AU2013205992A1 - Uterine Manipulator - Google Patents

Abstract

A utero-vaginal manipulator (100) comprises a vaginal delineator/manipulator (10B) comprising a hollow tube (12) having a distal end and a proximal end, a distal tip (24) for passing through the vagina and for positioning between the upper vaginal wall and the cervix and one or more gas leakage prevention means (94, 97) for preventing leakage of gas from the distal end to the proximal end of the hollow tube, a uterine manipulator shaft (52) being slidably received within the hollow tube (12), the uterine manipulator shaft (52) having a manipulator tip (54) for positioning in the uterus during use, the manipulator shaft (52) being movable by the surgeon. The invention also relates to the vaginal delineator/manipulator (10B). ItI

Description

UTERINE MANIPULATOR TECHNICAL FIELD [0001] The present invention relates to a utero-vaginal manipulator. The present invention also relates to a vaginal delineator/manipulator and to a uterine manipulator. The devices of the present invention may be used in gynaecological surgical operations. BACKGROUND ART [0002] Hysterectomies involve removal of the uterus. In conventional hysterectomy techniques, a large cut is made in the abdominal wall and the uterus is removed via the large cut. Although this technique has been successfully used for many years, the patient can experience significant post-operative pain and post-operative recovery can be lengthy. [0003] Laparoscopic surgical procedures involve making small cuts in the abdominal wall. The abdominal cavity is inflated with insufflations gas (which is typically carbon dioxide) and laparoscopic instruments are inserted through the small cuts. The surgeon views the site of the operation using a laparoscopic camera or telescope. Other laparoscopic instruments are used for cutting, diathermy and stitching/suturing of structures within the abdomen (depending upon the operation being conducted). Laparoscopic surgical procedures are considerably less invasive than traditional surgical techniques. Laparoscopic surgical procedures typically result in a shorter recovery period for the patient. [0004] Hysterectomies are now being conducted using laparoscopic techniques. Laparoscopic hysterectomies typically involve inserting a uterine manipulator or vaginal tube into the vagina of the patient. The vaginal tube will typically extend into the vagina. The uterine manipulator is used to hold and move the uterus so that the surgeon will always have a clear view of the area at which he or she needs to place the laparoscopic surgical instruments, as well as to more clearly delineate the vaginal wall. Uterine manipulators and vaginal tubes that have been previously used include the McCartney tube, the Clermont manipulator and the RUMI manipulator with Koh cup. The laparoscopic ports/cuts will be made in the abdominal wall. The surgeon will then typically inspect the vital structures around the uterus, such as the ureter, bladder, bowel, blood vessels, etc. The surgeon will then diathermy and cut the top uterine ligaments and make an incision on to the utero-vesical peritoneum and broad ligament. The bladder will be dissected from the vaginal wall. The arteria uterine and pericervical fascia will be cut and subjected to diathermy. The vaginal wall will be cut by electrical diathermy or harmonic scalpel. After removing the uterus through the vagina, the upper vaginal wall will be sutured.

