushed safely through the vagina and can be retrieved abdominally. Secondly, the vault occluder helps to identify the edges of the vaginal vault and facilitate stitching, whilst the vaginal occluder prevents leakage of the pneumoperitoneum.

[0093] In summary, the uterine manipulator as described herein provides for complete removal of a human uterus laparoscopically in a manner that is more accurate and faster than using current uterine manipulators.

[0094] Advantageously, the pointer of a uterine manipulator according to the invention allows the surgeon to easily identify the cervix-vaginal junction and therefore readily make the first incision in the cervix-vaginal junction.

[0095] The uterine manipulator is simple to manoeuvre and therefore reduces the time taken for the surgical procedure and also minimizes organ damage.

[0096] In the present specification and claims (if any), the word 'comprising' and its derivatives including 'comprises' and 'comprise' include each of the stated integers but does not exclude the inclusion of one or more further integers.

[0097] 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, the appearance 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. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

[0098] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims (if any) appropriately interpreted by those skilled in the art.

Claims

1. A uterine manipulator comprising:

(ii) a vaginal occluder associated with the first member; and

(iii) securing means to secure the first member in a position relative to the second member,

such that in use, the pivot means connects the first and second members and allows the first and second members to pivot with respect to each other and the securing means prevents further pivoting once the desired position of the first member with respect to the second member is obtained.

2. The uterine manipulator of claim 1, wherein in use, the pointer structure is visible through the abdomen and marks the cervix-vaginal junction.

3. The uterine manipulator of claim 1 or claim 2, wherein the pointer structure further comprises a semi-circular structure which in use, is positioned at the cervix-vaginal junction.

4. The uterine manipulator of any one of claims 1 to 3, wherein the vaginal occluder is a solid hemisphere.

5. The uterine manipulator of any one of claims 1 to 3, wherein the vaginal occluder is a solid spherical cap.

6. The uterine manipulator of any one of claims 1 to 3, wherein the vaginal occluder is a solid spherical segment.

7. The uterine manipulator of any one of claims 1 to 6, wherein the vaginal occluder is made from medical-grade silicon.

8. The uterine manipulator of any one of claims 1 to 7, wherein the pivot means comprises a slip joint.

9. The uterine manipulator of claim 8, wherein the securing means comprises angled teeth on each member that interlock to prevent movement.

10. The uterine manipulator of claim 8, wherein the securing means comprises a slip joint.

12. The uterine manipulator of any one of claims 1 to 10, further comprising a device for stitching the vaginal cuff.

13. The uterine manipulator of claim 12, wherein the device for stitching the vaginal cuff is a vault occluder and comprises a triangular prism-shape structure in combination with a rod adapted to be attached to the first member.

14. The uterine manipulator of claim 13, wherein the vault occluder is made from medical- grade silicon.

15. A method of total laparoscopic hysterectomy, wherein the method comprises utilising a uterine manipulator comprising:

(ii) a vaginal occluder associated with the first member; and

16. The method of claim 15, wherein the pointer structure is visible through the abdomen and marks the cervix-vaginal junction.

17. The method of claim 15 or claim 16, wherein the pointer structure further comprises a semi-circular structure which is positioned at the cervix-vaginal junction.

18. The method of any one of claims 15 to 17, wherein the vaginal occluder is a solid hemisphere.

19. The method of any one of claims 15 to 17 wherein the vaginal occluder is a solid spherical cap.

20. The method of any one of claims 15 to 17, wherein the vaginal occluder is a solid spherical segment.

21. The method of any one of claims 15 to 20, wherein the vaginal occluder is made from medical-grade silicon.

22. The method of any one of claims 15 to 21, wherein the pivot means comprises a slip joint.

23. The method of claim 22, wherein the securing means comprises angled teeth on each member that interlock to prevent movement.

24. The method of claim 22, wherein the securing means comprises a slip joint.

25. The method of any one of claims 15 to 24, wherein the uterine manipulator further comprises a device for stitching the vaginal cuff.

26. The method of claim 25, wherein the device for stitching the vaginal cuff is a vault occluder comprising a triangular prism- shape structure in combination with a rod adapted to be attached to the first member.

27. The method of claim 26, wherein the vault occluder is made from medical-grade silicon.