WO2024069476A1

WO2024069476A1 - Integrated uterine manipulator

Info

Publication number: WO2024069476A1
Application number: PCT/IB2023/059617
Authority: WO
Inventors: Giorgia GAIA
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-09-27
Filing date: 2023-09-27
Publication date: 2024-04-04
Anticipated expiration: 2025-03-27
Also published as: IT202200019764A1

Abstract

The present invention relates to a uterine manipulator, in particular a disposable uterine manipulator, which may be integrated into a V-NOTES (Vaginal natural orifice transluminal endoscopic surgery) system, in particular in such a way that it does not take any additional space relative to the outer disc at the vaginal introitus, being incorporated into the disc itself without limiting the diameter of the vaginal introitus and therefore the movement of laparoscopic instruments.

Description

Integrated uterine manipulator

The present invention relates to a uterine manipulator, in particular a disposable uterine manipulator, which can be integrated into a V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) system.

Prior Art

Benign ovarian pathology refers to the presence of cystic ovarian neoformations of different histological nature (endometriotic cysts, mucinous cysts, serous cysts, dermoid cysts, etc.). These neoformations, which are sometimes symptomatic but more often clinically silent, are detected during the gynaecological examination and the diagnosis is confirmed by transvaginal sonography. The surgical approach to the treatment of benign ovarian pathology has over the years seen a significant reduction in the incidence of traditional laparotomy involving the opening of the abdomen in favour of an increase in minimally invasive techniques among which mainly laparoscopy. In 2009, a Cochrane systematic review, including 9 randomised controlled trials with a total of 769 patients, indicated laparoscopy as preferable compared to laparotomy in the gynaecological field in terms of reduced incidence of fever, urinary tract infections, post-operative complications, post-operative pain, hospital stay, total costs, and aesthetic outcome of skin scars. In line with these clinical results and the progressive development of technology, minimally invasive surgery has evolved in different directions. Minimally invasive surgery has attempted, in developing robotic surgery, to reproduce in a minimally invasive context the three-dimensional vision and manoeuvrability of open surgery in response to the significant costs currently associated with the purchase of the robotic system and disposable material. Technological advancement has also resulted in the development of the Single Port approach that uses a single umbilical laparoscopic access instead of the traditional 4 abdominal accesses in an atempt to further reduce wall invasiveness at the expense of a loss of degrees of freedom of movement for the operator.

In line with this field of surgery, natural orifice transluminal endoscopic surgery (V-Notes) was born, which uses access to the pelvis or abdomen through natural orifices such as the oral cavity or vagina, completely eliminating skin wall incisions. This technique made its debut in the field of general surgery in 2005 when the first transluminal transgastric appendectomy was published {"Per oral transgastric endoscopic appendectomy in human", N. Reddy, P. Rao, Paper presented at 45th Annual Conference of Gastrointestinal Endoscopy of India, Jaipur, India, February 28-29 2004). The V-Notes system has since then been considered the new frontier of the minimally invasive approach and other general surgery (cholecystecimia), urology (nephrectomy) and gynaecology operations (adnexiectomy, hysterectomy, ovarian cyst removal, salpingectomy, lymphadenectomy, myomectomy) followed.

The V-Notes system, as it is structured today, allows minimally invasive surgery by the vaginal route thanks to the combination of two (2) discs, respectively an outer disc and an inner disc, connected to a plastic-coated membrane that maintains the pneumoperitoneum and allows the protected introduction of minimally invasive laparoscopy-specific instruments through the vagina with access to the pelvis. The system consists of an inner plastic disc existing in three (3) sizes, which is inserted after a posterior culdotomy into the posterior vaginal fornix.

The inner disc is connected via a transparent plastic tubular system to a second outer disc which is applied to the vaginal introitus. A gelatin disc called GelSeal Cup is attached to the outer disc and allows the passage of three (3) trocars by acting as a fulcrum and maintaining the pneumoperitoneum. Adapted and specific tools for the V-NOTES system are not required. Trocars allow the passage of the 10-mm laparoscopic optics and of 2 5-mm operator instruments. From a procedural perspective, the Gealseal cup with the housed trocars is atached to the outer disc. The pneumoperitoneum is created by insufflating air or other fluid through a dedicated tube attached to the tap of the Gealseal cup of the trocar.

