Extrauterine manipulator system consisting of two main parts, a first part comprising an adjustable manipulator and a second part for containing the co 2 gas pneumoperitoneum once the upper part of the vagina is cut

Abstract

The invention relates to a manipulator system for laparoscopic extrauterine hysterectomy, which comprises two main parts: a first part (I), which is an abdominal part comprising an adjustable manipulator having a detachable adjustable handle at the end thereof for holding and manipulating the uterus inside the uterine cavity; and a second part (II), which is a vaginal part inserted into the patient's vagina and formed by a cup, a plastic tube and a suction element, the second part allowing the CO2 gas pneumoperitoneum to be contained once the upper part of the vagina is incised. The system solves issues relating to the complexity of use and the costs associated with current manipulators.

Description

[0001] EXTRAUTERINE MANIPULATOR SYSTEM FORMED BY TWO MAIN PARTS. THE FIRST PART COMPRISES AN ADJUSTABLE MANIPULATOR AND A SECOND PART, TO CONTAIN THE CO2 GAS PNEUMOPERITONEUM ONCE THE UPPER PART OF THE VAGINA IS CUT

[0002] Field of Invention

[0003] The present invention relates to the field of manipulators or mobilizers for performing a hysterectomy, specifically to a system comprising two main parts, a first part (I) comprising a manipulator for extrauterine hysterectomy by means of a laparoscopic route, which comprises at its end a loop made from a material selected from surgical nylon, disposable to grasp and manipulate the uterus inside its cavity, and a second part (II), a vaginal part composed of a cup and a piece in the form of a suction cup, which slide through a flexible plastic tubular piece of 12 mm in diameter, which are inserted under pressure into the vagina of a patient, pieces which together allow to contain the pneumoperitoneum of CO2 gas once the upper part of the vagina is cut.

[0004] Background of the Invention

[0005] The following discussion of the prior art is intended to present the invention in an appropriate technical context and to allow its advantages to be properly appreciated. However, unless clearly stated otherwise, reference to any prior art in this specification should not be construed as an express or implied admission that such art is widely known or forms part of the common knowledge in the field.

[0006] The invention relates to the field of devices and systems for the surgical use of a mobilizer for extrauterine hysterectomy by means of a laparoscopic approach.

[0007] A hysterectomy is a recommended surgery for patients experiencing pelvic pain and / or excessive bleeding. In most cases, surgeries are options to improve patients' health, as is the case with a hysterectomy.

[0008] This surgery consists of the removal of the uterus, preserving - or not - the ovaries depending on the age and the surgical indication.

[0009] One of the techniques most recommended by experts is laparoscopic hysterectomy, considered one of the least invasive and whose removal of the uterus is carried out through the vagina, while the incisions are made at the level of the bikini line.

[0010] Laparoscopically assisted vaginal hysterectomy: This refers to patients in whom a procedure is performed laparoscopically, for example: lysis of adhesions, oophorectomy or salpingo-oophorectomy, then the conventional vaginal hysterectomy is performed.

[0011] For this surgical procedure, carbon dioxide gas (CO2) is currently used for insufflation of the abdominal cavity (pneumoperitoneum).

[0012] - Laparoscopic hysterectomy: involves the laparoscopic ligation of the uterine vessels. After the ligation, the rest of the surgery can continue laparoscopically or vaginally.

[0013] - Laparoscopic supracervical hysterectomy: as the name suggests, this involves leaving the cervical stump partially or completely intact. This technique leaves the cervix intact, preserving the uterosacral and cardinal ligaments. Some authors believe that sexual function is better protected by safeguarding the cervix and vagina. The uterus is removed by morcellation from above or below.

[0014] Much confusion has arisen due to the multitude of techniques used in this surgical procedure and the terminology employed. Therefore, classifications have been proposed to assess the technique used and the extent of the laparoscopic procedure. One such classification is the Clermont-Ferrand classification, which is described below:

[0015] Type I: includes hemostasis and sectioning of the adnexal pedicles and round ligaments, which releases the cusp of the broad ligament and facilitates the remaining maneuvers via the vaginal route. Type II: combines uterovesical detachment and hemostasis of the uterine pedicles.

