Portable laparoscopic trainer

Abstract

To provide a portable surgical training device.SOLUTION: The trainer includes a top cover spaced apart from a base to form a pseudo body cavity for locating model organs that are substantially obscured from the field of view of a user. The top cover includes a video display, fixed insertion ports, and interchangeable inserts containing pseudo tissue layers. The training device has open sides for demonstrating and training lateral surgical techniques including a pseudo or live tissue colon attached to a support leg for simulating transanal minimally invasive surgery. A training endoscope with an adjustable focal length for use with the trainer, in particular, an optical trocar is disclosed. The surgical trainer can be inclined and is well suited for training laparoscopic surgery techniques and demonstrating surgical instruments.

Description

[Technical Field]

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 61 / 389,141, entitled "Portable Pelvic Trainer," filed October 1, 2010, and U.S. Provisional Patent Application No. 61 / 476,657, entitled "Portable Laparoscopic Trainer," filed April 18, 2011. The entire disclosures of these applications are hereby incorporated by reference.

[0002] This application relates generally to surgical training tools, and more particularly to simulators for teaching and practicing various surgical procedures related to laparoscopic, abdominal, and transanal minimally invasive surgery. [Background technology]

[0003] Simulated trauma pelvic trainers are of interest in the field of laparoscopy because they provide a functional, inexpensive, and realistic means for training surgeons and residents in the fundamental skills and representative techniques used in laparoscopic surgery, such as grasping, manipulating, cutting, and ligating, as well as how to perform specialized surgical procedures, such as colectomies and cholecystectomies, that use these fundamental skills.

[0004] It is understood that practice of both basic laparoscopic skills as well as surgical techniques can be performed in non-surgical settings. The use of simulation trainers has been shown to significantly increase the skill level of new laparoscopic surgeons. These trainers are excellent tools for training future surgeons in non-surgical settings. Improved, realistic, and effective surgical trainers are needed. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Provisional Patent Application No. 61 / 389,141 [Patent Document 2] U.S. Provisional Patent Application No. 61 / 476,657 [Patent Document 3] U.S. Patent No. 7,473,221 [Patent Document 4] U.S. Patent No. 6,958,037 [Patent Document 5] U.S. Patent No. 7,650,887 [Patent Document 6] U.S. Patent Application No. 2009-0187079 [Patent Document 7] U.S. Patent Application No. 2010-0094227 Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention generally provides a modular pelvic simulation trainer that accepts various inserter modules to facilitate training in a variety of minimally invasive surgical techniques, including, for example, trocar insertion and performance of minimally invasive procedures using trocars, manually assisted access devices, and single-site port devices. [Means for solving the problem]

[0007] According to one aspect of the present invention, a surgical training device is provided. The training device includes a base and an upper cover connected to the base by at least one leg and spaced apart from the base to form an internal cavity between the base. The training device has a substantially open side and further includes a first insert connected to the upper cover. An upper portion of the first insert is removably connected to a lower portion to form an encasement having an opening in the upper portion and an opening in the lower portion. The encasement contains a removable insert material simulating human tissue. The insert material is disposed between the upper and lower portions of the first insert to form a penetrable tissue simulation region for accessing the internal cavity.

[0008] According to another aspect of the present invention, a surgical training device is provided. The surgical training device includes a base and an upper cover coupled to and spaced from the base, forming an internal cavity between the base. At least one leg interconnects and separates the upper cover and the base. The at least one leg has an aperture facing the internal cavity. The surgical training device further includes a tube having a proximal end and a distal end. The proximal end of the tube is interconnected to the aperture such that the aperture forms an access port to the lumen of the tube. The distal end of the tube extends into and is suspended within the internal cavity.

