Patent Description:
Simulated wound pelvic trainers are gaining interest in the field of laparoscopy as they provide a functional, inexpensive and practical means to train surgeons and residents the basic skills and typical techniques used in laparoscopic surgery such as grasping, manipulating, cutting and tying knots as well as how to perform specific surgical procedures such as colectomies and cholecysectomies that utilize these basic skills. Trainers are also effective sales tools for demonstrating medical devices.

It can be appreciated that both the basic laparoscopic skills, as well as surgical procedures themselves, can be practiced in a non-surgical setting. It has been demonstrated that the use of simulation trainers greatly enhances the skill levels of new laparoscopists, and are a great tool to train future surgeons in a non-surgical setting. There is a need for improved, realistic and effective surgical trainers.

The present invention relates to a surgical training device as defined in the sole independent claim <NUM>.

The present invention generally relates to a modular pelvic simulation trainer that may accommodate different insert modules to facilitate training on a wide variety of minimally invasive surgical procedures, including, for example, the insertion of trocars, performing minimally invasive procedures through trocars, hand-assisted access devices, and single-site port devices. More specifically, the invention provides a surgical training device as recited in Claim <NUM>.

Example of known surgical training device are disclosed in European patent application, publication number <CIT> and US patent application, publication number <CIT>. Hand-access devices, single-port devices and retraction devices similar to embodiments disclosed herein are also disclosed in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

<FIG> shows a portable pelvic/laparoscopic trainer, comprising a torso-shaped top cover <NUM>, which is connected to a bottom plate or base <NUM> through collapsible hinges <NUM>. A monitor <NUM> is attached to the top cover <NUM> and can be folded against the top cover <NUM> for portability or storage in a low-profile orientation.

Also shown in <FIG> is one example of an insert <NUM> that fits into an opening in the top cover <NUM>. In thisexample, the insert <NUM> has multiple, fixed apertures <NUM>, which optionally function as trocar or surgical instrument insertion sites, as well as one large opening <NUM>, into which a hand-access device, single-site device or tissue simulation region may be inserted. The insert <NUM> is formed from a material having sufficient strength and rigidity to provide mechanical support for the hand access or single-site device during use. One preferred material is a hard plastic, which provides sufficient rigidity and strength, but which is light weight for easy portability of the trainer unit. In another variation, the apertures <NUM> and opening <NUM> are formed directly in the top cover <NUM>.

As shown in <FIG>, another example of the top cover <NUM> has an opening <NUM> adapted to accept other example of inserts, for example, a foam pad to simulate the skin or several layers of skin and tissue. In another example, the insert may contain multiple layers of foam or other suitable material, preferably color-coded to simulate the various layers of the abdominal wall.

A schematic of a pad or insert <NUM> simulating the abdominal wall is shown in <FIG>. In this variation of the insert <NUM>, multiple layers of foam or foam-like material are used to simulate the appearance, texture and density of the various layers of the abdominal walls. For example, a top layer <NUM> simulating the skin may be fashioned from a pink, beige, tan, brown or black material. One suitable material is the beige/tan, orange or pink foam sheets by CREATIVE HANDS®, available in <NUM> thickness sheets.

A second layer <NUM> may be added to the pad, simulating a subcutaneous fat layer. One suitable material for this layer is seat cushion foam, available at most fabric stores in one-inch thick sheets. Alternatively, two to three sheets of closed cell packing material, available as padded wrap from most hardware stores in approximately <NUM>/<NUM>-inch thick sheets, may be used.

A third layer <NUM> of one or more sheets is added to the pad to simulate the muscle layers of the abdominal wall. One suitable material for this layer is Red Foamie CREATIVE HANDS® Foam, preferably two to three sheets stacked together. Preferably, two to three layers of simulated muscle as used in the pad.

A fourth layer or layers <NUM> of simulated fascia may be disposed between the simulated muscle layers <NUM>. One suitable material for the simulated fascia is thin dish pack, available at most office supply or hardware stores.

