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 located inside the enclosure. The simulated tissue model is adapted for practicing hysterectomies, and includes at least a simulated uterus and a simulated vagina. The simulated tissue model is suspending inside the enclosure with two planar sheets of silicone such that the tissue model is located between the two sheets each of which forms a fold and is connected to the frame. The frame 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 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 relates generally to surgical training tools, and more particularly to simulated tissue structures and models for teaching and practicing various surgical techniques and procedures associated with, but not limited to, laparoscopic, endoscopic, and minimally invasive surgery.

[0002] Description of Related Applications This application claims priority to and benefits from U.S. Provisional Patent Application No. 62 / 173,180, filed June 9, 2015, entitled "Hysterectomy model," which is incorporated herein by reference in its entirety. [Background technology]

[0003] Medical students learning new surgical techniques and experienced surgeons must undergo extensive training before they are qualified to operate on human patients. This training must teach proper technique using a variety of medical instruments to cut, pierce, clamp, grasp, staple, cauterize, and suture various types of tissue. The range of situations trainees may encounter is wide. For example, various organs and patient anatomies and diseases are presented. The thickness and consistency of various tissue layers may also vary from one part of the body to the next and from patient to patient. Different procedures require different skills. Furthermore, trainees must practice their skills in a variety of anatomical environments influenced by factors such as the patient's size and condition, the adjacent anatomical landscape and landscape of the target tissue, and whether the target tissue is easily accessible or relatively inaccessible.

[0004] Many teaching aids, training devices, simulated trainers (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 may be encountered and can be used to practice endoscopic, laparoscopic, and minimally invasive surgical procedures. In laparoscopic surgery, a trocar or cannula is inserted to access the body cavity and create a channel for the insertion of a camera, e.g., a laparoscope. The camera provides a live video feed capturing images, which are then displayed to the surgeon on one or more monitors. At least one additional small incision is made, through which another trocar / cannula is inserted to create a path through which surgical instruments can be inserted to perform the procedure observed on the monitor. The target tissue location, e.g., the abdomen, is typically expanded by delivering carbon dioxide gas to insufflate or insufflate the body cavity to create a working space large enough to accommodate the scope and instruments used by the surgeon. Insufflation pressure within the tissue cavity is maintained using specialized trocars. Laparoscopic surgery offers many advantages over open procedures, including less pain, less bleeding, and shorter recovery times due to smaller incisions.

[0005] Laparoscopic or endoscopic minimally invasive surgery requires a higher skill level than open surgery because the target tissue is not directly observed by the physician. The target tissue is observed via a monitor that displays a portion of the surgical site accessed through a small opening. Therefore, the physician must visually locate tissue planes, practice three-dimensional depth perception on a two-dimensional viewing screen, instrument delivery, suturing, precision cutting, and tissue and instrument manipulation. Typically, models mimicking specific anatomical structures or procedures are placed in a simulated pelvic or lumbar training device, where the anatomical model is hidden from direct visualization by the physician. Ports in the training device are used to practice techniques performed on the hidden anatomical model through instruments. The simulated pelvic trainer provides a functional, inexpensive, and practical means of training surgeons and residents in how to perform the basic skills and typical techniques used in laparoscopic surgery, such as grasping, manipulating, cutting, knotting, suturing, stapling, and cauterizing, as well as specific surgical procedures utilizing these basic skills. The simulated pelvic trainer is also an effective marketing tool for demonstrating the medical equipment required to perform these laparoscopic procedures.

[0006] One such procedure is a hysterectomy, which involves removal of the uterus. A hysterectomy may be performed transvaginally, through the vaginal canal, or abdominally, through a small incision in the abdomen. Vaginal hysterectomies have historically been difficult to train due to limited visibility. Unlike laparoscopic procedures, there are no cameras to project the procedure onto a screen, and unlike open procedures, there are no large incisions that can be viewed by multiple people. Therefore, the best way to teach a vaginal hysterectomy is through a mock model. Therefore, a model for training hysterectomies is needed.

[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 has an enclosure with an inner surface, an outer surface, and at least one opening at the proximal end. The surgical simulator has a simulated tissue model including a simulated uterus with a spherical portion at the distal end, which 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 simulated tissue model is suspended within the enclosure of the simulated pelvis, with the spherical portion of the simulated uterus located near the distal end and the tubular portion of the simulated vagina located near the proximal end of the simulated pelvis. The tubular portion has a lumen accessible through at least one opening in the simulated pelvis.

