Hysterectomy model

Abstract

To provide a surgical simulator for surgical training.SOLUTION: The simulator includes a frame defining an enclosure and a simulated tissue model 30 located inside an enclosure. The simulated tissue model 30 is adapted for practicing hysterectomies. The simulated tissue model 30 at least includes a simulated uterus and a simulated vagina. The simulated tissue model 30 is suspending inside the enclosure with two planar sheets of silicone such that the tissue model 30 is located between the two sheets each of which form a fold and which are both connected to the frame 34. The frame 34 may be shaped like a cylinder and located inside a cavity of a larger laparoscopic trainer (training instrument) having a penetrable simulated abdominal wall. The tissue model 30 is interchangeable and accessible laterally through an aperture provided in a support leg of the trainer.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] This application generally relates to surgical training tools, and more particularly to simulated tissue structures and models that teach and practice various surgical techniques and procedures related to (but not limited to) laparoscopic surgery, endoscopic surgery, and minimally invasive surgery.

[0002]

Description of Related Applications

Background Art

[0003] Medical students and practicing physicians learning new surgical techniques (procedures) must undergo extensive training before they are qualified to operate on human beings as patients. This training must teach the proper techniques for using various medical instruments to cut, penetrate, clamp, grasp, staple, cauterize, and suture various forms of tissue. The range of scenarios that a trainee may encounter is wide. For example, various organs and the patient's anatomical structures and diseases are presented. The thickness and consistency of various tissue layers also vary from one part of the body to an adjacent part, and moreover, there will be various cases for each patient. Different techniques require different skills. Further, the trainee must practice techniques in various anatomical environments that are affected by factors such as the patient's physique and pathological condition, the adjacent anatomical landscape of the target tissue, and whether the target tissue is easily accessible or relatively inaccessible.

[0004] Many teaching aids, training devices, simulation training apparatuses (simulators) and model organs are available for one or more aspects of surgical training. However, there is a need for models or simulated tissue elements that can be encountered and used to practice endoscopic, laparoscopic, and minimally invasive surgical techniques (surgical procedures). In laparoscopic surgery, trocars or cannulas are inserted to access the body cavity or create channels for the insertion of cameras, such as laparoscopes. The camera provides live video feed captured images, which are then displayed to the surgeon on one or more monitors. At least one additional small incision is made, and a path is created through which another trocar / cannula can be inserted to allow surgical instruments to be inserted to perform procedures observed on the monitor. The target tissue location, such as the abdomen, is typically expanded by delivering carbon dioxide gas to ventilate or insufflate the body cavity to create a working space large enough to receive the scope and instruments used by the surgeon. The gas insufflation pressure within the tissue cavity is maintained by using a dedicated trocar. Laparoscopic surgery offers many advantages when compared to open surgical techniques. These advantages include less pain, less bleeding, and a shorter recovery period due to the smaller incisions.

[0005] In laparoscopic or endoscopic minimally invasive surgery, a higher skill level is required compared to open surgery. This is because the target tissue is not directly observed by the surgeon. The target tissue is observed by a monitor that displays a portion of the surgical site accessed through a small opening. Therefore, the surgeon needs to visually determine tissue planes, practice three-dimensional depth perception on a two-dimensional observation screen, instrument handover, suturing, high-precision cutting, and manipulation of tissues and instruments. Typically, a model that mimics a specific anatomical structure or technique is placed within a simulated pelvic or lumbar training device, where the anatomical model is hidden from direct visualization by the surgeon. Ports provided on the training device are used to practice techniques performed on the anatomical model hidden from visualization through the instruments. The simulated pelvic training device is a functional, inexpensive, and practical means of training surgeons and residents on the basic skills and typical techniques used in laparoscopic surgery, such as grasping, manipulation, cutting, knotting, suturing, stapling, cauterization, and how to perform specific surgical procedures utilizing these basic skills. The simulated pelvic training device is also an effective sales tool for demonstrating the medical instruments required to perform these laparoscopic procedures.

[0006] One procedure is hysterectomy, which involves removing the uterus. Hysterectomy may be performed through a vaginal approach, removing the uterus transvaginally through the vaginal canal, or through an abdominal approach, through a small incision made in the abdomen. Vaginal hysterectomy has historically been difficult to train for due to limited visibility. Unlike laparoscopic procedures, there is no camera projecting the surgery onto a screen, and unlike open procedures, there is no large incision through which multiple people can observe. Therefore, the best way to teach vaginal hysterectomy is through a simulation model. Thus, there is a need for a model for training hysterectomy.