[0016] Type III: performs the dissection of the cervix via an intrafascial route, hemostasis of the cervicovaginal pedicles and begins the vaginal opening.

[0017] Type IV: This involves performing the entire hysterectomy laparoscopically, including the vaginal opening and closure. The only time the vaginal opening is used is for the removal of the specimen.

[0018] With the methods and technical details in place to avoid and minimize the risk of injuries inherent to laparoscopic procedures (trocars and pneumoperitoneum), these injuries should not occur, as they decrease with the experience of the surgeon and surgical team. The most important thing after injuring a structure is its timely diagnosis and treatment during the same surgical procedure, as this is what defines the patient's postoperative course.

[0019] In the field of manipulators or mobilizers for hysterectomy and the types of devices used for this purpose, there is a continuous demand for a simple and safe manipulator that provides greater patient safety and greater dexterity for the physician. Several aspects are relevant to achieving these objectives, such as the effectiveness of the manipulator / mobilizer. The design of the manipulator for extrauterine hysterectomy via laparoscopy, which comprises a loop for grasping and manipulating the uterus within its cavity, can influence and improve some of the previously identified aspects. This is because it does not require insertion through the vaginal cavity, but rather through a laparoscopic approach. Furthermore, by reducing the size of the loop for insertion and then, once inside the uterine cavity, expanding and maneuvering the loop through an external mechanism incorporated within the manipulator.

[0020] Some types of manipulators: gripping, clamping, cutting and dissecting, electric, retraction

[0021] For prior art information, see Australian Patent No. 677782, which describes an intrauterine mobilizer consisting of a bipolar surgical loop and its method of use in surgery. The snare instrument has a continuous, flexible, electrically insulating loop that traps the uterus to provide localized, targeted necrosis and hemostasis of the protruding tissue of a patient.

[0022] The document from the National Library of Medicine, Medicine (Baltimore). 2023 Jun 2; 102(22): e33927 should also be consulted.

[0023] Published online 2023 Jun 2. doi: 10.1097 / M D.0000000000033927

[0024] PMCID: PMC10238037

[0025] PMID: 37266642

[0026] Surgical outcomes of intra-abdominal versus vaginal approach for uterine manipulation during total laparoscopic hysterectomy.

[0027] A new and different technique (reining technique) is described that allows abdominal manipulation of the uterus in a laparoscopic hysterectomy, and the advantages and disadvantages of this method are discussed.

[0028] The aim of this study was to define a new method for manipulating the uterus during laparoscopic hysterectomy. A total laparoscopic hysterectomy (TLH) was performed using the newly defined technique in 29 patients between July 2016 and July 2017. In this new technique, the uterus was secured to the uterine body and fundus with polyester tape, allowing for abdominal manipulation. The technique was successfully performed on the first attempt in 93.1% of cases. It was repeated in two cases (6.9%) because the polyester tape slipped away from the uterus on the first attempt. The mean application time was 11.2 minutes. A vaginal manipulator was not required in any of the cases. There were no intraoperative complications.In conclusion, this method has the advantages of not requiring any vaginal manipulator, reducing the number of people needed during the operation, allowing almost maximum manipulation of the uterus in three dimensions, and giving the surgeon direct control of these manipulations. On the other hand, the technique also presents some shortcomings that should be discussed and improved in the future. Impact of the statement: What is already known about this topic? In a laparoscopic hysterectomy, manipulation of the uterus is essential for the anatomical dissection of the regions and for completing the operation without complications. In this study, we describe a new and different technique (the rein technique) that allows abdominal manipulation of the uterus in a laparoscopic hysterectomy and discuss the advantages and disadvantages of this method. What do the results of this study add? The procedure was easily performed in most patients.An additional uterine manipulator was not required in any of the cases. What are the implications of these findings for clinical practice and / or future research? In conclusion, the uterine manipulation technique with reins is effective and safe.