[0008] According to another aspect of the present invention, a surgical simulator for surgical training is provided. The simulator includes a simulated pelvic frame having an inner surface and an outer surface, with a substantially uniform thickness defined between the inner surface and the outer surface. The simulated pelvic frame defines a substantially cylindrical shape. The cylindrical shape has an open proximal end and an open distal end, with a lumen defined between the open proximal end and the open distal end. The simulated pelvic frame has a longitudinal axis and includes a top side and a bottom side. The simulated pelvic frame includes simulated tissue models 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 chord, a simulated vascular system, a simulated bladder, and a simulated colon. The simulated tissue models are removably coupled to the simulated pelvic frame such that the simulated tissue models are provided floating within the lumen.

[0009] According to another aspect of the present invention, there is provided a surgical simulator for surgical training. The simulator has a base and a top cover connected to the base at a distance from the base to define an internal cavity between the base and the top cover. The simulator has at least two legs interconnecting the top cover and the base at a distance from each other and separating the top cover from the base. One of the at least two legs has an aperture facing the internal cavity. The simulator further has a simulated uterus having a distal end connected to a proximal end of a simulated vagina. The simulated vagina has a lumen with a proximal opening. The proximal opening is interconnected with the aperture so that the aperture provides an access port to the lumen of the simulated vagina. The simulated vagina and simulated uterus extend into the internal cavity. One or more of the simulated uterus and simulated vagina are suspended within the internal cavity. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a top perspective view of a surgical training instrument of the present invention; FIG. [Figure 2] FIG. 1 is a frontal top perspective view of a model of the present invention. [Figure 3A] FIG. 1 is a top perspective view of a pelvic frame of the present invention. [Figure 3B] FIG. 1 is a top perspective view of a pelvic frame of the present invention. [Figure 3C] FIG. 1 is a top perspective view of a pelvic frame of the present invention. [Figure 3D] FIG. 1 is a plan view of a pelvic frame in a flat orientation in accordance with the present invention. [Figure 4A] FIG. 1 is a caudal end view of a model within the surgical training instrument of the present invention. [Figure 4B] FIG. 1 is a side view of a model within the surgical training instrument of the present invention. [Figure 4C] FIG. 1 is a side view of a model within the surgical training instrument of the present invention. [Figure 4D] FIG. 1 is a frontal, top perspective view of a model within the surgical training instrument of the present invention. [Figure 4E]FIG. 1 is a caudal end view of the surgical training instrument of the present invention. [Figure 5A] FIG. 1 is a side view of a vaginal adapter of the present invention. [Figure 5B] FIG. 1 is a top perspective view of a vaginal adapter of the present invention. [Figure 6A] FIG. 1 is a side view of a vaginal adapter of the present invention. [Figure 6B] FIG. 1 is a top perspective view of a vaginal adapter of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] A surgical training device 10 designed to simulate a patient's torso, e.g., the abdominal region, is shown in FIG. 1 . The surgical training device 10 includes a body cavity 12 that is substantially hidden from the user and receives simulated or live tissue, model organs, training models, or the like, as described herein. The body cavity 12 is accessed through a tissue simulation region 14 that is penetrated by a user using instruments to perform a surgical procedure on the tissue or training model visible within the body cavity 12. While the body cavity 12 is shown as being accessible through the tissue simulation region, the body cavity 12 may alternatively be accessed using a manual access instrument or a single-site port instrument. An exemplary surgical training device is described in U.S. patent application Ser. No. 13 / 248,449, filed Sep. 29, 2011, entitled "Portable Laparoscopic Trainer," which is incorporated herein by reference in its entirety. The surgical training instrument 10 is particularly well suited for practicing laparoscopic or other minimally invasive surgical procedures.

[0012] Still referring to FIG. 1 , the surgical training device 10 includes a top cover 16 connected to and spaced from a base 18 by at least one leg or foot 20. FIG. 1 shows multiple legs 20. The surgical training device 10 is configured to simulate a patient's torso, e.g., the abdominal region. The top cover 16 represents the anterior surface of the patient, and the space 12 between the top cover 16 and the base 18 represents the patient's interior or body cavity where organs reside. The surgical training device 10 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and their associated instruments in a simulation of a patient undergoing a surgical procedure. Surgical instruments are inserted into the cavity 12 through the tissue simulation area 14 and through pre-drilled holes 22 in the top cover 16. Various tools and techniques can be used to penetrate the top cover 16, thereby performing a simulated procedure on a simulated organ or training model placed 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 that holds the model (not shown) in place. To help hold the simulated tissue model or 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 place substantially below the tissue simulation area 14. Other means for holding the tissue model include a patch of hook-and-loop fastening material (VELCRO®) attached to base 18 within model receiving area 24, which patch of hook-and-loop fastening material is removably connectable to a complementary piece of hook-and-loop fastening material (VELCRO®) attached to the model.

