Portable laparoscopic training device

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.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application No. 61 / 389,141, entitled "Portable Pelvic Trainer," filed on October 1, 2010, and U.S. Provisional Patent Application No. 61 / 476,657, entitled "Portable Laparoscopic Trainer," filed on April 18, 2011. By expressly indicating the source, all the contents disclosed in these applications are incorporated as part of the disclosure of this specification.

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

Background Art

[0003] Mock injury pelvic trainers have attracted interest in the field of laparoscopy. This is because these trainers provide a functional, inexpensive, and practical means for training surgeons and residents in the basic skills and representative techniques such as grasping, manipulating, cutting, and ligating used in laparoscopic surgery, as well as the methods of performing special surgical techniques such as colectomy and cholecystectomy that utilize these basic skills.

[0004] It will be understood that both basic laparoscopic surgical skills and the practice of surgical techniques can be carried out in a non-surgical setting. It has been shown that the use of simulation trainers can significantly enhance the skill level of new laparoscopic surgeons. These trainers are excellent tools for training future surgeons in a non-surgical setting. There is a need for improved, practical, and effective surgical training devices.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

[0006] As a whole, the present invention provides a modular pelvic simulation trainer that accepts various insertion modules to facilitate the training of various minimally invasive surgical techniques. The surgical techniques include, for example, the insertion of trocars and the performance of minimally invasive procedures using trocars, manual access devices, and single-site port devices. [Means for Solving the Problems]

[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 that is connected to the base by at least one leg and spaced apart from the base, forming an internal cavity therebetween. The training device has a substantially open side and further includes a first insert connected to the upper cover. The upper portion of the first insert is removably connected to the lower portion, forming an encasement having an opening in the upper portion and an opening in the lower portion. The encasement houses a removable insert material that mimics human tissue. The insert material is disposed between the upper and lower portions of the first insert, forming a penetrable tissue simulation area 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 that is connected to the base and spaced from the base, the upper cover forming an internal cavity therebetween. At least one leg interconnects and spaces apart the upper cover and the base. At least one leg has a hole 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 with the hole such that the hole 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] According to another aspect of the present invention, a sleeve or endoscope tip is provided that, when connected to a camera, facilitates a rapid change in the depth of focus of the camera, and thus allows for the use of a single simple and cost-effective camera to focus within the trainer to monitor simulated laparoscopic surgical techniques, for example, to focus on the tip of an instrument monitoring the insertion of a trocar through a simulated abdominal wall. BRIEF DESCRIPTION OF THE DRAWINGS

[0010]

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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. By explicitly citing the sources, all the content disclosed in these documents is considered part of the disclosure of this specification.

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

[0013] As shown in FIG. 1, an embodiment of the insert 5 is fitted into the opening of the upper cover 1. In this embodiment, the insert 5 has a number of fixed holes 6. These holes, although optional, function as trocars or surgical instrument insertion sites. The insert 5 further has one large opening 7 into which a hand access device, a single-site device, or a tissue simulation area can be inserted. The insert 5 is formed of a material having sufficient strength and rigidity to provide mechanical support for the hand access device or single-site device during use. One preferred material is rigid plastic. This provides sufficient rigidity and strength but is lightweight, facilitating the carrying of the trainer unit. In another aspect, the holes 6 and the opening 7 are formed directly in the upper cover 1.

[0014] As shown in FIG. 2, another embodiment of the upper cover 8 has an opening 9 adapted to receive another embodiment of the insert, for example, a foam pad mimicking the skin or some layers of the skin and tissue. In another embodiment, the insert may include a number of layers made of foam or other suitable material, preferably color-coded to mimic the various layers of the abdominal wall.

[0015] A pad mimicking the abdominal wall or the insert 5 is schematically shown in FIG. 3. In this aspect of the insert 5, a number of layers made of foam or foam-like material are used to simulate the appearance, feel, and density of the various layers of the abdominal wall. For example, the upper layer 10 mimicking the skin may be formed of a pink material, a beige material, a tan material, a brown material, or a black material. One suitable material is a beige / tan, orange or pink foam sheet, Creative Hands (CREATIVE HANDS is a registered trademark), available as a 2 mm thick sheet.