[0029] Therefore, there remains a need for an economical, convenient, fast, and suitable uterine manipulator system for performing surgical procedures, eliminating the need for an assistant and, most importantly, offering the most appropriate range of motion. This system would address some existing drawbacks related to current manipulators and the various techniques being developed, and would also allow for hemostasis—that is, a reduction in uterine bleeding—when required, for example, in the case of a myomectomy for the removal of fibroids located in the uterine wall. Hemostasis is achieved by compressing the area of ​​the cervix where the arteries enter, thus preventing uterine bleeding.

[0030] Summary of the Invention

[0031] The invention relates to providing a system comprising two parts: the first abdominal part (I) related to a manipulator for laparoscopic extrauterine hysterectomy, and the second vaginal part (II), consisting of a cup and a suction cup-like piece, which slide through a flexible plastic tube 12 mm in diameter. These parts are inserted under pressure into a patient's vagina, and together they contain the pneumoperitoneum of CO2 gas once the upper part of the vagina is incised. This and other objectives, which will become apparent below, are achieved by means of the manipulator system for laparoscopic extrauterine hysterectomy, as defined in claim 1.

[0032] A number of non-exhaustive embodiments, variants, or alternatives of the invention are defined by means of the dependent claims.

[0033] Effects of the invention

[0034] The present invention comprises a technological advantage over known systems by using a two-part system (I and II), the first part (I) consisting of a manipulator comprising a disposable loop at its right end, and a second part (II) vaginal part consisting of a plastic tube cup and nipple which allows the pneumoperitoneum of CO2 gas to be contained once the upper part of the vagina is cut, to perform an extrauterine hysterectomy by means of a laparoscopic route, of simple design, effective and low production cost.

[0035] Brief Description of the Figures

[0036] In order that the present invention may be more easily understood, reference will now be made to the accompanying drawings which illustrate a preferred embodiment of the invention, in which:

[0037] Figure 1 shows a perspective view of the manipulator, according to the invention.

[0038] Figure 2 shows a front elevation view of the manipulator, according to the invention.

[0039] Figure 3 shows a detailed view of the inward and outward displacement of the insert that carries a disposable handle at its right end, which slides through the inside of a surgical stainless steel tube, according to the invention.

[0040] Figure 4 shows a detailed view of the vaginal part of the system being inserted through the vagina of a patient, according to the invention.

[0041] Figure 5 shows a detailed schematic view of a uterus being manipulated by means of the disposable loop, according to the invention. Figure 6 is a detailed view of the cylindrical, pacifier-like piece of the second part of the system, for containing the pneumoperitoneum of CO2 gas, according to the invention.

[0042] Figure 7 is a view of the first cylindrical portion at the left end that acts as a lock nut for the main tubular portion, according to the invention.

[0043] Figure 8 is a view of the second cylindrical portion that acts as a handle for the main tubular portion, where the fixing pin of the insert that carries the disposable handle, according to the invention, can be seen at its upper right end.

[0044] Figure 9 is a detailed view of the fixing bolt of the insert that carries the disposable handle, according to the invention.

[0045] Detailed Description of the Invention

[0046] The present invention will now be described with reference to the following embodiments, which are to be considered in all respects as illustrative and not restrictive. In the figures, the corresponding features within the same embodiment or common to different embodiments have been assigned the same reference numbers.

[0047] The present invention consists of a manipulator system (1) for medical use in laparoscopic surgical procedures, where it is necessary to manipulate the uterus (U) in the abdomen (A) of a patient (P) in an agile and safe manner in order to extract the uterus (U) from the patient's body (P) after a series of procedures via laparoscopic hysterectomy. The manipulator system (1) for extrauterine hysterectomy via laparoscopy (2) is composed of two separate main parts (I and II), which in turn comprise other movable parts arranged inside.

[0048] In Figures 1, 2, and 3, the abdominal part (I) of the system (1) can be observed, comprising a main rigid tubular portion (3) with a diameter of 5 mm, made from surgical stainless steel, with a length of approximately 35 cm. A removable surgical stainless steel insert (4) with a diameter of 4 mm and a length of 20 cm slides through its interior. This insert has a hook (5) attached to its right end (ED), which allows a disposable handle (6) made from a suitable plastic material to be securely and removably attached. This handle has a connecting ring (7) located at its posterior end, which allows manipulation of the uterus (U) to perform the surgical intervention.

