uterine manipulator

专利摘要:
Uterine manipulator The present invention includes a uterine manipulator system comprising: a collar including a first platform attached to the inner surface of the collar a stabilizer including a stabilizer rim adapted to engage the first platform and an axis adapted to pass the stabilizer and hollow barrel of the collar. paste with a bulbous tip. other embodiments are described herein.
公开号:BR112015022686A2
申请号:R112015022686-8
申请日:2014-03-11
公开日:2019-10-29
发明作者:K Ahluwalia Prabhat；Ahluwalia Puja
申请人:K Ahluwalia Prabhat；Ahluwalia Puja；
IPC主号:

专利说明:

UTERINE MANIPULATOR
Context [0001] American Patent Application Publication No. 13 / 091,517, entitled FORNIX MANIPULATOR and filed on April 21, 2011 (application517), shares a common inventor with this application. Application No. 517 discloses a fornix manipulator including a collar and stabilizer to be attached to a uterine stem. The fornix manipulator addresses several problems, including imprecise fornix delimitation and deviation; vaginal shortening; abdominal deflation; blocked cervical access; unnecessary tissue damage from blind device recovery, insertion and cervical recovery, and lack of a platform for organ dissection.
Brief Description of the Drawings [0002] The accompanying drawings are included to provide an additional understanding of the general inventive concept and are incorporated and form a part of this specification. The drawings illustrate exemplary modalities of the general inventive concept and, together with the description, serve to explain principles of the general inventive concept. Features and advantages of modalities of the present invention will become apparent from the attached claims, the following detailed description of one or more example modalities, and the corresponding figures:
Figure 1 illustrates a conventional uterine manipulator of application no. 571.
Figures 2A - 2B illustrate modalities of a uterine manipulator containing a uterine stem, tip, collar, stabilizer and a pressing part including an external tube, fixation part and screw.
Figures 3A - 3H illustrate modalities of a uterine manipulator, in which either end of the collar is being used as a receiving end.
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Figures 4A - 4F illustrate three perspectives of a collar modality in addition to a cross-sectional view. Figures 4E - 4F illustrate cross-sectional views of alternative arrangements of a necklace.
Figures 5A - 5D illustrate a modality of a stabilizer fitted to either end of a collar.
Figures 6A - 6E illustrate an embodiment of a stabilizer with an eyeliner.
Figures 7A - 7B illustrate an embodiment of a reinforced stabilizer.
Figures 8A - 8H illustrate modalities of a uterine stem, modalities of a dye release system, modalities of an adolescent uterine manipulator system, and modalities of an adult uterine manipulator system.
Figures 9A - 9B illustrate a modality of a point in addition to a cross section.
Figures 10A -10E illustrate modalities of a tip.
Figures 11A - 11B illustrate a one-pointed embodiment and a cross-sectional view.
Figures 12A-12E illustrate modalities of a handle.
Figures 13A-13C illustrate embodiments of a necklace.
Figures 14A (I) - 14H illustrate modalities of a stabilizer.
Figures 15A - 15C illustrate modalities of a stabilizer attached to a collar.
Figures 16A-16F illustrate a modality of a uterine manipulator system used in conjunction with a fulcrum and interconnection to assist in the articulation of the interim manipulator.
Figure 17 illustrates a modality including an interim and fulcrum manipulator.
Figures 128A-18B include modalities of a fulcrum.
Detailed Description
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3/48 [0003] Preferred modalities of the general inventive concept will be described in more detail with reference to the accompanying drawings. These modalities are foreseen so that this disclosure will be meticulous and complete, and will transmit the scope of the general inventive concept to the technicians in the subject. The modalities of the general inventive concept can, however, be materialized in different ways and should not be interpreted as limited to the modalities provided for here. Although numerous specific details are provided for here, modalities of the invention can be practiced without these specific details. "One modality", "several modalities" and the like indicate modality / s so described (s) may include particular aspects, structures or characteristics. Some modalities may have some, all, or none of the characteristics described for other modalities. "First," second "," third "and similar terms describe a common object and indicate different instances of similar objects being referred to. Such adjectives do not imply that the objects thus described must be given in a given sequence, whether temporally, spatially, in classification, or in any other way. Similar numbers refer to similar elements completely. Known structures and techniques were not shown in detail to avoid hiding and understanding this description.
[0004] One embodiment of the invention includes an improvement in uterine manipulators and dye delivery systems that address several issues, such as minimizing surgical error, facilitating dye release, promoting easy manipulation of a patient's anatomy, and / or reducing costs of healthcare and hospital. One embodiment includes a uterine manipulator having a collar, stabilizer, uterine stem, external tube, pressure part, loop, and / or special tip. Another modality includes a dye release system having a uterine stem and a special tip. However, modalities are not limited to addressing these issues, and other benefits, features, and / or utilities may be apparent to a person skilled in the art.
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4/48 [0005] Figure 1 shows a schematic of a uterine manipulator 30, including a collar 10, stabilizer 20, and balloon tip 35 of application No. 571. More specifically, Figure 1 shows a sagittal cross section of a female pelvis. The cervix opens to the uterus 104. On one side of the vagina 107, towards the front of the body, is a bladder 112. On the other side of the vagina 107, towards the rear of the body, is the rectum 109 between intestines 110 and anus 108, which opens from rectum 109 out of the body. Surgeons can access the uterus 104 and other organs from the abdominal cavity 111.0 The fornix is a cylindrical ring of tissue surrounding the cervix and lower uterus. The lower cylindrical ring is the intravaginal fornix 101, which surrounds the cervix and is visible from the vaginal canal. The upper cylindrical ring of the fornix is the intra-abdominal fornix. When viewed from the abdomen, the anterior half of the intra-abdominal fornix 113 may be visible, but it is not demarcated or obvious to the human eye. The intra-abdominal fornix ring 113 passes between uterus 104 and rectum 109, and also passes between uterus 104 and bladder 112, as indicated by FIG. 1.
[0006] Several problems and injuries can result when using conventional devices, known as uterine manipulators, to manipulate the fornix. These problems include imprecise fornix delimitation and deviation; vaginal shortening; and abdominal deflation. The injury can also result from blocked cervical access and cervical recovery; blind device insertion and recovery; and lack of a platform while dissecting vital organs away from the fornix and vaginal wall.
[0007] Figures 2A - 2B illustrate a modality from two different angles. The uterine manipulator 30 includes a uterine stem 31, tip 70, collar 10, stabilizer 20, an external tube 61, and a pressing part 60, comprising a fixation part 62 and screw 63 (e.g., adjustment screw). In Figure 2A, the smaller diameter end 11 of the collar 10 is the receiving end for the neck
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5/48 of the uterus. In Figure 2B, the larger diameter end 12 of the collar 10 is the receiving end for the cervix. In other words, necklace 10 is reversible.
[0008] Figures 3A - 3D and 3E illustrate a modality of a uterine manipulator 30 from four perspectives including a loop 32, inlet 40, cap 34, manipulator rod 31, tip 70, collar 10, stabilizer 20, an external tube 61, and a pressing part 60. In Figures 3A - 3D, the end 11 of the collar 10 is the receiving end for the cervix. In Figures 3E - 3H, the end 12 of the collar 10 is the receiving end for the cervix. In other words, necklace 10 is reversible.
DOUBLE-USE NECKLACE [0009] Figures 4A - 4D illustrate a shape of a necklace 10 in one embodiment. Figure 4A is a top view of an embodiment of collar 10, Figure 4B is a perspective view, Figure 4C is a side view, and Figure 4D is a cross-sectional view of Figure 4C.
[0010] The collar 10 includes two ends 11 and 12, the diameter of the end 12 exceeding the diameter of the end 11. A side wall 14 defines a profile of the collar 10 with an inner surface 14a and outer surface 14b. The side wall also defines an opening 11a of the end 11 and another opening 12a of the opposite end 12. Between the openings 11a and 12a, the side wall 14 also defines an internal cavity 19 and is fluted with ridges 9. The side wall can be smooth , have regular ridges, or irregular ridges of varying width and size. The side wall can be of regular or irregular density.
[0011] The opening 11a is defined by a rim 13 having an outer rim 13a, an inner rim 13b, and a rim surface 13c between the outer and inner edges 13a and 13b. Collar 10 can also include a second outer rim
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13f separated by a duct or gutter 13g. Additional rim borders can be added as needed (eg 2, 3, 4, 5 or more).
[0012] In addition, the necklace has a double bezel. Just as aperture 11a is defined by a rim 13, so is aperture 12a defined by a rim 15. The rim has an outer rim 15a, an inner rim 15b, and a rim surface 15c between the outer and inner edges 15a and 15b. It can also have a second outer edge 15f separated by a 15g duct or gutter. Additional rim borders can be added as needed (for example, 2, 3, 4, 5 or more). Order No. 517 describes a variety of rim shapes and configurations applicable to the rim 13 of the end 11, represented in many of the figures. These shapes and configurations are also applicable to the rim 15 of the end 12. Furthermore, although the collar is described as double-rimmed, it can also be single-rimmed. The number of rings at one end of the collar need not match the number of rings at the other end.
[0013] The cervix has different lengths, diameters and shapes. Surgeons can outline and manipulate the fornix using either the rim 15 of the extremity 12, or the rim 13 of the extremity 11, depending on which extremum fits most comfortably or appropriately around the cervix. In other words, the end 12 or the 11 end of the collar 10 can serve as a receiving end of the collar that slides over the cervix and comes into contact with the intravaginal fornix.
[0014] In the modality shown in Figure 4A - 4D, the surgeon has two alternative diameters to fit the cervix - the diameter of the end 11 defined by the rim member 13c or alternatively, the larger diameter of the end 12 defined by the rim member 15c. Because there is variation in the cervical size of the patients, both extremities being the possible receiving extremity save substantially time and cost for hospitals and surgeons. To
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7/48 instead of testing with multiple necklaces, surgeons need only try on either side of a necklace.
[0015] In addition to reducing surgical time and cost, the double-rim collar reduces the risk of surgical error resulting from an overestimated cervical size. Surgeons may overestimate the size of the cervix due to optical illusions. In particular, the vaginal wall and tissue surrounding the cervix may mislead the surgeon into believing that the cervix is larger than it is. However, with a double-rimmed collar, a surgeon who believes that the cervix is larger in diameter can apply the larger end 12 as the receiving end. She can also test her assumption by trying the reverse lower extremity (extremity 11) to determine whether she overestimated the cervical diameter. If overestimated, she can use the smaller end.
[0016] The double ring collar does not complicate insertion or recovery. Even though the larger diameter end 12 is used as the receiving end, the smaller diameter end 11 can be inserted into the vaginal canal first, allowing the vaginal opening to expand to the widest diameter as the device is inserted. Once the collar is in the vaginal canal, the surgeon can rotate the device into the vaginal canal and slide the appropriate end over the cervix. If the end is too big or too small in diameter for the cervix, the surgeon can slide the collar 10 off the cervix, rotate the device, and slide the other end onto the cervix. Alternatively, the device can be inserted laterally, so that the side wall 14 is inserted first.
[0017] Repeated tests indicate that in some modalities, the distances 17a and 17b between the edges of the rings 13c and 13f, and 15c and 15f, respectively, can be 0-2 mm, 2-4 mm, 4-6 mm, or 6-8 mm. In some modalities, the distances 17c and 17d between the edges of the rings 13a and 13b, and 15a and 15b, respectively, can
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8/48 be 0-2 mm or 2-4 mm. In some embodiments, the diameter 17e of the end 11 can be between 15-20 mm, 20-25 mm, or 25-30 mm, 30-35 mm, or 35-40 mm, or 4045 mm. In some embodiments, the diameter 17f of the end 12 may be between 20-25 mm, 25-30 mm, 30-35 mm, 35-40 mm, or 40-45 mm. In some embodiments, the distance 17g between end 11 and end 12 can be between 5-10 mm, ΙΟΙ 5 mm, 15-20 mm, 20-25 mm, 25-30 mm, 30-35 mm, or 35-40 mm. The diameter can be 40 mm or more for women who have undergone natural childbirth.
[0018] A thread, weft, or strip (hereinafter "strip") 64 can connect between collar 10 and outer tube 61, pressing part 60, stem 31, loop 32 or any part of the uterine manipulator 30 to allow easy removal of collar 10 along the uterine manipulator 30, as shown in Figures 3E and 3G. The collar 10 can include a hole 14e along the side wall 14 or either the end of the collar 11 or the end 12, as shown in Figure 13B. Shoot 64 can be connected to hole 14e through a ring, knot, loop, glue or any other means. Alternatively, the strip can be tied around the diameter of the side walls of the collar 14, as shown in Figure 3G. In another embodiment, strip 64 is connected to collar 10 but does not connect to any other part of the uterine manipulator system and is instead loosened, inside or outside the vaginal canal, as shown in Figure 3F.