[0013] A video display monitor 28 hinged to the top cover 16 is shown in a closed orientation in FIG. 1 . The video monitor 28 can be connected to various visual systems that transmit images to the monitor. For example, a laparoscope inserted through one of the pre-drilled holes 22 or a webcam (webcam) installed in the cavity and used to observe the simulated procedure can be connected to the video monitor 28 and / or a mobile computing device to provide images to the user. Audio recording or transmission means can also be provided and integrated with the training device 10, thereby providing audio and visual capabilities. Portable storage devices, such as flash drives, smartphones, digital audio or video players, or other digital mobile devices, can also be provided to record training procedures for demonstration purposes and / or play back pre-recorded footage on the monitor. Of course, connection means can be provided to provide audiovisual output to a screen larger than the monitor. In another variation, the top cover 16 does not include a video display but includes means for connecting a laptop computer, mobile digital device, or tablet to the training device via wire or wirelessly.

[0014] When assembled, the top cover 16 is positioned directly above the base 18 with the legs 20 disposed substantially circumferentially 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 size and have substantially the same peripheral contours. The internal cavity is partially or completely hidden from view. In the variation shown in FIG. 1 , the legs have openings to allow ambient light to illuminate the internal cavity as much as possible, while advantageously providing as little weight as possible for portability. The top cover 16 is detachable from the legs 20, which are detachable from the base 18 or foldable, such as by hinges, relative to the base 18. Thus, the unassembled training device 10 has a reduced height that facilitates portability. In essence, 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 surgical model accessible through a hole 22 provided in at least one tissue simulation area 14 and / or the top cover 16, allowing a user to access the model through the hole 22 to practice laparoscopic or endoscopic minimally invasive surgical procedures.

[0015] A model 30 for practicing hysterectomy, and in particular vaginal hysterectomy, in accordance with the present invention is shown in FIG. 2. The model 30 is configured to be placed within the surgical training instrument 10 described above or other similar surgical trainer. 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 defining a hollow simulated uterine cavity 42. The spherical portion 40 is connected to a tubular portion 44 defining a vaginal canal 46 having an opening 48. The simulated uterus 32 further includes a simulated cervix 50 (shown in FIG. 4A) disposed within the simulated uterus 32 at a location substantially between the uterine cavity 42 and the vaginal canal 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 includes simulated fallopian tubes 54 connected to 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. The silicone construction gives the simulated uterus 32 a more realistic weight when the attached simulated cervix 50 is being pulled and manipulated. The foam construction of the simulated uterus 32 facilitates the placement of the simulated uterus 32 in a floating position within the simulated pelvic cavity. Additionally, during removal of the simulated uterus 32, the lightweight foam flexes more easily than a simulated uterus 32 made of high durometer silicone, allowing a larger simulated uterus 32 to be placed within the model 30 and still be removed. The foam uterus 32 compresses and flexes as it is removed through the vaginal opening 48, similar to a real surgical procedure. The simulated uterus 32 weighs approximately 300-500 grams and is constructed of foam with a durometer selected to accurately represent the size and weight of a real uterus that can typically be removed vaginally without extensive morcellation. In another form, the simulated uterus 32 is a combination of silicone and foam to give the simulated uterus 32 a more realistic appearance while still retaining the flexibility of foam. The foam can be molded, and then silicone can be applied over the foam, for example, on a rotational mold. The simulated uterus 32 is typically pink in color, with the fallopian tubes 54 and ovaries being clear or white. Additionally, the simulated uterus 32 may include an embedded tumor, cyst, and / or an ectopic pregnancy within the fallopian tubes 54. The model 30 may further include a simulated vasculature or blood vessel system 58, such as blood vessels. The simulated vasculature 58 is made of solid or hollow tubular silicone or other suitable elastomer. A liquid may be contained within the hollow tube of the simulated vasculature 58. The simulated vasculature 58, which mimics a blood vessel, may be red in color.Model 30 may further include a mock chord 59, such as a uterosacral chord 59, made of a silicone material as can be seen in Figures 2 and 4E. Model 30 may further include a round tubo-ovarian ligament 61 attached to frame 34 shown in Figure 2.

