WO2022186790A1 - Uterus manipulation mechanism - Google Patents

Abstract

The invention is designed as the manipulation mechanism of the uterus for the purpose of using in laparoscopic operations and relates to the uterus manipulation mechanism as a whole system ensuring the movement limitation developed to decrease the complications in the favour of the patient alongside medical personnel gaining maximum movement freedom with one grasp in operations related to uterus such as hysterectomy, myomectomy, oophorectomy, sacrohysteropexy, endometriosis, etc. and uterus manipulation mechanism that involves other systems that assist the determination or manipulation of the cervix positioned in the cervical cap integrated to this system.

Description

UTERUS MANIPULATION MECHANISM

TECHNICAL FIELD OF THE INVENTION

This invention is designed as the manipulation mechanism of the uterus for the purpose of using particularly in laparoscopic operations and relates to the uterus manipulation mechanism as a whole system ensuring the movement limitation developed to decrease the complications in the favour of the patient alongside medical personnel gaining maximum movement freedom with one grasp in operations related to uterus such as hysterectomy, myomectomy, oophorectomy, sacrohysteropexy, and endometriosis, etc. and other systems that assist the determination or manipulation of the cervix positioned in the cervical cap integrated to this system.

STATE OF THE ART

Considering the criteria taken into account when evaluating the success of the operation such as patient benefit, short recovery time, and rapid return to normal activities and life routine, it has been understood that some of the problems experienced in the current manipulators are about the designed due to the the assumption that the postoperative complications of the patient should be kept at minimum. Some of the identified deficiencies are as follows:

1- Problems that increase the load on the patient due to the tips entering the uterus allowing linear scanning, scanning a limited area, and the movement of the elements that should not move in the patient in the desired scans outside the limited area are being experienced.

2- While auxiliary elements such as the sealing element on the tip helps to get the uterus out after the operation, it cannot help the medical personnel to take it out at the desired angle due to its immobile design. 3- The patent document numbered "US2010106163" in the state of the art has been examined as a result of the preliminary research made in the latest technology. Said application describes an apparatus which is fixed by insertion into the uterus. In the said invention, a cervical fixation portion and balloon and long shaft system entering the uterus can be seen. Another patent document in the state of the art is the patent document numbered "US9717524B2". The said patent application describes a device in the form of a sleeve to close the vaginal cuff of the vaginal canal after operations such as hysterectomy in which the cervix is removed.

4- Another patent document in the state of the art is the patent document numbered "US2009137970". Said patent application describes universal laparoscopic uterus manipulators/dilators that are variable to match the length of the uterus to avoid the risk of perforation and to provide excellent pelvic exposure regardless of uterus size, shape and location.

5- Dislocation and slipping of the cervical caps that include the cervix, and thus increasing the possibility of damaging the ureters and intestines in close neighbourhood due to the location, causes the operation to be prolonged. Moving at fixed or limited angles, not having sufficient inner depths or not fitting the fornix properly may not help to mark the cervix as the area to be cut during the incision, and may also increase the complications that may occur in the patient after the incision procedure.

6-The main body or shaft parts not remaining fixed in the part that enters the vaginal canal and the sealing element or elements on them, if any, causing air or gas escape from the movement during manipulation and restricting the field of view results in prolongation of the surgery. 7- Since the locking mechanism, which is not on the handle and whose movement cannot help it to stop at the desired angle, proves insufficient in some positions where it cannot remain stable at the desired angle, it is not possible to eliminate the complications that may occur in the patient since the medical personnel will reflect all the force on the patient. 8- Another patent document in the state of the art is the patent document numbered "W02020018046A3". Said patent application is an invention titled “needle manipulators” that helps during incision in the cervix.

An increase in laparoscopic operations has been achieved with the use of a uterus manipulator, thus the operation time was shortened, recovery time was reduced, and the patient is provided with a better comfort and cosmetic appearance. Manipulators that does not serve the purpose and has technically insufficient movement capability causes complications in the patient during and after the operation and prolongs the recovery time, and these complications cause post-operation material and immaterial losses. While the movement mechanisms of the manipulators used in the state of the art are designed in general in order to prevent these complications, complications are seen in the patient due to the fact that the parts that should not move after entering the vaginal canal have no movement capability, and are used in the vaginal canal by turning 180° or in some cases 360°. Manipulators in the state of the art work within a limited framework considering the patient's benefit. In addition to these, some of the manipulators move partially and insufficiently within the patient, cannot maintain their position, and are insufficient in localization of the incision site. In fact, even though healthcare personnel do not prefer it, they sometimes have to remove the existing manipulators partially or completely and then reinsert them during the operation for this reason. Meanwhile air escapes from the system occurs and the field of view of the surgical team is lost. For these reasons, there has been a need to design new manipulators that are superior in terms of mobility and ability and will provide convenience to healthcare personnel during the operation, and reduce the time.

As the cervical caps of the manipulators in the state of the art that include the cervix after they enter the vaginal canal cannot be positioned comfortably in the area to be incised by the doctor who will perform the operation, parts that should not move, like the shafts of the manipulators, apart from the parts that should move, like intrauterine tip and cervical cap, have to be moved. In this respect, it is not possible for the medical personnel to perform better than expected. The reason for this is that the capability of the mobile parts of the manipulator is insufficient, and the parts that should be stable is trying to be moved unnecessarily. Meanwhile the current position cannot be maintained, the incision line is lost if the incision had started, the potential of bleeding and injury of neighbouring organs due to wrong incision increases, the duration of the operation prolongs and even the operation which started laparoscopic is completed laparotomic due to air escapes from the abdomen.

One of the problems that are expected to be solved during the cutting phase of the vaginal cuff is that the air that may leak from the vaginal canal during this incision is stopped by the sealing elements. In the current technique, balloon, gasket, bellows etc. are used as sealing elements. These sealing elements are attached as either added afterwards or fixed to the manipulator. During the movement of the manipulator, the sealing elements may be displaced.

During the operation steps or during the cuff incision, the cervical cap not being fully seated and the tips that do not have sufficient mobility cause the inability to position the uterus adequately, the inability to determine the cuff incision site clearly, the shift of the incision line, the prolongation of the operation and possible complications.

As a result, since the freedom of movement in the current manipulator is generally design to be linear, the parts such as the main body or the shaft that should not move in the vaginal canal are unavoidably moved by the medical personnel during the movement of the cervical cap and the intrauterine manipulation tip which includes the cervix for spatial scanning in the uterus and this causes possible complications in the patient.

THE AIM OF THE INVENTION

In the uterus manipulator mechanism develop by this invention, developments such as;

• A structure that provides freedom of movement as well as a certain movement restriction of the parts that need to be mobile to reduce post-operative complications,

• The ability of the cervical cap and intrauterine manipulation tip to scan not linearly, but spatially, while providing immobility in the main body during manipulation,

• The ability to move the intrauterine manipulation tip and cervical cap in the uterus manipulator mechanism + - 55 degrees in all directions in the use of the lockable trigger handle without the trigger, • Having ergonomics that allows a lockable trigger handle, vertical movement lock with five adjustments and alternative grip of the stabilizer side arm suitable for right and left hand control,

• Having a braking system that is realized by the harmonious operation of the moving parts in the main body shaft part,

• The additional 90 degree vertical movement lock to be able to lock the intrauterine manipulation tip and the cervical cap, which work in integration with each other at four additional adjustable angles, one being the beginning,

• In the use of the lockable trigger handle with the additional 90 degrees vertical movement trigger, the ability to provide an additional 90 degrees vertical movement to the manipulation provided before its use without the trigger,

• The ability of the manipulation provided by the additional 90 degree vertical movement trigger to return to the starting point with the effect of the spring force nested between the cervical cap and the parallel disc with canal space,