DOUBLE-USE NECKLACE FOR UNIVERSAL STABILIZER [0019] Each necklace 10 can use a stabilizer 20 in some ways to further outline the fornix. When the end 26 of the stabilizer 20 is pressed against an end or rim of the collar 10, the collar 10 delineates the fornix intra-abdominally. However, if the collar is dual-use and the diameters of the end of the collar 12 and the end of the collar 11 are different, then the stabilizer must be made in two different sizes, with two diameters corresponding to the respective diameters of the ends 11 and 12 of the collar , or
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9/48 alternatively rim 13 and 15 if the stabilizer is configured to press against the collar rim. This is expensive and complicated.
[0020] Figures 5A - 5D illustrate a modality in which a single universal stabilizer 20 can be used to stabilize either end of the collar 10. In this embodiment, the collar 10 contains an internal ridge, shelf, boundary, rim, ring, protrusion or shelf (hereinafter “shelf”) 14c located between the collar end 12 and collar end 11 and in communication with or attached to the wall 14. Figures 4B and cross section 4D also show a shelf 14c placed at the midpoint of the collar 10.
[0021] Figure 5A is a top-down view of an embodiment in which the end of the stabilizer 26 is inserted at the end of the collar 11 and pressed against the inner shelf of the collar 14c. Figure 5B is a perspective view. Figure 5C shows that a mode of stabilizer 20 can be inserted at either end 11 or end 12 of collar 10. Specifically, rim 25 of stabilizer 20 can snap, slide, lock or simply be pressed against either side of shelf 14c. In other embodiments, the stabilizer arms 22 - whether joined by a rim or not - can snap, snap or stop inside or on the inner shelf 14c from either end of the collar, depending on which end the surgeon chooses to use one end of recipient to contact the cervix.
[0022] Figure 5D shows a cross section of Figure 5C in which one stabilizer 20 leans against one side of the shelf 14c while another stabilizer 20 leans against the opposite face of the shelf 14c. The illustration of two stabilizers immediately touching either face of shelf 14c in Figures 5C and 5D is just to illustrate how a single end of stabilizer 26 can be pressed against shelf 14c from either end 11 or end 12 of collar 10, not to show that two stabilizers are used
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10/48 simultaneously. Thus, only one stabilizer is needed, instead of two, which reduces hospital and surgical costs.
[0023] As shown in Figure 5D, shelf 14c can be located anywhere between ends 11 and 12, including, but not limited to, the middle point of sidewall 14. When shelf 14c is located near or at from the middle of the wall 14 as shown in Figures 5A-5D, the rim 25 or pitch of the stabilizer 20, whether joined by a rim 25 or not, can engage, contact, or be pressed against either side of the shelf 14c on the wall inner side 14a.
[0024] In some embodiments, the wall of the collar 14 may have one or more sets of shelves lining up in two or more locations of the wall 14. In other words, the interior of the side wall 14 of the collar 10 may contain a series of shelves parallel lines spaced evenly or not. For example, a shelf 14c may be positioned away from the middle point and closer to the end of the collar 11, and another shelf 14c may be positioned closer to the end of the collar 12, as shown in Figure 4F. In such an embodiment, when a stabilizer end 26 abuts the shelf 14c, the distance between the base part of the stabilizer 21 and the receiving end of the collar is greater than if the shelf 14c were placed in the middle point of the inner wall 14. This modality creates a longer internal cavity 19 to accommodate longer cervices, which slide across the length of the collar (eg, Figure 13B). The shelf sets can have identical designs, or they can have different designs according to the possibilities described below.
[0025] In another embodiment, the collar wall 14 can have more than two sets of shelves to accommodate stabilizers of different depths and diameters. For example, a necklace may contain one or more shelves 14c located on either side of the middle point 14 of the inner wall, as shown in
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Figure 4E. Thus, a stabilizer with a larger diameter can touch a shelf located closer to the end 11 or end 12 of the collar, while a stabilizer of a smaller diameter can be designed to slide past the first shelf and press against a second shelf. near or at the middle point of the collar wall 14. Several shelves of different diameters would accommodate different lengths of cervix. The shelf sets can have identical designs, or they can have different designs according to the possible modalities described below.
[0026] In one embodiment, a shelf 14c may be comprised of one or more continuous circular rings, protrusions, or projections on which the pitchforks 22, rim 25, or end 26 of the stabilizer clicks, slides, locks, or simply presses against . In another embodiment, shelf 14c may be one or more shelf flaps, protrusions, boundaries, than pitchforks 22, rim 25 (which may or may not be continuous in different modes), or end 26 of the stabilizer pops, slides, closes inside or is simply pressed against. The broken tabs on the shelf have the same or different shapes and are smooth, irregular or mixed. In another embodiment, shelf 14c may be comprised of a subset of both continuous and interrupted shelves. Mixed shelves would facilitate a locking mechanism of the stabilizer ring 25 to the collar 10. In other embodiments, when a collar contains multiple sets of shelves, one set may be continuous while the other set is interrupted. A set can also include both continuous and interrupted subsets to facilitate a locking function.
[0027] In other embodiments, a shelf 14c can be folded against the side wall 14, be rounded, have a trapezoidal or polygonal surface, or the like to facilitate more security and stability of the end of the stabilizer or rim 25. In addition, a shelf 14c can have a shelf
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12/48 folded or perpendicular 14d to reduce slip or slippage of the stabilizer rim and hold it in place. The folded shelf 14d can be continuous or interrupted as a series of shelf flaps, with possible configurations described in the previous paragraph. A folded shelf or shelf flaps is / are particularly useful / useful on the side of the shelf facing the end 12, which may have a larger surface area because of the increasing diameter of the side wall 14 from the end 11 to the end 12 Alternatively, the inner side walls can be of varying thickness to achieve the same effect as shelves or to support a shelf or multiple shelves.
[0028] The surface area of the shelf 14c can be increased to the point where it creates a continuous disc or surface without holes. In such an embodiment, the disc creates a closed end of the collar so that the end of the stabilizer 25 is pressed against the closed end. This modality reduces the double-use collar to a simple-use collar and limits intravaginal access to the cervix.
[0029] In some embodiments, the 17h distance between shelf 14c and end 11 can be between 2-5 mm, 5-10 mm, 10-15 mm, 15-20 mm, 20-25 mm, or 25-30 mm . In some embodiments, the distance 17i between the shelf 14c and the end 12 can be between 2-5 mm, 5-10 mm, 10-15 mm, 15-20 mm, 20-25 mm, or 25-30 mm. In some embodiments, the distance 17j between the inner edge of the shelf 14c and the edge closest to the shelf edge 14d may be between 0-1 mm, 1-2 mm, 2-4 mm, 4-6 mm, or 6- 8 mm. In some embodiments, the thickness of the 17k shelf can be between 0-1 mm, 1-2 mm, 2-4 mm, 4-6 mm, 6-8 mm, or 8-10 mm.
DOUBLE-USE STABILIZER [0030] Figures 6A - 6E illustrate a stabilizer 20 according to an embodiment of the invention. As shown in Figure 6A, the stabilizer 20 includes a base part 21, pitchforks 22 extending from the base part 21, and a rim 25 unifying pitchforks 22 (although other arrangements may precede
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13/48 a continuous ring and include one or more pitchforks). The base part 21 includes walls 23 that define an opening 24 in a central part of the base part. Opening 24 is large enough to pass a tube or stem, such as the stem 31 of a uterine manipulator (as shown in Figure 2A). The opening may also include an extended guide hole with walls 33 to facilitate passage of the rod, as shown in Figure 14C. In another embodiment, the stabilizer has a side wall 29 without pitchforks or windows, as shown in Figure 14A.
[0031] As shown in Figure 6a, the stabilizer 20 contains a rim surface having an outer edge 25a, an inner edge 25b, and a rim surface 25c between the outer and inner edges and 25b. The stabilizer 20 also includes a second outer rim rim 25f separated from the surface 25a by a duct or gutter 25g.
[0032] Figures 14A through 14F illustrate alternative modalities of the stabilizer, containing characteristics that can be mixed and combined. Figure 14A shows a stabilizer with a side wall 29. This side wall 29 can have one or more windows or holes 27, as shown in Figures 14E - 14H. Figure 14B shows a modality that is single-rim, while Figure 14C shows a dual-rim modality. Figure 14D shows an embodiment of a stabilizer with grooved or fluted side walls.
[0033] Figures 14E through 14F illustrate four views of an embodiment of a stabilizer. Figure 14E is a side view, 14F is a cross-sectional view, 14G is a top-down view, and 14H is an angled view. In this embodiment, the stabilizer 20 includes a base part 21, a side wall 29 extending from the base part 21 with windows 27, and a rim 25. The opening 24 is large enough to pass a tube or rod, such as like a stem 31 of a uterine manipulator. Opening 24 also includes an extended guide with walls 33 to facilitate passage of the stem. Holes 27 can be used to suture
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14/48 the cervix with stabilizer 20 for easy removal of the cervix after a colpotomy or hysterectomy. In other words, a surgeon can pass a needle and thread through the hole to suture the cervix to the side wall of the stabilizer 29. The side wall 29 can be smooth, or alternatively grooved or fluted according to the stabilizer pitchforks shown in Figure 14D.
[0034] Order No. 517 describes a variety of rim shapes and configurations applicable to the rim 13 of the end 11, also represented in many of the figures. These and other shapes and configurations are also applicable to rim 25 of stabilizer 20. The stabilizer can also serve as an eyeliner for abnormally small cervices and may contain a gutter 25g as shown in Figure 6B to facilitate an incision. For example, for abnormally small cervices that are smaller in diameter than the 11th end of the collar 10, the surgeon can slide the stabilizer over the cervix without the accompanying collar, and use the stabilizer rim 25 to outline the fornix, as shown in Figure 8E. Small cervices do not require the same support as a normal or large cervix; therefore, the stabilizer is sufficient to serve as a fornix manipulator or eyeliner, further reducing the need for multiple collars and saving costs.
[0035] In some modalities, the stabilizer can have a number of modalities. In some embodiments, the weight 171 between the base part 21 and the unifying ring 25 can be between 5-10 mm, 10-15 mm, 15-20 mm, 20-25 mm, or 25-30 mm. In some embodiments, the 17m diameter of the rim 25 can be between 10-15mm, 15-20mm, 20-25, 25-30mm, 30-35mm, or 35-40mm. In some embodiments, the diameter 17n of the base part 21 can be between 5-10 mm, 10-15 mm, 15-20 mm or 20-25 mm. In some embodiments, the diameter 17 ° of opening 24 may be between 0-2 mm, 2-4 mm, 4-6 mm, 6-8 mm, or 8-10 mm.
REINFORCED STABILIZER
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15/48 [0036] Figures 7A - 7B show that a stabilizer 20 can be connected to an external tube 61 made of plastic, metal, nanofibers or some other biocompatible material. Tube 61 slides over part of the uterine stem 31, as shown in Figure 2A, and therefore minimizes the risk of stabilizer 20 falling into the vaginal canal after removal of the vagina. The outer tube 61 also allows for more stable application or force against the stabilizer 20 and reduces slippage of the stabilizer against the uterine collar and stem when the uterine manipulator system is in use against a cervix. The outer tube 61 can be connected to the stabilizer 20 or manufactured as a part. An external tube 61 can completely surround the stem 31, as shown in Figure 2A, or it can partially surround the stem. The outer tube can partially surround the stem and remain slidable along the stem. The outer tube 61 can extend a partial or total length of the stem, as shown in Figure 17.
[0037] A disc or other object can intermediate the connection between the external tube 61 and the stabilizer 20 in order to allow a more uniform distribution of pressure from the external tube 61 against the stabilizer 20, and to prevent abdominal air from leaking out. from the opening of the stabilizer when an incision is made during a colpotomy.
[0038] As shown in Figure 2B, the outer tube 61 can also be part of or in fluid communication with a pressing part 60 that protects the outer tube 61 to a desired part of the uterine stem 31. The pressing part 60 can be composed of a fixing part 62 connected to a screw 63 (for example, an adjustment screw). When the pressure part is moved to a desired point on the stem 31, the screw 63 (which is connected to the fixing part 62) can be tightened to the stem 31. This fixes the pressing part 60 to the stem 31. In another embodiment, the pressing part may be comprised of a spring-loaded clamp or slide clamp that clicks into place when released. In yet another
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In this embodiment, a clasp may include an adjustment screw or any other clasp such as, for example, a stop collar. A stop collar (also called a stem collar) is a mechanical clasp that goes around a rod or rod with a screw or clamp or other clamping mechanism to secure the collar in position. Stop collars can take the form of small rings. A user can hold the collar in place by working a screw through the collar and onto the stem, or by holding the collar to distribute the pressure more evenly and reduce the risk of damage to the stem. A stop collar can use a threaded part which, when tightened, drives an element against the inner rod to lock the shaft in place. A stop collar is a mechanical stop, which can attach components (eg, outer tube 61) to a stem (eg, stem 31), and can be used for positioning, limiting and separating activities.
[0039] When the pressing part 60 is pressed against the outer tube 61, the fornix can be more precisely delineated. This is because the pressing part presses the outer tube 61, which in turn applies pressure to the stabilizer 20 (which may or may not be attached to the outer tube 61). The stabilizer 20 applies pressure against the collar 10, which causes the collar of the collar to be pressed against the intravaginal fornix and distends the fornix. When the pressing part 60 is connected to the outer tube 61, there is less slippage between the two components and the pressure is more directly applied to the fornix.