[0017] 3A-3D, the frame 34 has a cylindrical shape defining an interior / lumen 60. The frame 34 has a first surface 62 interconnected to a second surface 64, with a thickness 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 made of a flexible foam material that is also slightly compressible. The frame 34 has one or more notches 66 extending between the first surface 62 and the second surface 64 to define a perimeter and holes. In one form, the frame 34 is made from a sheet of foam material cut according to the pattern shown in FIG. 3D. FIG. 3D shows a perimeter having a top portion 68 and a bottom portion 70 interconnected by first and second sides 72, 74. The top portion 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 iliac crests. The bottom portion 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 portion 72 has a first inferior lobe 82 with a first foramen 86, and the second side portion 74 has a second inferior lobe 84 with a second foramen 88. The first and second inferior lobes 82, 84 represent the left and right ischia, and the first and second foramen 86, 88 represent the obturator foramen of the human pelvis. A thick piece of foam is cut to have the flat pattern shown in FIG. 3D. The foam piece is then bent so that the first and second inferior lobes 82, 84 join together in a tubular configuration. When joined, the two lobes 82, 84 represent the pubic / pubo-pubic symphysis. The two lobes 82, 84 may be joined by adhesive or connected in another suitable manner. In another configuration, the two lobes 82, 84 are not joined together and remain spaced apart, forming a half-cylindrical or split-tubular configuration. The frame 34 is bendable and may be made of a material that will retain its shape after bending, such as aluminum.Additionally, clips 26 and wires connected to the trainer 10 can be used to hold the two lobes 82, 84 in an upward, cylindrical configuration while still positioned within the trainer 10. The anatomy of the pelvis is shown in FIG.

[0018] The frame 34 is made of a soft, compressible, semi-rigid foam that can be die-cut and then glued to a precise shape. If the frame 34 is made of hard plastic, it can be a thin thermoform that is initially formed to a precise shape, or it can be a thick plastic that is cut to the shape of the pelvis and then heat-formed into a cylindrical shape. The frame 34 can also be made of a deformable metal that retains its shape. The frame 34 is not a perfect replica of the anatomy; it only needs to include certain features selected for practicing certain procedures that require certain features as anatomical reference points or visual landmarks or views for the physician. For example, for practicing vaginal hysterectomy, important features of the pelvis are the iris of the pelvic inlet and its attachment to the pelvic sidewall. For practicing transanal total mesorectal excision (TATME), the L-shape of the sacrum is an important landmark. For hernia procedures, the pubic tubercle is an important landmark. Frame 34 may be fabricated with all anatomically correct features or only those features necessary for a particular procedure. Thus, frame 34 and model 30 can be used to mimic vaginal hysterectomy, transabdominal hysterectomy, colectomy, hernia, ta TME, and other pelvic procedures. In another form, frame 34 is conical or frustoconical in shape with an open proximal end and an open distal end.

[0019] Referring back to FIG. 2 , the model 30 may further include a simulated bladder 90. The simulated bladder 90 is a hollow, air-filled component typically made of silicone or other elastomeric material. In another embodiment, the simulated bladder contains a liquid. The simulated bladder 90 is coupled to the frame 34 by adhesive or other means. The simulated bladder is coupled to the first surface 62 or the inner surface of the frame 34. The simulated bladder 90 is attached in alignment with the vertical axis, with the two lobes 82, 84 in juxtaposition at the location representing the pubic bone. Once coupled, the simulated bladder 90 extends into the lumen 60 of the frame 34. The simulated bladder 90 may further include a simulated ureter 94. In one embodiment, the simulated ureter 94 is coupled to the simulated bladder 90. The simulated ureter is made of solid or hollow tubular silicone.

[0020] 2, model 30 may further include a simulated colon 92 or portion of an intestine. The simulated colon 92 is a tubular structure having a lumen. The simulated colon 92 is positioned within interior 90 of frame 34, along a substantially vertical axis, and on first surface 62 against second projection 80 of frame 34. The simulated colon 92 may be attached to frame 34 using an adhesive. The simulated colon 92 may be made of silicone or other suitable elastomeric material, colored pink or other suitable color, and may or may not include a simulated tumor.

[0021] The first sheet 36 is a thin layer of clear 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 simulated 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 bulbous portion 40 and the tubular portion 44 along at least a portion of the length of the simulated uterus 32, as shown in FIG. 2. The first sheet 36 is then folded back toward the top of the model 30 and then back toward the first end 100 of the first sheet 36, thereby creating a crease near the tubular portion 44 of the simulated uterus 32. At least a portion of the first sheet 36 near its second end 102 is attached to the frame 34 such that the bottom surface 98 of the first sheet 36 is attached to the frame 34 in the general location where the two lobes 82, 84 are juxtaposed to create a cylindrical configuration for the frame 34. The attachment of the first sheet 36 may also help hold the frame 34 in a cylindrical configuration. 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 then folded around portions of the first side 72 and second side 74 of the frame 34. When a simulated 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 simulated bladder 90 by the adhesive, thereby capturing the simulated bladder 90 between the frame 34 and the first sheet 36. A portion of the second end 102 of the first sheet 36 is folded around an 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 positioned above the second or outer surface 64 of the frame 34, as seen in FIG. 4D . The first sheet 36 is sized and shaped to provide the simulated uterus 32 suspended within the interior 60 of the frame 34. The simulated vasculature 58 can be attached to the top surface 96 or bottom surface 98 of the first sheet 36.The configuration of the first sheet 36 forms a pocket-like structure, where the top surface 96 of the first sheet 36 is at least partially folded back onto itself, creating a floating webbing that mimics the peritoneal layer.