A fifth layer <NUM>, simulating the pre-peritoneal fat layer, may also be fashioned from two to three sheets of closed cell packing material.

As described herein, an insert simulating an abdominal wall can be used to train operators on the proper technique for inserting a trocar. In particular, the use of optical trocars allows the visualization of the insertion process into the skin, and protrusion into the abdominal cavity. Using a camera or endoscope adapted to focus on the tip of the trocar, users can track the progress of the trocar insertion through the various layers of the simulated abdominal wall on the display monitor of the trainer.

<FIG> shows a close-up view of another variation of an insert <NUM> having a large circular opening <NUM> adapted to accept a hand-access device or single-site device. Since the use of a hand-access device in a non-clinical training environment requires the insert to be stable and rigid, the edge <NUM> will feel un-natural to the trainee when it is contacted by the trainee during use. Similarly, the use of a single-site device on simulated tissue will feel rigid and un-natural to the trainee when the edge <NUM> is touched with laparoscopic tools during use in a training environment. To provide a more natural feel, <FIG> illustrates a retractor <NUM> placed inside the opening <NUM> of an insert <NUM> or directly into an opening <NUM> of the top cover <NUM> of the trainer. The retractor <NUM> includes an annular ring <NUM> that provides a softer, more natural-feeling edge <NUM>. Similarly, <FIG> illustrates a retractor <NUM> that has a smaller diameter annular ring <NUM> to provide a softer, more natural-feeling edge <NUM>. In one variation, the annular ring <NUM>, <NUM> is formed from silicone, but as the skilled practitioner will note, other materials that simulate the tactile feel and density of a wound incision site, particularly one protected by a wound retractor, can be used. The retractor <NUM> with a larger diameter opening is particularly useful with a hand-access device, while the retractor <NUM> with a smaller diameter opening is particularly useful with a single-site device. A single-site device is an access portal inserted into a single incision in the patient typically made at the navel through which an endoscope and other surgical hand instruments are inserted to perform advanced, minimally invasive laparo-endoscopic surgery.

<FIG> shows a single-site device <NUM> that is secured to the insert retractor <NUM> of <FIG>. An endoscope and working tools such as graspers, scissors, etc. are inserted through the trocar ports <NUM>, <NUM>, <NUM> to enter the trainer cavity. As the user manipulates the endoscope camera and hand tools within the confines of the trocar ports <NUM>, <NUM>, <NUM>, the tools and/or camera may contact the edge <NUM> of the retractor <NUM> which will now feel more natural, while the underlying surface of the insert <NUM> or large opening <NUM> will still provide sufficient rigidity to provide mechanical support for the single-site device <NUM> or hand-access device during use.

<FIG> shows a schematic drawing of a laparoscope that may be used with a surgical training device in accordance with the present invention. The laparoscope comprises a camera <NUM> that is mounted at the distal end of a shaft <NUM>, which connects to a handle <NUM>. The camera <NUM> is powered, and the video signal is fed through cable <NUM>, which terminates in a plug <NUM> for connection to a computer, video display, and power source. Plug <NUM> connects to the directly to the trainer, where it connects to electrical power and a monitor display. The electrical power source may be external or internal to the trainer.