[0049] The removable insert (4) slides in (D) and out (F) through the interior of the main rigid tubular portion (3) made of surgical stainless steel 5 mm in diameter, thus allowing the inner diameter (23) of the loop (6) to be enlarged or decreased, and sliding out (F) allows its removal from the interior of the main rigid tubular portion (3) for sterilization and replacement of the disposable loop (6).

[0050] Towards the right end (ED) of this abdominal part (I) is located a first cylindrical portion of larger dimension as an adjustable handle (7), with a length of 10 cm, an outer diameter of 2.54 cm, and a centered perforation (8) inside with a diameter of 5 mm, to allow passage through the main rigid tubular portion (3), this adjustable handle (7) only slides back a shorter distance (9), around the left end (ED) of the main rigid tubular portion (3), until it limits at a stop flange (10).This adjustable handle (7) has located at its upper right end a smaller cylindrical portion as a fixing bolt (11), oriented horizontally on the adjustable handle (7), centered and oriented downwards is a spun cylindrical portion of smaller dimension and diameter (12) that allows rotation clockwise or counterclockwise to tighten or loosen said adjustable handle (7) around the main rigid tubular portion (3), so as to move it outwards (F) or inwards (D) fixing or loosening it to allow manipulation of the disposable loop (7) inside the uterus (U).

[0051] Towards the right end (ED) of the main rigid tubular portion (3), there is a third cylindrical portion in the form of a counter nut (13), with a length of 3 cms and a diameter of 5 mms, inside it has inserted a spun cylindrical piece (14) that allows it to be screwed around the spun end (15) of the main rigid tubular portion (3), and allows the manipulator (1) to be completely disassembled.

[0052] Figure 4 shows a view of the second part (II) of the system (1), the vaginal part, which is formed by a plastic tube (16) 12 mm in diameter and 20 cm long around which, at its left end (El), there is a vaginal insertion device (17) formed by a conical cylindrical piece in the form of a cup (18) which orients the larger diameter portion of the cone towards the inside of the vagina (V) or towards the abdomen (A) immediately towards the right end (ED) of this cup-like piece (18) there is a cylindrical portion of smaller diameter (19) which opens outwards to form a semi-spherical piece (20) which limits in an edge in the form of a ring of larger diameter (21) than the semi-spherical piece (20) in the form of a pacifier.This second part (II) of the system is introduced through the vagina (V) by pressing the cup (18) inside the cervix (22) together with the semi-spherical piece (20) as a pacifier, leaving the 12 mm diameter plastic tube (16) outside the vagina (V), so as to allow the pneumoperitoneum of CO2 gas to be contained once the upper part of the vagina (V) is cut.

[0053] In Figure 5, a view of the disposable loop (6) arranged to surround and embrace a uterus (U) to be operated on can be observed.

[0054] Figure 6 is a detailed view of the vaginal part (II) of the system (1), where the cup (18), semi-spherical piece (20) in the shape of a pacifier and tubular piece (16) can be seen.

[0055] Figure 7 is a detailed view of the cylindrical portion acting as a lock nut (13) for disassembling and additionally maneuvering the manipulator (1), a side view to observe the central perforation inside which is located a spun cylindrical portion (14) that allows screwing into the left end (El) of the spun (15) of the main rigid tubular portion (3).

[0056] Figure 8 is a detailed view of the cylindrical portion in the form of an adjustable sliding handle (7) to allow disassembly and additional maneuvering of the manipulator (1). Additionally, on its upper right end, there is a fixing bolt (11) that allows the adjustment of the disposable handle (6) by pushing the manipulator (1) inwards (D) or outwards (F), closing or opening the diameter (23) of the disposable handle (6) in the form of a loop. In the side view, the central perforation (8) can be seen inside which the main rigid tubular portion (3) is located.

[0057] Figure 9 is a detailed view of the fixing bolt (11). You can see the lower cylindrical threaded portion (12) which allows the fixing bolt (11) to be screwed or loosened from its threaded hole (24) located on the upper right end of the handle (7), so that the insert (4) can be slid inwards (D) or outwards (F), or the disposable handle (6) can be left in a fixed position as a loop, with the fixing bolt (11) tightened.