Most of the studies in the gynaecological literature report series of V-Notes applied to benign ovarian pathology (as in bilateral adnexiectomy - cystectomy) and benign uterine pathology (as in hysterectomy) for a total of 628 cases from 2012 to 2020. Benign adnexal pathology represents the fifth cause leading to gynaecological pathology hospitalisation in the United States, whereof 80% of cases are successfully treated laparoscopically.

When applied to ovarian pathology, studies comparing the current V-Notes technique with traditional laparoscopy have reported significantly shorter operating time for experienced operators, less intra-operative blood loss, less post-operative pain and shorter hospital stay in favour of the former.

The equivalence of the clinical results at least in the initial studies and the total absence of skin scars make this technique preferable especially for younger patients among whom benign ovarian pathology is widespread.

Notwithstanding these advantages, the V-NOTES technique is little widespread worldwide, despite the ovarian pathology has a very' high incidence.

The poor diffusion of the V -notes technique can reasonably be related with two well-known technical difficulties: i) the first, which cannot be changed, is the limited degree of freedom provided to the operator's hands compared to traditional laparoscopy by virtue of the close fulcrum of the instruments in V-notes, and the second is the limited exposure of the pelvic surgical field compared to traditional laparoscopic surgery, which avails itself of a dedicated operator to manage a uterine manipulator that allows lateralisation and anti-retroversion of the uterine viscera. Since the ovaries are connected via the salpinges and via the uterine-ovarian ligaments to the uterus, the displacement of the uterus allows the extension of the ligaments, thus making them visible and thus making it easier to handle them during clotting, grasping and sectioning. Alternating exposure of the pelvic angles also makes it easier to access the ligaments of the pelvic infundibulum, manage any bleeding and secure the ureter housed in the ovarian fossa. In laparoscopy, uterus manipulation is a fundamental part of the surgical approach. Known uterine manipulators used in laparoscopy are disclosed for instance in Patent documents US2019/0223912A1 and US2020/0337729A1. However, these manipulators are not adaptable to the minimally invasive V-NOTES (Vaginal natural orifice transluminal endoscopic surgery) because the gelatin disc (Gelseal Cup) provided for this application prevents their use, in particular it prevents the insertion of the manipulator into the vaginal introitus; moreover, in the V-NOTES technique known to date, the insertion of the manipulator into the intrauterine site is also prevented by the gas (typically CO2) containment system which is insufflated through the vaginal route to the abdominal cavity through the opening of the Douglas pouch. The lack of the manipulator in the current state of V-notes means that the uterine viscera falls posteriorly due to the natural effect of gravity above the ovaries and occupies the pelvic pouch, greatly hindering the vision and mobility of the instruments. The possibility of also manipulating the uterine viscera in V-notes surgery, moving it as required in a cranio-caudal or latero-lateral direction (to the left when working on the right and vice versa, or posteriorly when working anteriorly) can greatly facilitate this surgical technique by reducing the learning curve and increasing its use.

To date, the V-notes system does not include the use of a manipulator; in other words, the V- NOTES system as currently marketed does not have a dedicated uterine manipulator. The outer disc maintaining the pneumoperitoneum entirely occupies the vaginal introitus and the insertion of non-integrated systems is not feasible (e.g., the Gealseal cup and pneumoperitoneum prevent the insertion of further instruments other than those integrated in the Gealseal cup) and not optimal because the limited space and the inability to freely move the manipulator axis limit its use. As mentioned, there already exist several manipulators on the market and widely used in the laparoscopic world, but with the V-notes system, the use of these known manipulators, such as those that would normally be used in laparoscopy, is not applicable.