As shown in <FIG>, the distal end of the camera shaft <NUM> houses a CMOS or CCD-based camera <NUM> which incorporates a lens system to provide for a focal depth of <NUM> (<NUM>-inches) to infinity, although the typical working focal depth for the trainer is approximately <NUM> to <NUM>,<NUM> (four to six inches). The scope tip <NUM> also incorporates light emitting diodes (LEDs) to enhance illumination during general use. The scope is insertable into optical trocars having a transparent distal end for viewing the insertion of the optical trocar through simulated tissue of the trainer where all ambient light is blocked. In such a case, the illumination at the tip of the scope provided by the LEDs is helpful for viewing the procedure. In addition to illumination, the visualization of the optical trocar insertion procedure also requires that the focal depth of the camera is reduced to about <NUM> to <NUM>, preferably about <NUM>, which is the typical distance between the tip of the scope and the tip of the obturator when the scope is inserted inside the optical trocar. In one variation, the change in the focal length of the camera is achieved by adding a lens assembly tip or cap <NUM>, <NUM>' to the end of the scope. The lens assembly tip <NUM>, <NUM>' of the camera <NUM>, <NUM>' is shown in <FIG>, respectively, where a lens <NUM>, <NUM>' is mounted to a tube <NUM>, <NUM>' that connects via connecting pins <NUM>, <NUM>' to the scope shaft <NUM>, <NUM>'. In one variation, the lens assembly tip <NUM>, <NUM>' is attached to the scope shaft <NUM> by screw threads or a snap-fit engagement so that the lens assembly does not detach when the scope is retracted from the obturator after insertion into the simulated skin. It should be noted that while <FIG> show the lens assembly tip <NUM>, <NUM>' as external to the scope shaft <NUM> the lens assembly tip <NUM>, <NUM>' is disposed entirely within the scope shaft <NUM> in another variation. In yet another variation, the change in the focal length of the camera is achieved by mounting a lens <NUM>, <NUM>' to the end of a thin sleeve <NUM>, <NUM>' that is pulled over the scope shaft <NUM>, <NUM>', as shown in <FIG>, respectively.

In either of the two examples described above, it will be appreciated by one of skill in the art that the trainer scope/camera can quickly and easily be converted from use with a single-site or hand-access device, wherein the operative focal depth is approximately <NUM> to <NUM> inches, to use with an optical trocar to monitor insertion through a simulated abdominal wall, wherein the operative focal depth is approximately of <NUM> to <NUM>, by either snapping or threading a tip onto the end of the scope or by sliding a sleeve over the shaft of the scope.

<FIG> shows yet another example, wherein the distal end of the shaft housing the camera <NUM> and/or LEDs can be connected via a flexible connector <NUM> to the remainder of the scope shaft <NUM> for variable angulation of the distal end of the scope. In another variation, the distal end of the scope is fixed at an angle of approximately <NUM> or <NUM> degrees with respect to the proximal end of the shaft <NUM> and in another variation, the distal end of the shaft is not angled with respect to the proximal end of the shaft <NUM> but the optics internal to the shaft <NUM> are configured to provide a fixed or variable angled field of view.

Referring now to <FIG> and <FIG>, here an endoscopic trainer <NUM> includes a top cover <NUM> connected to a base <NUM> by a plurality of legs <NUM>. The laparoscopic trainer <NUM> is configured to mimic the torso of a patient such as the abdominal region. The top cover <NUM> is representative of the anterior surface of the patient and the space between the top cover <NUM> and the base <NUM> is representative of an interior of the patient or body cavity where organs reside. The trainer <NUM> is a useful tool for teaching, practicing and demonstrating various surgical procedures and their related instruments in simulation of a patient. Surgical instruments are inserted into the cavity through pre-established apertures in the top cover <NUM>. Various tools and techniques may be used to penetrate the top cover <NUM> to perform mock procedures on model organs placed between the top cover <NUM> and the base <NUM>. The base <NUM> includes a tray (not shown) for holding simulated or live tissue. The tray is placed in a tray-receiving portion <NUM> of the base <NUM>. The tray-receiving portion <NUM> of the base <NUM> includes framelike elements for holding the tray in place. To help retain simulated or live organs on the base, a clip attached to a retractable wire is provided at locations <NUM>.