r Any bleeding from pedicles will have diathermy, if required. After closing the laparoscopic ports, the operation will be complete. [0005] The present inventor has conducted many laparoscopic hysterectomies. During those surgical procedures, the present inventor has noticed that currently available uterine manipulators and vaginal tubes have limitations that make them more difficult to use. For example, the McCartney tube is not able to manipulate the uterus. Therefore, it can be difficult to do a laparoscopic hysterectomy as there is a constant need for any assistance to move the uterus around. Further, a number of surgeons tend to rotate the tube. This can also make the operation more difficult for the assistant as well as for the surgeon. [0006] The Clermont uterine manipulator is able to manipulate that the uterus well. However, to delineate the vagina or to make an incision on the vagina, it is necessary that someone must constantly rotate the vaginal part of the manipulator. This is laborious for an assistant or the surgeon. Further, after making an incision to the vagina, problems can be experienced in some cases with gas leaks as the manipulator is not sufficient to prevent gas leakage. This can lead to a loss of insufflations gas from the abdominal cavity. [0007] The RUMI uterine manipulator with Koh cup cannot separately manipulate the vagina and the uterus. Rather, manipulation of the uterus causes manipulation of the vagina, and vice versa. This can be a disadvantage in some cases. As a result of this, the cup does not sufficiently delineate the vagina and it can be difficult to visualise the edge of the cup during a laparoscopic procedure. This can potentially increase complications as well as make the operation more challenging. [0008] It is an object of the present invention to provide a vaginal delineator/manipulator and a utero-vaginal manipulator that overcome or ameliorate one or more of the above disadvantages, or at least provides a commercial alternative to existing vaginal delineators or uterine manipulators. [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] Throughout this specification, the terms "distal" and "proximal" shall be used with reference to the surgeon as the reference point, e.g. distal means distal to the surgeon and proximal means proximal to the surgeon. [0011] In a first aspect, the present invention provides a vaginal delineator/manipulator comprising a hollow tube having a distal end and a proximal end, a distal tip for passing through the vagina and for positioning between the upper vaginal wall and the cervix and one or more gas leakage prevention means for preventing leakage of gas from the distal end to the proximal end of the hollow tube. [0012] In a second aspect, the present invention provides a utero-vaginal manipulator comprising a vaginal delineator/manipulator comprising a hollow tube having a distal end and a proximal end, a distal tip for passing through the vagina and for positioning between the upper vaginal wall and the cervix and one or more gas leakage prevention means for preventing leakage of gas from the distal end to the proximal end of the hollow tube, a uterine manipulator shaft being slidably received within the hollow tube, the uterine manipulator shaft having a manipulator shaft tip for positioning in the uterus during use, the uterine manipulator shaft being movable by the surgeon. [0013] In some embodiments, the vaginal delineator/manipulator has a handle at or near its proximal end. The handle allows for easier manipulation of the vaginal delineator by the surgeon. The handle may be integrally formed with the tube or it may be formed as a separate component and subsequently attached to the tube. [0014] In some embodiments of the present invention, the vaginal delineator/manipulator comprises a replaceable distal tip. The replaceable tip may comprise a single use tip. Alternatively, the replaceable tip may comprise a re-usable tip that may be used a number of times. In this manner, should the distal tip be damaged after repeated use, the distal tip can be removed from the vaginal delineator/manipulator following completion of the surgery and replaced with a fresh distal tip prior to the next operation in which the vaginal delineator/manipulator is used. A single replaceable tip may be used many times (for example, 10 or 20 or more uses) if it is not damaged during surgery. However, the, sterilization department of the hospital is likely to require that the tip be eventually replaced. Consequently, the sterilization department will require that the replaceable tip be changed for a new one. Therefore, the hospital will buy a new replaceable tip. The replaceable distal tip may be connected to the hollow tube by any suitable mechanism. For example, the replaceable distal tip may threadably engage with the tube such that the replaceable distal tip can be screwed onto the tube. In another embodiment, the replaceable distal tip may be provided with a bayonet fitting that engages with a complementary fitting on the tube. In other embodiments, a friction fit may be used to affix the -P replaceable distal tip to the tube. The person skilled in the article will readily appreciate that a number of alternative systems may be used to affix the replaceable distal tip to the