• The cervical cap on the uterus manipulator mechanism to have a guide needle that helps to mark the place where the incision will be made during incision determination after taking the cervix into it,

• The ability to make the control of the back and forth movement of the guide needle by bringing it up to the slots coming out of the lower part of the lockable trigger handle and with the intervention of the holding and abutment rod via the auxiliary elements passing through the canal gaps,

• Having the three-phase safety measure in the uterus manipulator mechanism for the guide needle to not leave the slot in unchecked way during its front and back movement,

• Gaining additional features that facilitate the removal of the needle back and forth movement element holding and abutment rods that assist the intervention of the guide needle or the injector line that helps inflate the intrauterine manipulation tip balloon or bellows balloon from the lockable trigger handle having structure with canal gap, by opening holes suitable for the ergonomic cover of the bottom of the handle which facilitates assembly,

• By adding a stabilizing side arm to the uterus manipulator mechanism, having additional safety measure that reduces the unwanted additional forces that may occur during the movement of the lockable trigger handle on the main body shaft part for manipulation and affect the patient's tissue on the stabilizer side arm instead of the patient tissue and thereby the post-operative complications,

• Adding anti-slip walls that prevent the back and forth movement of the stabilizer side arm on the main body shaft part,

• The stabilizer side arm being able to be removed in accordance with the right hand or left hand grip preference and re-attached from the other side if necessary with a tight grip mouth that expands and narrows by means of the spring structure on the stabilizer side arm,

• Having a canal gap in the main body shaft part, which ensures the harmonious operation of parts such as the needle back and forth auxiliary movement element and the injector line for inflating the intrauterine manipulation tip balloon or the bellows balloon, together with the parts that help the manipulation movement working on the main body shaft part, without interfering with one another's operation,

• In addition to having the main observation cavity in the cervical cap which, when considered alone compared to its equivalent, allows observation and intervention during manipulation with a maximum opening of 150 degrees with its structure that provides the widest opening at once for the medical personnel, also having side observation spaces with a maximum opening of 56 degrees,

• Having a 6-knot handle that provides upper and lower grip in the lockable trigger handle,

• In the lower grip position starting from the second knot, the lockable trigger handle having an opening suitable for an additional 90 degree vertical movement trigger to grasp the hand from above,

• The intrauterine manipulation tip, that acts in integration with the cervical cap as the gap between the lockable trigger handle and the additional 90 degree vertical movement trigger closes, having a structure that provides an additional 90 degrees vertical movement,

• Keeping the non-balloon part of the vaginal balloon long to prevent air or gas escape in the anterior and posterior region of the vaginal balloon,

• The attachment surfaces of the vaginal balloon being on the movable rings,

• Providing air or gas seal transfer in the injector line coming into the cervical cap by joining the double-sided injector line connected to the cervical cap on one side and to the intrauterine manipulation tip on the other, • The intrauterine manipulation tip having a double security measure that provides air tightness when it is placed into the cervical cap,

• The ring and the vaginal balloon or bellows balloon connected on it having a ring abutment wall, which prevents it from moving further from the main body shaft part too much, getting free from the main body shaft part and falling into the section where the parallel disc is, and touching to the moving parts,

• Enabling additional functions such as guide needles to work in an integrated manner through the structures with canal gaps,

• The intrauterine manipulation tip being in different sizes, the ability to attach and detach upon the need to choose different sizes and/or to ensure sterilization, opening a slot at the end that assists the optional cap, presence of a canal space that helps the vaginal balloon or bellows balloon to inflate, having surface continuity on the cervical abutment wall when fully inserted into the cervical cap, and having a tight fit surface to the cervical cap,

• The optional flexible cap on the intrauterine manipulation tip having a soft structure that will not cause trauma to the patient after entering into the uterus,

• Having a vertical movement trigger that provides an additional 90 degrees of vertical movement,

• Having a vertical movement tension auxiliary element that carries the additional 90 degree vertical movement tension auxiliary element through its canal hollow structure,

• In the initial position where the guide needle is not used during the operation, the storage slot opened on the largest diameter hollow circular abutment surface of the cervical cap to have have additional security measures by being configured at the back in such a way that the movement that will occur by pulling the holding and abutment rod of the needle forward movement auxiliary element at the stage of starting to use the guide needle is prevented from rubbing against the tissue touching the abutment wall, and also

• The rear bellows ring, cervical cap ring and reciprocating main body shaft part rings being produced from at least two parts in order to prevent possible problems that may arise after assembly in one-piece production, and also to solve the problems of getting stuck in comfortable forward, backward and rotary movements, having male-female connection slots opened in harmony to ensure interlocking and surface continuity, that benefit the use of healthcare professionals and provide solutions to their needs are aimed.

DEFINITIONS OF THE FIGURES DESCRIBING THE INVENTION Figures prepared to better describe the uterus manipulator mechanism system developed with this invention are presented in the appendix and their definitions are below.

Figure - 1 Side view of the uterus manipulator mechanism in the the needle forward movement auxiliary pulled position Figure - 2 Back and bottom view of uterus manipulator mechanism without stabilizer side arm and back bellows

Figure - 3 Perspective view of the front block showing the connections of the motion system inside the main body the shaft part, which has been rendered invisibility

Figure - 4 Perspective view of the front block shown with the main body shaft part, main body shaft part ring, cervical cap ring in accordance with Figure 3

Figure - 5 Perspective view of the vaginal balloon or bellows balloon in accordance with Figure- 4 in the version where the cross-sectional inner view is added, with the intrauterine manipulation tip and balloon added Figure - 6 Cervical cap top view Figure - 7 Bottom view of cervical cap with guide needle and Section A-A line Figure - 8 Section A-A view in accordance with Figure-7

Figure - 9 Main body shaft part side view and lines of Section B-B and Section C-C Figure - 10 Section B-B view, in accordance with Figure - 9 Figure - 11 Section C-C 200% enlarged view, in accordance with Figure - 9 Figure - 12 Perspective view of stabilizer side arm assembled

Figure - 13 Side view of the handle with lockable trigger assembled

Figure - 14 Front view of the lockable trigger handle with right and left vertical movement lock assembled and Section D-D line

Figure - 15 Section D-D view, in accordance with Figure - 14 Figure - 16 Rear perspective view of the uterus manipulator mechanism Figure - 17 The view of the mechanism in accordance with Figure - 16 showing the auxiliary elements passing through the canal gaps with invisibility given, and Detail A and Detail B circle lines

Figure - 18 Detail A view in accordance with Figure - 17 Figure - 19 Detail B view in accordance with Figure - 17

Figure - 20, the view of the unseen circles and edges expressed with dashed lines, with the cervical cap and cervical cap ring assembled in accordance with the harmonic incision and Figure 6, and the Section E-E line

Figure - 21 Section E-E view in accordance with Figure - 20 Figure - 22 Perspective view in accordance with Figure - 20

Figure - 23 Side view of the intrauterine manipulation tip and Section F-F line Figure - 24 Section F-F view in accordance with Figure - 23

Figure - 25 Side view of the optional flexible cap that touches the uterine wall and the auxiliary assembling element with an air-tight element injector line inlet to the cervical cap in accordance with Figure 23 and Section G-G line

Figure - 26 Section G-G view in accordance with Figure - 25

Figure - 27 Side view of parallel disc with canal gap and Section H-H line

Figure - 28 Section H-H view in accordance with Figure - 27

Figure - 29 Detail C and Detail D circles with perspective view showing the steering connection elements between the lockable trigger handle and the parallel disc with canal gaps Figure - 30 Detail C view in accordance with Figure - 29 Figure - 31 Detail D view in accordance with Figure - 29

DEFINITIONS OF ELEMENTS AND PARTS FORMING THE INVENTION

In order to better explain the uterus manipulator mechanism system developed with this invention, the parts in the figures are numbered one by one, and their definitions are given below.