[0022] The second sheet 38 is a thin layer of clear silicone material having a top surface 104, a bottom surface 106, a first end 108, and a second end 110. In one embodiment, 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 simulated uterus 32. In particular, the bottom surface 106 near the first end 108 of the third sheet 38 is attached along at least a portion of the length of the simulated uterus 32 to one or more of the spherical portion 40 and the tubular portion 44 located on the opposite side from the side to which the first sheet 36 is attached. The first sheet 36 is attached to the front side of the model 30, which is also the front side of the simulated uterus 32. The second sheet 38 is attached to the rear side of the model 30, which is also the rear side of the simulated uterus 32. After the second sheet 38 is attached to the posterior side of the simulated uterus 32, it is folded toward the top of the model 30 and then toward a first end 108 of the second sheet 38, creating a crease near the tubular portion 44 of the simulated uterus 32. At least a portion of the second sheet 38 near its second end 110 is attached to the frame 34 such that a bottom surface 106 of the second sheet 38 is attached to the frame 34 at the general location of the second protrusion 80. 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 inner surface of the frame 34, and the bottom surface can be folded around an edge of the frame 34 such that at least a portion of the second end 110 of the second sheet 38 is connected to the second surface 64 or outer surface of the frame 34. When the simulated colon 92 is employed in the model 30, the second end 110 of the second sheet 38 is also adhesively attached to the exterior surface of the simulated colon 92, or at least overlaps and is not adhesively attached, so that at least a portion of the simulated colon 92 is captured or disposed between the frame 34 and the second sheet 38. The second sheet 38 is sized and shaped to provide the simulated uterus 32 in a floating state within the interior 60 of the frame 34 even when the model 30 is inverted.The simulated vasculature 58 can be attached to the top surface 104 or bottom surface 106 of the second sheet 38. The configuration of the second sheet 38 forms a pocket-like structure, where the top surface 104 of the second sheet 38 is folded at least partially onto itself. The second sheet 38 creates a floating webbing that mimics the peritoneal layer.

[0023] 4A-4E, model 30 is shown positioned within a surgical trainer 10 similar to the surgical trainer described with reference to FIG. 1. Model 30 is shown positioned within body cavity 12 and oriented such that top 68 of frame 34 faces cranially relative to simulated trainer 10 and vaginal opening 48 of simulated uterus 32 faces caudally relative to simulated trainer 10. Model 30 may be coupled to surgical trainer 10 by clip 26 attached to trainer 10. Retractable clip 26 can be extended and attached to any portion of model 30, such as frame 34 of model 30. Additionally, second or outer surface 64 of model 30 may include a hook-and-loop fastener configured to attach to a complementary portion of a hook-and-loop fastener connected to base 18 of trainer 10. Together with one or more fasteners, such as clips 26 and / or hook-and-loop fasteners, model 30 is securely attached to trainer 10 so that model 30 of trainer 10 can be manipulated in a simulated surgical procedure without being removed from body cavity 12. Model 30 is further connected to trainer 10 by a transvaginal adapter 112, which is sized and shaped to interconnect top cover 16 and base 18 as an additional caudally positioned leg 20 of surgical training instrument 10.

[0024] 5A and 5B and 6A and 6B, there is shown a vaginal adapter 112. Referring again back to FIG. 1, the top cover is shown suspended above the base by five legs 20. In one form, six legs 20 are provided in the form of a vaginal adapter 112, as shown in FIGS. 4A-4D. The trainer 10 can be assembled with an optional sixth support structure or leg, which is shaped to mimic a vaginal procedure, including a vaginal hysterectomy.