[0040] In some embodiments, the diameter 17p of tube 61 may be between 2-4 mm, 4-6 mm, 6-8 mm, or 8-10 mm, 10-12 mm, or 12-14 mm. In some embodiments, the length 17q can be between 5-15 cm, 15-25 cm, 25-35 cm, or 3545 cm.
[0041] Alternatively, the outer tube 61 can extend outside the vagina 107, with or without a pressing part 60 as shown in Figure
17. An extended external tube 61 allows a surgeon to adjust the length of the
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17/48 stem 31 extended through the vaginal canal and uterus by holding the pressing portion of the outer tube 61 out of the vaginal canal and then sliding the stem 31 in front of the canal or back out of the canal. Sliding of the stem 31 can be facilitated if the stem 31 is attached to a handle 32. When the stem 31 is attached to the handle 32, a surgeon can adjust the length of the stem 31 extended through the vaginal canal and uterus by holding the tube fixed outer 61 while pushing or pulling back handle 32. In this embodiment, outer tube 61 operates as a sliding or sliding element. The outer tube can extend a partial length of the rod, or alternatively it can exceed the length of the rod.
THE UTERINE STEM [0042] Figures 8A - 8C show possible modalities of a uterine stem 31, a tube made of plastic, metal, or any other biocompatible material, or a combination thereof. For example, stem 31 may be a combination of metal or plastic encased in plastic or non-conductive material. In one embodiment, stem 31 contains an internal conduit for fluid flow. In another embodiment, the tube does not contain an internal conduit.
[0043] In embodiments where the stem has an internal conduit, the inlet end of the stem 31 may contain an inlet 40 configured to receive fluid, as shown in Figures 8D - 8F. Once injected, the fluid can travel through an outlet 37 at the distal tip of the stem and into the uterus, or through an outlet 71 at a special tip 70 and into the uterus, as shown in Figures 8C & 8D respectively. Inlet 40 can include a cap 34 and close, double threaded or other mechanism or valve to control the fluid through stem 31. As shown in Figures 3A - 3B and Figure 12E, inlet 40 can be attached to either stem 31, stem 32, or both. Similarly, cover 34 can be screwed to inlet 40, handle 32, or both.
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18/48 [0044] Figures 8D - 8H show a rod in combination with several parts, which may or may not be used, depending on the intended use or characteristics of the patient. For example, Figure 8D shows a rod 31 coupled to a tip 70 and handle 32 to create a dye delivery system. Figure 8E shows the addition of a stabilizer 20 and stem 61 to create an adolescent uterine manipulator system suitable for smaller cervices. Figure 8F shows the addition of a collar 10 to create an adult uterine manipulator system for adult cervices. Figure 8G and Figure 8H show the addition of a fulcrum 50 to create a pivot point for the uterine manipulator in the simple and complex uterine manipulator system, respectively.
[0045] The outlet end of the stem 31 may contain a part of screw 36, as shown in Figure 8A. As shown in Figure 8A, a screw part 36 can be comprised of wires, roots or flanks configured to allow for a special tip (such as element 70 shown in Figure 8D) or balloon to be screwed on to release dye, inflation or other medical purposes. Alternatively, the stem may have one or more openings or holes 37 at its tip or along the distal side walls of the stem. The orifice 37 can be circular, rectangular, oval, or any other polygonal or trapezoidal shape.
[0046] The stem 31 can have several shapes, as illustrated in Figures 8A - 8C. Figure 8A shows a curved shaft 31. Figure 8B shows a straight shaft 31. Figure 8C shows a shaft with three sections. The third section 49 is designed for complete or partial insertion into the uterine cavity. Second section 48 is designed to travel partially or completely through the vaginal canal. The first section 47 is designed for partial or complete protrusion out of the vaginal canal. The first section 47 can contain a loop 32 and / or outlet 40 with a lid 34. As shown in Figure 8C, the third section 49 can be curved or sharply angled to facilitate manipulation and elevation of the uterus intra-abdominally from organs
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19/48 vital signs such as the sigmoid neck. Here, the second section 48 includes a second long axis and the third distal section 49 includes a distal end that runs through the long axis of the second section 48 at an intersection angle between 0 and 90 degrees.
[0047] The advantage of the straight nail with a curved tip, as shown in Figure 8C, is that nail movements correlate with movements or displacements of the uterus. For example, rotation of the loop leads to direct rotation of the uterus. The movement of the nail along the horizontal axis leads to the horizontal displacement of the uterus. The movement of the nail along the vertical axis leads to the vertical displacement of the uterus. This is not true for multiple rod curved modalities, as shown in Figure 8A. For example, a clockwise rotation of a modality with a straight shaft with a curved tip (for example, a shaft shown in Figure 8C) leads to the corollary on the right or clockwise rotation of the uterus. However, in a multi-curved stem, exposing the right fornix requires rotation and a disproportionate upward and rightward movement (diagonal movement) of the stem in order to achieve the same desired orientation. This complex diagonal vector movement is required because of the multiple curvature architecture and the fulcrum fata in the pelvic cavity. Complex vector movements lead to complex instructions from the surgeon to the assistant holding the stem or uterine manipulator system. In contrast, the straight shaft and curved tip as shown in Figure 8C allows clear instructions from the surgeon to the assistant. Clearer instructions can be facilitated by using a directional handle described in more detail below.
[0048] In an alternative embodiment, the entire shape of the stem is malleable. In another modality, the second and third sections are malleable. In another embodiment, the third distal section is malleable. In the latter embodiment, a third malleable section would prevent the distal section from being manipulated 360 degrees along the second axis section and 360 degrees along the axis orthogonal to the second section, or
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20/48 a combination of both. Malleable material includes rubber and other biocompatible materials referenced in this specification or otherwise used in the industry.
[0049] In some modalities, the length of the third section 49, or uterine part, is from 4 cm to 15 cm, and can be adjustable. In another embodiment, the length of the uterine part is approximately 6cm to 10cm. The desired second section 48 for the vaginal canal can be 4cm to 18cm, depending on the patient's age. Alternatively, it can be a narrow range between 6cm and 14cm. The third section 27 containing the handle can be 6 cm or more. In one embodiment, the total length of the uterine stem from the proximal end to the distal end is greater than 15 cm. In an adult mode, this length can be between 25cm and 40cm, or more or less. Alternatively, the uterine stem can be malleable in shape and the outer tube can be used to adjust the length, as described below. In addition, an acute angle Φ between the second section 48 and the third section 49 facilitates manipulation and uterine elevation, as shown in Figure 8C. In one embodiment, this angle is curved and gradual, as shown in Figure 8C, although it can also be acute. In one embodiment, this angle can be from 20 degrees to 80 degrees, as shown in Figures 8C - 8F. The angle can be adjustable to achieve a greater or lesser angle.
THE UTERINE ROD TIP [0050] The distal end of the rod 31 intended for insertion into a uterus can include one or more holes 37 along the side wall to facilitate the release of dye through the internal lumen of the rod, as shown in Figure 8A . In addition, an orifice can be placed in the most distal part of the stem end to release dye in the most distal part, as shown in Figure 8B. Alternatively, a tip 70 can be attached to the distal end to reduce the
Petition 870190099786, of 10/04/2019, p. 37/66 / 48 risk of perforation of the uterine wall, as shown in Figure 8D- 8F. In one embodiment, the tip 70 can be considered a part of the distal end of the stem 31.
[0051] Figure 9A shows a one-pointed embodiment 70, and Figure 9B shows a cross-sectional view. The outlet end of the uterine stem 31 can be attached to or screwed to a tip 70 made of plastic, rubber, polyurethane, balloon-like biocompatible material, or other biocompatible or combination material. The tip can be fixed by glue, welding or another mechanism. In addition, the tip and / or the stem may contain external ridges, wires, flanks or roots to facilitate a screw mechanism for mounting. Tip 70 is inserted through the cervical canal and into the uterus, as shown in Figure 17.
[0052] As shown in Figures 9A - 9B, tip 70 may include one or more holes or openings 71 dispersed along side walls 79. The holes may be circular, oval, rectangular in shape, or any other shape, including shape trapezoidal, polygonal or an irregular circle shape. The holes may be microscopic or visible to the human eye. The purpose of the orifices is to release dye (for example, blue or indigo-carmine dye) into the uterus for, for example, a "fallopian tube clearing" test - an examination performed to determine whether the fallopian tubes are free and if there are abnormalities in the uterine cavity. To perform the procedure, a surgeon opens the inlet 40 located at the inlet end of the uterine stem 31 (as shown in Figure 8B) or in the distal part of the loop 32 (as shown in Figure 8D), and connects to a syringe containing dye at the entrance. The dye is then injected into the uterine nail 31 and travels along the internal lumen of the nail 31 to the tip 70 (see Figure 17 showing anatomical references). The dye then escapes through tip 70 through hole 71 (or holes) located on the side walls 70 inward
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22/48 of the uterus 104 for the test. If the fallopian tube contains an abnormality, the dye leaks out of the uterus and the fallopian tube is visible in the pelvic cavity 111.
[0053] The hole or series of holes 71 can also be located at the farthest end 75 from the tip 70, rather than on the side walls 79 in one embodiment. However, if the tip 70 is pressed against the uterine wall, the dye does not fill the uterus or enter the fallopian tube, but instead remains on the tip or is alternatively absorbed by the tissue of the uterus or muscle. This can generate a false negative test result, the current state of which the tip of the art balloon often generates. Therefore, in one embodiment, the holes are along the side walls of the tip 70 to minimize the risk of false negatives by increasing the likelihood that the dye will enter the uterus. Alternatively, if a special tip is not employed, one or more holes 37 may exist along the side walls of the stem 31, as shown in Figure 8A.
[0054] As shown in Figures 10A-10E, the tip 70 may have an hourglass, dumbbell, curved or curved shape. Alternatively it may have less curvature, as shown in Figure 10E, or none or very limited curvature (as shown in Figure 10B). The curves or humps located at points 73 and / or 72 (shown in Figures 9A & 9B) serve to create a back seal between the tip and the cervical canal. This prevents the dye from leaking. In addition, the curvature at point 72 prevents the tip from slipping out of the uterus, through the cervix into the vaginal canal. The curve at point 73 provides a rounded, coarse and expanded surface to minimize the risk of perforation of the uterine wall, which can occur if the uterine manipulator is inserted too deeply into the uterus. However, the curvature or number of humps can vary. One end may have a hump, as shown in Figure 10B, although it makes the device less effective since it is likely to slide out easily. Or the tip may have two or more humps (for example, 2, 3, 4, 5 and so on). Alternatively,
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23/48 the tip may have different shapes (as shown in Figures 10A-10E) at any point including its distal end, such as an oval, rectangular, oblong, arrow shaped, and the like. In other embodiments, the tip may have a single rounded snake head, as shown in Figure 10E.
[0055] The wall thickness of the tip 70 of the side walls 79 can vary to create an empty oval core 74, as shown in Figure 9B. Alternatively, the wall may be of uniform thickness as shown in Figure 11 A. The tip 70 may also have a grooved exterior to prevent slippage out of the uterus into the vaginal canal. The ridges can be in a proximal or distal part of the tip, as shown in Figure 11B, or the ridges can be in the total length of the tip 70. The ridges can be horizontal, vertical, crossed, or in any design. Tip 70 may also include internal ridges at its proximal end to facilitate screwing the tip to the distal end of the stem.
[0056] In some embodiments, the tip length 17r can be between 10-15mm, 15-20mm, 20-25mm, 25-30mm, 30-35mm, 35-40mm, 40-45mm, 45-50mm, 50-55mm , or 55-60mm. In some modalities, the distance between the two humps at point 73 and 72 can be 10mm to 30mm. The minimum diameter of orifice (s) 71 can be 0-2mm, 2-4mm, 4-6mm, 6-8mm, or 8-1 Omm. In some embodiments, the diameter 17t at points 73 and 72 can be between 3-5mm, 6-7mm, and 8-1 Omm. The diameter 17 of the narrow middle part can be between 0-2mm, 2-4mm, 4-6mm, 6-8mm, or 810mm.
[0057] A uterine manipulator system that is comprised of a stem 31 and a tip 70 can serve as a simple dye release system, as shown in Figure 8D. In addition, a modified uterine manipulator system for small cervices may exist using stabilizer 20 without collar 10,
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24/48 as shown in Figure 8E. In a modified system, an external tube 61 and the pressing part 60 can be used for additional support and stability.
UTERI ROD STRAP IN [0058] FIG. 12A shows a modality of the loop 32 of the uterine stem 31 containing a marking, ridge, or compass at 42 to indicate the appropriate angle and direction in which to hold the loop 32. Current uterine manipulators have no indication of the proper placement of the manipulator. Physical markers or language in 42, such as "This Side Up" or "Top", would indicate to the holder the proper placement of the manipulator and would minimize the risk of twisting the manipulator in the wrong direction during surgery. The area with the physical area can be flat or recessed to stamp a label.