[0007] According to one aspect of the present invention, a surgical simulator for surgical training is provided. The surgical simulator has a simulated pelvis with a proximal end and a distal end. The simulated pelvis includes an enclosure having an inner surface, an outer surface, and at least one opening provided at the proximal end. The surgical simulator has a simulated tissue model including a simulated uterus with a spherical portion at the distal end, and the simulated uterus is connected to a simulated vagina with a tubular portion at the proximal end. The simulated tissue model is connected to the simulated pelvis such that the spherical portion of the simulated uterus is disposed near the distal end and the tubular portion of the simulated vagina is disposed near the proximal end of the simulated pelvis, and the simulated tissue model floats within the enclosure of the simulated pelvis. The tubular portion has a lumen accessible through at least one opening of the simulated pelvis.

[0008] According to another aspect of the present invention, a surgical simulator for surgical training is provided. The simulator has a simulated pelvis frame with an inner surface and an outer surface, and a substantially uniform thickness is defined between the inner surface and the outer surface. The simulated pelvis frame defines a substantially cylindrical shape. The cylindrical shape has an opening proximal end and an opening distal end, and a lumen is configured between the opening proximal end and the opening distal end. The simulated pelvis frame has a longitudinal axis and includes a top side portion and a bottom side portion. The simulated pelvis frame has a simulated tissue model including one or more of a simulated uterus, a simulated vagina, a simulated cervix, a simulated fallopian tube, a simulated ovary, a simulated ligament or cord, a simulated vasculature, a simulated bladder, and a simulated colon. The simulated tissue model is removably connected to the simulated pelvis frame such that the simulated tissue model floats within the lumen.

[0009] According to another aspect of the present invention, a surgical simulator for surgical training is provided. The simulator has a base and a top cover connected to the base at a distance from the base so as to form an internal cavity therebetween. The simulator has at least two legs that interconnect the top cover and the base while being spaced apart from each other and separate the top cover from the base. One of the at least two legs has a hole facing the internal cavity. The simulator further has a simulated uterus with a distal end connected to the proximal end of the simulated vagina. The simulated vagina has a lumen with a proximal opening. The proximal opening is interconnected with the hole so that the hole provides an access port to the lumen of the simulated vagina. The simulated vagina and the simulated uterus extend into the internal cavity. One or more than one of the simulated uterus and the simulated vagina are provided in a floating state within the internal cavity.

Brief Description of the Drawings

[0010]

Figure 1

Figure 2

Figure 3A

Figure 3B

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Figure 3D

Figure 4A

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Figure 4C

Figure 4D

Figure 4E

Figure 5A

Figure 5B

Figure 6A

Figure 6B

Mode for Carrying Out the Invention

[0011] A surgical training instrument 10 made to mimic a patient's torso, for example, the abdominal region, is shown in FIG. 1. The surgical training instrument 10 is substantially hidden from the user and includes a main body cavity 12 that receives a mimicked or living tissue or model organ or training model, etc. described herein. The main body cavity 12 is accessed through a tissue simulation region 14 that is penetrated by the user performing a surgical procedure on a tissue or practice model provided so as to be visible within the main body cavity 12 using the instrument. The main body cavity 12 is shown as being accessible through the tissue simulation region, but as a modification, the main body cavity 12 may be accessed using a hand-held access instrument or a single-site port instrument. An exemplary surgical training instrument is described in U.S. Patent Application No. 13 / 248,449, filed on September 29, 2011 (Title of the Invention: Portable Laparoscopic Trainer), which is hereby incorporated by reference in its entirety and made a part of this specification. The surgical training instrument 10 is particularly suitable for practicing laparoscopic or other minimally invasive surgical techniques.

[0012] Still referring to FIG. 1, the surgical training instrument 10 has a top cover 16 that is connected to a base 18 by at least one leg or leg 20 and is spaced from this base. FIG. 1 shows a plurality of legs 20. The surgical training instrument 10 is made to mimic a patient's torso, for example, the abdominal region. The top cover 16 represents the front surface of the patient, and the space 12 between the top cover 16 and the base 18 represents the interior or body cavity of the patient where organs are present. The surgical training device 10 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and related instruments in a simulation when a patient undergoes a surgical technique. The surgical instrument passes through the tissue simulation area 14 and is inserted into the cavity 12 through a hole 22 provided in advance in the top cover 16. Various tools and techniques can be used to penetrate the top cover 16, thereby performing simulation techniques on a simulated organ or practice model disposed between the top cover 16 and the base 18. The base 18 has a model receiving area 24 or tray for staging or holding a simulated tissue model or living tissue. The model receiving area 24 of the base 18 has a frame-like element for holding a model (not shown) in a fixed position. To assist in holding a simulated tissue model or a living organ on the base 18, a clip attached to a retractable wire is provided at location 26. The retractable wire is extended and then clipped to hold the tissue model in a fixed position substantially below the tissue simulation area 14. Other means for holding the tissue model include a patch of hook-and-loop fastening material (so-called VELCRO®) attached to the base 18 within the model receiving area 24, and this patch of hook-and-loop fastening material can be removably connected to a complementary piece of hook-and-loop fastening material (VELCRO®) attached to the model.