[0009] In accordance with another aspect of the present invention, a sleeve or endoscope tip is provided which, when coupled to a camera, facilitates rapid changes in the camera's depth of focus, thus allowing a single, simple, cost-effective camera to be used and focused on the interior of a trainer to monitor a simulated laparoscopic surgical procedure, for example, focusing on the tip of an instrument to monitor the insertion of a trocar through the simulated abdominal wall. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a top perspective view of a surgical training device according to the present invention. [Figure 2] FIG. 2 is a perspective view of the upper cover of the training device according to the present invention as seen from above. [Figure 3] FIG. 3 is a side view of an insert according to the invention, adapted to mimic the cross section of the abdominal wall. [Figure 4] FIG. 4 is a partial perspective view from above of an insert according to the invention with a circular opening. [Figure 5A] FIG. 5A is a perspective view from above of an insert according to the invention with a circular opening. [Figure 5B] FIG. 5B is a perspective view from above of an insert according to the invention with a circular opening. [Figure 6]FIG. 6 is a top perspective view of a single port device of an insert according to the present invention. [Figure 7] FIG. 7 is a perspective view of the endoscope according to the present invention as seen from above. [Figure 8] FIG. 8 is a perspective view showing a portion of the distal end of an endoscope according to the present invention in a transparent manner. [Figure 9A] FIG. 9A is a perspective view showing a portion of a lens assembly chip according to the present invention in a transparent manner. [Figure 9B] FIG. 9B is a cross-sectional view of a lens assembly tip mounted on the distal end of an endoscope according to the present invention. [Figure 10A] FIG. 10A is a perspective view showing a portion of a transparent sleeve at the distal end of an endoscope according to the present invention. [Figure 10B] FIG. 10B is a cross-sectional view of a sleeve at the distal end of an endoscope according to the present invention. [Figure 11] FIG. 11 is a cross-sectional view of the distal end of an endoscope having a flexible tip according to the present invention. [Figure 12] FIG. 12 is a perspective view of another embodiment of a laparoscopic trainer according to the present invention. [Figure 13] FIG. 13 is a top view of the laparoscopic trainer of FIG. 12 according to the present invention. [Figure 14] FIG. 14 is a perspective, partially cut away view of an insert according to the present invention. [Figure 15] FIG. 15 is an exploded perspective view of an insert according to the present invention. [Figure 16A] FIG. 16A is an exploded side view of an insert according to the present invention. [Figure 16B] FIG. 16B is a top perspective view of an insert material according to the present invention. [Figure 17] FIG. 17 is a perspective view of a laparoscopic trainer with an insert and a leg with a tube attached, according to the present invention. [Figure 18] FIG. 18 is a schematic diagram of a perspective view of a leg according to the invention with a tube and insert attached. [Figure 19]FIG. 19 is a perspective view of a leg having an insert according to the present invention. [Figure 20] FIG. 20 is a perspective view of a laparoscopic trainer according to the present invention, including an access device, an insert, and a tube with an artificial tumor. [Figure 21] FIG. 21 is a perspective view of a laparoscopic trainer angled forward in accordance with the present invention. [Figure 22] FIG. 22 is a perspective view of a laparoscopic trainer angled rearward in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] Hand access devices, single-port devices, and retrieval devices similar to the embodiments disclosed herein are disclosed in U.S. Patent No. 7,473,221, U.S. Patent No. 6,958,037, U.S. Patent No. 7,650,887, Published U.S. Patent Application No. 2009-0187079, and Published U.S. Patent Application No. 2010-0094227, the entire disclosures of which are hereby incorporated by reference.

[0012] Figure 1 shows one embodiment of the disclosed portable pelvic / laparoscopic surgery trainer. The trainer includes a torso-shaped upper cover 1. Cover 1 is connected to a lower plate or base 2 by a folding hinge 3. A monitor 4 is attached to upper cover 1 and can be folded onto upper cover 1 for transport or storage in a low-profile orientation.

[0013] As shown in FIG. 1 , one embodiment of the insert 5 fits into an opening in the top cover 1. In this embodiment, the insert 5 has multiple fixed holes 6. These holes optionally function as trocar or surgical instrument insertion sites. The insert 5 also has one large opening 7 through which a hand access device, single-site device, or tissue simulation area can be inserted. The insert 5 is formed of a material with sufficient strength and rigidity to provide mechanical support for the hand access device or single-site device during use. One preferred material is hard plastic, which provides sufficient rigidity and strength yet is lightweight, making the trainer unit easy to transport. In another embodiment, the holes 6 and openings 7 are formed directly in the top cover 1.

[0014] 2, another embodiment of the top cover 8 has openings 9 adapted to receive other embodiments of the insert, such as a foam pad that simulates skin or several layers of skin and tissue. In another embodiment, the insert may include multiple layers of foam or other suitable material, preferably color-coded to simulate various layers of the abdominal wall.

[0015] An abdominal wall-simulating pad or insert 5 is shown schematically in FIG. 3. This embodiment of insert 5 uses multiple layers of foam or foam-like material to simulate the appearance, feel, and density of the various layers of the abdominal wall. For example, the skin-simulating top layer 10 may be formed from a pink, beige, tan, brown, or black material. One suitable material is beige / tan, orange, or pink foam sheet, Creative Hands (CREATIVE HANDS is a registered trademark), available in 2 mm thick sheets.

[0016] A second layer 11 may be added to the pad to simulate the subcutaneous fat layer. One suitable material for this layer is 1 inch thick seat cushion foam, available at many stores that sell fabrics and textiles. Alternatively, two to three approximately 1 / 8 inch thick sheets of closed-cell fill material, available as padded wrap at many hardware stores, may be used.