[0059] As previously discussed, loop 32 can also have directional components to facilitate precise instructions from the surgeon and corresponding movements of the assistant's uterine manipulator holding the manipulator. In particular, the handle may have a triangle-shaped, polygonal, curved or mixed base part 45 with a distinct tip 46 along an axis orthogonal to the shaft axis. In other words, the handle may include a base portion 45 that projects orthogonally (or any other angle) towards the proximal end of the stem. The base part 45 allows a person holding the uterine manipulator to know how many degrees the device is rotated.
[0060] This rotation of the rod 31 is often obscure in current modalities where a hand wraps entirely around the loop 32, or where the rotations of the wrist do not clearly translate into rotations of the device to the human eye. For example, when the base part 45 is comprised of a triangle with a tip 46, as shown in the embodiment in Figure 12D, the surgeon can instruct the device holder to point the triangle tip to the left or to the right, alternatively at 9 am or 3 am to reach the setting
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Desired 25/48. In addition to the words “9 o'clock” or “3 o'clock”, “left” or “right” or any other directional language of the type can be printed on either side of the handle. In addition, tip 46 may also contain a point or other marking to facilitate simple instructions, such as "right point" or "left point" to instruct the holder to rotate the handle accordingly.
[0061] The base part 45 can also be understood as a vertical stick, rod or bar 55 attached perpendicularly or at any angle of the handle 32, as shown in Figure 12B, which allows similar instruction and printed directional language. The bar 55 can have a triangular or pyramidal structure attached to the base part 45, as shown in Figure 17. The bar 55 can extend through both sides of the handle 32, forming a T shape, as shown in Figure 12E. Bar 55 can be rectangular, triangular, or any other polygonal shape. It can be curved or a combination of curves and polygonal shapes. Alternatively, the bar 55 and the handle 32 can form a vertical lever-type cable, where the fingers are intended to wrap around the face connecting to or proximal to the stem and the thumb is inserted to rest perpendicular to the fingers on the distal part handle 32, as shown in Figure 12E. When connected to a robotic arm, the cable may consist of a robotic arm accessory 220. This accessory may allow forward, vertical, horizontal and rotational rotation or six degrees of freedom of the robotic arm and uterine manipulator system.
[0062] Figures 13A - C, 14A - H and 15A - C illustrate alternative modalities of a stabilizer 20 and collar 10. Each of the arrangements shown in Figures 13A-13C generally show opposite ends of a collar where one or more ends has a larger diameter than the other end. Like the collar shown in Figure 2A, the collars 10 shown in Figures 13B and 13C include ridges on the outer wall to help guide a cutting surface. Figure 13B shows an additional hole 14e to facilitate attachment of strip 64. Figure 13B also shows
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26/48 a shelf 14c located in a distal part, in which Figure 13C shows a shelf 14c located in the middle point of the collar wall 14. Figures 14A through 14D show modalities of a stabilizer configured for attachment to a collar
10. Figure 14A shows a stabilizer 20 without pitchforks and instead of side wall 29. Figure 14C shows a stabilizer with a double rim configured to outline use on a small cervix. Figure 14D shows a stabilizer with fluted outer walls configured to reduce slippage in the vaginal canal. Figures 14E - 14F illustrate a modality of a stabilizer with side walls 29 and small windows 27. Figures 15A - 15C show modalities of a collar and stabilizer manufactured as one piece.
FULCHER [0063] To facilitate accurate displacement of the uterus, the stem may contain a fulcrum (hereinafter “fulcrum”) 50 or an accessory to position a fulcrum or fulcrum point, as shown in Figure 8G - 8H. Fulcrum 50 can be placed intravaginally or exist outside the vagina. When placed intravaginally, the fulcrum can be comprised of a disc, plate or sponge as shown in Figure 8G. Alternatively, the fulcrum can be spherical or rounded in shape as shown in Figure 8H. Alternatively, the fulcrum can be polygonal or trapezoidal in shape. The fulcrum 50 can be positioned or slidable along any part of the stem 31. For example, the fulcrum 50 can surround the second section 48 or the third section 49 of the stem 31, as shown in Figure 8G; it can surround, be attached to or part of the external tube 61, as shown in Figure 17; or the fulcrum 50 can be positioned between components, such as the outer tube 61 and a pressing part 60, or between the stabilizer 20 and the outer tube 61.
[0064] Figure 18A shows a fulcrum modality in which it is a disk structure with one or more arms 134, rim 130 and hole 132. There is space between the arms to facilitate the insertion of a tentacle and provide access to the neck of the
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27/48 uterus. Alternatively, as shown in Figure 18B, the fulcrum may contain no arms and be comprised of a solid disc with one or more holes. When a solid object with a simple orifice to receive the rod, the fulcrum serves as a plug against intra-abdominal air leaks after an incision made in the fornix. Ring 130 is adapted to contact the vaginal wall. The fulcrum 50 may also exist, alternatively, as a spherical, oval, trapezoidal and polygonal shape. The fulcrum can also be spherical or round in shape, or have depth extended to the vaginal canal. Hole 132 may be at the center point of the fulcrum or another point.
[0065] In some embodiments, the fulcrum 50 may be a sponge that slides over the stem 31 between the stabilizer and the handle of the stem. A sponge prevents CO2 from escaping from the abdominal area when the fornix is incised. This sponge can be configured to expand into and fill the vaginal cavity. Alternatively, the sponge can be located between the stabilizer 20 and the collar 10, and fill any extra space in the cavity 19 of the collar not filled by the cervix. The sponge can be gauze or similar. It can be comprised of natural or synthetic sponge, foam, or any material that naturally expands into the vaginal cavity.
[0066] In addition, a plate, tube, speculum or retractor (hereinafter “retractor”) 82 can be placed intravaginally to provide resistance against or fix support for 0 fulcrum 50. Figure 17 illustrates a modality of a uterine manipulator having a collar 10, stabilizer 20, uterine stem 31, external tube 61, pressing part 60, loop 32, tip 70, and fulcrum 50, used in conjunction with a vaginal retractor 82.
[0067] The vaginal retractor 82 is placed inside the vaginal canal and used to expand the upper and lower walls of the vagina. A uterine manipulator stem
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28/48 travels between the retractor and is inserted into the cervix. The retractor plates provide a fixed platform against which the fulcrum 50 operates.
[0068] The retractor 82 can be understood by a structure like spoon with an elongated body and distal concave part of larger diameter than the elongated body. Alternatively, retractor 82 may be a speculum, or be comprised of a plate, which may have a concave curvature or one or more protrusions perpendicular to the elongated plate, as in a “Sims Retractor”. Or the retractor 82 can be comprised of a simple elongated body, which can be concave or connected. The retractor 82 can also be comprised of a hollow tube with two open ends, or a speculum structure with a diameter larger than the uterine manipulator system to allow horizontal and vertical movement of the rod within the tube. Or retractor 82 can be any tool or surface that provides a fixed plane. The material can be metal, plastic, or any other biocompatible material.
[0069] In another embodiment, fulcrum 50 can be created by coupling an external arm 220 to a stem 31, loop 32 or external tube 61 of a uterine manipulator system 30, or dye release system, as shown in Figures 16A - 16F. As shown in Figures 16A and 16B, arm 200 can attach to second section 48 or first section 47 or stem 31 to create a fulcrum 50 at the attachment point of arm 90 of stem 31 (for example, second section 48 or first section 47 of stem 31 as shown in Figures 8C). The arm can also attach to the third section 49, however, this can be invasive in the vaginal canal. When the stem 31, or other component parts of a uterine manipulator system (for example, loop 32 or external tube 61) attached to an external arm, a fulcrum 50 is created at the point of attachment. The fulcrum 50 allows movements of the external arm to correlate with movements of the uterine manipulator system 30 and, when inserted
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29/48 in the uterus, movements of the uterus 104. A fulcrum is particularly well suited for the stem shapes illustrated in Figures 8B & Figure 8C.
[0070] The arm 200 can be comprised of an arm part of a robotic surgery platform. In robotic surgery, an automated arm leads to automated movements of the uterine manipulator system 30, as shown in Figures 16E - 16D.
[0071] Alternatively, the arm may have an attachment point 202, which holds, bolts or attaches to an operating table, as shown in Figure 16C. Alternatively, attachment point 202 can be attached to a patient's extremities, such as legs. Figure 16C shows an arm 200 attached to a plate 95, on which the patient's body rests and is therefore immobile due to the gravitational force of the patient's body. The plate can be fixed to the operating table 98 by means of strip (s) 99 or another fixing mechanism to ensure that it is immobile. Alternatively, the strap can surround the patient and be secured by means of a knot, velcro or other fastening mechanism. Plate 95 can be any circular, oval, rectangular, square, polygonal or other mixed shape.
ARTICULATION SYSTEM [0072] The uterine manipulator system 30 or dye release system may include a fulcrum 50 comprised of a connection to assist in the articulation of the uterine manipulator. The connection may include, for example, a collection of rigid rods interconnected by pivots and / or clamps to allow selected varieties of movement. The selected varieties of movement are adapted to extend into a three-space envelope needed or expected to be necessary for the uterus undergoing the procedure.
[0073] The connection, for example, may include an arm 200, as shown in Figure 16A and Figure 16B, (such as a Martin arm). The arm includes an attachment part 202 comprised of a clamp, a right angle 204, a rod
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Secondary 30/48 206, a tertiary rod 208 and an end clamp 110. The attachment point 202 is configured to secure the arm 200 to a fixed surface in proximity to the patient, such as an operating table.
[0074] The attachment point 202 can connect to the right angle rod at a first end and can have two degrees of freedom. Attachment point 202 may include a rotational component that can be released or secured with a locking knot. Attachment point 202 may also include a second locking node that allows sliding translation of the right angle rod 204.
[0075] The right angle rod 204 may have a long part 204a configured to extend through a linear opening 202a defined in the attachment part 202. The right angle rod may include a short part 204b extending at a right angle to the long part 204a and support a ball on its free end. The long portion 204a of the right angle rod 204 can be dimensioned and formed to extend vertically in the anterior-posterior thickness of a patient reclined on the operating table. The short portion 204b of the right-angle nail 204 can be sized to partially close the distance between the edge of the table and the patient's uterus.
[0076] Secondary rod 206 may include a lockable socket 212 at a first end. The lockable socket 212 can be configured to receive the ball at the free end of the right angle rod 204. The lockable socket 212 can be configured to allow the secondary rod 206 to move with three rotational degrees of freedom relative to the right angle rod 204. Lockable socket 212 can be configured for a friction fit with the right angle rod ball 204. The friction fit can be calibrated to allow a healthcare professional to move the secondary rod 206 relative to the right angle rod 204 to remain relatively fixed when not under the forces of one hand.
Petition 870190099786, of 10/04/2019, p. 47/66 / 48 [0077] Secondary rod 206 may be a linear rod and relatively smaller than the long part of the right angle rod 204 and about the same length as the shorter part of the right angle rod.
[0078] Secondary rod 206 may include a second end with a lockable pivot 214. Lockable pivot 214 may connect the second end of secondary rod 206 to a first end of the tertiary rod. The lockable pivot may include a locking node 214b configured to secure the simple degree of freedom between the secondary and tertiary rods.
[0079] The tertiary rod 208 is a linear rod that can be the same length as the secondary rod 206. The tertiary rod 208 may include a second end 208a with a socket similar to the socket of the secondary rod 206.
[0080] The end clamp 210 includes a ball configured to rotate with three degrees of rotational freedom within the socket of the tertiary stem 208. The end clamp 210 includes a C-shaped or U-shaped body defining an opening configured to receive a slide part or stem of the uterine manipulator. End clamp 210 also includes a screw mechanism 216 having a lever on one free end and a locking face on one end extending to open the C or U-shaped body on end clamp 210. The lever can be grasped to turn the screw and advance the locking face to the part of the uterine manipulator extending through the body opening. The screw mechanism 216 is therefore configured to lock or secure the uterine manipulator in place in relation to the end clamp 210.
[0081] Once the uterine manipulator is attached to the end clamp 210, the intervening mobile connections between the rods allow a relatively complete range of six degrees of freedom of movement in relation to
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32/48 patient. At the same time, the healthcare professional can selectively fix the various connecting joints to eliminate degrees of freedom and provide more controlled manipulation of the uterus. A modified arm 200 with less degrees of movement and fewer intervening rods can be used, as illustrated in Figure 16F.