[0058] Those skilled in the field will appreciate that the principles of this description are not limited to the specific example discussed or illustrated in the figures. For example, although the tubular cylindrical portions have diameters of 5 and 4 mm in terms of cross-section, other configurations for the tubular portions are feasible.

[0059] Approximation terms are intended to encompass ranges of values ​​that do not change the function or outcome of the described structure or process. For example, the term "around" generally refers to a range of numerical values ​​that someone skilled in the art would consider equivalent to the cited numerical value or to have the same function or outcome. Similarly, the antecedent "substantially" means largely, but not completely, the same form, mode, or degree, and the particular element will have a variety of configurations that someone with ordinary knowledge of the art would consider to have the same function or outcome. For example, "substantially parallel" need not be exactly 180 degrees but can also encompass slight variations of a few degrees depending on the context.

[0060] While aspects of this description have been shown and described in particular with reference to the preceding embodiments, those skilled in the art will understand that various additional embodiments can be achieved by modifying the machines, systems, and methods described without departing from the spirit and scope of the description. It is understood that such embodiments fall within the scope of this description as determined by the claims and any equivalent thereof.

[0061] Industrial Application

[0062] The present invention, according to its application, finds use in the field of devices and systems for the surgical use of a mobilizer for extrauterine hysterectomy by means of laparoscopy, in clinics, hospitals, small and medium-sized enterprises in the production of plastic and silicone parts, and in the metal / mechanical industry in the production of tubular portions and fastening pieces such as surgical steel screws.

[0063] Reference list

[0064] Abdomen

[0065] D Inwards

[0066] F Outwards

[0067] ED Far right

[0068] The far left

[0069] Patient P

[0070] Uterus

[0071] Part I handle

[0072] Part II Vaginal

[0073] 1 Extrauterine Manipulator System

[0074] 2. Laparoscopic approach

[0075] 3 Main rigid tubular portion, 5 mm diameter

[0076] 4 Removable surgical stainless steel inserts, 4 mm diameter

[0077] 5 Crochet hook

[0078] 6 Disposable handle

[0079] 7 End connecting ring handle

[0080] 8 Centered drilling

[0081] 9 Shortest distance

[0082] 10 Stop flange Fixing bolt

[0083] Smaller cylindrical portion spun with a smaller diameter

[0084] Cylindrical portion acting as a lock nut

[0085] Spinned cylindrical portion

[0086] Spinned end

[0087] Plastic tube, 12 mm diameter

[0088] Vaginal insertion device

[0089] Bowl

[0090] Cylindrical portion of smaller diameter

[0091] Semi-spherical piece

[0092] Larger diameter ring

[0093] Cervix

[0094] Handle opening diameter

[0095] Top spun perforation handle

Claims

CLAIMS 1. A manipulator system (1) for extrauterine hysterectomy by means of a laparoscopic approach (2), comprising a loop (6) for grasping and manipulating a uterus (U) within its cavity, which resolves some drawbacks related to the complexity of use and associated costs of current manipulators, CHARACTERIZED in that it comprises: - two assembly parts (I and II) - abdominal part (I) and - vaginal part (II), where the abdominal part (I) comprises a main rigid tubular portion (3), with a diameter of 5 mms, made from surgical steel, with a length of about 20 cms, through its interior slides a removable insert of surgical stainless steel (4) with a diameter of 4 mms which has at its right end (ED), attached in a fixed manner a hook of the (crochet) type (5), which allows to securely and removably attach a disposable loop (6) made from a suitable plastic material, which has located at its posterior end a connecting ring (7), attached in a fixed manner to it, which allows manipulation of the uterus (U) in order to perform a surgical intervention, this removable insert (4) slides inwards (D) and outwards (F) through the interior of the main rigid tubular portion (3) of surgical stainless steel of 5 mms diameter,so as to allow its removal from inside the main rigid tubular portion (3) for sterilization and replacement of the disposable loop (6), and the second part (II), vaginal part is composed of a cup (18) and a semi-spherical piece (20) in the form of a pacifier that limits in a rim or ring of larger diameter (21), which slide through a flexible plastic tubular piece of 12 mm in diameter (16), which are introduced under pressure into the interior of a vagina (V) of a patient (P), pieces which together allow to contain the pneumoperitoneum of CO2 gas once the upper part of the vagina (V) is cut.