[0016] A second layer 11 mimicking the subcutaneous fat layer may be added to the pad. One suitable material for this layer is a 2.54 cm (1 inch) thick sheet cushion foam available at many stores that sell fabrics. In another embodiment, two or three sheets approximately 3.18 mm (about 1 / 8 inch) thick made of closed-cell foam material, which can be obtained as a padded wrap at many hardware stores, may be used.

[0017] Add a third layer 12 made of one or more sheets mimicking the muscle layer of the abdominal wall to the pad. One suitable material for this layer is Red Foamie CREATIVE HANDS (Red Foamie CREATIVE HANDS is a registered trademark), preferably with two or three sheets stacked on top of each other. Preferably, use two or three layers of pseudo-muscle in the pad.

[0018] One or more fourth layers 13 of pseudo-fascia are arranged between the pseudo-muscle layers 12. One suitable material for the pseudo-fascia is a thin dish pack available at many stationery and hardware stores.

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

[0020] As described herein, an insertion body mimicking the abdominal wall may be used in training the operator on suitable techniques for inserting a trocar. Specifically, by using optical trocars, the insertion process into the skin and the protruding process into the abdominal cavity can be visualized. The user can use a camera or endoscope focused on the tip of the trocar to track the progress of the trocar insertion through the various layers of the pseudo-abdominal wall on the display monitor of the trainer.

[0021] Figure 4 shows an enlarged view of another embodiment of the insert 5 having a large circular opening 16 adapted to receive a hand access device or a single-site device. Since the hand access device is used in a non-clinical training environment, it is necessary for the insert to be stable and rigid, and when the trainee comes into contact with the edge 17 during use, the edge 17 is felt to be unnatural to the trainee. Similarly, when using a single-site device with a phantom tissue, when the edge 17 comes into contact with a laparoscopic tool during use in a training environment, it is felt to be hard and unnatural to the trainee. To provide a more natural feel, FIG. 5A shows a trocar 18 disposed inside the opening 16 of the insert 5, i.e., directly inside the opening 7 of the upper cover 1 of the trainer. The trocar 18 includes an annular ring 19 that provides a relatively soft and more natural-feeling edge 20. Similarly, FIG. 5B shows a trocar 21 having a relatively small-diameter annular ring 22 that provides a relatively soft and more natural-feeling edge 23. In one embodiment, the annular rings 19, 22 are made of silicone, but as will be understood by those skilled in the art, other materials may be used to simulate the tactile sensation and density of the incision site, particularly the incision site protected by the trocar. The trocar 18 with the large-diameter opening is particularly useful for use with a hand access device, while the trocar 21 with the small-diameter opening is particularly useful for use with a single-site device. A single-site device is an access port inserted into a single incision formed at the patient's umbilicus, through which an endoscope and other surgical hand tools are inserted to perform the latest minimally invasive laparoscopic-endoscopic surgery.

[0022] Figure 6 shows a single-site device 24 fixed to the insert trocar 21 of FIG. 5B. An endoscope and working tools such as a grasper (holder) and forceps are inserted into the cavity of the trainer through the trocar ports 25, 26, 27. When the user operates the endoscope camera and hand tools within the trocar ports 25, 26, 27, the tools and / or camera come into contact with the edge 23 of the trocar 21. This is felt to be more natural, but the lower surface of the insert 5 or the large opening 7 still provides sufficient rigidity to provide mechanical support for the single-site device 24 or the hand access device during use.

[0023] Figure 7 is a schematic view of a laparoscope, which is a part of the laparoscope trainer disclosed in the present invention. The laparoscope includes a camera 28 attached to 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 with a plug 32 that connects to a computer, a video display, and a power source. The plug 32 is directly connected to the trainer. Here, it is connected to the power source and the monitor display. The power source may be external or internal to the trainer.