[0082] In another embodiment, an arm can be connected to a tripod structure, as shown in Figure 16F. In such an embodiment the legs of the tripod 200, which can be two or more, would support a base part 202 and would have mechanisms similar to a Martin arm. For example, the height or vertical translation could be controlled by an attachment part 202 and the device could include a secondary rod 206, a tertiary rod 208 and an end clamp 210. Secondary rod 206 can also include a lockable socket 212 in a first end configured to receive the ball at the free end. Lockable socket 212 can be configured to allow secondary rod 206 to move with three rotational degrees of freedom. Secondary rod 206 can also include a second end with a lockable pivot 214. Lockable pivot 214 can connect the second end of secondary rod 206 to a first end of the tertiary rod. Lockable pivot 214 can include a locking node 214b configured to secure the simple pivoting degree of freedom between the secondary and tertiary rods. The tertiary rod 208 can include a second end 208a with a socket similar to the socket of the secondary rod 206. The end clamp 210 includes a ball configured to rotate with three degrees of rotational freedom within the socket of the tertiary rod 208. The end clamp 210 includes a C or U-shaped body defining an opening configured to slide a screw mechanism 216 having a lever at a free end and a locking face at one end extending to the opening of the C or U-shaped body end clamp 210. The lever can be gripped to turn the screw and advance the locking face
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33/48 for the part of the uterine manipulator extending through the opening of the body. The screw mechanism 216 is therefore configured to lock or secure the uterine manipulator in place in relation to the end clamp 210.
[0083] Instead of a hand operated arm, connection 150 may include several motors to form a partial or complete robotic system 240. Figure 16D illustrates a robotic arm 220 coupled to a manipulator system 30 and Figure 16E illustrates an arm robot 220 and uterine manipulator system 30 as part of a robotic system. The robotic system can be configured to achieve the same six degrees of freedom of movement within the envelope required to perform uterine manipulation. The robotic system may be a generalized robotic arm 220 with an effector end 221 configured to grip or block into the uterine manipulator. Effector 221 also serves as a 50 fulcrum. A commercially available robotic arm system, for example, is the da Vinci surgical system sold by Intuitive Surgical. The connection system does not need to be commercially available, but instead it could selectively combine various dimensions and motorization to better meet the desired amount of precision, movement and control desired by the healthcare professional.
[0084] Not every modality of a uterine manipulator system necessarily includes the aspects, structures or characteristics described in the specification. For example, a uterine manipulator system can be comprised of a rod 31 and tip and can serve as a simple dye delivery system, as shown in Figure 8D. Tip 70 can also be replaced with a balloon. In other embodiments, the system may also include a fulcrum 50 or fulcrum accessory. Alternatively, the system may also include a stabilizer 20 which may or may not be accompanied by an external tube 61. In other embodiments, the system may additionally include a collar 10.
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34/48 [0085] The uterine manipulator system and its various modalities can be packaged, sold or delivered as a kit with a tool or surgical device, such as an arm, connection, robotic arm or any device that facilitates articulation. In addition, more necklaces and stabilizers can be sold in a single uterine manipulator kit. For example, such a kit may include one or more collars and one or more stabilizers in addition to stem 31, tip 70 and handle 32. Alternatively, a kit may include stem 31, tip 70 and handle 32, but collars and stabilizers are sold separately. The device can come pre-assembled or separately with the system. The kit can include other materials such as appropriate marking, one or more sterile barriers (for example, 2 barriers), trays, bags and a box. These other components can be sterile.
[0086] All parts can be constructed from a variety of materials, including, but not limited to plastic, metal, cloth, textiles, synthetic fibers, nylon, rubber, Silicone (Polydimethylsiloxane), Polyurethane (for example, Aromatic Aliphatic ), Urethane Polycarbonate, Polyvinyl Chlorite (PVC), Polyethylene Mesh or Film (for example, LLDPE, LDPE, HDPE), Polypropylene, Nylon, Pebax, Polycarbonate Mesh or Film, or other materials with other suitable or similar properties.
[0086] Several examples of modalities are now discussed.
[0087] Example A includes a uterine manipulator, comprising a uterine stem, collar and stabilizer; wherein the collar has a first end having a first opening with a ring to surround the first opening, and a second end having a second opening with a ring to surround the second opening; the second end having a larger diameter than the first end, and the collar having an inner surface and an outer surface to define an inner cavity; and a stabilizer comprising a base part and a plurality of pitchforks extending from the base part; where the rod
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35/48 uterine glide through the base part of the stabilizer, and the ends of the stabilizer pitchforks contact the collar.
[0088] Another example includes the uterine manipulator of Example A, where the collar has a trapezoidal cross-sectional shape, a domed, polygonal cross-sectional shape or a combination of polygonal and domed cross-sectional shape.
[0089] Another example includes the uterine manipulator of Example A, in which the collar has a plurality of parallel ridges around an external surface of the collar.
[0090] Another example includes the uterine manipulator of Example A, where the necklace has one of an orifice, ring, flap, or other shelf attached to the necklace to receive a strip.
[0091] Another example includes the uterine manipulator of Example A, in which one or more hoops include an outer border, an inner border, and a rim surface between the outer border and the inner border to define the opening, and the surface of rim is angled with respect to a plane defined by the outer edge.
[0092] Another example includes the uterine manipulator of Example A, in which one or more hoops include a shelf extending inwards towards the middle part of the collar from the first end.
[0093] Another example includes the uterine manipulator of Example A, in which one or more hoops comprise a first outer rim edge adjacent to the first opening and a second outer rim edge separated from the first outer rim edge by a gutter.
[0094] Another example includes the uterine manipulator of Example A, in which the base part of the stabilizer has a guide hole. Another example may include the object of the immediately preceding example, where the ends of the pitchforks
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36/48 contact a gutter on the inner surface between the second rim and the collar wall.
[0095] Another example includes the uterine manipulator of Example A, in which the ends of the pitchforks contact an internal surface of the collar.
[0096] Another example includes the uterine manipulator of Example A, in which the ends of the stabilizer pitchforks contact a collar loop.
[0097] Example B includes the uterine manipulator of Example A, in which the stabilizer includes a stabilizing ring connecting the ends of the pitchforks that are opposite the base part. Another example includes a uterine manipulator from Example B, where the stabilizing ring contacts the inner surface of the collar. Another example includes the uterine manipulator of Example B, where the stabilizing ring contacts a collar ring. Another example includes the uterine manipulator of Example B, where the stabilizing rim contacts a gutter on the inner surface between an outer rim border and the collar wall.
[0098] Example C includes the uterine manipulator of Example A, wherein the internal surface of the collar wall includes one or more shelves. Another example includes the uterine manipulator of Example C, where the stabilizing ring contacts the shelf on the inner surface of the collar wall. Another example includes the uterine manipulator of Example C, in which the stabilizer pitchforks contact a shelf on the inner surface of the collar wall. Another example includes the uterine manipulator of Example C, where the shelves contain additional angled shelves. Another example includes the uterine manipulator of Example C, where the shelf (s) constitutes / in a circular inner rim or border along the internal surface of the collar wall. Another example includes the uterine manipulator of Example C, where the shelf (s) is / are located at the middle point between the inner and outer ends of the collar.
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37/48 [0099] Another example includes the uterine manipulator of Example A, where the stabilizing rim includes an outer rim, an inner rim, and a rim surface between the outer rim and the inner rim to define the opening.
[0100] Another example includes the uterine manipulator of Example A, in which the stabilizing ring comprises a first outer ring border adjacent to the first opening and a second external ring border separated from the first ring border by a gutter.
[0101] Another example includes the uterine manipulator of Example A, in which the stabilizing pitchforks extend from the base part to form one of a "U" shape, a "V" shape, or a wishbone shape, with the base part located at the central point of the “U”, the “V”, and the wishbone, respectively.
[0102] Another example includes the uterine manipulator of Example A, in which the ends of the plurality of pitchforks opposite the base part of the stabilizer are not mechanically connected to each other.
[0103] Another example includes the uterine manipulator of Example A, in which the base part of the stabilizer is connected to allow a hollow tube.
[0104] Another example includes the uterine manipulator of Example A, in which a pressing part includes a screw and a fixing part slides over the uterine stem.
[0105] Example D includes the uterine manipulator of Example A, where the stem includes an entrance at one end and an exit at the opposite end. Another example includes the handler of Example D, where the entry is a double thread. Another example includes the uterine manipulator of Example D, where the entrance includes a cap. Another example includes the uterine manipulator of Example D, where the outlet is a hole in the side wall of the nail. Another example includes the uterine manipulator of Example D, where the end containing the outlet has a portion of
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38/48 screw. Another example includes the uterine manipulator of Example D, where the outlet is a hole in the side wall of the nail.
[0106] Example E includes a uterine manipulator from Example D, where the outlet end of the stem includes a tip. Another example includes the uterine manipulator of Example E, in which the cap is detachable. Another example includes the uterine manipulator of Example E, where the tip includes one or more holes. Another example includes the uterine manipulator of the previous example, where the holes are in the lateral walls of the tip. Another example includes the uterine manipulator of Example E, where the tip has an hourglass, dumbbell, or curved shape. Another example includes the uterine manipulator of Example A, where the tip has a fluted portion.
[0107] Another example includes the uterine manipulator of Example A, where the stem includes a loop. Another example includes the uterine manipulator from the previous example, where the handle has a marking, peak, compass or shelf.
[0108] Example 1 includes a uterine manipulator system comprising: (1) a collar including (a) (i) a first end comprising a first opening, having a first diameter, surrounded by a first ring, (a) (ii) a second end, opposite the first end, having a second opening, having a second diameter that is larger than the first diameter, surrounded by a second ring, (a) (iii) an internal surface, coupling the first end to the second end, adapted to contact a cervix, (a) (iv) an outer surface adapted to contact a vaginal wall, (a) (v) a hollow tunnel, including the inner surface, the first opening, and the second opening in which the hollow tunnel is adapted to receive the cervix; and (a) (vi) a first shelf connected to the internal surface and located between the first and the second ends; and where the first shelf includes a first surface and a second surface opposite the
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39/48 first surface, the first surface being between the second surface and the second end and the second surface being between the second surface and the first surface; (2) a stabilizer including (b) (i) a first stabilizer end consisting of a base part with a stabilizer opening, (b) (ii) a second stabilizer end, opposite the first stabilizer end having a rim of stabilizer adapted to couple the first shelf or the second shelf, wherein the diameter of the first stabilizer end is less than a diameter of the second stabilizer end; (3) a rod configured to pass through the stabilizer opening; wherein the stem contains a hollow internal channel coupling the distal end of the stem to a proximal end of the stem; and wherein the distal end of the stem includes at least one opening of the distal stem in fluid communication with the hollow inner channel, and the proximal end of the stem includes at least one proximal opening of the stem in fluid communication with the hollow inner channel; (4) a bulbous part having a maximum bulb diameter greater than the maximum stem diameter; wherein the bulbous part includes a first part, a second part, and a third part; wherein the second part is located between the first part and the third part; wherein the first part is configured to couple with the distal end of the stem; wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter; wherein the second diameter is smaller than the first diameter and the third diameter; and wherein at least one or more bulbous opening part is located in the second part and is in fluid communication with the distal stem opening and the hollow internal channel.
[0109] In example 2, the object of Example 1 can optionally include a first ring including a first inner rim, separated by a first gutter from a first outer rim; wherein the second rim includes a second inner rim, separated by a second gutter from the second outer rim; where the
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40/48 the first outer edge is closer to the first inner edge than the second outer edge in a linear direction; where the second outer edge is closer than the second inner edge to the first outer edge in a linear direction; and where the first outer edge is further from a center of the collar in a radial direction than the first inner edge; and the second outer edge is further away from the center of the collar in a radial direction than the second inner edge.