[0013] The video display monitor 28 hinged to the top cover 16 is shown in the closed orientation in FIG. 1. The video monitor 28 can be connected to various visual systems that send images to the monitor. For example, it is inserted through one of the pre-provided holes 22 or a web camera (webcam) provided in the cavity, and it is advisable to connect a laparoscope used to observe simulated procedures to the video monitor 28 and / or a mobile computing device to provide images to the user. Also, audio recording or sending means may also be provided and integrated with the training device 10, thereby providing audio and visual functions. A portable storage device, such as a flash drive, smartphone, digital audio or video player, or other digital mobile device, is also provided for recording training procedures for demonstration purposes and / or playing back pre-recorded videos on the monitor. Naturally, connection means are provided to provide the audio-visual output to a screen larger than the monitor. In another variant, the top cover 16 does not include a video display and includes means for connecting to a laptop computer, mobile digital device, or tablet and connecting this to the training device by wire or wirelessly.

[0014] During assembly, the top cover 16 is positioned directly above the base 18 with the legs 20 disposed substantially along the perimeter and interconnected between the top cover 16 and the base 18. The top cover 16 and the base 18 are of substantially the same shape and dimensions and have substantially the same peripheral outer profile. The internal cavity is partially or completely hidden from view. In the variant shown in FIG. 1, the leg portion has openings so that ambient light can illuminate the internal cavity as much as possible and, advantageously, provides as much weight reduction as possible for portability. The top cover 16 is removable from the leg portion 20, and the leg portion 20 is removable from or foldable relative to the base 18 by a hinge or the like. Thus, the training device 10 in the unassembled state has a reduced height for easy portability. Essentially, the surgical training device 10 includes a simulated body cavity 12 that is hidden from the user. The body cavity 12 is configured to receive at least one tissue simulation area 14 and / or at least one surgical model accessible through a hole 22 provided in the top cover 16, and the user can access the model through the hole 22 to practice laparoscopic or endoscopic minimally invasive surgical procedures.

[0015] According to the present invention, a model 30 for practicing hysterectomy, particularly vaginal hysterectomy, is shown in FIG. 2. The model 30 is configured to be disposed within the surgical training instrument 10 described above or other similar surgical trainers. The model 30 includes a simulated uterus 32 connected to a frame 34 by a first sheet 36 and a second sheet 38. The simulated uterus 32 has a spherical portion 40 that forms a hollow simulated uterine cavity 42. The spherical portion 40 is connected to a tubular portion 44 that forms a vaginal tube 46 having an opening 48. The simulated uterus 32 further has a simulated cervix 50 (shown in FIG. 4A) disposed within the simulated uterus 32 substantially at the location between the uterine cavity 42 and the vaginal tube 46. The simulated cervix 50 has a slit 52. The simulated cervix 50 is made of solid high-durometer silicone.

[0016] The simulated uterus 32 further has simulated fallopian tubes 54 connected to the ovaries 56. The simulated uterus 32, fallopian tubes 54 and ovaries 56 are made of silicone or other elastomeric materials, which may include other materials combined with silicone, such as foam materials. The simulated uterus 32 is made of silicone or lightweight foam, such as urethane or silicone foam or a combination of the two. When the simulated cervix 50 in the attached state is pulled and manipulated, the configuration with silicone gives the simulated uterus 32 a more realistic weight. The fact that the simulated uterus 32 is made of foam makes it easier to provide the simulated uterus 32 in a floating state within the simulated pelvic cavity. Also, when removing the simulated uterus 32, the lightweight foam bends more easily than the simulated uterus 32 made of high durometer silicone, whereby a large simulated uterus 32 can be placed within the model 30 and still be removed. The foam uterus 32 contracts or bends when it is removed through the vaginal opening 48 as in an actual operation. The simulated uterus 32 weighs approximately 300 to 500 grams and the simulated uterus 32 is composed of a durometer foam selected to accurately represent the size and weight of an actual uterus that can be normally removed transvaginally without major dissection. In another form, the simulated uterus 32 is a combination of silicone and foam such that it gives a more realistic appearance while still having the flexibility of foam. It is good to mold the foam and then apply the silicone, for example, to cover the foam on a rotary mold. The simulated uterus 32 is generally peach-colored, and the fallopian tubes 54 and ovaries are translucent or white. Further, the simulated uterus 32 may include implanted tumors, cysts and / or ectopic pregnancies within the fallopian tubes 54. The model 30 may further include a simulated vasculature or vascular system 58, such as blood vessels. The simulated vascular system 58 is made of solid or hollow tubular silicone or other suitable elastomer. There may be a liquid within the hollow tube of the simulated vascular system 58. The simulated vascular system 58 mimicking blood vessels is preferably red in color.Model 30 may further include a simulated cord 59, such as a uterosacral cord 59, made of a silicone material as can be understood in FIGS. 2 and 4E. Model 30 may further include an infundibulopelvic round ligament 61 attached to the frame 34 shown in FIG. 2.