[0025] The vaginal adapter 112 has a flat plate 114 with an inner surface 116 for facing toward the interior of the trainer and an outer surface 118 for facing outward toward the user. The plate 114 is rectangular in shape, with an aperture 120 extending from the inner surface 116 to the outer surface 118 of the plate 114. In one form, the aperture 120 is circular in shape. In another form, the aperture 120 is shaped like an elongated oval, with the aperture oriented perpendicular to the longitudinal axis of the adapter 112. In another form, the aperture 120 is elongated oval in shape, with the aperture oriented perpendicular to the longitudinal axis of the adapter. As shown in FIGS. 5A-6B , the plate 114 further has insertable means, such as tabs 122 or U-shaped channels, for connecting the vaginal adapter 112 to the top cover 16 and base 18 to help support and space the top cover 16. A vaginal adapter 112 is disposed between the top cover 16 and the base 18, and includes a side access hole 16 positioned externally relative to the trainer 10 or substantially perpendicular to the top cover 16 and base 18. The plate 114 further includes a plurality of molding holes 124 surrounding or positioned around the main hole 120 and configured for overmolding a soft simulated vaginal tissue interface made of silicone or the like. In another embodiment, the interface allows the vaginal adapter to be inserted into the hole 120 of the plate 112. The tissue interface (not shown) has a hole substantially coaxial with the plate hole 120. A tubular extension 126 is integrally formed on the inner surface of the vaginal 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 than the tubular extension 126 in FIGS. 5A and 5B. The tubular extension 126 is sized and shaped so that the tubular portion 44 of the simulated uterus 32 can be stretched around the extension 126 and secured to the transvaginal adapter 112, such that the vaginal canal 46 is supported in an open configuration that is aligned with and accessible through the aperture 120 of the adapter 112, as shown in Figures 4A-4D.Tubular extension 126 serves as a connector connecting model 30 to trainer 10 in a manner that allows access to the interior of the uterus, as in an actual surgical procedure. In one form, tubular extension 126 is a cylindrical extension with a radially extending distal flange 128 extending around at least a portion of extension 128 to help secure and hold model 30 attached to trainer 10. Tubular portion 44 of model 30 is attached to tubular extension 126 by pulling tubular portion 44 over distal flange 128, if present, and over and around tubular extension 126, with the outer diameter of tubular extension 126 being the same as or slightly larger than the relaxed inner diameter of tubular portion 44, thereby maintaining tubular portion 44 secured to vaginal adapter 112. Vaginal adapter 112 can be made of a flexible or rigid material. If the adapter 112 is made of a rigid material, it will tend to mimic the vaginal canal 46 in an already retracted state. If the adapter 112 is made of a flexible or 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, which keeps the top cover 16 of the trainer 10 supported so that the practitioner can still practice retraction upon opening the vaginal canal 46 at the adapter 112.

[0026] In use, the model 30 is placed within the surgical training instrument 10 and held in place by hook-and-loop fasteners and / or retracting clips 26. The tubular portion 44 is attached to the transvaginal adapter 112 by stretching the vaginal opening 48 over the tubular extension 126 of the adapter 112. To further conceal the model 30, a curtain placed around the side of the trainer 10 can be employed so that visualization is only possible through the simulated vaginal canal 46. A surgical retractor is then used to retract the vaginal canal 46. The vaginal canal 46 is made of a flexible thermoplastic elastomer (TPE). The TPE provides resistance as it retracts and attempts to spring back to its original shape, allowing the user to practice realistic retraction. The transvaginal adapter 112 of FIGS. 6A and 6B with the long tubular extension 126 is used to simulate a vaginal canal in an already retracted state. Therefore, the transvaginal adapter 112 allows the physician to practice hysterectomy without needing an extra hand or assistance to perform 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 canal 46 with a retractor and the assistance 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 may or may not be selected for the purpose of practicing retraction of the vaginal canal 46. Next, the simulated cervix 50 is grasped and pulled toward the opening 48 of the vaginal canal 46. The simulated cervix 50 is made of a 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 real surgical tools and pulled without fear of ripping or tearing the silicone. 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. A sheet of cotton or other webbing-like material can be placed within the model 30 between the vaginal canal 46 and the simulated bladder 90. As mentioned above, the simulated bladder 90 is a hollow, air-filled component.If the physician accidentally cuts the simulated bladder 90 by making a large incision while peeling the simulated vaginal mucosa, the simulated bladder 90 may make a popping sound to provide immediate feedback to the physician, especially if the simulated bladder 90 contains fluid.