1- Uterus manipulator mechanism 2- Lockable trigger handle 3- Reciprocating movement tension member providing additional 90 degrees vertical movement

4- Vertical movement trigger

5- Balloon or bellows balloon injector line tip

6- Stabilizer side arm

7- Injector line tip

8- Vaginal balloon or bellows balloon

9- Cervical cap

10- Marked cover

11- Balloon or bellows balloon

12- Intrauterine manipulation tip

13- Rotatable reciprocating main body shaft part ring

14- Injector line sealing stopper

15- Main body shaft part

16- Vertical motion lock with five adjustments

17- Connection element that supports the vertical movement trigger and the vertical movement lock with five adjustments

18- Connection element that supports the lockable trigger handle and the vertical action trigger

19- Lockable trigger handle entry of needle backwards movement element

20- Lockable trigger handle entry of needle forward movement element

21- Adhesion outer surface notches

22- Steering auxiliary element

23- Internal fixed central element of the handle motion system with canal gap

24- Spring to reverse vertical movement

25- Support element with ball joint and canal gap

26- Parallel disc with canal gap

27- Vertical motion tension member of cervical cap

28- Cervical cap ring

29- Cervical cap ring cradle

30- The surface of the cervical cap with the widest opening

31- Main observation gap 32- Auxiliary observation gaps

33- Needle reciprocating canal gap

34- Needle forward movement auxiliary element canal gap

35- Cervix abutment surface

36- Guide needle

37- Pinhole

38- Needle forward stopping notch

39- Guide needle auxiliary element canal

40- Intrauterine manipulation tip injector line canal

41- Vertical motion auxiliary element tension slot router

42- Vertical motion auxiliary element tension slot

43- Vertical motion auxiliary element canal

44- Assembling neck of cervical cap

45- Spring slot

46- Router connection element

47- Canal gap

48- Needle stopping notch of cervical cap

49- Guide needle first use sealing surface

50- Cervical cap ring slot

51- Ball joint holding the cervical cap side

52- Ball joint holding the handle with lockable trigger side

53- Stabilizer side arm back and forth anti-slip wall

54- Ring abutment wall

55- Main body shaft part surface

56- Rear bellows element grip flat surface

57- Stabilizer side arm handle

58- Compression latch

59- Tension spring

60- Adhesion inner surface notches

61- Connection pin

62- Abutment slot in compression latch of tension spring 63- Abutment slot in the stabilizer side arm handle of the tension spring

64- Neck surface

65- Canal hollow parallel disc in lockable trigger handle

66- Elliptical contact surface

67- Six-knot handle

68- Under-handle cover

69- Palm grip surface

70- Over-hand grip surface

71- Cylindrical surface

72- Male female connection elements of rings

73- Abutment surface of the vertical movement trigger

74- Joint abutment surface of the vertical movement lock with five adjustments and vertical movement trigger

75- Injector line entry under lockable trigger handle

76- Canal separation line

77- Knotting, fixing and storage slot

78- Connection element canal gaps providing tension

79- Injector line, connection element providing tension and needle reciprocating transmission auxiliary element canal

80- Connection ball joint to the lockable trigger handle of the canal transmission support element that provides centring into the ball joint

81- Spherical surface centred on the ball joint holding the lockable trigger handle part of the main body shaft part

82- Spherical abutment surface in +- 55 degree movement of steering auxiliary element in lockable trigger handle

83- Internal fixed centre element, disc abutment surface parallel to the handle

84- Connection slot for the steering auxiliary element that transmits the handle movement to the cervical cap

85- Lockable trigger handle steering connection element slot start, end and link bearing

86- Needle backwards movement auxiliary element

87- Needle forward movement auxiliary element 88- Intrauterine manipulation tip balloon inflation injector line

89- Additional 90 degree vertical movement tension auxiliary element

90- Needle back and forth movement auxiliary element intermediate passage storage path

91- Cervical cap suitable for harmonic incision

92- Passage gap

93- Line exit

94- Line entry

95- Top tight fit surface with cervical cap

96- Cervical abutment surface at the same level with the cervical cap after assembling the cervix abutment wall

97- Flexible cap slot

98- Optional flexible cap with balloon

99- Balloon part of optional flexible cap with balloon

100-Bellows of optional flexible cap with balloon

101- Assembling element of optional flexible cap with balloon

102- Auxiliary assembling element with double-sided injector line inlet

103-First air-tight assembling element

104- Second air-tight assembling element

105-Needle backwards movement element holding and abutment rod

106-Needle forward movement element holding and abutment rod

107- Additional 90 degree tension auxiliary element slot

108- Reciprocating tension element slot

109-Vertical movement supporting slot

110-Bottom tight fit assembling slot

111-Intrauterine manipulation tip medium tight fit assembling slot

112-Top tight fit assembling slot

113- Vaginal balloon inflation zone

114- Rear bellows

115- Rear bellows ring

116- Rear bellows abutment surface

117- Centre attachment slots to steering auxiliary element 118- Spherical abutment surface of steering auxiliary element in parallel disc with canal gap

119- Parallel disc neck with canal gap

120- Steering groove of vertical movement auxiliary element of parallel disc with canal gap

121- Vertical movement abutment surface of parallel disc with canal gap

122- Vertical movement supporting slot

123- Additional 90 degree vertical movement gap of cervical cap in parallel disc with canal gap

124- Reciprocating guide needle auxiliary element canal slot

125- Spring slot for reversing vertical movement

126- The contact surface that limits the +-55 degrees angular movement from all directions of the parallel disc with canal gap to the main body shaft part

127- Connection element slot start, end and connection bearing of parallel disc with canal gap

128- Spherical surface centred on the ball joint holding the cervical cap side of the main body shaft part

129- Vertical movement auxiliary element side canal transmission gap

130- Connection element passage canal of the disc

131-Ball joint supporting element abutment surface

132- The flexible surface of the first contact with the uterine wall

133-Bottom tight fit surface with cervical cap

134- Second air-tight element abutment surface

135- Cervical cap abutment surface

136- Air-tight element abutment surface

137- Top surface of the assembling to the first air-tight element and below, the lower surface of the middle part tight fit to the cervical cap

138- Handle supporting slot

139-Perforated centre support protrusion on the back of the handle

DETAILED DESCRIPTION OF THE INVENTION

In order not to prevent tissue trauma (bleeding, tearing, crushing) in the vaginal canal due to the fact that the shaft part cannot provide independent and angular movement to the intrauterine manipulation tip during insertion or operation as the main body shaft part and the parts corresponding to the intrauterine manipulation tip in some of the existing manipulators are produced as one piece, the intrauterine manipulation tip(s) (12) and cervical cap(s) (9) that need to be movable are designed to move independently of the main body shaft part (15).

Again, in some other manipulators, the problem caused by the movement of the parts corresponding to the vaginal balloon or bellows balloon (11) which need to be immobile causing air or gas escape and in the meantime to prevent the damage to the tissue air or gas escape within the vaginal balloon or bellows balloon (11), it is design to be placed on the rotatable reciprocating main body shaft ring (13) and to allow the movement freedom of the manipulator to prevent the problems that would cause problems for the patient during the operation, and holding the balloon or bellows balloon (11) steady within the vaginal canal and thereby be suitable for the laparoscopic and/or robotic hysterectomies.