[0017] Further, referring to FIGS. 3A - 3D, the frame 34 has a cylindrical shape that defines an interior / lumen 60. The frame 34 has a first surface 62 interconnected to a second surface 64, and a thickness is defined between the first surface 62 and the second surface 64. The first surface 62 constitutes the inner surface of the cylindrical shape of the frame 34, and the second surface 64 constitutes the outer surface of the cylindrical shape of the frame 34. The frame 34 is also made of a flexible foam material that is slightly compressible. The frame 34 has one or more notches 66 that extend between the first surface 62 and the second surface 64 to form an outer perimeter and holes. In one form, the frame 34 is made of a sheet of foam material cut according to the pattern shown in FIG. 3D. FIG. 3D shows an outer perimeter having a top 68 and a bottom 70 interconnected by a first side 72 and a second side 74. The top 68 has two curved portions 76a, 76b interconnected at a first protrusion 78 along a vertical axis. The two curved portions 76a, 76b represent the left and right ilium / iliac crests. The bottom 70 has a second protrusion 80 located along the vertical axis. The first protrusion 78 represents the sacrum of the human pelvis, and the second protrusion 80 represents the coccyx. The first side 72 has a first lower lobe 82 with a first hole 86, and the second side 74 has a second lower lobe 84 with a second hole 88. The first and second lower lobes 82, 84 represent the left and right ischiums, and the first hole 86 and the second hole 88 represent the obturator foramina of the human pelvis. A single piece of foam having a thickness is cut to have the flat pattern shape shown in FIG. 3D. Next, the foam piece is curved such that the first lower lobe 82 and the second lower lobe 84 are joined to each other in a cylindrical form. When the two lobes 82, 84 are joined, they represent the pubis / pubic symphysis. The two lobes 82, 84 may be joined by an adhesive or connected in another suitable manner. In another form, the two lobes 82, 84 are not joined to each other and remain separated in a semi - cylindrical or split - cylinder form. The frame 34 is bendable, and this frame may be made of a material that retains its shape after bending, such as aluminum.Also, when using the clip 26 and wire connected to the trainer 10, the two lobes 82, 84 can be held in an upward state and in a cylindrical form while remaining positioned within the trainer 10. The anatomical structure of the pelvis is shown in FIG. 7.

[0018] The frame 34 is made of a soft and compressible semi-rigid foam that can be die-cut and then formed into an exact shape with an adhesive. If the frame 34 is made of a rigid plastic, the frame 34 may be a thin thermoform initially formed into an exact shape, or a thick plastic cut into a pelvic shape and then formed into a cylindrical shape with heat. The frame 34 may be made of a deformable metal that retains its shape. The frame 34 does not need to be a complete replica of the anatomical structure, but only needs to include certain features selected to allow a particular procedure to be practiced that requires anatomical reference points or visual landmarks or landscapes for the physician. For example, for practicing vaginal hysterectomy, important features of the pelvis are the constriction of the pelvic inlet and the attachment to the pelvic sidewall. For practicing transanal total mesorectal excision (ta TME), the L-shape of the sacrum is an important landmark. For hernia procedures, the pubic tubercle is an important landmark. The frame 34 may be made to have only all the anatomically accurate features or the features required for a particular procedure. Thus, the frame 34 and the model 30 can be used for the simulation of vaginal hysterectomy, abdominal hysterectomy, colectomy, hernia, ta TME, and other pelvic procedures. In another form, the frame 34 has a conical or frustoconical shape with a proximal opening end and a distal opening end.

[0019] Referring back to FIG. 2 and with reference thereto, the model 30 may further include a simulated bladder 90. The simulated bladder 90 is typically a hollow air-filled component made of silicone or other elastomeric material. In another form, the simulated bladder contains liquid. The simulated bladder 90 is connected to the frame 34 by an adhesive or other means. The simulated bladder is connected to the first surface 62 or the inner surface of the frame 34. The simulated bladder 90 is attached in an aligned state with a vertical axis at a location where the two lobes 82, 84 are juxtaposed at a location representing the pubis. When connected, the simulated bladder 90 extends into the lumen 60 of the frame 34. The simulated bladder 90 may further have a simulated ureter 94. In one form, the simulated ureter 94 is connected to the simulated bladder 90. The simulated ureter is made of solid or hollow tubular silicone.

[0020] Still referring to FIG. 2, the model 30 may further include a simulated colon 92 or a portion of the intestine. The simulated colon 92 is a tubular structure having a lumen. The simulated colon 92 is placed on the first surface 62 within the interior 90 of the frame 34 and substantially along the vertical axis and against the second protrusion 80 of the frame 34. It is preferable to attach the simulated colon 92 to the frame 34 using an adhesive. The simulated colon 92 is made of silicone or other suitable elastomeric material, and this simulated colon is colored peach or other suitable color, and such simulated colon may or may not contain a simulated tumor.