[0017] A third layer 12 is added to the pad, consisting of one or more sheets that simulate the muscle layer of the abdominal wall. One suitable material for this layer is Red Foamie Creative Hands (Red Foamie CREATIVE HANDS is a registered trademark), preferably two to three sheets stacked on top of each other. Preferably, two to three layers of simulated muscle are used in the pad.

[0018] One or more fourth layers of pseudofascia 13 are disposed between the pseudomuscle layers 12. One suitable material for the pseudofascia is a thin dish pack available at many stationery and hardware stores.

[0019] The fifth layer 14, which simulates the preperitoneal fat layer, may also be formed from two or three sheets of closed-cell foam material.

[0020] As described herein, simulated abdominal wall inserters may be used to train operators in the proper technique for inserting trocars. Specifically, optical trocars can be used to visualize the process of insertion into the skin and protrusion into the abdominal cavity. Using a camera or endoscope focused on the tip of the trocar, the user can track the progress of the trocar's insertion through the various layers of the simulated abdominal wall on the trainer's display monitor.

[0021] FIG. 4 shows a close-up view of another embodiment of an inserter 5 having a large circular opening 16 adapted to accept a hand access device or a single-site device. To use a hand access device in a non-clinical training environment, the inserter needs to be stable and rigid, and when a trainee comes into contact with edge 17 during use, edge 17 feels unnatural to the trainee. Similarly, using a single-site device with simulated tissue can feel stiff and unnatural to the trainee when edge 17 comes into contact with a laparoscopic tool during use in a training environment. To provide a more natural feel, FIG. 5A shows a retractor 18 positioned inside opening 16 of inserter 5, i.e., directly within opening 7 of trainer top cover 1. Retractor 18 includes an annular ring 19 that provides a relatively soft, more natural-feeling edge 20. Similarly, FIG. 5B shows a retractor 21 with a relatively small diameter annular ring 22 that provides a relatively soft, more natural-feeling edge 23. In one embodiment, the annular rings 19, 22 are made of silicone, although one skilled in the art will appreciate that other materials may be used that simulate the texture and density of an incision site, particularly one protected by a retractor. Retractors 18 with larger openings are particularly useful for use with hand-access devices, while retractors 21 with smaller openings are particularly useful for use with single-site devices. A single-site device is an access portal inserted through a single incision made at the patient's navel through which endoscopes and other surgical hand instruments are inserted to perform modern minimally invasive laparoscopic-endoscopic surgery.

[0022] Figure 6 shows the single-site device 24 secured to the inserter retractor 21 of Figure 5B. An endoscope and working tools, such as graspers or scissors, are inserted into the trainer cavity through trocar ports 25, 26, 27. As the user manipulates the endoscopic camera and hand tools within the trocar ports 25, 26, 27, the tools and / or camera contact the edge 23 of the retractor 21. While this feels more natural, the underside surface or large opening 7 of the inserter 5 still provides sufficient rigidity to provide mechanical support for the single-site device 24 or hand access device during use.

[0023] 7 is a schematic diagram of a laparoscope that is part of the laparoscopic trainer disclosed in this invention. The laparoscope includes a camera 28 mounted at the distal end of a shaft 29. The shaft 29 is connected to a handle 30. Power is provided to the camera 28 and a video signal is supplied through a cable 31. The cable terminates in a plug 32 that connects to a computer, video display, and power source. The plug 32 is connected directly to the trainer, where it connects to a power source and a monitor display. The power source may be external or internal to the trainer.

[0024] As shown in FIG. 8, the distal end of the camera shaft 33 houses a CMOS or CCD-based camera 34. This camera incorporates a lens system with a focal depth ranging from 4 inches to infinity, with a typical focal depth for trainers being approximately 4 inches to 6 inches. The scope tip 35 also incorporates light-emitting diodes (LEDs) for powerful illumination during typical use. A scope, such as an endoscope or laparoscope, can be inserted through the optical trocar, which has a transparent distal end for viewing the insertion of the optical trocar through the simulated tissue of the trainer, where all ambient light is blocked. In such cases, the illumination at the scope tip provided by the LEDs aids in viewing the surgical procedure. In addition to illumination, the camera's focal depth must be reduced to approximately 5 mm to 10 mm, preferably approximately 7 mm, to allow viewing of the optical trocar insertion procedure. This is the typical distance between the tip of the scope and the tip of the obturator when the scope is inserted into an optical trocar. In one embodiment of the present invention, the focal length of the camera is changed by adding a lens assembly tip or cap 36, 36' to the end of the scope. The lens assembly tips 36, 36' for the cameras 34, 34' are shown in Figures 9A and 9B, respectively. In these figures, lenses 38, 38' are attached to tubes 37, 37'. These tubes are connected to scope shafts 40, 40' via connecting pins 39, 39'. In one embodiment, the lens assembly tips 36, 36' are attached to the scope shaft 40 by threads and a snap-fit ​​engagement to prevent the lens assemblies from coming off when the scope is retracted from the obturator after insertion through the simulated skin. It should be noted that while Figures 9A and 9B show lens assembly tips 36, 36' external to scope shaft 40, in another embodiment, lens assembly tips 36, 36' are located entirely within scope shaft 40. In yet another embodiment, lenses 42, 42' are attached to the ends of thin sleeves 41, 41' that fit over scope shafts 43, 43', and the focal length of the camera is changed by pulling the sleeve over the shaft, as shown in Figures 10A and 10B, respectively.