[0024] As shown in FIG. 8, a camera 34 using a CMOS or a CCD is housed at the distal end of the camera shaft 33. This camera incorporates a lens system with a depth of field ranging from 10.16 cm (4 inches) to infinity. However, a typical depth of field for the trainer is from about 10.16 cm (4 inches) to 15.24 cm (6 inches). At the scope tip 35, light-emitting diodes (LEDs) are further incorporated for strong illumination during general use. A scope such as an endoscope or a laparoscope can be inserted into an optical trocar with a transparent distal end for viewing the insertion of the optical trocar through the phantom tissue of the trainer. Here, all ambient light is blocked. In such a case, the illumination of the scope tip formed by the LEDs helps to view the surgical procedure. In addition to the illumination, to be able to view the optical trocar insertion procedure, it is necessary to reduce the depth of field of the camera to about 5 mm to 10 mm, preferably to about 7 mm. This is a typical distance between the tip of the scope and the tip of the obturator when the scope is inserted into the optical trocar. In one aspect of the present invention, the focal length of the camera is changed by adding lens assembly chips or caps 36, 36' to the end of the scope. The lens assembly chips 36, 36' of the cameras 34, 34' are shown in FIGS. 9A and 9B respectively. In these figures, lenses 38, 38' are attached to tubes 37, 37'. These tubes are connected to the scope shafts 40, 40' via connecting pins 39, 39'. In one aspect, the lens assembly chips 36, 36' are attached to the scope shaft 40 by screw and snap-fit engagement so that the lens assembly does not come off when the scope is retracted from the obturator after insertion into the phantom skin. FIGS. 9A and 9B show the lens assembly chips 36, 36' outside the scope shaft 40. However, in another aspect, it should be noted that the lens assembly chips 36, 36' are entirely disposed within the scope shaft 40. In yet another aspect, as shown in FIGS. 10A and 10B respectively, lenses 42, 42' are attached to the ends of thin sleeves 41, 41' covering the scope shafts 43, 43', and the focal length of the camera is changed by pulling the sleeves on the shafts.

[0025] In any of the two embodiments described above, it will be understood by those skilled in the art that the trainer scope / camera can be quickly and easily changed from use with a single-site device to use with a hand-access device. For monitoring insertion through a simulated abdominal wall, the working focal length for use with an optical trocar is from about 10.16 cm (about 4 inches) to about 15.24 cm (about 6 inches). By either snapping or passing the chip onto the end of the scope, or by sliding a sleeve over the shaft of the scope, the working focal length is from about 5 mm to 10 mm.

[0026] FIG. 11 shows yet another embodiment of the present invention. In this embodiment, to vary the angle of the distal end of the scope, the distal end of the shaft housing the camera 34 and / or the LEDs can be connected to the remainder of the scope shaft 40 via a flexible connector 44. In another aspect, the distal end of the scope is fixed at an angle of about 30° to 45° with respect to the proximal end of the shaft 40, and in another aspect, the distal end of the shaft is not angled with respect to the proximal end of the shaft 40, but the optical system inside the shaft 40 is formed to provide a fixed or variable angle of view.

[0027] Next, referring to FIGS. 12 and 13, these figures show a surgical trainer 50 according to the present invention. The endoscopic trainer 50 includes an upper cover 52 connected to a base 54 by a plurality of legs 56. The laparoscopic trainer 50 has a form resembling 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 interior of the patient, i.e., the body cavity containing the organs. The trainer 50 is a useful tool for educating, practicing, and demonstrating various surgical procedures and the instruments associated with these procedures in a patient simulation. 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 mock procedures on the model organs disposed between the upper cover 52 and the base 54. The base 54 includes a tray (not shown) for holding the mock tissue or live tissue. The tray is disposed in a tray receiving portion 60 of the base 54. The tray receiving portion 60 of the base 54 includes a frame-like element for holding the tray in a predetermined location. To assist in holding the mock tissue or live tissue on the base, a clip attached to a retractable wire is provided at position 61.