[0021] The first sheet 36 is a thin layer of a transparent silicone material having a top surface 96, a bottom surface 98, a first end 100, and a second end 102. In one form, the first sheet 36 is transparent and at least one of the top surface 96 and the bottom surface 98 is patterned. The first sheet 36 is attached to the mock uterus 32. In particular, the bottom surface 98 near the first end 100 of the first sheet 36 is attached to one or more of the spherical portion 40 and the tubular portion 44 along at least a portion of the length of the mock uterus 32, as shown in FIG. 2. Next, the first sheet 36 is folded back towards the top of the model 30 and then folded back towards the first end 100 of the first sheet 36, thereby creating a fold near the tubular portion 44 of the mock uterus 32. At least a portion located near the second end 102 of the first sheet 36 is attached to the frame 34 such that the bottom surface 98 of the first sheet 36 is attached to the frame 34 at a common location where the two lobes 82, 84 are juxtaposed to form a cylindrical form for the frame 34. The attachment of the first sheet 36 may also serve to hold the frame 34 in a cylindrical form. An adhesive is used to attach the bottom surface 98 of the first sheet 36 to the frame 34. The bottom surface 98 of the first sheet 36 is attached to the first surface 62 or the inner surface of the frame 34 and is then bent around a portion of the first side 72 and the second side 74 of the frame 34. When the mock bladder 90 is employed in the model 30, the second end 102 of the first sheet 36 is also attached to the outer surface of the mock bladder 90 by an adhesive, thereby capturing the mock bladder 90 between the frame 34 and the first sheet 36. A portion of the second end 102 of the first sheet 36 is bent around the edge of the frame 34 and attached to the second surface 64 of the frame 34, such that at least a portion of the second end 102 of the first sheet 36 is located above the second surface or outer surface 64 of the frame 34 as visible in FIG. 4D. The first sheet 36 is sized and shaped such that the mock uterus 32 is provided floating within the interior 60 of the frame 34. The mock vascular system 58 may be attached to the top surface 96 or the bottom surface 98 of the first sheet 36.The form of the first sheet 36 forms a pocket-like structure, in which case the top surface 96 of the first sheet 36 is folded back at least partially towards itself. The first sheet 36 creates a floating webbing that mimics the peritoneal layer.

[0022] The second sheet 38 is a thin layer of a transparent silicone material having a top surface 104, a bottom surface 106, a first end 108, and a second end 110. In one form, the second sheet 38 is transparent and at least one of the top surface 104 and the bottom surface 106 is patterned. The second sheet 38 is attached to the mock uterus 32. In particular, the bottom surface 106 near the first end 108 of the third sheet 38 is attached to one or more of the spherical portion 40 and the tubular portion 44 located on the opposite side as viewed from the side where the first sheet 36 is attached along at least a portion of the length of the mock uterus 32. The first sheet 36 is attached to the front side of the model 30, which is also the front side of the mock uterus 32. The second sheet 38 is attached to the rear side of the model 30, which is also the rear side of the mock uterus 32. After the second sheet 38 is attached to the rear side of the mock uterus 32, it is folded back towards the top of the model 30 and then folded back towards the first end 108 of the second sheet 38, thereby creating a fold near the tubular portion 44 of the mock uterus 32. At least a portion located near the second end 110 of the second sheet 38 is attached to the frame 34 such that the bottom surface 106 of the second sheet 38 adheres to the frame 34 at the general location of the second protrusion 80. An adhesive is used to attach the bottom surface 106 of the second sheet 38 to the frame 34. The bottom surface 106 of the second sheet 38 is attached to the first surface 62 or the inner surface of the frame 34, and this bottom surface is preferably folded around the edge of the frame 34, such that at least a portion of the second end 110 of the second sheet 38 is adapted to be connected to the second surface or the outer surface 64 of the frame 34. When the mock colon 92 is employed in the model 30, the second end 110 of the second sheet 38 is also attached to the outer surface of the mock colon 92 by an adhesive or at least overlapped and not attached by an adhesive, such that at least a portion of the mock colon 92 is adapted to be captured or disposed between the frame 34 and the second sheet 38. The second sheet 38 is sized and shaped to be provided in a floating state within the interior 60 of the frame 34 even when the model 30 is turned over with the mock uterus 32.The simulated vascular system 58 may be attached to the top surface 104 or the bottom surface 106 of the second sheet 38. The form of the second sheet 38 forms a structure like a pocket, in which case the top surface 104 of the second sheet 38 is bent at least partially facing itself. The second sheet 38 creates a floating webbing that mimics the peritoneal layer.