tube. [0015] The distal tip of the vaginal delineator/manipulator may have a straight end. Alternatively, the distal tip of the vaginal delineator may have an oblique end or a lip. If the distal tip is a replaceable distal tip, the surgeon may select the distal tip having a shape that the surgeon most prefers to use. [0016] The gas leakage prevention means may comprise one or more gas seals within the hollow tube. The one or more gas seals may comprise one or more universal seals, such as a seal used in a laparoscopic trocar. The one or more gas seals may comprise tri-cut seals. The one or more gas seals may comprise a gas seal that overlies a proximal end of the hollow tube. The one or more gas seals may form a gas seal when the uterine manipulator shaft is not present in the hollow tube. The one or more gas seals may form a seal with an outer surface of the uterine manipulator shaft when the shaft is present in the hollow tube. [0017] The vaginal delineator/manipulator may have a distal portion having a first peripheral length and a proximal portion having a smaller peripheral length. In one embodiment, the distal portion of the vaginal delineator/manipulator may have a first circumference and the proximal portion may have a smaller circumference. For example, the distal portion of the vaginal delineator/manipulator may have a larger diameter than the diameter of the proximal portion of the vaginal delineator/manipulator. As a result of this design, the vaginal delineator/manipulator is easier to manipulate. Further, in this embodiment, the inner diameter of the passageway that passes through the proximal portion of the vaginal delineator/manipulator may be smaller than the inner diameter of the passageway in the distal portion of the vaginal delineator/manipulator. The smaller inner diameter in the proximal portion assists in keeping the uterine manipulator shaft straight and firmly positioned/located relative to the vaginal delineator/manipulator and this stops or minimises unwanted movement of the uterine manipulator shaft. In some embodiments, a shoulder is formed between the distal portion and the proximal portion of the vaginal delineator/manipulator. [0018] In some embodiments, the vaginal delineator/manipulator is essentially straight. For example, a longitudinal axis of the horizontal tube may comprise an essentially straight axis. In other embodiments, the vaginal delineator/manipulator may be curved. [0019] The vaginal delineator/manipulator may be made from a medical grade plastic, such as acetol copolymer, polytetrafluoroethylene(such as Teflon), PEEK, PVC etc. In other embodiments, the vaginal delineator/manipulator may be made from a medical grade stainless steel, aluminium, or titanium. [0020] The uterine manipulator shaft is fitted with a manipulator tip. The manipulator tip may comprise a replaceable manipulator tip. The manipulator tip may be affixed to the uterine manipulator shaft by a threaded engagement. In this manner, the manipulator tip may be screwed onto the uterine manipulator shaft. The manipulator tip may be affixed to the uterine manipulator shaft using other fixing systems, such as bayonet fixing systems. The skilled person will appreciate that other fixing systems may also be used. [0021] The manipulator tip may be provided in a number of different lengths. In this regard, the anatomy of each particular patient's uterus will determine the desirable length of the manipulator tip to be used. [0022] The manipulator tip may comprise a distal portion extending at an angle to a proximally-located portion. In this manner, the manipulator tip may take on the appearance of being bent. In other embodiments, the manipulator tip may comprise a curved shank. By providing the manipulator tip in this shape, enhanced manipulation of the uterus is facilitated the manipulator tip. In other embodiments, the manipulator tip is essentially straight. [0023] The uterine manipulator shaft may be fitted with a handle to facilitate movement of the manipulator shaft by the surgeon. The handle may be removably attached to the uterine manipulator shaft. [0024] In one embodiment of the present invention, use of the utero-vaginal manipulator involves affixing the desired manipulator tip to the uterine manipulator shaft after the manipulator shaft is inserted into the hollow tube of the vaginal delineator such that the uterine manipulator shaft is received in the hollow tube. The handle may then be affixed to the vaginal delineator/manipulator tube. The manipulator tip is then inserted into the uterus. The uterine manipulator shaft may be sutured to the uterus. The vaginal delineator/manipulator may then be slid upwardly along the uterine manipulator shaft until the distal tip thereof is positioned between the upper wall of the vagina and the cervix. Advantageously, the vaginal delineator/manipulator may be moved separately to the uterine manipulator shaft. This allows for independent manipulation of the uterus and the cervix/upper vaginal wall. In this regard, it will be appreciated that the present invention is designed to allow the uterine manipulator shaft to be moved longitudinally relative to the vaginal delineator/manipulator whilst also being able to be rotated to a certain extent relative to the vaginal delineator/manipulator.