A video display monitor <NUM> that is hinged to the top cover <NUM> is shown in a closed orientation in <FIG> and <FIG> and in an open orientation in <FIG>, <FIG>. The video monitor <NUM> is connectable to a variety of visual systems for delivering an image to the monitor. For example, an endoscope inserted through one of the pre-established apertures or a webcam located in the cavity and used to observe the simulated procedure can be connected to the video monitor <NUM> and/or a mobile computing device to provide an image to the user. Also, audio recording or delivery means may also be provided and integrated with the trainer <NUM> to provide audio and visual capabilities. Means for connecting a portable memory storage device such as a flash drive, smart phone, digital audio or video player, or other digital mobile device is also provided, to record training procedures and/or play back pre-recorded videos on the monitor for demonstration purposes. Of course, connection means for providing an audio visual output to a larger screen other than the monitor is provided. In another variation, the top cover <NUM> does not include a video display but includes means for supporting a laptop computer, a mobile digital device or tablet such as an IPAD® and connecting it by wire or wirelessly to the trainer.

When assembled, the top cover <NUM> is positioned directly above the base <NUM> with the legs <NUM> located substantially around the periphery and interconnected between the top cover <NUM> and base <NUM>. The top cover <NUM> and base <NUM> are substantially the same shape and size and have substantially the same peripheral outline. Although the trainer <NUM> has no sidewalls, the legs <NUM> partially obscure the internal cavity from view from an otherwise open-sided trainer <NUM>. In the variation shown in <FIG>, the legs include openings to allow ambient light to illuminate the internal cavity as much as possible and also to advantageously provide as much weight reduction as possible for convenient portability. The top cover <NUM> is removable from the legs <NUM> which in turn are removable or collapsible via hinges or the like with respect to the base <NUM>. Therefore, the unassembled trainer <NUM> has a reduced height that makes for easier portability.

Still referring to <FIG> and <FIG>, the top cover <NUM> includes a first insert <NUM> removable and replaceable with respect to the top cover <NUM>, in particular, insertable into and removable from an opening formed in the top cover <NUM>. The first insert <NUM> includes a plurality of apertures <NUM> to serve as fixed insertion ports for a variety of instruments. The apertures <NUM> may include various seals. The first insert <NUM> also includes a tissue simulation region <NUM> for simulating the skin or several layers of tissue.

In one embodiment, the tissue simulation region <NUM> is configured as a second insert <NUM> provided within the first insert <NUM>. The second insert <NUM> is removable and replaceable via snap-fit, friction fit or threaded engagement or other means with respect to the top cover <NUM> or with respect to the first insert <NUM> if provided. In the embodiment shown in <FIG> and <FIG>, the second insert <NUM> is removable and replaceable with respect to the first insert <NUM>. Of course, one or more second inserts <NUM> or tissue simulation regions <NUM> may be provided in the first insert <NUM> or directly in any location of the top cover <NUM> with or without the use of a first insert <NUM>. The tissue simulation regions <NUM> are connected to the top cover <NUM> and are removable and replaceable.