2. The manipulator (1) for extrauterine hysterectomy, according to claim 1, CHARACTERIZED in that towards the right end (ED) of this abdominal part (I) there is located a first cylindrical portion of larger dimension in the form of an adjustable handle (7), with a length of 10 cm, an outer diameter of 2.54 cm, and a perforation centered (8) inside with a diameter of 5 mm, to allow passage through it of the main rigid tubular portion (3), this adjustable handle (7) only slides backwards a shorter distance (9), around the left end (ED) of the main rigid tubular portion (3), until it is limited in a stop flange (10).

3. The manipulator (1) for extrauterine hysterectomy, according to claim 2, CHARACTERIZED in that the adjustable handle (7) has located at its upper right end a smaller cylindrical portion as a fixing pin (11), oriented horizontally on the adjustable handle (7), centered and oriented downwards is located a smaller cylindrical portion of smaller dimension and diameter (12) that allows rotation clockwise or counterclockwise to tighten or loosen said adjustable handle (7) around the main rigid tubular portion (3), so as to move it outwards (F) or inwards (D) fixed or loosening it to allow manipulation of the disposable loop (7) inside the uterus (U).

4. The manipulator (1) for extrauterine hysterectomy, according to claim 3, CHARACTERIZED in that towards the right end (ED) of the main rigid tubular portion (3), there is a third cylindrical portion in the form of a counter nut (13), with a length of 3 cm and a diameter of 5 mm, inside of which is inserted a spun cylindrical piece (14) that allows it to be screwed around a spun end (15) of the main rigid tubular portion (3), and allows the manipulator (1) to be completely disassembled.

5. The manipulator (1) for extrauterine hysterectomy, according to Claim 4, CHARACTERIZED in that the cylindrical portion in the form of an adjustable handle (7) is sliding so as to allow disassembly and additional maneuvering of the manipulator (1), additionally on its upper right end there is a fixing bolt (11) which allows the adjustment of the disposable handle (6) by pushing the manipulator (1) inwards (D) or outwards (F), closing or opening the diameter (23) of the disposable handle (6) in the form of a loop, in the side view a central perforation (8) can be seen inside which a main rigid tubular portion (3) is located.

6. The manipulator (1) for extrauterine hysterectomy, according to claim 5, CHARACTERIZED in that the fixing pin (11) has a lower cylindrical threaded portion (12) that allows the fixing pin (11) to be screwed or loosened from its threaded perforation (24) located on the upper right end of the handle (7), so as to slide the insert (4) inwards (D) or outwards (F), or to leave the disposable handle (6) in a fixed position, with the fixing pin (11) tightened.

7. A second part of the manipulator system (1) for extrauterine hysterectomy, CHARACTERIZED in that it comprises the vaginal part, which is formed by a plastic tube (16) of 12 mm in diameter and 20 cm in length around which, at its left end (El), a vaginal insertion device (17) is located, formed by a conical cylindrical piece in the form of a cup (18) which orients the larger diameter portion of the cone towards the inside of the vagina (V) or towards the abdomen (A) immediately towards the right end (ED) of this cup-like piece (18) is located a cylindrical portion of smaller diameter (19) which opens outwards to form a semi-spherical piece (20) which limits in the form of a ring of larger diameter (21), than the semi-spherical piece (20) in the form of a pacifier.

8. The second part (II) of the manipulator system (1) for extrauterine hysterectomy according to claim 7, CHARACTERIZED in that the part The vaginal device is inserted through the vagina (V) by pressing the cup (18) together with the semi-spherical piece (20) into a cervix (22) as a pacifier, leaving the 12 mm diameter plastic tube (16) outside the vagina (V), so as to allow the pneumoperitoneum of CO2 gas to be contained once the upper part of the vagina (V) is cut.

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