[0025] 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. BRIEF DESCRIPTION OF DRAWINGS [0026] Various embodiments of the invention will be described with reference to the following drawings, in which: [0027] Figure 1 shows a perspective view of a vaginal delineator/manipulator in accordance with an embodiment of the present invention; [0028] Figure 2 shows a side view of the vaginal delineator/manipulator shown in figure 1; [0029] Figure 3 shows a top view of the vaginal delineator/manipulator shown in figure 1; [0030] Figure 4 shows an end view of the vaginal delineator/manipulator shown in figure 1; [0031] Figure 5 shows a schematic side view of a vaginal delineator/manipulator in accordance with another embodiment of the present invention; [0032] Figure 6 shows a view of an oblique tip suitable for use with the vaginal delineator/manipulator shown in figure 5; [0033] Figure 7 shows a view of a straight tip suitable for use with the vaginal delineator/manipulator shown in figure 5; [0034] Figure 8 shows a view of another straight tip suitable for use with the vaginal delineator/manipulator shown in figure 5; [0035] Figure 8A shows a view of another tip suitable for use with the vaginal delineator/manipulator shown in figure 5; [0036] Figure 9 shows a side view of a uterine manipulator shaft suitable for use in embodiments of the present invention; [0037] Figure 10 shows a side view of the uterine manipulator shaft with the tip and handle removed; [0038] Figures 11 to 14 show views of replaceable tips suitable for attachment to the uterine manipulator shaft shown in figure 10; [0039] Figure 15 shows a view of the handle after being removed from the uterine manipulator shaft; [0040] Figure 16 shows a top view of a vaginal delineator/manipulator in accordance with another embodiment of the present invention. In figure 16, the components of the vaginal delineator are shown apart and in line for assembly; and. [0041] Figure 17 shows a perspective view of the fully assembled utero-vaginal manipulator in accordance with an embodiment of the present invention. DESCRIPTION OF EMBODIMENTS [0042] It will be appreciated that the drawings have been provided for the purposes of illustrating preferred embodiments of the present invention. Therefore, it will be understood that the present invention should not be considered to be limited solely to the features as shown in the attached drawings. [0043] Figures 1 to 4 show various views of a vaginal delineator/manipulator 10 in accordance with an embodiment of the present invention. The vaginal delineator/manipulator 10 is suitably made from a medical grade plastic material. The vaginal delineator/manipulator 10 is suitably made from a rigid plastic material. The vaginal delineator/manipulator is in the form of a hollow vaginal tube. [0044] The vaginal delineator/manipulator 10 comprises a hollow tube 12 the hollow tube 12 having a passageway 14 extending therethrough from a proximal end to a distal end. The proximal opening 16 of the passageway 14 can be clearly seen in figure 4. The passageway also has a distal opening. The tube 12 has a proximal portion 18 and a distal portion 20. The distal portion 20 has a larger diameter then the proximal portion 18. A shoulder 22 is formed between the proximal portion 18 and the distal portion 20 of the tube 12. [0045] The hollow tube 12 may be fitted with a replaceable tip 24. Provision of a replaceable tip allows the surgeon to select a tip shape that he or she is most comfortable with. [0046] The proximal end of the vaginal delineator 10 is provided with a handle 26. Handle 26 may be integrally formed with the hollow tube 12 or it may be formed as a separate component and subsequently attached to the hollow tube 12. The handle 26 may be removably attached to the hollow tube 12. The handle 26 allows the surgeon to easily manipulate and move the vaginal delineator 10. The handle is connected to the tube at region 19, which comprises a region of slightly larger diameter than the diameter of the proximal portion 18 of the hollow tube. The diameter of the region 19 may be similar to the outer diameter of the distal portion 20 of the hollow tube. [0047] Figure 5 shows a side view of another embodiment of the vaginal delineator/manipulator in accordance with an embodiment of the present invention. The vaginal delineator/manipulator 30 shown in 5 is not drawn to scale. The vaginal delineator/manipulator 30 includes a number of features in common with the