[0023] Next, referring to FIGS. 4A - 4E, the model 30 is shown disposed within the same surgical training device 10 as described with reference to FIG. 1. The model 30 is shown positioned within the body cavity 12 such that the top 68 of the frame 34 faces in the cephalic direction of the simulated training device 10 and the vaginal opening 48 of the simulated uterus 32 faces in the caudal direction of the simulated training device 10. The model 30 may be connected to the surgical training device 10 by a clip 26 attached to this trainer 10. The retractable clip 26 can be pulled out and attached to any part of the model 30, for example, the frame 34 of the model 30. Also, the second surface or outer surface 64 of the model 30 may have a hook - and - loop fastener (surface fastener) configured to be attached to a complementary part of a hook - and - loop fastener (surface fastener) connected to the base 18 of the trainer 10. Together with one or more fasteners, such as the clip 26 and / or the surface fastener, the model 30 is firmly attached to the trainer 10 so that the model 30 of the trainer 10 can be manipulated in a simulated surgery without coming out of the body cavity 12. The model 30 is further connected to the trainer 10 by a transvaginal adapter 112, which is dimensioned and shaped to connect between the top cover 16 and the base 18 as an additional leg 20 positioned in the caudal direction of the surgical training device 10.

[0024] Next, referring to FIGS. 5A and 5B and FIGS. 6A and 6B, the transvaginal adapter 112 is shown. Referring also back to FIG. 1, the upper cover is shown floating above the base by five legs 20. In one form, six legs 20 are provided in the form of the transvaginal adapter 112 as shown in FIGS. 4A-4D. The trainer 10 may preferably be assembled with an optional sixth support structure or leg, which is shaped to mimic transvaginal surgery, including hysterectomy.

[0025] The transvaginal adapter 112 has a flat plate 114 with an inner surface 116 for facing towards the interior of the trainer and an outer surface 118 for facing outwardly towards the user. The plate 114 is rectangular in shape and has holes 120 extending through the plate 108 from the inner surface 116 to the outer surface 118. In one form, the holes 120 are circular in shape. In another form, the holes 120 are shaped like an elongated ovoid and are oriented perpendicular to the longitudinal axis of the adapter 112. In another form, the holes 120 are elongated ovoid in shape and are oriented perpendicular to the longitudinal axis of the adapter. As shown in FIGS. 5A-6B, the plate 114 further has means, such as tabs 122 or U-shaped channels, insertable to connect the transvaginal adapter 112 to the top cover 16 and the base 18 to help support and space apart the top cover 16. The transvaginal adapter 112 is disposed between the top cover 16 and the base 18 and has side access holes 16 positioned outwardly of the trainer 10 or substantially perpendicular to the top cover 16 and the base 18. The plate 114 further has a plurality of molding holes 124 configured to overmold a soft simulated vaginal tissue interface made of silicone or the like that surrounds or is positioned around the main hole 120. In another form, the interface is insertable into the holes 120 of the transvaginal adapter 112. The tissue interface (not shown) has holes substantially coaxial with the plate holes 120. A tubular extension 126 is integrally provided at the inner surface of the transvaginal adapter 112 and extends into the simulated body cavity 12 of the trainer 10. The tubular extension 126 is longer in FIGS. 6A and 6B as compared to the tubular extension 126 of FIGS. 5A and 5B. The tubular extension 126 can stretch the tubular portion 44 of the simulated uterus 32 around the extension 126 and can be fixed to the transvaginal adapter 112 such that the vaginal tube 46 is dimensioned and shaped to be supported in an open configuration that aligns with and is accessible through the holes 120 of the adapter 112 as shown in FIGS. 4A-4D.The tubular extension 126 serves as a connector that couples the model 30 to the trainer 10 in a manner that allows access to the interior of the uterus as in an actual surgery. In one form, the tubular extension 126 is a cylindrical extension having a radially extending distal flange 128 that extends around at least a portion of the extension 128 to help secure and hold the model 30 in an attached state to the trainer 10. The tubular portion 44 of the model 30 is attached to the tubular extension 126 by pulling the tubular portion 44 over and onto and around the tubular extension 126 when the distal flange is provided, and the outer diameter of the tubular extension 126 is the same as or slightly larger than the relaxed inner diameter of the tubular portion 44, whereby the tubular portion 44 is kept in a fixed state to the transvaginal adapter 112. The transvaginal adapter 112 can be made of a flexible material or a rigid material. When the adapter 112 is made of a rigid material, this adapter tends to mimic the vaginal tube 46 in a retracted state. When the adapter 112 is made of a flexible material or a soft material, the adapter 112 is suitable for practicing retraction. In another form, the transvaginal adapter 112 has a tubular extension 126 made of a soft flexible material and a plate 114 made of or surrounded by a rigid material, whereby the top cover 16 of the trainer 10 is kept in a supported state, whereby the physician can still practice retraction upon opening of the vaginal tube 46 at the adapter 112.