[0025] Those skilled in the art will appreciate that in either of the two embodiments described above, the trainer scope / camera can be quickly and easily converted from use as a single-site device to use as a hand-access device. For monitoring insertion through the simulated abdominal wall, the working focal length for use with an optical trocar is approximately 4 inches to 6 inches. By either snapping or threading the tip onto the end of the scope, or by sliding a sleeve over the shaft of the scope, the working focal length is approximately 5 mm to 10 mm.

[0026] 11 illustrates yet another embodiment of the present invention, in which the distal end of the shaft housing the camera 34 and / or LEDs can be connected to the remainder of the scope shaft 40 via a flexible connector 44 to provide variable angles at the distal end of the scope. In another embodiment, the distal end of the scope is fixed at an angle of approximately 30° to 45° relative to the proximal end of the shaft 40, and in another embodiment, the distal end of the shaft is not angled relative to the proximal end of the shaft 40, but the optics within the shaft 40 are configured to provide a fixed or variable angle field of view.

[0027] 12 and 13, a surgical trainer 50 according to the present invention is shown. The endoscopic trainer 50 includes an upper cover 52 connected to a base 54 by multiple legs 56. The laparoscopic trainer 50 is configured to resemble a patient's torso, such as the abdominal region. The upper cover 52 represents the front of the patient, and the space between the upper cover 52 and the base 54 represents the patient's interior, i.e., the body cavity containing the organs. The trainer 50 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and the instruments associated with these procedures on a simulated patient. Surgical instruments are inserted into the body cavity through pre-formed holes in the upper cover 52. Various tools and techniques are used to penetrate the upper cover 52 and perform simulated procedures on model organs positioned between the upper cover 52 and the base 54. The base 54 includes a tray (not shown) for holding simulated or live tissue. The tray is placed in a tray-receiving portion 60 of the base 54. The tray receiving portion 60 of the base 54 includes a frame-like element to hold the tray in place. A clip attached to a retractable wire is provided at location 61 to help hold the simulated or live tissue on the base.

[0028] A video display monitor 62, hinged to the top cover 52, is shown in a closed orientation in FIGS. 12 and 13 and in an open orientation in FIGS. 1, 21, and 22. The video monitor 62 can be connected to a variety of visual systems for transmitting images to the monitor. For example, an endoscope inserted through one of the pre-drilled holes or a webcam placed within a body cavity and used to observe the simulated procedure can be connected to the video monitor 62 and / or a mobile computer to provide images to the user. Additionally, audio recording or transmission means may be provided on or integrated with the trainer 50 to provide audio and visual capabilities. Additionally, means are provided for connecting a portable memory storage device, such as a flash drive, smartphone, digital audio or video player, or other digital mobile device, for recording training procedures and / or playing previously recorded videos on the monitor for demonstration purposes. Of course, connection means are also provided for providing audio-visual output to a larger screen rather than a monitor. In another embodiment, the top cover 52 does not include a video display, but rather is provided with means for supporting a laptop computer, mobile digital device, or tablet such as an iPad (IPAD is a registered trademark) and connecting it to the trainer via wire or wirelessly.

[0029] When assembled, the top cover 52 is positioned substantially around the periphery of the top cover 52 and base 54, and is positioned directly above the base 54 with legs 56 interconnecting them. The top cover 52 and base 54 are substantially the same shape and size and have substantially the same peripheral contours. Although the trainer 50 has no side walls, the legs 56 partially obscure the interior cavity, and the other sides of the trainer 50 are open. In the embodiment shown in FIG. 12, the legs have openings that allow ambient light to maximize illumination of the interior cavity. Furthermore, these openings advantageously minimize weight for ease of portability. The top cover 52 is detachable from the legs 56, which are either detachable or foldable relative to the base 54, such as by hinges. Thus, the unassembled trainer 50 has a low profile, which facilitates portability.