The parts designed according to the production stage are in disposable sterile packages, with a lockable trigger handle (2), stabilizer side arm (6), main body shaft part (15), vaginal balloon or bellows balloon (8), cervical cap in different alternatives (9) and a guide needle (36) suitable for all different alternatives, integrated with each other, and combined with the intrauterine manipulation tip (12) in sterile packages with different alternatives, each of which has its own length to ensure that the integrity of the uterus manipulator mechanism is provided. In order to have different alternatives in the cervical cap (9) that will include the cervix, and to be able to choose and place the most suitable diameter since it has a wide range of options, the most suitable cervical cap (9) is selected after the measurement is made by means of an auxiliary equipment. After measuring the depth of the uterus with a hysterometer or pre-operative ultrasound, the appropriate length is selected and the intrauterine manipulation tip(s) (12) are removed from their sterile package and attached to the uterus manipulator mechanism (1) to be ready before the surgery.

With the completion of all surgical materials prepared for the patient before the operation, the uterus manipulator mechanism (1) is placed into the patient before starting the laparoscopic case. FIGURE.5 there is a balloon or bellows balloon (11) of the intrauterine manipulation tip, which is flexible enough to not cause trauma to the patient when it hits the opposite wall of the uterus is on the intrauterine manipulation tip (12) which enters into uterus; this balloon is inflated in values in accordance with the anatomy. Vaginal balloon or bellows balloon (8) on the main body shaft part (15) can be inflated in accordance with the patient's anatomy in order to prevent gas or air escape from the vaginal canal during the incision process of the case. By means of the rings on the main body shaft (15) and at the back of the cervical cap (9), even if the uterus manipulator mechanism (1) moves in the vaginal canal, these rings which are activated to keep the movement of the vaginal balloon or bellows balloon (8) that prevents air or gas escape significantly constant, provide the patient a more painless operation process and the healthcare personnel the advantage of more comfortable use.

The lockable trigger handle (2), designed with the ergonomics of the user in mind, provides maximum freedom of movement with one hand holding position in desired dimensions by moving the intrauterine manipulation tip (12) and the cervical cap (9) that covers the cervix, as well as providing movement restriction to reduce complications. The handle locking mechanism located on the lockable trigger handle (2) allows freedom of movement by pressing when the user wants to move the uterus manipulator mechanism (1). It is a second locking mechanism that will be operated when the positioning is at the desired angle or angles, that is, by pressing the trigger, allowing the additional freedom of movement to 90 degrees upwards by itself, its advantage is that with the movement of the lockable trigger handle (2) in the downward direction, it provides the freedom of movement of the uterus manipulator mechanism (1), which is restricted in undesirable angles, at the desired angles in the upward direction.

The stabilizer side arm (6) on the main body shaft part (15) connected to the uterus manipulator mechanism (1) shown in FIGURE 12. is formed as a rigid cannula with a flat shape and when it is positioned during the operation, the patient's body will not be used in the counter force of this movement, and with this force provided by the stabilizing side arm (6), it is aimed to minimize the deformation or complications that may occur in the patient thanks to the conscious and counter force applied by the healthcare worker.

By firm adherence provided by stabilizer side arm adherence outer surface notches (21) on the main body shaft part holding mutually onto the stabilizer side arm adherence inner surface notches (60) and easiness of ergonomic holding with left or right hand, the force the lockable trigger handle (2) will create on the main body shaft part (15) will be exerted on the stabilizer side arm (6) and not to the patient.

The main body the shaft part (15) connected to the uterus manipulator mechanism (1) shown in FIGURE.10 is formed as a rigid cannula with a flat shape and provides a safe freedom of movement by keeping the movable mechanisms inside the body away from the working surface.

During the period when it takes the cervix inside it, to prevent the cervical cap (9) shown in FIGURE 6 from sliding and the use becoming difficult, and for the control of it being more comprehensive after placing it comfortably to the fornix, the main observation gap (31) and the auxiliary observation gaps (32) on the cervical cap (9) are used.

There is an injector line that helps to inflate the vaginal balloon or the bellows balloon (8) located on the main body shaft part (15) from a minimum of 40 cc to a maximum of 135 cc. After inflating this balloon in the vaginal canal, in order to prevent it from moving during the operation, rings that can move 360 degrees on the cervical cap ring (28) on the back of the cervical cap and on the main body shaft (15) are designed.

The design of the cervical cap (9) in accordance with the bipolar, monopolar and ultrasonic incisions shown in FIGURE.22 (for example, a metal piece such as plastic, ceramic or stainless steel) allows healthcare personnel to use it alternatively.

While starting the operation, the healthcare personnel inserts the uterus manipulator mechanism (1), the cervical cap (9) and the intrauterine manipulation tip (12) inserted through the vaginal route, and after abdominal region is inflated with carbon dioxide the operator can provide more secure controls with notification tactile feedback to the cervical cap (9) and uterus in the vagina through the equipment used. If deemed necessary, an alternative is presented so that they can also benefit from the guide needle (36) that can act as a guide in the cervix. In the hysterectomy stages, the surgeon performs the procedure by separating the uterus, ovaries, fallopian tubes from the upper part of the vagina, blood vessels and connective tissue from the abdominal part by means of auxiliary equipment. In case of a situation that may cause damage to other organs during the manipulation, the surgeon can turn it in any direction by means of the intrauterine manipulation tip (12) placed inside the uterus, and helps to eliminate all risks.

There is no tactile (touch) sense, especially in robotic surgery operations. In this case, the area where the incision will be made must be determined securely. During the determination of the incision area with the guide needle (36) shown in FIGURE 8, the medical personnel will have the opportunity to determine the place where the incision will be made in a healthier and safer way. If needed during the incision, the guide needle in the closed position (36) can be revealed with the help of needle forward movement element holding and abutment rod (106) under the lockable trigger handle (2) and can be brought back to closed position with the help of the needle backwards movement element holding and abutment rod (105) after the operation.

To mark the cervix from under it, by guide needle (36) forward movement element lockable trigger handle entry (20) and needle forward movement element holding and abutment rod (106) and when the incision is finished, needle backwards movement element lockable trigger handle entry (19) needle backwards movement element holding and abutment rod (106) abutting, the guide needle (36) is embedded back into the cervical cap (9) cervical cap needle reciprocating canal gap (33).

The spring (24) that serves to reverse the vertical movement is designed with sufficient force to return the cervical cap (9) angularly to the starting position when the vertical movement trigger (4) is released, by calculating the force that the angle formed on the cervical cap (9) will create on itself when the vertical movement trigger (4) is pressed.

It is seen that while 21.32% freedom of movement can be achieved only with the intrauterine manipulation tip (12) and cervical cap (9) that are desired to move in the ergonomic grip calculations of the uterus manipulator mechanism (1), with the addition of our newly developed vertical movement trigger (4) system, an additional 20.81% spatial freedom of movement has been gained. In this way, an area of 42.13% can be easily reached, and while doing this, the side arm (6) and the uterus manipulator mechanism (1) can be held stronger, thus keeping the main body and shaft part (15) immobile.

In order to choose the most suitable diameter of the cervical cap (9) that includes the cervix, the diameter of the cervix is measured by means of auxiliary equipment and the most suitable diameter cervical cap (9) is selected. Inside each of the cervical caps is a guide needle (36) that can move forward and backward. In this way, it is dipped into the cervix at any time during the operation and acts as a guide there.

After ensuring the movement limitation of the needle forward movement auxiliary element (86) connected to the pin hole (37) of the guide needle (36) connected to the cervical cap needle reciprocating canal gap (33) within the cervical cap needle slot (28) embedded into the cervical cap (9) within the uterus manipulation mechanism (1), and after releasing the guide needle (36) from the starting position by pulling the needle forward movement auxiliary element (86) coming out of lockable trigger handle entry (19) for the incision determination, by pulling the needle forward movement auxiliary element (86) to prevent the guide needle (36) releasing from the cervical cap needle reciprocating canal gap (33) and by needle backwards movement element lockable trigger handle entry holding and abutment rod (106) abutting against needle backwards movement element lockable trigger handle entry (19), it is ensured that the guide needle (36) does not leave the cervical cap needle movement element passage holding route (90).