[0110] In example 3, the object of Examples 1-2 can optionally include a first ring with a diameter between 25mm and 40mm; where the diameter of the second ring is between 25mm and 45mm; where the diameter of the stabilizing rim is between 15mm and 35mm; wherein the distance between the first end and the second end is less than 40mm; and where the first diameter and the third diameter is 5mm to 10mm.
[0111] Example 4 includes a uterine manipulator system comprising: a collar including (a) (i) a first end comprising a first opening, having a first diameter, surrounded by a first ring, (a) (ii) a second end , opposite the first end, having a second opening, having a second diameter that is larger than the first diameter, surrounded by a second ring, (a) (iii) an internal surface, coupling the first end to the second end, adapted to contact a cervix, (a) (iv) an outer surface adapted to contact a vaginal wall, (a) (v) a hollow tunnel, including the inner surface, the first opening, and the second opening in which the hollow tunnel is adapted to receive the cervix; and (a) (vi) a first shelf connected to the internal surface and located between the first and the second ends; wherein the first shelf includes a first surface and a second surface opposite the first surface, the first surface being between the second surface and the first end and the second surface being between the second end and the first surface; and a stabilizer including (b) (i) a first end of
Petition 870190099786, of 10/04/2019, p. 57/66 / 48 stabilizer composed of a base part with a stabilizer opening, (b) (ii) a second stabilizer end, opposite the first stabilizer end, having a stabilizer ring adapted to be attached to the first shelf or the second shelf, wherein a diameter of the first end of the stabilizer is less than a diameter of the second end of the stabilizer.
[0112] In example 5, the object of Example 4 can optionally include a rod configured to pass through the stabilizer opening; wherein the stem contains a hollow internal channel coupling a distal end of the stem to a proximal end of the stem; wherein the proximal end of the stem includes at least one stem opening in fluid communication with the hollow internal channel; and wherein the stem includes a part of the middle between the proximal end of the stem and the distal end of the stem.
[0113] In Example 6, the object of Examples 4-5 can optionally include the middle part with a long axis of the middle part and the distal end with a long axis of the middle part that crosses the long axis of the middle part at a crossing angle between 0 and 90 degrees.
[0114] In example 7, the object of Examples 4-6 can optionally include the stabilizer with at least one window between the stabilizing rim and the base part.
[0115] In example 8, the object of Examples 4-7 can optionally include a first configuration in which the stabilizer ring engages the first surface and not the second surface; and a second configuration in which the stabilizing ring engages the second surface and not the first surface.
[0116] In example 9, the object of Examples 4-8 can optionally include a second shelf connected to the inner surface and located between the second end and the first shelf; where in a first configuration the stabilizer ring connects directly to the first shelf and not to the second shelf;
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42/48 and where in a second configuration the stabilizer ring connects directly to the second shelf and not to the first shelf.
[0117] In example 10, the object of Examples 4-9 can optionally include the internal surface of the necklace including two or more internal shelves; and wherein the stabilizer ring is configured to engage at least one internal shelf.
[0118] In example 11, the object of Examples 5-10 can optionally include the distal end of the stem including a bulbous part having a maximum bulb diameter greater than a maximum diameter of the stem; wherein the maximum bulbous diameter is adapted to resist removal of the distal end of the cervix; and in which at least one or more bulbous opening part is located in a bulbous part and is in fluid communication with the proximal stem opening and the hollow internal channel.
[0119] In Example 12, the object of Example 11 can optionally include the bulbous part including a first part, a second part, and a third part; wherein the second part is located between the first part and the third part; wherein the first part is configured to couple the distal end of the rod; wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter; wherein the second diameter is smaller than the first diameter and the third diameter; and wherein the second part includes at least one or more bulbous part opening.
[0120] In example 13, the object of Examples 5-12 can optionally include a fulcrum configured to slide slidably to the rod, where the rod rotates around the fulcrum; in which the fulcrum is selected from the group comprising a disc, a plate, a ball, a ring with pitchforks, and a sponge; and wherein the fulcrum is configured to fit within a vaginal canal comprising the vaginal wall; and where the fulcrum contains an orifice for receiving the rod.
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43/48 [0121] In example 14, the object of Examples 5-14 can optionally include a fulcrum configured to slide the rod and where the rod rotates around the fulcrum and a powered interconnection configured to articulate the system through six degrees of freedom; and where the powered interconnection includes an effector end configured to interact with the system.
[0122] In example 15, the object of Examples 12-14 can optionally include a conduit in which the conduit is hollow with an inner diameter greater than the diameter of the stabilizer opening and a diameter of the rod; wherein the distal end of the conduit is configured to couple with the base part; wherein the conduit is configured to slide between the proximal end of the stem and the distal end of the stem; and wherein the base part is distal to the conduit, and one or more bulbous part opening is distal to the stabilizer.
[0123] In Example 16, the object of Example 15 can optionally include a proximal end of the conduit adapted to engage a fastener to securely tighten the conduit to the rod.
[0124] In example 17, the object of Examples 5-16 can optionally include the middle part including a long axis of the middle part and the distal end including a long axis of the distal end that crosses the long axis of the middle part; and where the angle between the two axes is adjustable and the curvature of the stem is malleable.
[0125] In example 18, the object of Examples 12-17 can optionally include the diameter of the first ring between 25mm and 40mm; where the diameter of the second ring is between 25mm and 45mm; the diameter of the stabilizing rim is between 15mm and 35mm; the distance between the first end and the second end is less than 40mm; and the first diameter and the third diameter is 5mm to 10mm.
[0126] Example 19 includes a uterine manipulator system comprising: (1) a rod configured to pass through the opening of the stabilizer; where the stem contains a hollow internal channel coupling a distal end of the stem to
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44/48 a proximal end of the rod; and wherein the distal end of the stem includes at least one distal opening of the stem in fluid communication with the hollow inner channel and the proximal end of the stem includes at least one proximal opening of the stem in fluid communication with the hollow inner channel; (2) a bulbous part having a maximum bulb diameter greater than the maximum diameter of the stem, wherein the bulbous part includes a first part, a second part, and a third part; wherein the second part is located between the first part and the third part; wherein the first part is configured to couple the distal end of the rod, where the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter; wherein the second diameter is smaller than the first diameter and the third diameter; wherein at least one or more bulbous part opening is located in the second part and is in fluid communication with the distal stem opening and the hollow internal channel; and where the first maximum diameter and the third diameter is 5mm to 10mm.
[0127] In example 20, the object of Example 19 can optionally include (1) a stabilizer comprising (a) (i) a first stabilizer end of a base part with a stabilizer opening, (a) (ii) a second stabilizer end, opposite the first stabilizer end; wherein a diameter of the first stabilizer end is less than a diameter of the second stabilizer end; wherein in a first configuration the stabilizer opening is slidable along the rod; wherein one or more of the bulbous opening part is distal to the stabilizer; and (2) a conduit in which the conduit is hollow with an internal diameter greater than the diameter of the stabilizer opening and a diameter of the rod; wherein the distal end of the conduit is configured to couple with the base part; wherein the conduit is configured to slide between the proximal end of the stem and the distal end of the stem; where the base part is distal to the conduit, and one or more opening of the bulbous part is distal to the
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45/48 stabilizer; and wherein a proximal end of the conduit is adapted to engage a closure to securely tighten the conduit to the rod.
[0128] In example 21, the object of Examples 6-18 can optionally include the proximal end of the stem being collinear with the middle part and the angle of intersection is adjustable.
[0129] In example 22, the object of Examples 5-18 may optionally include the distal proximity of the stem including a first part, a second part, and a third part where the second part is located between the first part and the third part, the first part being proximal to the second part; wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter, and the second diameter is less than the first diameter, and a third diameter, and the second diameter is less than the first diameter and the third diameter; and where the first diameter is greater than a maximum stem diameter.
[0130] In example 23, the object of Examples 22 can optionally include one or more of the distal opening of the stem included in the second part.
[0131] In example 24, the object of Examples 23 can optionally include a first configuration in which the opening of the stabilizer is slidable along the rod; and wherein one or more of the distal opening of the rod is distal to the collar, and the collar is distal to the stabilizer.
[0132] In Example 25, the object of Examples 4-18 can optionally include the stabilizer including at least one window between the stabilizer rim and the base part, and between two or more pitchforks that couple the base part to the stabilizer rim.
[0133] In example 26, the object of Examples 11-18 can optionally include the bulbous part including a first part, a second part, and a third part; where the second part is located between the first part and the third part
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46/48 part; wherein the second part is located between the first part and the third part; wherein the first part is configured to couple with the distal end of the stem; wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter; wherein the second diameter is smaller than the first diameter and the third diameter; and wherein an end distal from the third part includes at least one or more of the bulbous opening part.
[0134] In Example 27, the object of Examples 14-18 can optionally include the fulcrum adapted for use with a vaginal retractor or speculum.
[0135] In example 28, the object of Examples 17-18 can optionally include the clasp including at least one set screw or stop collar.
[0136] In example 29, the object of Examples 16-18 can optionally include a disk configured to engage the distal end of the conduit and the base part.
[0137] In example 30, the object of Examples 5-18 can optionally include a strip or wire configured for connection to the necklace.
[0138] In example 31, the object of Example 30 can optionally include the necklace having an orifice, ring or protrusion to receive the strip or thread.
[0139] In Example 32, the object of Examples 5-18 can optionally include a handle coupled to the proximal distance of the stem, the handle including a projection that projects orthogonally to a long axis of the proximal end of the stem.
[0140] In example 33, the object of Examples 32 can optionally include the projection including a pointed end.
[0141] In example 34, the object of Examples 13-18 can optionally include the fulcrum configured to connect to an arm with six degrees of freedom.
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47/48 [0142] In example 35, the object of Example 34 can optionally include the arm configured to be connected to a table, a robotic platform, a plate, a cushion, a sledge, or a fixed point.
[0143] In example 36, the object of Examples 5-18 can optionally include a connection configured to articulate the system.
[0144] In example 37, the object of Example 36 can optionally include the connection including at least a degree of freedom to articulate the system.
[0145] In example 38, the object of Example 37 can optionally include the degree of freedom being rotated to approximately a sagittal plane of the patient.
[0146] In example 39, the object of Example 38 can optionally include where approximately the sagittal plane of the patient is about 5 degrees from the sagittal plane.
[0147] In example 40, the object of Example 39 can optionally include the connection configured to articulate the system through six degrees of freedom.
[0148] In example 41, the object of Example 40 can optionally include the link configured to selectively block relative movement of its links.
[0149] In example 42, the object of Example 37 can optionally include the powered interconnection configured to articulate the system.
[0150] In example 43, the object of Example 42 can optionally include the powered interconnect including an end effector configured to interact with the system.
[0151] In example 44, the object of Example 43 can optionally include the powered interconnect being a robotic arm having six degrees of freedom.
[0152] In example 45, the object of Example 5 can optionally include a sponge configured to slide slidably onto the stem.
[0153] While the present invention has been described with respect to a limited number of modalities, those skilled in the art will appreciate various modifications and
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48/48 variations of this. The attached claims are intended to cover all such modifications and variations that fall within the true spirit and scope of the present invention.