[0028] The video display monitor 62 hinged to the upper 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 various visual systems for sending images to the monitor. For example, an endoscope inserted into one of the pre-formed holes or a web camera placed in the 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. Further, acoustic recording or sending means may be provided in and integrated with the trainer 50 to provide acoustic and visual functions. Further, 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 to record the training procedure and / or play back a previously recorded video on the monitor for demonstration purposes. Of course, connection means are provided for providing audio-visual output to a relatively large screen rather than a monitor. In another aspect, the upper cover 52 does not include a video display, and means are provided 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 either wired or wirelessly.

[0029] When assembled, the upper cover 52 is disposed substantially around the upper cover 52 and the base 54 and is positioned directly above the base 54 by legs 56 interconnecting them. The upper cover 52 and the base 54 are of substantially the same shape and size and have substantially the same peripheral contour. Although the trainer 50 has no side walls, the legs 56 partially conceal the internal cavity, and the other sides of the trainer 50 are open. In the embodiment shown in FIG. 12, the legs are provided with openings that can illuminate the internal cavity as much as possible by ambient light. Further, these openings advantageously reduce the weight as much as possible to facilitate carrying. The upper cover 52 is removable from the legs 56, and the legs 56 are either removable or can be folded with respect to the base 54 by means of hinges or the like. Thus, the trainer 50 in the unassembled state is low in height, which facilitates carrying.

[0030] Referring further to FIGS. 12 and 13, the upper cover 52 includes a first insert 64. The first insert 64 is removable and replaceable with respect to the upper cover 52 and, in particular, can be inserted into and removed from an opening formed in the upper cover 52. The first insert 64 is provided with a plurality of holes 66 that serve as fixed insertion ports for various instruments. Various seals are provided in these holes 66. The first insert 64 further includes a tissue simulation area 68 for mimicking some layers of skin or tissue.

[0031] In one embodiment, the tissue simulation region 68 is formed as a second insert 70 provided within the first insert 64. The second insert 70 is removable and replaceable with respect to the upper cover 52 or, if provided, with respect to the first insert 64 by snap fitting, friction fitting, or screwing, or other means. In the embodiments 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 regions 68 may be provided directly on the first insert 64 or at any location on the upper cover 52, with or without using the first insert 64. The tissue simulation region 68 is connected to the upper cover 52 and is removable and replaceable.

[0032] Next, referring to FIGS. 14 to 16, these figures show one aspect of the second insert 70. The second insert 70 is generally cylindrical and has a circular cross-section, but the second insert 70 may use any shape so that it can be inserted into and removed from the complementary-shaped opening of the upper cover 52 or the first insert 64. The second insert 70 includes an upper ring or upper portion 72 connected to a lower ring or lower portion 74 by screwing. Thereby, the insert material 76 is packed between these upper and lower portions, providing the user with the tissue simulation area 68. The upper ring 72 includes an upper surface 78 and a side wall 80 provided with threads on the outer surface. The upper surface 78 extends inward to form an upper pressing edge surrounding the opening. The upper surface 78 further extends outward to form a lip for resting on the first insert 64 or the upper cover 52. In one aspect, the upper pressing edge includes at least one protruding portion or spur (not shown) extending downward to assist in biting into the insert material 76 and holding it in place. The lower ring 82 extends inward to form a lower pressing edge surrounding the opening. This lower pressing edge, together with the upper pressing edge, holds the layer of pseudo-tissue within the insert 70. In one aspect, the lower pressing edge includes at least one protruding portion or spur (not shown) extending upward to assist in biting into the insert material 76 and holding it in place. In another aspect, the insert 70 includes a support ring 86 sized to fit inside the ring structure. The upper ring 72 and the lower ring 74 are connected by screwing, and when the insert material 76 and the support ring 86 are used, the support ring 86 is captured within the ring structure between the upper and lower pressing edges. The upper ring 72 and the lower ring 74 can further be connected by other means such as snap-fit engagement and interference fit engagement. A part of the insert material 76 inside the upper pressing edge remains exposed and can be accessed from above, and a part of the insert material 76 inside the lower pressing edge is exposed and can be accessed and viewed from below. The exposed portions are suitable for penetrating various instruments such as trocars and scalpels into the tissue. The second insert 70 can be inserted into the complementary-shaped hole of the upper cover 52, and in another aspect, the first insert 64 is fixedly but removably connected thereto.The insertion body material 70 mimics penetrable tissue layers, through which instruments can pass, providing access to body cavities and performing various surgical procedures on a pseudo-organ hidden substantially out of sight by the upper cover 52 and disposed in a pseudo-cavity.