vaginal delineator/manipulator 10 shown in figures 1 to 4 and, for convenience, those features will be shown by using the same reference numerals as used in figures 1 to 4, but with the addition of an "A". These features need not be described further. [0048] The vaginal delineator/manipulator 30 shown in figure 5 has a proximal end cap 34 fitted thereto. The end cap 34 includes a passageway 36 passing therethrough. The passageway 36 is provided with an outer gas seal 38 and an inner gas seal 40. The gas seals 38, 40 act to prevent leakage of gas from the distal end of the hollow tube 14A through the proximal and of the hollow tube 14A. The gas seals may comprise universal seals or tri-cut seals. The vaginal delineator 12A also includes a replaceable tip 32. [0049] Figures 6, 7 and 8 show different variations of replacement tips that can be used with the vaginal delineator/manipulator 30 shown in figure 5. For example, the replaceable tip 40 shown in figure 6 has a male threaded portion 42 that can threadably engage with a complementary female threaded portion on the hollow tube 14A. This allows the replaceable tip 40 to be screwed onto the hollow tube 14A. It will be understood that the hollow tube may be provided with a male threaded portion and the replaceable tip may be provided with a female threaded portion. [0050] The replaceable tip 40has a passageway extending therethrough. As can also be seen from figure 6, the replaceable tip 42 has an oblique cut end at its distal end. [0051] Figures 7 and 8 show views of replaceable tips 46 and 48, respectively that may also be used with the vaginal delineator/manipulator 30 shown in figure 5. The replaceable tips 46, 48 are generally similar to the replaceable tip 40 shown in figure 6, except the replaceable tips 46, 48 have straight cut distal ends, such that the plane in which the distal end sits extends perpendicularly to the longitudinal axis of the replaceable tips 46, 48. Tip 48 has a projection 47 extending around its circumference to provide another region that delineates a region that is spaced from the end of the tip. This may be useful in delineating another region for the surgeon to use in radical hysterectomy. For example, the projection 47 may be located 3 cm from the end of the tip 48 so that the surgeon came use projection 47 as a delineation or guide during radical hysterectomy or cancer cases to ensure that full removal of possible cancer cells is achieved. Figure 8A shows another replaceable tip 49 having a square cut end and a lip 51. [0052] The vaginal delineator/manipulator shown in figures 1 to 8 may be used by itself in surgical procedures such as laparoscopic sacrocolpopexy. The vaginal delineator/manipulator can also be used in conjunction with a uterine manipulator to thereby provide a utero-vaginal manipulator. A suitable uterine manipulator is shown in figure 9. The uterine manipulator shaft 50 shown in figure 9 includes a shaft portion 52, a removable tip 54 and a removable handle 56. The shaft portion 52 has a diameter that allows it to pass through the passageway extending through the proximal portion 18 of the vaginal delineator/manipulator 10. Suitably, the diameter of the shaft portion 52 is slightly smaller than the inner diameter of the passageway passing through proximal portion 18 of vaginal delineator/manipulator 10. In this way, the vaginal delineator/manipulator 10 can slidably receive the shaft portion 52 of the uterine manipulator 50. Further, the snug fit between the outer diameter of shaft 52 and the inner diameter of the passageway through proximal portion 18 of the vaginal delineator/manipulator 10 acts to locate the radial position of the shaft within the vaginal delineator/manipulator. [0053] The shaft 52 is shown in figure 10 with the tip 54 and handle 56 removed. As shown in figure 10, the shaft 52 includes a proximal male extension 58 having a neck portion 60. In order to fit the handle, a hollow extension 62 on the handle 56 is slid over the proximal male extension 58. As shown in figure 15, an opening 64 is provided in the hollow extension 62 on the handle 56. A retaining screw or similar (not shown) is used to hold the handle in position. The handle is essentially fixed to the shaft and would normally not be removed from the shaft. The skilled person will appreciate that they are a number of other well known systems that could be used for removably attaching the handle to the shaft. The handle may also be integrally formed with