[0030] 12 and 13, the top cover 52 includes a first insert 64. The first insert 64 is removable and replaceable with respect to the top cover 52, specifically, insertable into and removable from openings formed in the top cover 52. The first insert 64 is provided with a number of holes 66 that serve as fixed insertion ports for various instruments. Various seals are provided in the holes 66. The first insert 64 further includes a tissue simulation region 68 to simulate several layers of skin or tissue.

[0031] In one embodiment, the tissue simulation area 68 is formed as a second insert 70 disposed within the first insert 64. The second insert 70 is removable and replaceable with respect to the top cover 52, or with respect to the first insert 64, if provided, by snap-fit, friction-fit, threaded engagement, or other means. In the embodiment shown in FIGS. 12 and 13, the second insert 70 is removable and replaceable with respect to the first insert 64. Of course, one or more second inserts 70 or tissue simulation areas 68 may be disposed in the first insert 64 or anywhere directly in the top cover 52, with or without the use of a first insert 64. The tissue simulation area 68 is coupled to the top cover 52 and is removable and replaceable.

[0032] 14-16, one embodiment of the second insert 70 is shown. The second insert 70 is generally cylindrical and has a circular cross-section; however, any shape may be used so that the second insert 70 is insertable and removable from a complementary opening in the top cover 52 or first insert 64. The second insert 70 includes an upper ring or portion 72 threadedly connected to a lower ring or portion 74, thereby enclosing insert material 76 between the upper and lower portions and providing the tissue simulation area 68 for the user. The upper ring 72 includes an upper surface 78 and an outer threaded sidewall 80. The upper surface 78 extends inward to form an upper ridge surrounding the opening. The upper surface 78 also extends outward to form a lip for mounting on the first insert 64 or top cover 52. In one embodiment, the upper ridge includes at least one downwardly extending protrusion or spur (not shown) that bites into the insert material 76 and helps hold it in place. The lower ring 74 includes a bottom surface 82 and an internally threaded sidewall 84. The bottom surface 82 extends inward to form a lower ridge that surrounds the opening. The lower ridge, together with the upper ridge, holds the layer of pseudo-tissue within the insert 70. In one embodiment, the lower ridge includes at least one upwardly extending protrusion or spur (not shown) that bites into the insert material 76 and helps hold it in place. In another embodiment, the insert 70 includes a support ring 86 sized to fit inside the ring structure. The upper and lower rings 72 and 74 are connected by a threaded engagement, capturing the insert material 76 and support ring 86, if used, within the ring structure between the upper and lower ridges. The upper and lower rings 72, 74 can also be connected by other means, such as snap-fit ​​and interference-fit engagements. A portion of the insert material 76 inside the upper ridge remains exposed and accessible from above, and a portion of the insert material 76 inside the lower ridge is exposed and accessible and visible from below. The exposed portion is suitable for penetration of various instruments, such as trocars or scalpels, into tissue. The second insert 70 can be inserted into a complementary shaped hole in the upper cover 52 and, alternatively, fixedly but removably connects the first insert 64 thereto.The insert material 70 simulates a penetrable tissue layer through which instruments can be passed to access a body cavity and perform various surgical procedures on a simulated organ placed in the simulated body cavity and substantially hidden from view by the top cover 52.

[0033] With particular attention to Figures 16A and 16B, the insert material 76 is selected to resemble the appearance and feel of the portion of the human body to be penetrated. Various numbers of layers of various consistencies, compositions, and colors are selected to best resemble the various areas of the human body for which the insert is to be formed. In another embodiment, the insert material 76 may be selected to mimic an access device that provides a penetrable gel or silicone layer through which an instrument can be passed. As shown in Figures 14, 15, and 16, multiple layers can be used to simulate the various areas of the human body to be penetrated. For example, multiple layers are shown in Figure 16A to mimic abdominal tissue. The first layer 88 is a skin layer, the second layer 90 is a layer simulating subcutaneous fat, the third layer 92 is a fascia layer, the fourth layer 94 is a muscle layer, the fifth layer 96 is another fascia layer, the sixth layer 98 is a preperitoneal fat layer, and the seventh layer 100 is a layer simulating peritoneum. The various layers have various thicknesses, compositions, and colors that generally approximate actual abdominal tissue. Additionally, an eighth layer 102 made of ethyl vinyl acetate (EVA) is included. In this embodiment, all layers are made of EVA foam except for the fat layer, made of yellow cellulose sponge, and the peritoneum layer, made of transparent polyolefin. When supported by the EVA eighth layer 102, the polyolefin visually and tactilely resembles actual peritoneum when penetrated with an optical obturator and viewed with an endoscope placed within the optical obturator. In contrast, the cellulose sponge advantageously exhibits an irregular appearance representative of actual human fat.