[0033] Particularly referring to FIGS. 16A and 16B, the insertion body material 76 is selected to resemble in appearance and feel 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 regions of the human body where the insertion body is to be formed. In another aspect, the insertion body material 76 may be selected to mimic an access device that provides a penetrable gel layer or silicone layer through which an instrument can pass. As shown in FIGS. 14, 15, and 16, multiple layers can be used to simulate the various regions of the human body to be penetrated. For example, in FIG. 16A, multiple layers are shown to mimic abdominal tissue. The first layer 88 is the skin layer, the second layer 90 is a layer mimicking the subcutaneous fat layer, the third layer 92 represents the fascia layer, the fourth layer 94 represents the muscle layer, the fifth layer 96 represents another fascia layer, the sixth layer 98 represents the preperitoneal fat layer, and the seventh layer 100 is a layer mimicking the peritoneum. The various types of layers have various thicknesses, compositions, and colors generally close to actual abdominal tissue. Further, an eighth layer 102 formed of ethyl vinyl acetate (EVA) is included. In this aspect, all layers except the fat layer formed of yellow cellulose sponge and the peritoneum layer formed of transparent polyolefin are formed of EVA foam. When supported by the EVA-made eighth layer 102, the polyolefin penetrates the optical plug and becomes visually and tactilely similar to actual peritoneum when observed with an endoscope disposed within the optical plug. In contrast, the cellulose sponge advantageously exhibits an irregular appearance typical of actual human fat.

[0034] Referring to FIG. 16B, in another embodiment mimicking abdominal tissue, the insert material 76 includes a plurality of layers stacked on top of each other. The first layer 88 is the uppermost layer mimicking the skin layer. The first layer 88 is formed of brown-colored EVA foam. The second layer 90 is a layer mimicking the subcutaneous fat layer and is formed of yellow cellulose sponge. The third layer 92 represents the fascia layer and is formed of white EVA foam. The fourth layer 94 represents the muscle layer and is formed of red EVA foam. The third layer 92 is adjacent to the fourth layer 94. The fifth layer 96 is a support layer formed of pink translucent foam and is formed of closed-cell polyethylene foam. The sixth layer 98 is another muscle layer and is formed of red EVA foam. The translucent pink closed-cell polyethylene foam layer is adjacent to the red EVA foam layer. The seventh layer 100 is a layer mimicking another fascia layer and is formed of white EVA foam. The eighth layer 102 represents the peritoneal layer and is formed of translucent white closed-cell polyethylene foam. The ninth layer 103 is formed of white EVA foam. The white EVA foam layer is adjacent to the 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 penetrated by a surgeon using a trocar. Endoscopic surgery is performed based on viewing the surgical field with an endoscope in locations where the image is obscured by tissue, blood, fluid, and condensation. Therefore, a trainee surgeon learns to develop a sharp tactile sense when handling specific body tissues or inserting surgical instruments. The insert material of the present invention provides an effective method for teaching a surgeon to develop a tactile interval. Similarly, the eighth layer 102 mimicking the peritoneum is also formed of closed-cell polyethylene foam. This advantageously provides a trainee surgeon with a realistic tactile feedback when penetrating the peritoneum. Since the eighth layer 102 is close to the bottom of the insert, the tactile response is prominent compared to the tactile response generated by the polyethylene layers such as the fifth layer 96, which is buffered or surrounded by many layers on both sides that blunt the tactile response.