the shaft. [0054] The distal end of the uterine manipulator shaft 52 includes a distal male projection 66 having a recessed region 68 extending around its circumference. The distal male projection 66 is used to attach a replaceable tip to the distal end of the manipulator shaft 52, by way of screw fitting or by way of a bayonet fitting. A whole (not shown) is provided near the distal end of the shaft 52 to enable the shaft to be sutured to the cervix. [0055] Figures 11 to 14 show different variations of replaceable tips 70, 72, 74, 76, respectively. With reference to figure 11, the replaceable tip 70 includes a proximal hollow I U projection 78 having an opening 80therein. This enables the proximal part of the replaceable tip 70 to be slid over the distal male projection 66 on the uterine manipulator shaft 52. A screw fitting or a bayonet fitting may be used to retain the tip on the shaft. [0056] The replaceable tips shown in figures 11 to 14 differ in the length of the tip. For example, tip 70 shown in figure 11 has a long distal extension 81. Tip 72 has a slightly shorter distal extension 82. Tip 76 has yet a shorter distal extension 84 whilst tip 74 has the shortest distal extension 86. As shown in the attached figures, the replaceable tips include the hollow proximal projection 78 that has an outer diameter that is essentially the same as the outer diameter of manipulator shaft 52. A region of enlarged diameter 88 is provided between the distal extension 81 and the hollow proximal projection 78 of the replaceable tip 70. This acts to prevent the tip be inserted too far into the uterus. Region 88 acts as a stop and prevents the tip from perforating the top of the uterus and other organs. To further minimise the risk of perforating the top of the uterus, the surgeon will typically select a tip that is at least 2 cm shorter than the length of the uterus. [0057] Figure 16 shows a vaginal delineator/manipulator 10B that is similar to that shown in figure 1 with further modifications to the proximal end. In figure 16, features that are common with the feature shown in figures 1 to 4 are denoted by a similar reference number, but with the letter "B" added thereto. The vaginal delineator/manipulator 10B shown in figure 16 includes a threaded portion 90 at a proximal end of thereof. An end cap 92 is provided with a complementary female threaded portion 93. End cap 92 has a passageway extending therethrough. The vaginal delineator 10B is provided with an inner seal 94 that is inserted into the passageway extending through the threaded portion 90. When the end cap 92 is screwed onto the threaded portion 90, the inner seal 94 is held securely in place. [0058] The end cap 92 has a proximal projection 95 that has a neck region 96. A closure 97 may be removably placed over the proximal projection 95 to fully close the passageway extending through the end cap 92. Although not shown in figure 16, the end cap 92 may be provided with an outer seal that sits between the proximal part of the region 93 and the proximal end of the end cap 92. The closure 97 may also be provided with or comprise a seal that can form a seal between the end cap and the closure. The uterine manipulator shaft may be inserted through the closure and the closure may form a seal with the shaft. [0059] In order to fully assemble the utero-vaginal manipulator, the uterine manipulator shaft 52 is passed through the vaginal delineator/manipulator 10B. Seals are formed about the shaft 52 by the closure 97 and the inner seal 94. The replaceable tip 70 is mounted to the I I manipulator shaft 52. The fully assembled utero-vaginal manipulator 100 is shown in figure 17. [0060] In order to use the utero-vaginal manipulator as shown in the attached drawings, the surgeon would normally conduct a gynaecological examination under anaesthesia and place a Sims speculum and a vaginal retractor into the vagina. The uterus length is then measured with a sound. The uterine cervix will be dilated, for example up to number 6 Hegar dilator. The desired uterine manipulator tip length will then be selected. This will normally be around 2 cm shorter than the uterus length. The replaceable tip on the uterine manipulator shaft may have a bent or curved tip, as shown in figure 9, or it may comprise a straight tip, as shown in figures 11 to 14. This will typically depend upon the choice of the surgeon. The desired size of the tube of the vaginal delineator/manipulator (normally selected from 35, 40 