[0034] Referring to FIG. 16B, in another embodiment simulating abdominal tissue, the insert material 76 includes multiple layers stacked on top of each other. A first layer 88 is the top layer simulating the skin layer. The first layer 88 is made of brown-colored EVA foam. A second layer 90 is a layer simulating the subcutaneous fat layer and is made of yellow cellulose sponge. A third layer 92 represents the fascia layer and is made of white EVA foam. A fourth layer 94 represents the muscle layer and is made of red EVA foam. The third layer 92 is adjacent to the fourth layer 94. A fifth layer 96 is a support layer made of pink translucent foam and is made of closed-cell polyethylene foam. A sixth layer 98 is another muscle layer and is made of red EVA foam. A translucent pink closed-cell polyethylene foam layer is adjacent to the red EVA foam layer. A seventh layer 100 is another layer simulating the fascia layer and is made of white EVA foam. The eighth layer 102 represents the peritoneum layer and is made of translucent, white, closed-cell polyethylene foam. The ninth layer 103 is made of white EVA foam. The white EVA foam layer is adjacent to a translucent, white, closed-cell polyethylene foam layer. The closed-cell polyethylene foam used as the support layer 96 between the two muscle layers in the insert material 76 advantageously provides a realistic tactile response when the surgeon penetrates using an obturator. Because endoscopic surgery is performed based on endoscopic visualization of the surgical field, where the image is obscured by tissue, blood, fluid, and condensation, surgical trainees learn to develop a keen tactile sense when handling specific body tissues or inserting surgical instruments. The insert material of the present invention provides an effective method for teaching surgeons to develop tactile sensitivity. Similarly, the eighth layer 102, which simulates the peritoneum, is also made of closed-cell polyethylene foam. This advantageously provides the surgical trainee with realistic tactile feedback upon penetrating the peritoneum. Because the eighth layer 102 is closer to the bottom of the insert, the tactile response is more pronounced than that produced by a polyethylene layer such as the fifth layer 96, which is buffered or surrounded by many layers on either side that dampen the tactile response.

[0035] The support ring 86 is an optional feature that provides support for the insert material 76 and prevents it from being extruded through the opening in the lower ring 74 as instruments are inserted. The support ring 86 also provides a degree of compression to the insert material 76 when inserted into the ring structure, simulating the resiliency of actual tissue. The support rings 86 are interchangeable, and different support rings 86 of different thicknesses may be substituted to simulate different regions of the body to be penetrated. For example, a thinner insert material 76 representing a thinner tissue layer would require a thicker support ring 86 to be inserted into the ring structure. Thus, advantageously, the overall thickness of the second insert 70 is kept constant, but the thickness of the insert material and support ring may be varied as needed to simulate desired tissue characteristics. The support ring 86 provides a thickness control layer for insert materials 76 of various thicknesses. The multiple layers of insert material 76 are joined by adhesive or other means, such as one or more plastic price tag holders 105, as shown in Figure 16B. These means are typically I-shaped and pass through all the layers, holding them together. In another embodiment, the multiple layers of insert material 76 are captured in a heat-shrinkable plastic sleeve that is open at the top and bottom.

[0036] The user can select the appropriate insert material 76 and associated support ring 86 for the body part to be penetrated. The support ring 86 is first inserted into the lower ring 74, and then the insert material 76 is placed onto the support ring 86, either piece by piece or as a single mass with all layers connected together by one or more price tag holders 105, as shown in FIG. 16B. The upper ring 72 is then connected to the lower ring, capturing the insert material and support ring 86 therebetween. A second insert 70 is then placed into a corresponding hole in the upper cover 52 of the trainer 50 and connected by threading, snap-fitting, compression fit, or other means known to those skilled in the art. The user can then demonstrate, practice, or teach various surgical procedures using various instruments to penetrate the insert material 76, and the penetration and surgical procedures are viewed via a camera and / or scope on a video image display on the video monitor 62. After penetrating the insert material 76 multiple times with the same or different instruments, the user removes the second insert 70 from the upper cover 52, unscrews the upper ring 72 from the lower ring 74, removes and discards the insert material 76, and places a new insert material 76 into the ring structure for another demonstration or further practice. The user can carry multiple insert layers 76 with various combinations of constituent layers and reconfigure the second insert 70 as desired, without having to reconfigure a larger insert or send the insert 70 to the manufacturer for reconfiguration. Of course, in an alternative embodiment, the second insert 70 may be eliminated entirely, and the first insert 64 may be formed in exactly the same manner as the second insert 70 described above to provide a larger simulated tissue area.