权利要求:
Claims (9)
[1]
(1) a rod configured to pass through the stabilizer opening;
wherein the stem contains a hollow internal channel coupling a distal end of the stem to a proximal end of the stem; and wherein the distal end of the stem includes at least one opening of a distal stem in fluid communication with the hollow inner channel, and the proximal end of the stem includes at least one proximal stem opening in fluid communication with the hollow inner channel. ;
(1) a collar including (a) (i) a first end comprising a first opening, having a first diameter, surrounded by a first ring, (a) (ii) a second end, opposite the first end, having a second opening , having a second diameter that is larger than the first diameter, the first diameter surrounded by a second ring, (a) (iii) an internal surface, coupling the first end to the second end, adapted to contact a cervix, ( a) (iv) an external surface adapted to contact a vaginal wall, (a) (v) a hollow tunnel, including the internal surface, the first opening, and the second opening in which the hollow tunnel is adapted to receive the cervix. uterus; and (a) (vi) a first shelf connected to the internal surface and located between the first and the second ends;
and wherein the first shelf includes a first surface and a second surface opposite the first surface, the first surface being between the second surface and the first end and the second surface being between the second end and the first surface;
1. Uterine manipulator system characterized by comprising:
[2]
(2) a bulbous part having a bulbous diameter greater than a maximum stem diameter;
wherein the bulbous part includes a first part, a second part, and a third part;
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2. System according to claim 1, characterized by:
the first ring includes a first inner rim, separated by a first ravine from a first outer rim; and wherein the second ring includes a second inner rim, separated by a second ditch from a second outer rim;
the first outer edge being closer to the second outer edge than the first inner edge in a linear direction; and where the second outer edge is closer to the first outer edge than the second inner edge in a linear direction; and
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2/9 and wherein the distal end of the stem includes at least one opening of a distal stem in fluid communication with the hollow internal channel, and the proximal end of the stem includes at least one proximal stem opening in fluid communication with the hollow internal channel;
(2) a stabilizer including (b) (i) a first stabilizing end consisting of a base part with a stabilizing opening, (b) (ii) a second stabilizing end, opposite the first stabilizing end, having a stabilizing rim adapted for coupling the first shelf or the second shelf, wherein a diameter of the first stabilizing end is less than a diameter of the second stabilizing end;
[3]
3. System according to claim 2, characterized by:
the diameter of the first ring is between 25mm and 40mm;
the diameter of the second ring is between 25mm and 45mm;
the diameter of the stabilizing ring is between 15mm and 35mm;
the distance between the first end and the second end is less than 40mm; and the first diameter and the third diameter are from 5mm to 10mm.
3/9 the first outer edge being further from a center of the collar in a radial direction than the first inner edge; and the second outer edge is further from the center of the collar in a radial direction than the second inner edge.
(3) a rod configured to pass through the stabilizer opening;
wherein the stem contains a hollow internal channel coupling a distal end of the stem to a proximal end of the stem;
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[4]
4/9 second stabilizing end, opposite the first stabilizing end, having a stabilizing ring adapted to couple it to the first shelf or the second shelf, wherein a diameter of the first stabilizing end is less than a diameter of the second stabilizing end.
4. Uterine manipulator system characterized by comprising:
a collar including (a) (i) a first end comprising a first opening, having a first diameter, surrounded by a first ring, (a) (ii) a second end, opposite the first end, having a second opening, having a second diameter that is larger than the first diameter, surrounded by a second ring, (a) (iii) an internal surface, coupling the first end to the second end, adapted to contact a cervix, (a) (iv) a surface external adapted to contact a vaginal wall, (a) (v) a hollow tunnel, including the inner surface, the first opening, and the second opening in which the hollow tunnel is adapted to receive the cervix; (a) (vi) a first shelf connected to the internal surface and located between the first and the second ends;
wherein the first shelf includes a first surface and a second surface opposite the first surface, the first surface being between the second surface and the first end and the second surface being between the second end and the first surface; and a stabilizer including (b) (i) a first stabilizer end composed of a base part with a stabilizer opening, (b) (ii) a
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(4) a bulbous part having a maximum bulb diameter greater than a maximum stem diameter;
wherein the bulbous part includes a first part, a second part, and a third part; wherein a second part is located between the first part and the third part;
wherein the first part is configured to couple the distal end of the rod;
wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter;
wherein the second diameter is smaller than the first diameter and the third diameter; and wherein at least one or more bulbous part openings are located in the second part and are in fluid communication with the distal stem opening and the hollow internal channel.
[5]
5/9 where in a first configuration the stabilizer ring connects directly to the first shelf and not to the second shelf; and where in a second configuration the stabilizer ring connects directly to the second shelf and not to the first shelf.
System according to claim 5, characterized in that the internal surface of the collar includes two or more internal shelves; and where the stabilizer ring is configured to engage at least one internal shelf.
System according to claim 5, characterized in that the distal end of the stem includes a bulbous part having a bulbous diameter greater than a maximum diameter of the stem;
wherein the maximum bulbous diameter is adapted to resist removal of the distal end of the cervix; and in which at least one or more bulbous part opening is located in the bulbous part and is in fluid communication with the proximal stem opening and the hollow internal channel.
System according to claim 11, characterized in that the bulbous part includes a first part, a second part, and a third part;
wherein the second part is located between the first part and the third part;
wherein the first part is configured to couple the distal end of the rod;
wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter;
wherein the second diameter is smaller than the first diameter and the third diameter; and
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5. System according to claim 4, characterized by containing a rod configured to pass through the stabilizer opening;
wherein the stem contains a hollow internal channel coupling a distal end of the stem to a proximal end of the stem;
wherein the proximal end of the rod includes at least one proximal rod opening in fluid communication with the hollow internal channel, and where the rod includes at least a part of the medium between the proximal end of the rod and the distal end of the rod.
[6]
6/9 wherein the second part includes at least one or more bulbous opening part.
13. System according to claim 5, characterized in that it includes a fulcrum configured for slidingly coupling to the rod and in which the rod pivots around the fulcrum, in which the fulcrum is selected from the group comprising a disc, a plate, a ball, a hoop with pitchforks, and a sponge; and wherein the fulcrum is configured to fit within a vaginal canal comprising the vaginal wall; and where the fulcrum contains an orifice for receiving the rod.
14. System according to claim 5, characterized in that it includes a fulcrum configured to slide slidably to the rod and in which the rod pivots around the fulcrum and a motorized connection configured to articulate the system;
wherein the connection is a robotic arm to articulate the system through six degrees of freedom; and wherein the motorized connection includes an effector end configured to interact with the system.
15. The system according to claim 12, characterized by having a conduit in which the conduit is hollow with an internal diameter greater than the diameter of the stabilizing opening and a diameter of the rod;
wherein the distal end of the conduit is configured to couple the base part;
wherein the conduit is configured to slide between the proximal end of the stem and the distal end of the stem; and wherein the base part is distal to the conduit, and one or more bulbous opening part is distal to the stabilizer.
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6. System according to claim 5, characterized by:
the middle part includes a long axis of the middle part and the distal end includes a long axis of the distal end which intersects the long axis of the middle part at an angle of intersection between 0 and 90 degrees.
[7]
7/9
16. System according to claim 15, characterized in that a proximal end of the conduit is adapted to be coupled to a closure to securely tighten the conduit to the rod.
17. System according to claim 5, characterized by:
the middle part includes a long axis of the middle part and the distal end includes a long axis of the distal end that crosses the long axis of part of the middle; and where the angle between the two axes is adjustable and the curvature of the stem is malleable.
18. System according to claim 12, characterized by:
the diameter of the first ring is between 25mm and 40mm;
the diameter of the second ring is between 25mm and 45mm;
the diameter of the stabilizing ring is between 15mm and 35mm;
the distance between the first end and the second end is less than 40mm; and the first diameter and the third diameter are from 5mm to 10mm.
19. Uterine manipulator system characterized by comprising:
System according to claim 4, characterized in that the stabilizer includes at least one window between the stabilizer ring and a base part.
[8]
8/9 where the second part is located between the first part and the third part;
wherein the first part is configured to couple the distal end of the rod;
wherein the first part, the second part, and the third part respectively include a first diameter, a second diameter, and a third diameter;
wherein the second diameter is smaller than the first diameter and the third diameter;
wherein at least one or more bulbous part openings are located in the second part and are in fluid communication with the distal stem opening and the hollow internal channel; and where the first diameter and the third diameter are from 5mm to 10mm.
20. System according to claim 19, characterized in that it includes (1) a stabilizer comprising (a) (i) a first stabilizing end of a base part with a stabilizing opening, (a) (ii) a second stabilizing end , opposite the first stabilizing end;
wherein a diameter of the first stabilizing end is less than a diameter of the second stabilizing end;
in which in a first configuration the stabilizer opening is slidable along the rod;
wherein one or more bulbous part openings are distal to the stabilizer, and (2) a conduit in which the conduit is hollow with an internal diameter greater than the diameter of the stabilizer opening and a diameter of the rod;
wherein the distal end of the conduit is configured to couple the base part;
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System according to claim 5, characterized in that, in a first configuration, the stabilizing ring is coupled to the first surface and not to the second surface; and in which, in a second configuration, the stabilizing ring is coupled to the second surface and not to the first surface.
System according to claim 5, characterized in that it comprises a second shelf connected to the internal surface and located between the second end and the first shelf;
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[9]
9/9 wherein the conduit is configured to slide between the proximal end of the stem and the distal end of the stem;
wherein the base part is distal to the conduit, and one or more openings of the bulbous part are distal to the stabilizer; and wherein a proximal end of the conduit is adapted to couple with a closure to securely tighten the conduit to the rod.