The intrauterine manipulation tip (12) is in different sizes and diameters in accordance with the patient's anatomy, and before starting the operation, the patient's intrauterine depth can be measured by means of auxiliary equipment, then the most suitable size can be selected, and it can be inserted into the uterus manipulator mechanism (1) by passing it through the cervical cap.

As seen in FIGURE. 13, during the cervical incision stage in the operation, five adjustable vertical movement locks (16) are activated to ensure that the uterus is brought to the desired position and stopped. The connection element (17) that supports the vertical movement trigger and the vertical movement lock with five adjustments acts as a safety here, and the connection element (18) that supports the lockable trigger handle and the vertical movement trigger allows it to be pressed and released easily.

As seen in FIGURE 15, the marked cover (10) located on the back of the uterus manipulator mechanism (1) is designed to comfortably put the desired mark on it, according to the possibility of being designed as disposable or sterilizable according to the production stage.

As can be seen in FIGURE 15, the fact that the neck surface (64) of the lockable trigger handle abutting against the main body with a maximum opening of +- 55 degrees is in a round design eliminates the possibility of abrasion on the main body shaft part (15).

As seen in FIGURE 15, the knots connected by knotting, fixing and storage slot (77) of the tension connection element with the canal separation line (76) through which the additional 90 degree vertical movement tension auxiliary element passes are stored in the same place where they are located on the back of the marked cover (10) and it is also designed to for branded cover (10) to fit tight to connection slot. In another embodiment of the invention, the knotting point is combined with a suitable apparatus and fixed on itself without knotting.

As seen in FIGURE 1, by delivering sterile water or air to inside with the help of an injector from the balloon or bellows balloon injector line tip (5), the possibility for the intrauterine manipulation cap balloon or bellows balloon (11) to deflate during the operation is eliminated by a injector line seal stopper (14).

As seen in FIGURE 15, by means of the reciprocating tension element slot (108) that provides the vertical movement trigger an additional 90 degrees vertical movement, the additional 90 degree tension auxiliary element slot (107) is designed to move the intrauterine manipulation tip (12) and the cervical cap (9) when the trigger that provides an upward vertical movement is pressed.

The uterus manipulator mechanism (1) has handle rear perforated middle support protrusion (139) formed out from the handle to provide angular movement capability of the vertical movement trigger (4) on the lockable trigger handle (2), and a handle supporting slot (138) in its centre for the connection element (18) that supports the lockable trigger handle and the vertical movement trigger are connected to each other to work.

Use and content of the uterine manipulator mechanism

After the patient is put to sleep in the lithotomy position under general anaesthesia, surgical field sterility is ensured. At this stage, the assistant medical personnel prepares the uterus manipulator mechanism (1).

It is formed by the combination of two different sterile package groups. The first group constitutes the majority of the uterus manipulator mechanism (1), which consists of 34 parts assembled within the sterile package. These 34 parts are as follows:

Lockable trigger handle (2)

Reciprocating tension element (3) providing additional 90 degrees vertical movement Vertical movement trigger (4)

Injector line tip (7)

Vaginal balloon or bellows balloon (8)

Cervical cap (9)

Marked cover (10)

Rotatable reciprocating main body shaft part ring (13)

Injector line sealing stopper (14)

Main body, shaft part (15)

Vertical movement lock with five adjustments (16)

Connection element (17) that supports the vertical movement trigger and the vertical movement lock with five adjustments together

Connection element (18) that supports the lockable trigger handle and the vertical movement trigger together

Steering auxiliary element (22)

Spring to reverse the vertical movement (24) Ball joint supporting element with canal gap (25)

Parallel disc with canal gap (26)

Vertical movement tension element of cervical cap (27)

Cervical cap ring (28)

Guide needle (36)

Steering connection element (46)

Parallel disc with canal gap in lockable trigger handle (65)

Six-knot handle (67)

Under-handle cover (68)

Needle backward movement auxiliary element (86)

Needle forward movement auxiliary element (87)

Intrauterine manipulation tip balloon inflation injector line (88)

Additional 90 degree vertical movement tension auxiliary element (89)

Cervical cap suitable for harmonic cut (91)

Auxiliary assembling element with double-sided injector line entry (102)

Needle backward movement element holding and abutment rod (105)

Needle forward movement element holding and abutment rod (106)

Rear bellows (114)

Rear bellows ring (115)

The first group sterile package contains a stabilizer side arm (6) consisting of a total of 4 parts assembled within itself. These 4 parts that make up the stabilizer side arm (6) are as follows:

Stabilizer side arm handle (57)

Compression latch (58)

Tension spring (59)

Connection pin (61)

The second group of sterile package contains the intrauterine manipulation tip (12), which consists of a total of 4 parts assembled within itself. These 4 parts that make up the intrauterine manipulation tip (12), with one varying, are as follows: Balloon or bellows balloon of the intrauterine manipulation tip (11) or Optional flexible cap with balloon (98)

Intrauterine manipulation tip (12)

Primary air-tight assembling element (103)

Secondary air-tight assembling element (104)

The total of 92 elements apart from these parts consists of elements like the functional design surface, cavity, canal, notch, connection element, etc. consists of the above elements.

Preparation stages of the uterus manipulator mechanism (1) before starting the manipulation:

1. Holding the cervix with a single gear.

2. Measuring the length of the uterus with auxiliary equipment such as a hysterometer.

3. Choosing the cervical cap (9) designed in different diameters suitable for the width of the cervix.

4. Selecting the intrauterine manipulation tip (12) suitable for the length of the uterus among the intermediate lengths most suitable for the patient's anatomy.

5. As seen in FIGURE. 26, the intrauterine manipulation tip (12), the secondary air-tight assembling element (104), the primary air-tight assembling element (103), and the auxiliary assembling element with double-sided injector line inlet (102) are assembled into the cervical cap (9) to receive the intrauterine manipulation cap balloon inflation injector line (88), and pushed to the parallel disc with gap (26) to fully seat it in its slot, thus ensuring the integrity of the uterus manipulator mechanism (1).

6. Fixing the stabilizer side arm (6), which is freely located inside the same sterile package as the uterus manipulator mechanism (1), to the uterus manipulator mechanism (1) in a way for stabilizer side arm adherence inner surface notches (60) to open and meet the main body shaft part adherence outer surface notches (21) when the auxiliary stabilizer side arm ergonomic clamp latch (58) is pressed in accordance with the right or left arm grip of the medical personnel to use it, and to adhere between the stabilizer side arm reciprocating anti-slip walls (53). 7. Checking that the main body shaft part ring (13), cervical cap ring (28) and rear bellows ring (115) easily reciprocate and rotate when it is observed that the male female connection elements (72) of the rings fit together properly.

8. Observing that the rear bellows ring (115) stops when it comes to the rear bellows abutment surface (116) and checking that it rotates.

9. Checking that the ring abutment wall (54) of the main body shaft part ring (13) is still and does not come off.

10. Checking that the cervical cap ring (28) rotates within the cervical cap ring slot (50) by means of the cervical cap ring cradle (29).

11. After checking whether the vertical movement trigger (4) is stuck due to the handle supporting slot (138) located in the middle support protrusion (139) with the hole on the back of the handle of the connection element (18) that supports the lockable trigger handle and the vertical movement trigger, checking the vertical movement trigger (4) by turning the five adjusted vertical movement lock (16) freely from the notches on the right and left sides while pressed to check whether the connection element (17) that supports the vertical action trigger of the five adjusted vertical movement lock (16) and the five adjusted vertical movement lock is experiencing a stuck situation with similar reasons.