[0035] The support ring 86 is an optional means for providing support to the insert body material 76 and preventing the insert body material 76 from being pushed out through the opening of the lower ring 74 when the instrument is inserted. The support ring 86 further compresses the insert body material 76 to some extent when inserted into the ring structure, mimicking the resilience of actual tissue. The support rings 86 are interchangeable and may be replaced with another support ring 86 of a different thickness to mimic various regions of the body to be penetrated. For example, a relatively thin insert body material 76 representing a relatively thin tissue layer requires inserting a relatively thick support ring 86 into the ring structure. Thus, advantageously, while keeping the overall thickness of the second insert 70 constant, the thickness of the insert body material and the support ring may be varied as needed to mimic the desired tissue characteristics. The support rings 86 provide a thickness adjustment layer for insert body materials 76 of various thicknesses. A number of layers of the insert body material 76 are connected by an adhesive or by other means such as one or more plastic price tag holders 105 as shown in FIG. 16B. These means are typically in the shape of an "I" and pass through all the layers, holding these layers together. In another aspect, a number of layers of the insert body material 76 are captured in a heat-shrinkable plastic sleeve that is open at the top and bottom.

[0036] The user can select a suitable insert material 76 and associated support ring 86 for the body part to be penetrated. First, the support ring 86 is inserted into the lower ring 74, and then the insert material 76 is placed on the support ring 86, either one by one or as a single mass with all layers connected to each other by one or more price tag holders 105 as shown in FIG. 16B. Then the upper ring 72 is connected to the lower ring to capture the insert material and the support ring 86 therebetween. Next, the second insert 70 is placed in the corresponding hole in the upper cover 52 of the trainer 50 and connected by screwing, snap fitting, compression fitting, or other means well known to those skilled in the art. Then, the user performs demonstrations, practices, or teachings of various surgical procedures using various instruments to penetrate the insert material 76 and observes the penetration and surgical procedures on a video image display shown on the video monitor 62 via a camera and / or scope. After penetrating the insert material 76 several times with the same or different instruments, the user removes the second insert 70 from the upper cover 52, removes the upper ring 72 from its screwed state with the lower ring 74, removes the insert material 76 and discards it, and inserts new insert material 76 into the ring structure for another demonstration or further practice. The user can carry multiple insert layers 76 with variously combined constituent layers and reconfigure the second insert 70 as desired. This does not require reconfiguring a relatively large insert or sending the insert 70 to the manufacturer for reconfiguration. Of course, in another aspect, the entire second insert 70 can be eliminated and the first insert 64 can be formed in exactly the same manner as the manufacturing method of the second insert 70 described above to provide a relatively large simulated tissue area.

[0037] Returning to FIG. 12, this figure shows an upper cover supported above the base by five legs. In one aspect, as shown in FIGS. 17 through 20, six legs are provided. The trainer 50 may be assembled with an optional sixth support structure, namely leg 106, formed to perform a simulation of transanal endoscopic microsurgery (TEMS). TEMS is also known as transanal minimally invasive surgery (TAMIS).