[0027] The model 30 advantageously includes a second sheet 38 that forms a fold between the simulated uterus 32 and the frame 34. Providing the simulated uterus 32 in a floating position within the frame 34 advantageously creates a realistic response during dissection and manipulation of the simulated uterus 32. In configurations where the simulated uterus is made of a lightweight foam material, the simulated uterus remains suspended, dangling, and swinging in response to manipulation with surgical instruments. The simulated uterus and simulated vagina are at least partially suspended within and connected to an enclosure defined by the pelvic frame or directly connected to an enclosure defined by the trainer. The floating position advantageously allows access to the folds of the second sheet, thereby enabling the practice of a posterior colpotomy to a posterior cul-de-sac incision by dissecting the peritoneum that forms the recto-uterine fold. The floating simulated uterus 32 allows the presence of a recto-uterine peritoneal fold. As described above, the simulated uterus 32 is suspended within a frame 34 made of a foam material that mimics the human pelvis. The simulated uterus 32 is suspended by a first folded sheet of silicone material attached to the front of the simulated uterus 32 and a second folded sheet of silicone material attached to the back of the simulated uterus 32. The frame 34 can be constructed of any material, such as a plastic material or a rigid foam material. The frame 34 serves as an attachment area for various simulated anatomical structures, including the broad ligament, ovaries 56, and fallopian tubes 54. The resilience of the silicone in these anatomical components allows the simulated uterus 32 to be pulled and manipulated and still remain attached to the frame 34. A frame 34 made of semi-rigid foam also allows movement when the simulated uterus is being manipulated. A more rigid frame 34 allows for less movement. Next, the physician divides the uterosacral cords 59. Next, the physician can practice anterior colpotomy to anterior capsular incision by incising the first sheet 38, which mimics the peritoneum forming the vesicouterine fold. The physician divides the tubo-ovarian ligaments 59 on each side of the simulated uterus 32.Due to the foam frame 34, the tubo-ovarian ligaments 59 remain realistically attached to the frame 34 even after they are divided from the simulated uterus 32. The simulated uterus 32 is then freed and removed. The physician then practices suturing the vaginal cuff closed by passing a needle with a suture through the tubular portion 44 of the model 30 to close the opening of the vaginal canal 46. Suturing the vaginal cuff in a real procedure is another difficult part of a vaginal hysterectomy due to space constraints. The tubular portion 44, made of TPE, holds the suture without tearing and limits the space available for instruments during the suturing process. The model 30 allows the physician to practice many difficult procedures on one model.

[0028] Any portion of model 30 can be made from one or more organic base polymers, including, but not limited to, hydrogels, homopolymer hydrogels, multipolymer hydrogels, rubber, latex, nitrile, protein, gelatin, collagen, soy, and inorganic base polymers such as thermoplastic elastomers, Kraton, silicone, foams, silicone-based foams, urethane-based foams, and ethylene vinyl acetate foams. Any of the base polymers can employ one or more fillers, such as cloth, woven or nonwoven fibers, polyester, nylon, cotton, and silk, as well as conductive filler materials such as graphite, platinum, silver, gold, copper, other additives, gels, oils, cornstarch, glass, dolomite, carbonate minerals, alcohols, deadners, silicone oils, pigments, foams, poloxamers, collagen, gelatin, and the like. The adhesives that can be used include, but are not limited to, cyanoacrylate-based, silicone-based, epoxy-based, spray-type adhesives, rubber-based adhesives, and the like.

[0029] It will be appreciated that various modifications can be made to the embodiments and alternatives disclosed herein. Accordingly, the above description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the invention.

Claims

1. 1. A surgical simulator for surgical training, comprising: a simulated pelvis having a proximal end and a distal end, the simulated pelvis comprising an enclosure having an inner surface, an outer surface and at least one opening at the proximal end; 1. A surgical simulator comprising: a simulated tissue model including a simulated uterus with a spherical portion at a distal end, the simulated uterus coupled to a simulated vagina with a tubular portion at a proximal end, the simulated tissue model coupled to a simulated pelvis such that the simulated tissue model is suspended within the enclosure of the simulated pelvis with the spherical portion of the simulated uterus positioned near the distal end and the tubular portion of the simulated vagina positioned near the proximal end of the simulated pelvis, the tubular portion having a lumen accessible through the at least one opening in the simulated pelvis.

2. 1. A surgical simulator for surgical training, comprising: a simulated pelvic frame having an inner surface and an outer surface, defining a substantially uniform thickness between the inner surface and the outer surface, the simulated pelvic frame defining a substantially cylindrical shape, the cylindrical shape having an open proximal end and an open distal end, a lumen defined between the open proximal end and the open distal end, the simulated pelvic frame having a longitudinal axis and including a top side and a bottom side; A surgical simulator having 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 chord, a simulated vascular system, a simulated bladder, and a simulated colon, the simulated tissue model being removably coupled to the simulated pelvic frame so as to be provided in a floating state within the lumen.

3. 1. A surgical simulator for surgical training, comprising: having a base, a top cover connected to the base and spaced apart from the base to define an interior cavity therebetween; at least two legs interconnecting the top cover and the base while being spaced apart from each other, one of the at least two legs having an aperture facing the internal cavity; a simulated uterus having a distal end connected to a proximal end of a simulated vagina, the simulated vagina having a lumen with a proximal opening, the proximal opening interconnected with the aperture such that the aperture provides an access port to the lumen of the simulated vagina, the simulated vagina and the simulated uterus extending into the internal cavity; The surgical simulator, wherein one or more of the simulated uterus and the simulated vagina are suspended within the internal cavity.