Manipulation stages after assembling the uterus manipulator mechanism (1) with the intrauterine manipulation tip (12) comprises the following procedure steps:

1. Presenting the cervical cap (9) suitable for the incision procedure to be made by the medical personnel or the cervical cap (91) suitable for the harmonic incision as an option in accordance with the patient's interest and adding the preferred cap which is deemed appropriate by the medical personnel to the assembly,

2. Following the enlargement of the vaginal canal with the help of an ecarteur, advancing the uterine manipulator mechanism (1) into the cervix, which is held with a single gear,

3. Preparing the intrauterine manipulation tip (12) for manipulation by advancing it until it reaches the uterine wall, and the cervical cap (9) is in a position to include the cervix, Checking that the vaginal balloon or bellows balloon (8) is fully seated on the main body shaft part ring (13), which can rotate 360 degrees and can move back and forth in order not to harm the patient during the manipulation in the vaginal canal, Inflating the balloon or bellows balloon (11) or optional flexible cap with balloon (98) located at the intrauterine manipulation tip (12) according to the anatomy of the patient by injecting a minimum of 3 cc to a maximum of 13 cc of air or sterile fluid from the balloon or bellows balloon syringe line tip (5) with the help of an injector, Observing the vaginal balloon inflation zone (113) and checking that it is inflated, Preventing the uterine manipulator mechanism (1) from coming out of the uterus unintentionally, After placing the cervical cap (9) that is suitable for the incision preference of the medical personnel, or the cervical cap (91) suitable for the harmonic incision, to the cervix, making the controls by using the main observation gap (31) and auxiliary observation gaps (32), In order to prevent the escape of gas from the abdominal region inflated with gas at the incision stage of the cervix in the vaginal canal during the operation, establishing the sealing security by inflating the vaginal balloon or bellows balloon (8) with the air or sterile liquid delivered by an auxiliary injector from the injector line tip (7) located under the lockable trigger handle (2) from a minimum of 40 cc to a maximum of 135 cc in accordance with the patient's anatomy and by pressing the notch on the injector line sealing stopper (14), Making the manipulation of the cervical cap (9) and the movable intrauterine manipulation tip (12) with the handle holding position as long as the lockable trigger handle (2) is sufficient, and with the help of the vertical movement trigger (4) if it is not sufficient, For the vertical movement lock with five adjustments (16) to work; first, pressing the vertical movement trigger (4) to release the five adjusted movement lock, then ensuring the locking by releasing the vertical movement lock (4) at the point where the vertical movement trigger and the vertical movement lock with five adjustments rest on the joint abutment surface (74) to keep the uterus at the angle that brings it to the desired position, By means of these rings, preventing the problems of adhesion to the vaginal canal caused by shrinkage or stretching of the inflated balloon prevention of the escape of air or gas from the vaginal canal during the operation by this movement. After starting the operation, during the hysterectomy phase, making the manipulation by holding the lockable trigger grip (2) at the back of the uterus manipulator mechanism (1), and an appropriate manipulation in the form of spatial scanning of the uterus right-left and up-down in the desired direction with the vertical movement trigger (4), Also, making an incision using energy modalities from the part we call the cuff, where the vagina and cervix meet, after the uterus is freed from all its ties, in accordance with the patient's interest and providing the surgeon with a working area, In cases where it is difficult to determine the location of the cervical cap (9), pushing the guide needle (36) in the system forward from the posterior fornix to determine the area where the incision will be made and starting the incision, During the incision of the cervix, taking the guide needle (36) positioned on the cervical cap (9), which includes the cervix, out according to the need, by the help of the needle forward movement element holding and abutment rod (106) located under the lockable trigger handle (2), and after the procedure, inserting the needle back to its place by means of the needle backwards movement holding and abutment rod (105), To remove the uterine manipulator mechanism (1) after the incision is completed; after deflating the vaginal balloon or bellows balloon (8) by opening the notch of the injector line sealing stopper (14) to allow the release of the previously delivered air or sterile liquid from the injector line tip (7) located under the lockable trigger grip (2), safely removing the uterus from the vaginal canal, To remove the uterus from the uterus manipulator mechanism (1), finalising the operation after deflating the balloon or bellows balloon (11) on the intrauterine manipulation tip (12), or the optional flexible cap with balloon (98) by opening the notch of the injector line sealing stopper (14) to allow the release of the previously delivered air or sterile liquid from the balloon or bellows balloon injector line tip (5).

Claims

1. A uterus manipulation mechanism (1) designed for laparoscopic and/or robotic hysterectomies, in line with the interest of the patient, with parts that must move being movable and parts that must not move being immovable, characterized in that it comprises;

• Lockable trigger handle (2) that provides + - 55 degrees angular freedom of movement in all directions to the cervical cap (9) and the intrauterine manipulation tip (12) connected to it when using the right or left hand grip without pressing the vertical movement trigger

(4),

• The stabilizer side arm (6), which, by means of its strong holding with the main body shaft part (15), has a structure that helps to dampen the force that the action of the lockable trigger handle (2) will create on the main body shaft part (15), thus eliminating the complications that may occur in the patient's tissue during manipulation,

• The main body shaft part (15) that accommodates the moving parts such as steering auxiliary element (22) not to move within the patient during the operation, internal fixed central element (23) with canal gap of the handle movement system, support element (25) with ball joint canal gap and additional 90 degree vertical movement tension auxiliary element (89) to perform actively during manipulation without interfering with each other.

• The vaginal balloon or bellows balloon (8), which holds on to all the walls of the vaginal canal and prevents the bending, shrinkage, gas or air escape that may occur in the vaginal canal, at the same time acts as isolation and provides resistance to the reciprocal movement and rotational movement, regardless of the anatomical structure of the vagina,

• Injector line tip (7) for inflating the vaginal balloon or bellows balloon (8),

• Cervical cap (9), which covers the cervix during the operation and has a structure to allow the auxiliary equipment that can move inside the main observation gap (31) to ensure that the cervix is fully inserted and inside the auxiliary observation gaps (32) on both sides if it is not sufficient, to interfere with the cervix,

• intrauterine manipulation tip balloon or bellows balloon (11)

• intrauterine manipulation tip (12) coming from balloon or bellows balloon injector line tip

(5) embedded in the uterine manipulator mechanism (1) and having air-tight, plug-in feature without having a self-exiting injector line, and allowing the balloon or bellows balloon (11) connected thereon to be inflated with air or sterile water,

• Balloon or bellows balloon injector line tip (5) embedded in the uterus manipulator mechanism (1), which ensures the delivery of air or sterile water to the intrauterine manipulation tip (12),

• Guide needle (36) working embedded in the cervical cap (9) with three safety measures that can act as a guide in the cervix, which can be managed under the lockable trigger handle (2),

• Needle forward movement element holding and abutment rod (106), which is used to remove the guide needle (36) from its slot if needed and has a safety measure to ensure that the guide needle (36) does not go back any further,

• Needle backward movement element holding and abutment rod (105), which allows the guide needle (36) to be inserted back into its slot after the guiding task is completed and has a safety measure to ensure that the guide needle (36) does not go forward any further,

• Injector line sealing stopper (14) located on the injector line tips (5,7),

• Vertical movement trigger (4) that allows the cervical cap (9) and the intrauterine manipulation tip (12) to move vertically according to the grip position of the lockable trigger handle (2) in the range of an the additional 0 to 90 degrees when pressed,

• Rotatable reciprocating main body shaft part ring (13) and cervical cap ring (28) located on the main body shaft part (15) and in the back of the cervical cap (9) and provide to keep the movement of the vaginal balloon or bellows balloon (8) constant, which prevents air or gas escape even if the uterus manipulator mechanism (1) moves in the vaginal canal,

• Five adjusted vertical movement lock (16) that can be rotated especially with the help of the thumb in the right or left single-handed position and allows the uterus to be brought to the desired position and stopped during the cervical incision stage.

2. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises the connection element (17) that supports the vertical movement trigger and five adjusted vertical movement lock.

3. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises an additional 90 degree vertical movement tension auxiliary element (89) which is tension transmission element between lockable handle (2) and cervical cap (9).

4. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises the connection element (17) that supports the vertical movement trigger with five adjustment vertical movement lock together, which allows the vertical movement trigger (4) to be easily pressed and released easily again by means of the connection element (18) that supports the lockable trigger handle and the vertical movement trigger together.

5. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the main body shaft part (15) comprises adhesion outer surface notches (21).

6. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises lockable trigger handle entry of needle backwards movement element (19).

7. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises lockable trigger handle entry of needle forward movement element (20).

8. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the main body shaft part (15) comprises

• adhesion outer surface notches (21),

• Ball joint holding the cervical cap side (51),

• Ball joint holding the lockable trigger handle side (52),

• The ring abutment wall (54), which prevents the ring and the vaginal balloon or bellows balloon connected thereon from moving further from the main body shaft part, and getting released from the main body shaft part and falling into the section where the parallel disc is, and ensures that it does not touch the moving parts,

• Surface of the main body shaft portion (55) where the lockable trigger handle (2) abuts at a maximum angle of + - 55 degrees in all directions,

• Rear bellows element coupling flat surface (56).

9. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the main body shaft part (15) comprises the steering auxiliary element (22) that enables the movement transmitted from the parallel disc (26) with the canal gap and the lockable trigger handle (2) to the cervical cap (9) by means of the ball jointed canal gapped support elements (25) of the internal fixed central element of the handle motion system with canal gap (23).

10. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the cervical cap (9) comprises

• Vertical movement element of the cervical cap (27) that provides the vertical movement of the cervical cap,

• Cervical cap ring cradle (29) to which the cervical cap ring (28) connects,

• The surface with the widest opening of the cervical cap (30),

• The main observation gap (31 ),

• The auxiliary observation gaps (32),

• Needle reciprocating movement canal gap (33),

• Needle forward movement auxiliary element canal gap (34),

• Cervix abutment surface (35),

• Guide needle auxiliary element canal (39),

• Intrauterine manipulation tip injector line canal (40),

• Vertical movement auxiliary element tension slot router (41),

• Vertical movement auxiliary element tension slot (42),

• Vertical movement auxiliary element canal (43),

• The assembling neck of the cervical cap (44),

• Spring slot (45) for returning the vertical movement of the cervical cap,

• Steering connection element (46),

• Canal gap (47) that prevents possible elongation or shortening of the injector line during the additional 90 degrees vertical movement of the cervical cap,

• The needle stopping notch (48) of the cervical cap, which prevents the forward movement of the guide needle (36), • Cervical cap ring slot (50) where the cervical cap ring (28) fits,

• Needle reciprocating movement auxiliary element intermediate passage storage path (90)

• Vertical movement tension element (27),

• Vertical movement supporting slot (109),

• Lower tight fit assembling slot (110),

• Intrauterine manipulation tip medium tight fit assembling slot (111),

• Top tight fit assembling slot (112),

• Vaginal balloon inflation zone (113).

11. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the guide needle (36) comprises

• The pin hole (37) located on the guide needle (36),

• Needle forward movement stopping notch (38) located on the guide needle (36).

12. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the guide needle (36) comprises first use sealing surface (49).

13. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the stabilizer side arm (6) comprises

• front and back anti-slip wall (53),

• Stabilizer side arm handle (57),

• Compression latch (58),

• Tension spring (59),

• Adhesion inner surface notches (60),

• Connection pin (61),

• The abutment slot (62) in the compression latch of the tension spring (59),

• Abutment slot (63) on the stabilizer side arm handle (57) of the tension spring (59).

14. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the lockable trigger handle (2) comprises Back and forth movement tension element (3), which gives an additional 90 degrees vertical movement to the intrauterine manipulation tip (12),

Neck surface (64) where the lockable trigger handle abuts on the main body shaft part at a maximum opening of +- 55 degrees in all directions,

The parallel disc with canal gap (65) in the lockable trigger handle,

Elliptical contact surface (66),

Six-knotted handle (67) allowing right and left hand, upper and lower grip,

Under-handle cover (68) to facilitate the assembling,

Handle tight grip palm clutch surface (69),

Handle tight grip over hand clutch surface (70),

Lockable trigger under-handle injector line entry (75),

Canal separation line (76), through which the additional 90 degree vertical movement tension auxiliary element (2) passes,

Tension connection element knotting, fixing and storage slot (77),

The tensioning connection element canal gaps (78),

Injector line, tension connection element and needle back and forth movement transmission auxiliary element canal (79),

Connection ball joint (80) of the canal transmission supporting element to the lockable trigger handle, which provides centring into the ball joint,

Spherical surface (81) centred on the ball joint holding the lockable trigger handle side of the main body shaft part,

Spherical abutment surface (82) at +- 55 degree movement of steering auxiliary element in lockable trigger handle,

Inner fixed central element handle parallel disc abutment surface (83),

Connection slot (84) for the steering auxiliary element, which transmits the handle movement to the cervical cap,

Steering connection element slot start, end and connecting bearing (85) of the lockable trigger handle,

Additional 90 degree tension auxiliary slot (107), • reciprocating tension element slot (108) that provides an additional 90 degrees vertical movement to the vertical movement trigger,

• Middle support protrusion (139) with the hole on the back of the handle formed out from the handle for the vertical movement trigger (4) to provide angular movement capability on the lockable trigger handle (2), and in the centre of it, handle supporting slot (138) for the connection element (18) supporting the lockable trigger handle and vertical movement trigger to each other to work.

15. A uterus manipulator mechanism (1) according to Claim 14, characterized in that the reciprocating tension element (3) providing additional 90 degrees vertical movement comprises a cylindrical surface (71) providing contact to vertical movement trigger (4).

16. A uterus manipulator mechanism (1) according to Claim 14, characterized in that the lockable trigger handle (2) comprises a braking system working with the frictional force composed of the system internal tension that ensures the cervical cap (9) and the intrauterine manipulation tip (12) to remain in the desired position when they arrive that position within the scope of +-55 degrees in all directions.

17. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the cervical cap ring (28), rotatable reciprocating main body shaft part ring (13) and the rear bellows ring (115) all comprise male-female connection elements (72) that make two items of the same part ready for use by combining them on the product during the assembling and have the structure to lock and provide surface continuity when interlaced.

18. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the vertical movement trigger comprises abutment surface (73).

19. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the five adjusted vertical movement lock and vertical movement trigger comprise a joint abutment surface (74).

20. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the guide needle (36) comprises needle backwards movement auxiliary element (86) and needle forward movement auxiliary element (87) which help it move backwards and move together.

21. A uterus manipulator mechanism (1) according to Claim 1, characterized in that in the uterus manipulator mechanism (1) that enables the inflation of the intrauterine manipulation tip balloon, it comprises the intrauterine manipulation tip balloon inflation injector line (88), which can be extended and shortened when necessary in its embedded status during manipulation and can be directed to the desired position according to the holding position.

22. A uterus manipulator mechanism (1) according to Claim 10, characterized in that it is a cervical cap (91) convenient for the harmonic incision that can be assembled to the cervical cap (9) and has a hollow structure to allow the passage of the guide needle (36).

23. A uterus manipulator mechanism (1) according to Claim 23, characterized in that it comprises the passage gap (92) opened on the cervical cap (91) convenient for the harmonic incision considering the exit point of the guide needle (36) when connected to the cervical cap (9) to increase the cervical cap (9) choices for the optional incision of cervix before the operation.