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同族专利:

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公开号 | 公开日

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AU2019200535A1|2019-02-28|

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AU2014249127A1|2015-11-05|

---

JP6730476B2|2020-07-29|

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CN105451673A|2016-03-30|

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WO2014164700A1|2014-10-09|

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JP2019122785A|2019-07-25|

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US20200297385A1|2020-09-24|

---

US20140276916A1|2014-09-18|

---

EP2996588A1|2016-03-23|

---

US9327097B2|2016-05-03|

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CN105451673B|2020-04-10|

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US10639072B2|2020-05-05|

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US20150148812A1|2015-05-28|

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JP2016515861A|2016-06-02|

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AU2014249127B2|2018-10-25|

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US20170112535A1|2017-04-27|

---

AU2019200535B2|2020-07-23|

---

US9522252B2|2016-12-20|

---

EP2996588A4|2016-11-23|

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法律状态:
2019-11-05| B11A| Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing|

---

2019-11-19| B04C| Request for examination: application reinstated [chapter 4.3 patent gazette]|

---

2019-12-03| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2020-01-21| B15K| Others concerning applications: alteration of classification|Free format text: AS CLASSIFICACOES ANTERIORES ERAM: A61B 17/42 , A61B 19/00 , A61M 25/01 Ipc: A61B 17/42 (2006.01), A61B 90/50 (2016.01), A61M 2 |

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2020-01-28| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2021-10-13| B350| Update of information on the portal [chapter 15.35 patent gazette]|

---

2021-11-16| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

优先权:

---

申请号 | 申请日 | 专利标题

---

US201361777350P| true| 2013-03-12|2013-03-12|

---

PCT/US2014/023247|WO2014164700A1|2013-03-12|2014-03-11|Uterine manipulator|

---