and 45 mm diameter) also needs to be chosen, depending on the cervix and vagina size. The uterine manipulator shaft (with tip attached) will be inserted through the vaginal delineator/manipulator and the replaceable uterine manipulator tip will be fitted on to the uterine manipulator shaft. After inserting the tip of the uterine manipulator shaft into the cervix of the uterus, the cervix will be sutured to the uterine manipulator shaft at the six o'clock and 12 o'clock position. The vaginal delineator/manipulator tube part will then be inserted into the vagina and the tube part will be attached to the patient drape with towel clips. The distal end of the hollow tube of the vaginal delineator/manipulator will be positioned between the upper vaginal wall and the cervix. Laparoscopic trocars will be inserted through small cuts made in the abdomen and the abdomen will be inflated with insufflation gas. After inspecting the anatomical structures such as the ureter, bowel, bladder, blood vessels, the top uterine ligaments will be diathermed and cut. The utero-vesical fold peritoneum and the interior-posterior broad ligament peritoneum will be cut. The bladder will be dissected from the anterior vaginal wall. After doing diathermy and cut for arteria uterinas and pericervical fascia, the vaginal wall will then be cut around the edge of the tip of the vaginal delineator/manipulator. In this regard, the tip of the vaginal delineator/manipulator provides a visual indicator to the surgeon as to the correct location to cut the vaginal wall. The tip of the vaginal delineator/manipulator also provides a physical guide around which the surgeon can cut the vaginal wall. The uterus can then be removed via the vagina. After removing the uterine manipulator shaft from the vaginal delineator/manipulator, the vaginal delineator /manipulator will be again inserted into (or will remain in) the vagina to prevent gas leakage and to help finish suturing of the vaginal wall. After checking for haemostasis, the operation will finish. [0061] The vaginal delineator/manipulator and utero-vaginal manipulator of the present invention provides a number of benefits not previously available. These include: I C_ [0062] -It can manipulate the uterus and vagina separately or together; [0063] -The vaginal delineator/manipulator can be used with the manipulator shaft or can be used without the manipulator shaft when the surgeon does not want to put anything into the uterus, for example, for cervical or endometrial cancer. [0064] - It can be used for laparoscopic radical hysterectomy as the second edge or projection of the vaginal delineator will help to cut (3cm) upper vagina; [0065] - The vaginal delineator/manipulator part can be used for specimen retrieval (for example, ovaries, ovarian cyst, fibroid, lymph nodes, etc.) [0066] - The vaginal delineator/manipulator can help to dissect the bladder and rectum from the vagina (eg. laparoscopic sacro further to our meeting from yesterday afternoon, please find attached and updated colpopexy or sacro hystero-colpopexy) [0067] - Problems with gas leakages are avoided; [0068] - The instrument does not have to be rotated by an assistant. If an assistant is used, the assistant only needs to push the uterine manipulator. [0069] - The instrument can be used with an utero-vaginal manipulator holder, therefore allowing instrument to be used without an assistant; [007)] - The instrument is a versatile instrument. It can be used in respect of the following operations: laparoscopically assisted vaginal hystecrectomy, oitai laparoscopic hysterectormiy +/ sacrocolpopexy. total Iaparoscopic radical hysterectomy, subtotal (supracervical) Iaparoscopic hysterectomy+/- sacrocolpopexy, laparoscopic sacrohystero-colpopexy, laparoscopic sacrocolpopexy(vaginal delineator only), and laparoscopic cerclage. [0071] In embodiments where the vaginal delineator/manipulator comprises a removable tip, the tip can be removed and replaced if the tip is damaged following repeated use. It will be understood that the tip of the vaginal delineator/manipulator can form a cutting guide or a cutting surface to facilitate cutting of the upper vaginal wall and this can lead to damage of the tip. [0072] 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. [0073] Reference throughout this specification to 'one embodiment' or 'an embodiment' I 'I 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. [0074] 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 (19)