24. A uterus manipulator mechanism (1) according to Claim 1, characterized in that the intrauterine manipulation tip (12) comprises

• Intrauterine manipulation balloon inflation line exit (93),

• Intrauterine manipulation balloon inflation line entry (94),

• Cervical cap and top tight fit surface (95),

• Cervical abutment surface (96) at the same level with the cervical abutment wall after assembling the cervical cap.

25. A uterus manipulator mechanism (1) according to Claim 25, characterized in that the intrauterine manipulation tip (12) comprises

• Flexible cap slot (97), • Flexible cap (98),

• The balloon part of the flexible cap (99),

• The bellows of the flexible cap (100),

• Flexible cap assembling element (101)

• Flexible surface for the first contact with uterine wall (132),

• Bottom tight fit surface with cervical cap (133),

• Second air-tight element abutment surface (134),

• Cervical cap abutment surface (135),

• Air-tight element abutment surface (136)

• Top assembling surface to the first air-tight element and the bottom surface (137) of the middle part tight fit to the cervical cap.

26. A uterus manipulator mechanism (1) according to Claim 26, characterized in that it comprises bilateral injector line entry auxiliary assembling element (102) between the intrauterine manipulation tip and the cervical cap.

27. A uterus manipulator mechanism (1) according to Claim 26, characterized in that it comprises first air-tight assembling element (103) of the intrauterine manipulation tip auxiliary to the cervical cap.

28. A uterus manipulator mechanism (1) according to Claim 26, characterized in that it comprises secondary air-tight assembling element (104) of double-sided injector line auxiliary to cervical cap.

29. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises internal fixed central element of the handle movement system with canal gap (23).

30. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises the spring (24) used to reverse the vertical movement by means of the inclination on it through the additional vertical movement emerging in the cervical cap (9) when the vertical movement trigger (4) is pressed.

31. A uterus manipulator mechanism (1) according to Claim 1, characterized in that it comprises

• rear bellows (114),

• the rear bellows ring (115), which provides the fixation of the rear bellows (114),

• rear bellows abutment surface (116) on which the rear bellows (114) abuts.

32. A uterus manipulator mechanism (1) according to Claim 17, characterized in that the parallel disc (65) with canal gap on the lockable trigger handle comprises

• Connecting slots (117) to the steering auxiliary element from the centre,

• The spherical abutment surface (118) of the steering auxiliary element,

• Parallel disc neck with canal gap (119),

• Vertical movement auxiliary element steering groove (120),

• V ertical movement abutment surface (121),

• Vertical movement supporting slot (122),

• Additional 90 degree vertical movement gap (123) of the cervical cap on the parallel disc,

• Reciprocating guide needle auxiliary element canal slot (124),

• Spring slot (125) for reversing vertical movement,

• The contact surface (126) that limits the angular movement to the main body shaft part of +-55 degrees from all directions,

• Connection element slot start, end and connecting bearing (127),

• Spherical surface (128) centred on the ball joint holding the cervical cap side of the main body shaft part,

• Vertical movement auxiliary element side canal transmission gap (129),

• Connection element passage canal of the disc (130),

• Ball joint supporting element abutment surface (131).

33. A uterus manipulator mechanism (1) according to any of the preceding Claims, characterized in that it comprises a marked cover (10) with the mark on it stating the ownership that resides between the lockable trigger handle (2) and vertical movement trigger (4), provides 90 degrees additional vertical movement, by being attached to the back side of the reciprocating tension element (3) preventing the contact from out after being connected due to connection need of the additional 90 degrees vertical movement tension auxiliary element (89).

34. The operation method of the uterus manipulator mechanism (1), characterized in that it comprises the steps of

• Adding the cervical cap (9) or cervical cap convenient for harmonic incision (91) to the uterus manipulation mechanism (1),

• Following the enlargement of the vaginal canal with the help of an ecarteur, advancing the uterine manipulator mechanism (1) into the cervix, which is held with a single gear,

• Advancing the tip of the intrauterine manipulation (12) until it reaches the uterine wall and the cervical cap (9) reaches a position to encompass the cervix,

• Fitting this vaginal balloon or bellows balloon (8) fully on the main body shaft part ring (13), which can rotate 360 degrees and move back and forth, in order not to harm the patient during the manipulation while in the vaginal canal,

• Inflating the balloon or bellows balloon (11) or optional flexible cap with balloon (98) located at the intrauterine manipulation tip (12) according to the anatomy of the patient by injecting a minimum of 3 cc to a maximum of 13 cc of air or sterile fluid from the balloon or bellows balloon syringe line tip (5) with the help of an injector,

• Using the main observation gap (31) and auxiliary observation gaps (32) in order to provide controls after the cervical cap (9), which is suitable for the incision preference of the medical personnel, or the cervical cap suitable for the harmonic incision (91) is placed on the cervix,

• In order to prevent the escape of gas from the abdominal region inflated with gas at the incision stage of the cervix in the vaginal canal during the operation, establishing the sealing security by inflating the vaginal balloon or bellows balloon (8) with the air or sterile liquid delivered by an auxiliary injector from the injector line tip (7) located under the lockable trigger handle (2) from a minimum of 40 cc to a maximum of 135 cc in accordance with the patient's anatomy and by pressing the notch on the injector line sealing stopper (14), • Making the manipulation of the cervical cap (9) and the movable intrauterine manipulation tip (12) with the handle holding position as long as the lockable trigger handle (2) is sufficient, and with the help of the vertical movement trigger (4) if it is not sufficient,

• For the vertical movement lock with five adjustments (16) to work; first, pressing the vertical movement trigger (4) to release the five adjusted movement lock, then ensuring the locking by releasing the vertical movement lock (4) at the point where the vertical movement trigger and the vertical movement lock with five adjustments rest on the joint abutment surface (74) to keep the uterus at the angle that brings it to the desired position,

• Preventing the problems of adhesion to the vaginal canal caused by shrinkage or stretching of the inflated balloon and air or gas escape from the vaginal canal during the operation with the movement created by the cervical cap ring (28) and the rotatable reciprocating main body shaft part ring (13),

• During the incision of the cervix, taking the guide needle (36) positioned on the cervical cap (9), which includes the cervix, out according to the need, by the help of the needle forward movement element holding and abutment rod (106) located under the lockable trigger handle (2), and after the procedure, inserting the needle back to its place by means of the needle backwards movement holding and abutment rod (105),

• In the hysterectomy stage, providing the manipulation is by holding the lockable trigger handle (2) on the back of the uterus manipulator mechanism (1) and manipulation of the uterus in the form of spatial scanning in the desired direction with the vertical movement trigger (4),

• After disposing of all the ties connected to the uterus, making an incision using energy modalities from the part we call the cuff where the vagina and cervix meet,

• In the determination of the cervix, determining the area to be cut by pushing the cervical cap (9) forward from the posterior fornix, and in cases where it cannot be determined, starting the incision with the help of marking with the guide needle (36) in the system,

• To remove the uterine manipulator mechanism (1) after the incision is completed; after deflating the vaginal balloon or bellows balloon (8) by opening the notch of the injector line sealing stopper (14) to allow the release of the previously delivered air or sterile liquid from the injector line tip (7) located under the lockable trigger grip (2), safely removing the uterus from the vaginal canal,

• To remove the uterus from the uterus manipulator mechanism (1), finalising the operation after deflating the balloon or bellows balloon (11) on the intrauterine manipulation tip (12), or the optional flexible cap with balloon (98) by opening the notch of the injector line sealing stopper (14) to allow the release of the previously delivered air or sterile liquid from the balloon or bellows balloon injector line tip (5).