[0026] In use, the model 30 is placed within the surgical training device 10 and held in place by the hook-and-loop fastener and / or retracting clip 26. The vaginal opening 48 is stretched over the tubular extension 126 of the adapter 112 to attach the tubular portion 44 to the transvaginal adapter 112. It is advisable to employ a curtain disposed around the side of the trainer 10 to further conceal the model 30, such that visualization is obtained only through the simulated vaginal tube 46. Next, a surgical retractor is used to retract the vaginal tube 46. The vaginal tube 46 is made of flexible thermoplastic elastomer (TPE). The TPE provides resistance when it is retracted and attempts to spring back to its original shape, enabling the user to practice a realistic retraction. The transvaginal adapter 112 of FIGS. 6A and 6B with the long tubular extension 126 is used to mimic the already retracted state of the vaginal tube. Thus, with the transvaginal adapter 112, the physician can practice a hysterectomy without the need for extra hands and assistance in performing the retraction. When using the transvaginal adapter 112 of FIGS. 5A and 5B with the short tubular extension 126, the physician will practice retracting the vaginal tube 46 using a retractor and with the help of an extra hand during the procedure. The transvaginal adapter 112 can be made of a rigid or flexible material or a rigid and flexible material as described above and can be selected or not for the purpose of practicing the retraction of the vaginal tube 46. Next, the simulated cervix 50 is grasped and pulled towards the opening 48 of the vaginal tube 46. The simulated cervix 50 is made of high durometer silicone compared to the surrounding tubular portion 44. The simulated cervix 50 is also made as a solid component that can be grasped with a real surgical tool and pulled without the risk of silicone ripping or tearing. A circumferential incision is made in the simulated cervix 50, and the physician can practice carefully peeling the vaginal mucosa from the simulated cervix 50. It is advisable to provide a sheet of cotton or other webbing material within the model 30 between the vaginal tube 46 and the simulated bladder 90. As described above, the simulated bladder 90 is a hollow air-filled component.If the doctor makes a large incision while peeling the simulated vaginal mucosa and accidentally incises the simulated bladder 90, the simulated bladder 90 may make a popping sound and give the doctor immediate feedback, especially when the simulated bladder 90 contains fluid.

[0027] Model 30 advantageously has a second sheet 38 that forms a crease between the simulated uterus 32 and the frame 34. Also, by providing the simulated uterus 32 in a floating state within the frame 34, advantageously, a response similar to that of a real object is created when the simulated uterus 32 is incised and manipulated. Also, in the form where the simulated uterus is made of a lightweight foam material, the simulated uterus remains in a suspended state, hangs down, and sways in response to manipulation by surgical instruments. The simulated uterus and the simulated vagina are at least partially kept in a floating state within an enclosure defined by a pelvic frame and are connected to this enclosure or directly connected to an enclosure defined by a trainer. By providing it in a floating state, advantageously, it is possible to approach the crease of the second sheet, and thereby practice posterior colpotomy to the posterior cul-de-sac incision by incising the peritoneum that forms the rectouterine fold. The floating simulated uterus 32 can have a rectouterine peritoneal fold. As described above, the simulated uterus 32 hangs within a frame 34 made of a foam material that mimics the human pelvis. The simulated uterus 32 is suspended by a first sheet of silicone material in a bent state provided on the front side of the simulated uterus 32 and a second sheet of silicone material bent on the rear side of the simulated uterus 32. The frame 34 can be made of any material, such as a plastic material or a rigid foam material. The frame 34 serves as an attachment area for various simulated parts of anatomical structures including the broad ligament, the ovary 56, and the fallopian tube 54. Due to the silicone elasticity of these anatomical components, the simulated uterus 32 can be pulled and manipulated, and this simulated uterus can still remain attached to the frame 34. The frame 34 made of a semi-rigid foam can also move when the simulated uterus is being manipulated. A more rigid frame 34 has less movement. Next, the doctor divides the uterosacral ligament 59. Next, the doctor can practice anterior colpotomy to the anterior cul-de-sac incision by incising a first sheet 38 that mimics the peritoneum forming the vesicouterine fold. The doctor divides the infundibulopelvic ligament 59 on each side of the simulated uterus 32.Due to the form frame 34, the fallopian tube ovarian ligament 59 remains attached to the frame 34 in a realistic state even after being separated from the simulated uterus 32. Next, the simulated uterus 32 is freed and removed. Next, the doctor performs the practice of closing the vaginal cuff by passing a needle with suture through the tubular portion 44 of the model 30 to close the opening of the vaginal canal 46. Suturing the vaginal cuff in an actual operation is another difficult part of vaginal hysterectomy due to space constraints. The tubular portion 44 made of TPE holds the suture without tearing and limits the space available for the instrument during the suturing process. With the model 30, the doctor can practice many difficult procedures on one model.