There is therefore a need for an integrated system specifically adapted for this surgical technique. In particular, the need is dictated by patient safety requirements in terms of an expected reduction in the number of intra-operative complications and/or an expected reduction in operating times (as will be seen below, this is due to the improved exposure of the intra-abdominal operating field thanks to the uterine manipulator according to the present invention) and/or an expected reduction in the learning curve in using the V- NOTES operating system (as will be seen below, this is due to the enlarged working angles thanks to the uterine manipulator according to the present invention).

Thus, surprisingly, a way was found to design and manufacture a manipulator, that is or that may be integrated into the V-notes system or into a similar minimally invasive surgery system with vaginal access. The introduction of this manipulator on the market may lead to an exponential expansion of this surgical technique (e.g. V-NOTES) to the benefit of patients affected by ovarian pathology.

Summary

The general object of the present invention is to overcome the above-mentioned drawbacks related to the known state of the art.

This general object as well as these and other more specific objects are achieved thanks to what is expressed in the appended claims which form an integral part of the present description.

List of figures

The present invention shall become more readily apparent from the detailed description that follows to be considered together with the accompanying drawings in which:

Fig. 1 shows a first partial and schematic side view of an embodiment of a uterine manipulator according to the present invention before it is ready for use.

Fig. 2 shows a second partial and schematic side view of the embodiment of Fig.1 and an innovative tubular bag,

Fig. 3 shows a third partial and schematic side view of the embodiment of Fig.2 in a first assembly step,

Fig. 4 shows a fourth partial and schematic side view of the embodiment of Fig.2 in a second assembly step,

Fig. 5 shows a section of a first schematic and simplified example of use of the uterine manipulator according to the present invention, and

Fig. 6 shows a section of a second schematic and simplified example of the use of the uterine manipulator according to the present invention.

Description The uterine manipulator object of the present invention consists of at least three (3) parts, preferably four (4) parts, hereinafter referred to as A, B, C and D (see for example Figures 1-4). The uterine manipulator comprises a blunt terminal element A, in particular in the form of a rod with a blunt end, with a length preferably of about 7 cm, a diameter preferably of about 3 mm surmounted by a sheath with a reservoir (al) inflatable with air or a fluid, more preferably made of soft plastic. Preferably, the terminal element A is made of plastic, advantageously soft plastic. Specifically, the blunt terminal element A is adapted to be inserted into the cervical canal and, through it, it is housed in the endometrial cavity. In particular, the terminal portion of the terminal element A is blunt, so as to protect and avoid possible uterine perforation when the terminal element A is inserted.

The intrauterine terminal element A continues with an arm B, in particular a straight rod, preferably having a length of 25 cm and a diameter of 6 mm. Preferably, the arm B is made of plastic, advantageously soft plastic.

The aforementioned terminal element A forms with the arm B an angle ranging from 160° to 180° (it should be noted that Figure 5 and Figure 6 are schematic Figures and show an angle of less than 160° but only for the sake of clarity' and simplification). The proximal end of the arm B, referred to as end X, ends in a removable conical tip bl. Preferably the removable conical tip b1 has a length of about 2 cm. The function of the tip is to pierce the gelatin disc and bring the proximal end X outwards.

According to the present invention, once the Gelseal Cup has been pierced, the tip is removed, e.g, by simply pulling, and the end of the arm B is mechanically connected, in particular, i t is engaged to the portion C as described below. From said inflatable reservoir al , a balloon originates which, once inflated with about 5 ml of a fluid, preferably a sterile fluid, holds the inserted terminal element in place in the endometrial cavity. Insufflation is carried out by means of a tube a2 with a length of preferably 50 cm, more preferably with a length of about 20 cm and a diameter preferably of about 1 mm. Preferably, the tube a2 is made of plastic, advantageously soft plastic, more advantageously transparent plastic, which runs adjacent to the rod B from the reservoir of the end, preferably held adherent thereto by hooks, and ends with a syringe access for inflating the same reservoir (see for example Figures 2, 3 and 4 wherein the tube a2 is partially shown). According to a preferred embodiment, the reservoir al is inflated with water or air. In particular, as wall be explained in more detail hereinafter, the reservoir al is inflated in such a way as to keep the terminal element A in the intrauterine site even during the displacements impressed on the manipulator by the operator.