[0037] Returning to Figure 12, this shows the top cover supported above the base by five legs. In one embodiment, six legs are provided, as shown in Figures 17-20. The trainer 50 may be assembled with an optional sixth support structure or leg 106 configured to simulate transanal endoscopic microsurgery (TEMS). TEMS is also known as transanal minimally invasive surgery (TAMIS).

[0038] The TEMS or TAMIS leg 106 includes a flat plate 108 with an inner surface facing the interior of the exerciser and an outer surface facing outward toward the user. The plate 108 has a hole 110 extending from the inner surface to the outer surface. As shown in FIGS. 18 and 19 , the plate 108 further includes a means, such as a tab 112 or a U-shaped channel 114, for inserting and connecting the TEMS or TAMIS leg 106 to the top cover 52 and base 54 to help support and space the top cover 52. The TEMS or TAMIS leg 106 is provided with a sphincter insert 116 that simulates an anus. The sphincter insert 116 includes a hole 118 that can be inserted into the hole 110 in the leg 106 and is coaxial with the hole 110 in the plate. In another embodiment, the insert 116 is glued to or formed over the leg 106 so that the insert 116 faces substantially outward toward the user. A tube 120 is coupled to the inner surface of the leg 106 such that the inner surface of the tube 120 communicates with the bore 110 in the leg 106 and, if a sphincter insert 116 is used, the lumen of the tube 120 communicates with the bore 118 in the sphincter insert 116. In another embodiment, a connector (not shown) is attached to the inner surface of the leg 106. The connector is a cylindrically shaped extension with a radially extending distal flange. The connector is configured to attach the tube 120 to the connector by pulling the tube 120 over the distal flange and over the connector, which has a connector diameter larger than the diameter of the tube in its relaxed state. This holds the tube 120 secured to the leg 106. Tube 120 may be suspended from the underside of top cover 52, to which a string clip 122 is attached, as shown in FIG. 20. Tube 120 may be formed from inanimate tissue, such as a calf's colon. In another embodiment, tube 120 is designed to resemble an intestine or colon and is made of silicone. Additionally, an artificial tumor 124, shown in FIG. 20, is disposed within tube 120. This allows the user to practice locating and removing these tumors. In one embodiment, artificial tumor 124 is darker in color than the tube and is disposed within the lumen of the tube.An access device 126 may be provided on the exterior surface of the plate 108. The access device is inserted into the sphincter insert 116 and into the hole 110, as shown in FIG. 20 . The access device 126 seals the proximal opening of the tube 120 at the leg 106, forming an insufflation port 128. The insufflation port 128 is a port for delivering insufflation fluid into the tube 120, expanding the tube 120 and creating a working space within the tube 120 for simulating an actual TEMS / TAMIS surgical procedure. If insufflation is used, the tube 120 is provided with a sealed distal end to contain the insufflation gas. Insufflation simulation, where the tube 120 is formed to resemble a pre-inflated colon, can be used without pressurization or gas. Such a tube 120 has a relatively large, inflated configuration, as if insufflated. The leg 106 advantageously provides a lateral approach to the body cavity of the trainer 50 for additional surgical procedures requiring a lateral or anal approach. The attachment of the legs 106 and associated tubing is particularly useful for users practicing closing the incision in the tubing 120 with sutures laterally, either through the top cover 52 or through the legs 106. Silicone tubing does not tear as easily as other materials when closing the incision in the tubing with sutures, providing an ideal training environment and training tool. Lighting devices, such as LEDs (not shown), are attached to the underside of the top cover 52 to illuminate the body cavity. The trainer 50 is suitable for simulating, but not limited to, the practice or demonstration of laparoscopic surgical procedures, including gynecological and urological surgical procedures, but can also be used for other surgical procedures requiring a lateral approach, including orthopedic applications.