[0038] The TEMS leg or TAMIS leg 106 includes a flat plate 108 with an inner surface facing the interior of the trainer and an outer surface facing outward toward the user. The plate 108 has holes 110 that penetrate from the inner surface to the outer surface. As shown in FIGS. 18 and 19, the plate 108 further includes means such as tabs 112 or U-shaped channels 114 for inserting and connecting the TEMS leg or TAMIS leg 106 into the upper cover 52 and the base 54 to assist in supporting and spacing the upper cover 52. An anal sphincter insert 116 is provided on the TEMS leg or TAMIS leg 106. The sphincter insert 116 can be inserted into the hole 110 of the leg 106 and includes a hole 118 coaxial with the hole 110 of the plate. In another aspect, the insert 116 is adhered to the leg 106 or formed by covering the leg 106 such that the insert 116 faces substantially outward toward the user. A tube 120 is connected to the inner surface of the leg 106. This is done such that the inner surface of the tube 120 communicates with the hole 110 of the leg 106 and, when using the sphincter insert 116, the lumen of the tube 120 is connected such that the lumen of the tube 120 communicates with the hole 118 of the sphincter insert 116. In another aspect, a connector (not shown) is attached to the inner surface of the leg 106. The connector is a cylindrical extension having a radially extending distal flange. The connector is formed to attach the tube 120 to the connector by pulling the tube 120 on the distal flange and on the connector having a connector diameter larger than the diameter of the relaxed tube. Thereby, the state where the tube 120 is fixed to the leg 106 is maintained. The tube 120 may be suspended from the lower surface of the upper cover 52 to which a stringed clip 122 is connected as shown in FIG. 20. The tube 120 may be formed of non-living tissue such as the colon of a calf. In another aspect, the tube 120 is designed to mimic the intestine or colon and is made of silicone. Further, an artificial tumor 124 shown in FIG. 20 is disposed on the tube 120. Thereby, the user can practice detecting and removing the positions of these tumors. In one aspect, the 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 outer surface of the plate 108. As shown in FIG. 20, the access device is inserted into the sphincter insert 116 and into the hole 110. The access device 126 seals the proximal opening of the tube 120 at the leg 106 and forms a gas injection port 128. The gas injection port 128 is a port for delivering a gas injection fluid into the tube 120, expanding the tube 120, and forming a working space within the tube 120 for simulating the actual TEMS / TAMIS surgical procedure. When gas injection is used, a tube 120 with a sealed distal end is provided to contain the gas injection gas. A simulation of gas injection where the tube 120 is formed to mimic a pre-expanded colon can be used without the use of pressurization or gas. Such a tube 120 is in a relatively large inflated form as if gas had been injected. The leg 106 advantageously provides a lateral approach of the trainer 50 to the body cavity for yet another surgical procedure that requires a lateral approach, i.e., an anal approach. The attachment of the leg 106 and the associated tube is particularly useful for a user who practices closing the incision of the tube 120 transversely with sutures through the upper cover 52 or through the leg 106. A silicone tube does not tear as easily as other materials when closing the incision of the tube with sutures and provides an ideal practice environment and practice means. For illuminating the body cavity, a lighting device such as LEDs (not shown) is attached to the lower surface of the upper cover 52. The trainer 50 is suitable for simulations not limited to laparoscopic surgical procedures including gynecological and urological surgical procedures, but can also be used for other surgical procedures including orthopedic applications that require a lateral approach.

[0039] Next, referring to FIGS. 21 and 22, these figures show another aspect of the trainer 50 having an upper cover 52 that forms an angle with respect to the base 54. This aspect includes two legs 130, 132 that connect and separate the upper cover 52 and the base 54. These two legs 130, 132 are formed so as to be able to adjust the angle of the upper cover 52 with respect to the base 54. By tilting the trainer, advantageously, it simulates a patient in the Trendelenburg position or the reverse Trendelenburg position. In the Trendelenburg position, the body is tilted so that the back is down and the feet are higher than the head and lies horizontally. The Trendelenburg position allows good access to the pelvic organs. This is because gravity pulls the intestine away from the pelvis, thereby preventing encroachment of the intestine in the pelvic surgical field and providing a relatively large working space in the abdominal cavity for the surgeon to operate on the organs relatively easily. The degree of tilt of the trainer is about 0° ± 60°. The selected angle is locked by tightening the wing nuts provided on the legs 130, 132. The tray for holding the pseudo-tissue or biological tissue in the pseudo-abdominal cavity is formed to be angled independently with respect to the base, or is connected to the upper cover 52 so that the tissue tray is tilted simultaneously by tilting the upper cover 52. FIGS. 21 and 22 show that only the upper cover 52 forms an angle with respect to the base 54, but in another aspect, the entire trainer 50 forms an angle with respect to the top plate of the table. Such a trainer 50 is provided with tilting means such as one or more jack screws or other height adjustment mechanisms well known to those skilled in the art. The jack screws are provided, for example, at each corner of the base 54 and are adjustable to tilt the entire trainer 50 as desired with respect to the top plate of the table. FIGS. 21 and 22 show that the trainer 50 is tilted forward and backward, but the trainer 50 may be formed to be tiltable laterally.