A pre-set valve (see reference a3 in Figure 6) prevents the reflux of gas or fluid from the inflatable reservoir al to the outside. Advantageously, the tube is fixed to the rod.

The uterine manipulator comprises a further straight rod C, advantageously made of plastic, more advantageously soft plastic, having a length preferably of 20 cm and a diameter preferably of 8 mm, wherein there is a distal end Y, which engages with the proximal end X of the arm B once the tip b1 has been removed, and a proximal end W, which ends with a ergonomical handle that can be maneuvered by a second surgical operator.

Advantageously, the uterine manipulator further comprises a tubular bag D, comprising a plasticized sheath system d2, preferably waterproof and/or transparent, adapted to maintain the induced pneumoperitoneum. Advantageously, the tubular bag D, more specifically the plasticized sheath system d2 is bifurcated; in other words, the tubular bag D, more specifically the plasticized sheath system d2 is Y-shaped. Advantageously, as will be beter described below, the modified tubular bag D further comprises three rings adapted to adhere to the inner walls of the respective designated anatomical sites. More specifically, the tubular bag D is adapted to maintain the pneumoperitoneum in such a way as to ensure proper use of the recently invented manipulator.

The system for maintaining the pneumoperitoneum, i.e. the tubular bag D, is adapted to house the uterine manipulator. According to a preferred embodiment, a first ring d1 made of semi-rigid plastic, about 4 cm in diameter and about 4 mm thick, is housed to embrace the cervix after a second inner ring d3 is placed through the culdotomy in the Douglas. The two rings d1 and d3 are connected to each other by the plasticized sheath system d2, which guarantees the pneumoperitoneum seal; in particular, the first ring d1 is mechanically connected to the end of a first bifurcation of the plasticized sheath system d2 and the second ring d3 is mechanically connected to the end of a second bifurcation of the plasticized sheath system d2. Both rings d1 and d3 are further connected through the transparent plastic sheath d2 to a third outer ring d4. In particular, the third ring d4 is mechanically connected to the end of the plasticized sheath system d2. In particular, the third ring d4 is adapted to adhere to the walls of the vaginal introitus.

Advantageously, the third ring d4 can already be set up by the V-NOTES system or be mechanically connected to the V-NOTES system.

The two rings d1 and d3 are therefore located: one d3 is inserted in the pelvic cavity (specifically as the V-notes system already provides) and the other d1 around the cervix. This displacement of the two rings d1 and d3 on two non-converging planes and longitudinally spaced by at least 4-6 cm (this distance depends on the patient's specific anatomy) means that they do not interfere with each other with the operator's movements; in other words, this displacement does not limit the operator's degrees of freedom of movement. Figures 1-6 schematically represent what is described above. In particular, in order to avoid fluid leaks, the ring d1 that surrounds the cervix must adhere perfectly to it; to this end, the ring d1 is advantageously manufactured in 3 different sizes: 2-3-4 cm in diameter.

From the surgical procedure perspective, and according to an embodiment of the present invention, once performed a posterior culdotomy, the inner ring d3 of the Douglas pouch is inserted. Then the second ring d1 is placed around the cervix without further incisions.

Advantageously, before inserting the ring d3, the size thereof is identified, in particular by using a standard posterior vaginal valva and a standard anterior vaginal valva to simply place the pericervical disc of an appropriate diameter to the neck. Advantageously, the uterine manipulator according to the present invention will provide three rings d3 measuring 2 cm, 3 cm and 4 cm in diameter respectively. Martin forceps are used to draw the cervix, which is probed with a hysterometer, the manipulator is then inserted through the ring d1 into the uterus and the balloon al is inflated through the tube a2. The removable tip b1 of the rod B pierces the outer disc of the GelSeal Cup after the other trocar accesses have been housed. The tip b1 pierces the GelSeal Cup in the lower portion thereof, particularly at the 6 o'clock position, so as not to interfere with the operator's accesses once in place. Once the GelSeal Cup has been connected to the outer ring, the removable tip b1 is removed and the two parts B and C of the manipulator rod (end Y with end X) are hooked together and the manipulator is then ready for use. The GelSeal Cup disc attached to its holder as provided by the V-NOTES system, in particular to the ring d4, closes the vaginal introitus and allows the creation of the pneumoperitoneum, e.g. by insufflating CO2 through the Gealseal cup tap of the trocar.