4. 4. The surgical simulator of claim 1, further comprising a first silicone sheet having a first end and a second end and a second silicone sheet having a first end and a second end, the first sheet and the second sheet being substantially flat, the simulated tissue model being suspended within the enclosure of the simulated pelvis by at least one of the first sheet and the second sheet, the simulated tissue model being connected to the first sheet and the second sheet and being disposed between the first sheet and the second sheet, and the first sheet and the second sheet being connected to the simulated pelvis.

5. the first end of the first sheet is connected to the top of the spherical portion of the simulated uterus and extends proximally along the simulated vagina, which is connected to the top of the tubular portion; the first flat sheet is folded upward near the proximal end and then extends distally along the top of the simulated pelvis; and the second end of the first sheet is connected to the simulated pelvis at the top of the simulated pelvis.

5. The surgical simulator of claim 1, wherein the first end of the second sheet is connected to the simulated uterus at the bottom of the bulbous portion and extends proximally along the simulated vagina connected to the bottom of the tubular portion, and the second sheet is folded downward near the proximal end and then extends distally.

6. 6. The surgical simulator of claim 1, further comprising a simulated bladder disposed between the first sheet and the top of the simulated pelvis, the simulated bladder being connected to the first flat sheet.

7. 7. The surgical simulator of claim 1, further comprising a simulated colon, the simulated colon being disposed between the second flat sheet and the bottom of the simulated pelvis, the simulated colon being connected to the second flat sheet and the bottom of the simulated pelvis.

8. 8. The surgical simulator according to claim 1, wherein the simulated pelvis is cylindrical in shape.

9. A surgical simulator according to any preceding claim, wherein the mock pelvis is frusto-conical in shape and defines an open enclosure.

10. The surgical simulator of any one of claims 1 to 9, wherein the simulated tissue model is made of silicone and foam.

11. 11. The surgical simulator of claim 1, wherein the simulated pelvis frame has a top end and a bottom end interconnected by a first side and a second side, the cylindrical shape being divided to define a gap between the first side and the second side, the gap extending from the top end to the bottom end along the longitudinal axis and centered along the top end.

12. The surgical simulator of any one of claims 1 to 11, wherein the simulated pelvis frame has at least one hole extending between the inner surface and the outer surface.

13. The surgical simulator of any preceding claim, wherein the simulated pelvis frame has at least one notch along the first side and the second side.

14. 14. The surgical simulator of claim 1, further comprising a first silicone sheet having an inner surface, an outer surface, a first end, and a second end, and a second silicone sheet having an inner surface, an outer surface, a first end, and a second end, wherein the first sheet and the second sheet are substantially flat, and the simulated tissue model is provided in a floating state between the first flat sheet and the second flat sheet.

15. 15. The surgical simulator of claim 1, further comprising a simulated uterus and a simulated vagina, wherein a length of the inner surface of the first sheet near the first end is connected to the top of the simulated tissue model, the length having a fold so that the second end of the first sheet is connected to the top of the simulated pelvic frame, and a length of the inner surface of the second sheet near the first end is connected to the bottom of the simulated tissue model, the length having a fold.

16. 16. The surgical simulator of claim 1, further comprising a simulated uterus, a simulated vagina, a simulated colon, and a simulated bladder, wherein a length of the inner surface of the first sheet near the first end is connected to the top of the simulated tissue model, the length having a fold so that the length of the inner surface of the first sheet is connected to the simulated bladder, the second end of the first sheet is connected to the top of the simulated pelvic frame, and a length of the inner surface of the second sheet near the first end is connected to the bottom of the simulated tissue model, the length having a fold so that the length of the inner surface of the second flat sheet is connected to the simulated colon, and the simulated colon is connected to the inner surface of the simulated pelvic frame.

17. 17. The surgical simulator of claim 1, further comprising a pelvic frame defining an enclosure, the one or more of the simulated uterus and the simulated vagina being suspended within the enclosure of the pelvic frame.

18. The surgical simulator of any one of claims 1 to 17, further comprising at least one simulated fallopian tube and ovary.

19. 19. The surgical simulator of any one of claims 1 to 18, wherein the one leg has an extension surrounding at least a portion of the aperture and extending toward the internal cavity, the simulated vagina being made of an elastic material, and the proximal opening being stretched over the extension to releasably couple the simulated vagina to the leg.

20. A surgical simulator according to any preceding claim, wherein the one leg has a molded hole located adjacent the hole and silicone overmolded around the hole.

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