[0040] Although specific embodiments have been shown and described in detail with reference to the exemplary embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the invention as set forth in the appended claims.

Explanation of Symbols

[0041] 1 Upper cover 2 Base 3 Foldable hinge 4 Monitor 5 Insertion body 6 Fixing hole 7 Opening

Claims

1. 1. A surgical training device comprising: With the base, a top cover coupled to the base, the top cover spaced from the base to define an interior cavity between the top cover and the base, the top cover having a first opening; a first insert removably inserted into the first opening and removably coupled to the top cover, the first insert having a second opening; and a second insert removably inserted into the second opening and removably coupled to the first insert, the second insert including a removable insert material simulating human tissue having a penetrable tissue simulation region for accessing the internal cavity; The top cover is configured to change angle with respect to the base. Surgical training devices.

2. A surgical training device, comprising: With the base, a top cover coupled to the base, the top cover spaced from the base to define an interior cavity between the top cover and the base, the top cover having a first opening; a first insert removably inserted into the first opening and removably coupled to the top cover, the first insert having a second opening; and a second insert removably inserted into the second opening and removably coupled to the first insert, the second insert including a removable insert material simulating human tissue having a penetrable tissue simulation region for accessing the internal cavity; The surgical training device is configured to change angle relative to a tabletop on which it is placed. Surgical training devices.

3. 3. The surgical training device of claim 1 or 2, wherein the first insert further comprises a plurality of fixed insertion ports for various instruments, the plurality of fixed insertion ports being disposed about the second opening.

4. The surgical training device of claim 3 , wherein each of the plurality of fixed insertion ports includes a seal.

5. The surgical training device of claim 3 or 4, wherein the second opening of the first insert is larger than any one of the plurality of fixed insertion ports.

6. The surgical training device of claim 1 , wherein the removable insert material is comprised of multiple layers configured to simulate an abdominal wall.

7. The surgical training device of claim 6, wherein the simulated abdominal wall provides visual feedback and tactile response for practicing a first entry technique.

8. 6. The surgical training device of claim 1, wherein the removable insert material is made of multiple layers, at least one of the layers being formed from a cellulose sponge.

9. 6. The surgical training device of claim 1, wherein the removable insert material comprises multiple layers, at least one layer configured to provide a tactile response upon penetration.

10. 10. The surgical training device of claim 9, wherein the at least one layer is formed from closed cell polyethylene foam.

11. 6. The surgical training device of claim 1, wherein the removable insert material comprises a plurality of layers, at least a first layer being formed from ethyl vinyl acetate foam and a second layer being formed from cellulose sponge.

12. The surgical training device of claim 11 , wherein the removable insert material further comprises a third layer formed of closed cell polyethylene foam.

13. 13. The surgical training device of claim 12, further comprising a fourth layer of ethyl vinyl acetate foam, wherein the third layer of closed cell polyethylene foam is located between the first layer and the fourth layer, and the second layer is located above the first layer.

14. 14. The surgical training device of claim 1, wherein the internal cavity is a height-adjustable substantially open-sided cavity, the internal cavity being partially obstructed from direct observation by a user.

15. 15. The surgical training device of claim 1, further comprising one or more simulated or live tissue structures disposed on a base within the internal cavity or in a tray located within a tray-receiving portion of the base.

16. The surgical training device of claim 2 , wherein the top cover is configured to change angle relative to the base.

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