The uterine manipulator of the present invention integrated into the V-notes system allows it to be manipulated by the second assistant who can simultaneously manage the camera. Thereby, the hands of the first operator are free to proceed at operative and non-expositional surgical times (tissue dissection, cloting and cuting). This is a significant advantage brought about by the uterine manipulator of the invention, integrated into the current V -notes system.

The uterine manipulator according to the invention, being integrated into the existing V-notes system, does not take any additional space relative to the outer disc but is incorporated into it, so the diameter of the vaginal introitus is not a limiting factor.

The improved exposure also allows for better management of any bleeding, potentially reducing the rate of laparotomic or laparoscopic conversions.

The object of the present invention is therefore also the uterine manipulator as described above for use in surgical treatment preferably by minimally invasive surgery, in particular through the vaginal route, with the V-NOTES system. According to an embodiment of the present invention, the uterine manipulator is preferably used in gynaecological surgical treatment, more preferably for surgical treatment of the uterus and adnexa. Even more preferably, the uterine manipulator of the present invention is used for the surgical treatment of cystic ovarian neoformations, preferably endometriotic cysts, mucinous cysts, serous cysts or dermoid cysts.

Claims

CLAIMS A uterine manipulator comprising:

--- a blunt terminal element (A) having a length of preferably about 7 cm and a diameter of preferably about 3 mm, said terminal element being surmounted by a sheath with a fluid-inflatable reservoir (al);

- an arm (B) having a length of preferably 25 cm and a diameter of preferably 6 mm, forming an angle ranging from 160° and 180° with said terminal element (A), wherein the proximal end of said arm (X) ends in a removable conical tip (bl); and

- a straight rod (C) having a length preferably of 20 cm and a diameter preferably of 8 ram, comprising a distal end (Y) that is engaged to the aforesaid proximal end (X) once the aforesaid removable tip (bl) has been removed. The uterine manipulator according to one of the preceding claims, wherein said reservoir (al) is inflated through a tube (a2) having a length preferably of about 20 cm which runs from said sheath with a reservoir (al) adjacent to the arm (B) ending with an access for an inflation syringe for said reservoir (al). The uterine manipulator according to one of the preceding claims, wherein said sheath with a reservoir (al) is adapted to be inflated with 5 ml of a fluid, preferably air or water. The uterine manipulator according to one of the preceding claims wherein the material of the terminal element (A) and/or the arm (B) and/or the straight rod (C) is soft plastic. The uterine manipulator according to one of the preceding claims wherein the straight rod (C) further comprises a proximal end (W) ending in an ergonomic han de1. The uterine manipulator according to one of the preceding claims, further comprising an integrated and adaptable tubular bag (D) for the exclusive use of the proposed system for maintaining the pneumoperitoneum. The uterine manipulator according to claim 6, wherein said tubular bag (D) comprises a plasticized sheath system (d2), in particular a bifurcated plasticized sheath system (d2). The uterine manipulator according to claim 7, wherein each end of said plasticized sheath system (d2) is mechanically connected to a ring ( d1, d3, d4) adapted to adhere to the inner walls of a respective anatomical site. The uterine manipulator according to one of the preceding claims suitable for use in surgical treatment, preferably with minimally invasive surgery with the V-NOTES system. The uterine manipulator according to one of the preceding claims suitable for use in gynaecological surgical treatment, preferably for the surgical treatment of the uterus. The uterine manipulator according to one of the preceding claims suitable for use in the surgical treatment of cystic ovarian neoformations, preferably endometriotic cysts, mucinous cysts, serous cysts or dermoid cysts.