[0028] Any part of the model 30 can be made of one or more types of organic base polymers. Such organic base polymers include, but are not limited to, hydrogels, homopolymer hydrogels, copolymer hydrogels, rubbers, latexes, nitriles, proteins, gelatin, collagen, soy, non-organic base polymers such as thermoplastic elastomers, kratons, silicones, foams, foams mainly composed of silicone, foams mainly composed of urethane, and ethylene vinyl acetate foams. One or more types of fillers, such as cloth, woven or non-woven fibers, polyester, nylon, cotton, and silk, can be employed in any base polymer, and conductive filler materials such as graphite, platinum, silver, gold, copper, and other additives, gels, oils, corn starch, glass, dolomite, carbonate minerals, alcohol, deadner, silicone oil, pigments, foams, poloxamers, collagen, gelatin, etc. can be employed. Examples of adhesives used include, but are not limited to, cyanoacrylate-based, silicone-based, epoxy-based, spray-type adhesives, and rubber-based adhesives.

[0029] It goes without saying that various modifications can be made to the embodiments and variations disclosed in this specification. Therefore, the above description should not be construed as limiting the present invention, but should be construed merely as an exemplification of preferred embodiments. Those skilled in the art will be able to conceive of other modified examples within the scope and spirit of the present invention.

Claims

**Claim 1** A surgical simulator for surgical training, comprising: A simulated pelvis defining an enclosure having an inner surface, an outer surface, and at least one opening; A simulated tissue model; A first sheet of silicone; A second sheet of silicone; The simulated tissue model includes a simulated uterus provided in a floating state by at least one of the first and second sheets of silicone within the enclosure of the simulated pelvis; The first and second sheets of silicone are connected to the simulated pelvis; A surgical simulator for surgical training. **Claim 2** The surgical simulator according to claim 1, wherein the simulated uterus further includes a simulated cervix located inside the simulated uterus. **Claim 3** The surgical simulator according to claim 2, wherein the simulated uterus further comprises a simulated fallopian tube connected to a simulated ovary. **Claim 4** The surgical simulator according to claim 3, wherein the simulated uterus is made of a foaming material combined with silicone. **Claim 5** The surgical simulator according to claim 1, wherein the simulated uterus has a spherical portion at its distal end, the spherical portion is connected to a simulated vagina having a tubular portion at its proximal end, and the tubular portion has a lumen accessible from at least one opening of the simulated pelvis. **Claim 6** The surgical simulator according to claim 1, further comprising a simulated colon located within the enclosure of the simulated pelvis. **Claim 7** The surgical simulator according to claim 1, wherein the simulated pelvis is cylindrical and the inner surface is interconnected with the outer surface. **Claim 8** The surgical simulator according to claim 6, wherein the simulated colon is disposed on the inner surface of the simulated pelvis. **Claim 9** The surgical simulator according to claim 1, wherein the simulated tissue model further comprises a simulated bladder within the enclosure of the simulated pelvis. **Claim 10** The surgical simulator according to claim 9, wherein at least one of the first sheet of silicone or the second sheet of silicone is connected to the simulated bladder and the simulated pelvis, and the simulated bladder is disposed between at least one of the first sheet of silicone or the second sheet of silicone and the simulated pelvis. **Claim 11** The surgical simulator according to claim 9, wherein the simulated bladder is connected to the inner surface of the simulated pelvis. **Claim 12** The surgical simulator according to claim 1, wherein the simulated pelvis is compressible. **Claim 13** The surgical simulator according to claim 12, wherein the simulated pelvis is made of a flexible foaming material.

14. The surgical simulator according to claim 1, wherein the simulated pelvis includes one or more notches extending between the inner surface and the outer surface.

15. The surgical simulator according to claim 1, further including a webbing different from the first sheet and the second sheet, connected to the simulated pelvis and the simulated tissue model, and the webbing is provided in the enclosure of the simulated pelvis with the simulated tissue model further floating therein.

16. Further including a surgical training instrument, wherein the surgical training instrument comprises a top cover, and a base disposed at an interval from the top cover, and the surgical training instrument forms an internal space configured to receive the simulated pelvis. The surgical simulator according to claim 1.

17. The surgical simulator according to claim 16, further including an adapter located between the top cover and the base, interconnected with the enclosure of the simulated pelvis, and defining an opening sized and configured to provide access to the enclosure, and the adapter is configured to simulate a vagina for vaginal surgery.

18. The surgical simulator according to claim 17, wherein the adapter further includes a tubular extension extending into the simulated pelvis, the tubular extension having a proximal end located at the adapter, and the distal end of the tubular extension is configured to receive a tubular structure attached to a simulated tissue structure.

19. The surgical simulator according to claim 1, wherein the first and second sheets of silicone are configured to allow the simulated tissue model to sway within the enclosure of the simulated pelvis in response to being manipulated.

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