[0039] 21 and 22, another embodiment of the trainer 50 is shown having an upper cover 52 angled relative to the base 54. This embodiment includes two legs 130, 132 that connect and space the upper cover 52 and the base 54. These two legs 130, 132 are configured to allow adjustment of the angle of the upper cover 52 relative to the base 54. Tilting the trainer advantageously simulates a patient in Trendelenburg or reverse Trendelenburg position. In Trendelenburg, the patient is tilted so that they lie on their back with their feet higher than their head. The Trendelenburg position allows for better access to the pelvic organs because gravity pulls the intestines away from the pelvis, preventing intestinal encroachment in the pelvic surgical field and providing a larger working space within the abdominal cavity where the surgeon can more easily manipulate the organs. The trainer can be tilted approximately 0° ±60°. The selected angle is locked by tightening the thumbscrews on the legs 130, 132. The tray for holding simulated tissue or living tissue within the simulated abdominal cavity can be independently angled relative to the base, or can be connected to the top cover 52 so that tilting the top cover 52 simultaneously tilts the tissue tray. While FIGS. 21 and 22 show only the top cover 52 angled relative to the base 54, in other embodiments, the entire trainer 50 is angled relative to the platform top. Such trainer 50 is provided with tilting means, such as one or more jack screws or other height adjustment mechanisms known to those skilled in the art. Jack screws, for example, can be provided at each corner of the base 54 and are adjustable to custom tilt the entire trainer 50 relative to the platform top. Although Figures 21 and 22 show trainer 50 tilting forward and backward, trainer 50 may also be configured to be tiltable to the side.

[0040] While the particular embodiment has been shown and described in detail with reference to exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as set forth in the appended claims. [Explanation of symbols]

[0041] 1 Top cover 2. Bass 3 Folding Hinge 4 monitors 5 Insert 6 fixing holes 7 Openings

Claims

1. In a surgical training device, With the base, a top cover connected to the base by at least one leg and spaced apart from the base to define a substantially open-sided interior cavity therebetween; a first insert coupled to the top cover; the first insert includes an upper portion removably connected to a lower portion to form an encasement having an opening in the upper portion and an opening in the lower portion; the first insert further comprising a removable insert material simulating human tissue disposed between the upper and lower portions of the first insert to provide a penetrable tissue simulation region for accessing the internal cavity.

2. 10. The surgical training device of claim 1, the top cover includes a first opening configured to receive a second insert; the second insert is removably inserted into the first opening and removably connected to the top cover; the second insert includes a second opening configured to receive the first insert, and the first insert is inserted into the second opening and coupled to the second insert.

3. 3. The surgical training device of claim 2, The second inserter includes at least one insertion port having a seal.

4. 10. The surgical training device of claim 1, The surgical training device, wherein the insert material comprises multiple layers.

5. 5. The surgical training device of claim 4, A surgical training device, wherein at least one of the layers is formed from a cellulose sponge.

6. 5. The surgical training device of claim 4, A surgical training device, wherein the insert is configured such that at least one layer of the insert material provides a tactile response upon penetration.

7. 7. The surgical training device of claim 6, 1. A surgical training device, wherein at least one layer of the insert material that provides a tactile response upon penetration is formed from closed-cell polyethylene foam.

8. 5. The surgical training device of claim 4, A surgical training device, wherein the insert material comprises a layer of translucent pink closed-cell polyethylene foam adjacent to a layer of red EVA foam.

9. 10. The surgical training device of claim 1, The first insert includes a removable support ring disposed between the upper and lower portions.

10. 10. The surgical training device of claim 1, A surgical training device, wherein the top cover is angled relative to the base.

11. 10. The surgical training device of claim 1, A surgical training device, wherein the surgical training device is configured to be at an angle with respect to a table top on which the device is placed.

12. In a surgical training device, With the base, an upper cover coupled to and spaced apart from the base to define an interior cavity therebetween; at least one leg interconnecting and separating the upper cover and the base, the leg having a hole facing the interior cavity; a tube having a proximal end and a distal end, the proximal end interconnected with the bore such that the bore provides an access port to a lumen of the tube, the distal end of the tube extending into the internal cavity.

13. 13. The surgical training device of claim 12, further comprising: an insert having an opening and connected to the leg; A surgical training device, wherein the opening of the insert communicates with the lumen of the tube and is configured to provide a real tissue-like interface.

14. 14. The surgical training device of claim 13, A surgical training device, wherein the insert is substantially annular in shape and the opening in the insert is circular.

15. 13. The surgical training device of claim 12, The tube includes an artificial tumor attached to the tube.

16. 13. The surgical training device of claim 12, A surgical training device wherein the tube is adapted for insufflation, the distal end of the tube is closed and the proximal end of the tube is sealed to prevent leakage of insufflation fluid.

17. 17. The surgical training device of claim 16, A surgical training device, wherein the proximal end of the tube is sealed with a removable access device having an insufflation port for delivering an insufflation fluid into the tube.

18. 13. The surgical training device of claim 12, A surgical training device that inflates the tube to simulate an insufflated colon.

19. 13. The surgical training device of claim 12, The at least one leg is disposed around a periphery of both the top cover and the base.

20. 13. The surgical training device of claim 12, The tube is suspended from the top cover.

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