1. A vaginal delineator/manipulator comprising a hollow tube having a distal end and a proximal end, a distal tip for passing through the vagina and for positioning between the upper vaginal wall and the cervix and one or more gas leakage prevention means for preventing leakage of gas from the distal end to the proximal end of the hollow tube.

2. A vaginal delineator/manipulator as claimed in claim 1 wherein the vaginal delineator/manipulator comprises a replaceable distal tip.

3. A vaginal delineator/manipulator as claimed in claim 2 wherein the distal tip of the vaginal delineator/manipulator has a straight end or an oblique end or a lip.

4. A vaginal delineator/manipulator as claimed in claim 2 or claim 3 wherein replaceable distal tip threadably engages with the tube such that the replaceable distal tip can be screwed onto the tube or wherein the replaceable distal tip is provided with a bayonet fitting that engages with a complementary fitting on the tube, or the distal tip is affixed to the tube by a friction fit.

5. A vaginal delineator/manipulator as claimed in any one of the preceding claims wherein the gas leakage prevention means comprises one or more gas seals within the hollow tube.

6. A vaginal delineator/manipulator as claimed in claim 5 wherein the one or more gas seals comprise one or more universal seals or tri-cut seals or a gas seal that overlies a proximal end of the hollow tube.

7. A vaginal delineator/manipulator as claimed in any one of the preceding claims wherein the vaginal delineator/manipulator has a distal portion having a first peripheral length and a proximal portion having a smaller peripheral length.

8. A vaginal delineator/manipulator as claimed in claim 7 wherein the distal portion of the vaginal delineator/manipulator has a larger diameter than the diameter of the proximal portion of the vaginal delineator/manipulator.

9. A vaginal delineator/manipulator as claimed in 8 wherein the inner diameter of the passageway that passes through the proximal portion of the vaginal delineator/manipulator is smaller than the inner diameter of the passageway in the distal portion of the vaginal delineator/manipulator.

10. A vaginal delineator/manipulator as claimed in any one of claims 7 to 9 wherein a I IJ shoulder is formed between the distal portion and the proximal portion of the vaginal delineator/manipulator.

11. A vaginal delineator/manipulator as claimed in any one of the preceding claims wherein the vaginal delineator/manipulator is essentially straight or wherein the vaginal delineator/manipulator is curved.

12. An utero-vaginal manipulator comprising a vaginal delineator/manipulator comprising a hollow tube having a distal end and a proximal end, a distal tip for passing through the vagina and for positioning between the upper vaginal wall and the cervix and one or more gas leakage prevention means for preventing leakage of gas from the distal end to the proximal end of the hollow tube, a uterine manipulator shaft being slidably received within the hollow tube, the uterine manipulator shaft having a manipulator tip for positioning in the uterus during use, the manipulator shaft being movable by the surgeon.

13. An utero-vaginal manipulator as claimed in claim 12 wherein the vaginal delineator/manipulator comprises a vaginal delineator/manipulator as claimed in any one of claims 2 to 11.

14. An utero-vaginal manipulator as claimed in claim 12 or claim 13 wherein the uterine manipulator shaft is fitted with a manipulator tip.

15. An utero-vaginal manipulator as claimed in claim 14 wherein the manipulator tip comprises a replaceable manipulator tip.

16. An utero-vaginal manipulator as claimed in claim 14 or claim 15 wherein the manipulator tip comprises a distal portion extending at an angle to a proximally-located portion, or the manipulator tip comprises a curved shank, or the manipulator tip is essentially straight.

17. An utero-vaginal manipulator as claimed in any one of claims 12 to 16 wherein the uterine manipulator shaft comprises a handle to facilitate movement of the manipulator shaft by the surgeon.

18. An utero-vaginal manipulator as claimed in any one of claims 12 to 17 wherein the gas leakage prevention means comprises one or more gas seals within the hollow tube.

19. An utero-vaginal manipulator as claimed in claim 18 wherein the one or more gas seals prevent leakage of gas when the uterine manipulator shaft is in the hollow tune and when the uterine manipulator shaft is not in the hollow tube.