Referring now to <FIG>, there is shown one variation of the second insert <NUM>. The second insert <NUM> is generally cylindrical with a circular cross-section although any shape may be used such that the second insert <NUM> is insertable and removable with respect to a complementarily shaped opening in the top cover <NUM> or in the first insert <NUM>. The second insert <NUM> includes a top ring or top portion <NUM> threadingly connected to a bottom ring or bottom portion <NUM> forming an encasement with insert material <NUM> located there between providing a tissue simulation region <NUM> for the user. The top ring <NUM> includes a top surface <NUM> and a sidewall <NUM> with a threaded outer surface. The top surface <NUM> extends inwardly to create an upper ledge encompassing an opening. The top surface <NUM> also extends outwardly to create a lip for resting on the first insert <NUM> or top cover <NUM>. In one variation, the upper ledge includes at least one downwardly extending projection or spur (not shown) configured to dig into and grip the insert material <NUM> to help retain it in position. The bottom ring <NUM> includes a bottom surface <NUM> and sidewall <NUM> with a threaded inner surface. The bottom surface <NUM> extends inwardly to create a lower ledge encompassing an opening to retain, along with the upper ledge, the layers of simulated tissue inside the insert <NUM>. In one variation, the lower ledge includes at least one upwardly extending projection or spur (not shown) configured to dig into and grip the insert material <NUM> and help retain it in position. In another variation, the insert <NUM> includes a support ring <NUM> sized to fit inside the ring structure. The top ring <NUM> and bottom ring <NUM> are connected via threads to capture the insert material <NUM> and support ring <NUM>, if used, inside the ring structure between the upper and lower ledges. The top ring <NUM> and bottom ring <NUM> are also connectable via other means such as by snap-fit and interference fit engagement. A portion of the insert material <NUM> interior of the upper ledge remains exposed and accessible from the top and a portion of the insert material <NUM> interior of the lower ledge is exposed and accessible and visible from the bottom. The exposed portions are suitable for practicing penetration of tissue with various instruments such as trocars, scalpels and the like. The second insert <NUM> is insertable into a complementary shaped aperture in the top cover <NUM> or, in an alternative variation, the first insert <NUM> and is securely but removably connected thereto. The insert material <NUM> simulates a penetrable tissue layer through which instruments may be passed to access the body cavity to practice various procedures on simulated organs and the like located in the simulated body cavity and substantially hidden from view by the top cover <NUM>.

With particular attention to <FIG>, the insert material <NUM> is selected to simulate the look and feel of that portion of the human body to be penetrated. A different number of layers having different consistencies, compositions and colors are selected to best simulate the different areas of the human body for which the insert is configured. Alternatively, the insert material <NUM> may be selected to simulate an access device that provides a penetrable gel or silicone layer through which instruments may be passed. As shown in <FIG>, multiple layers can be employed to simulate different areas of the human body to be penetrated. For example, in <FIG>, multiple layers are shown to simulate abdominal tissue. The first layer <NUM> is a skin layer, a second layer <NUM> simulates a subcutaneous fat layer, a third layer <NUM> represents a fascia layer, a fourth layer <NUM> represents a muscle layer, a fifth layer <NUM> represents another fascia layer, a sixth layer <NUM> represents a pre-peritoneal fat layer, and a seventh layer <NUM> simulates the peritoneum. The different types of layers have different thicknesses, compositions and colors to closely approximate real abdominal tissue layers. An eighth layer <NUM> made of ethyl vinyl acetate (EVA) is also included. In this variation, all of the layers are EVA foam layers except for the fat layers which are made of yellow cellulose sponge and the peritoneum layer which is made of clear polyolefin. When backed by the eighth layer <NUM> of EVA, the polyolefin layer visually and tactilely resembles a real peritoneum while being penetrated by an optical obturator and observed via an endoscope disposed inside the optical obturator whereas the cellulose sponge advantageously provides an irregular look typical of real human fat.

With reference to <FIG>, in another variation that simulates abdominal tissue, the insert material <NUM> comprises a plurality of layers stacked upon each other in which the first layer <NUM> from the top simulates a skin layer. The first layer <NUM> is made of tan colored EVA foam. The second layer <NUM> simulates a subcutaneous fat layer and is made of yellow cellulose sponge. The third layer <NUM> represents a fascia layer and is made of white EVA foam. The fourth layer <NUM> represents a muscle layer and is made of red EVA foam. The third layer <NUM> is adjacent to the fourth layer <NUM>. A fifth layer <NUM> is a support layer made of translucent foam that is pink in color and made from closed cell polyethylene foam. A sixth layer <NUM> is another muscle layer and is made of red EVA foam. The translucent pink closed cell polyethylene foam layer is adjacent to the red EVA foam layer. The seventh layer <NUM> simulates another fascia layer and is made of white EVA foam. The eighth layer <NUM> represents a peritoneum layer and is made of translucent white closed cell polyethylene foam. The ninth layer <NUM> is another support layer to visually and tactilely resemble the peritoneum. The ninth layer <NUM> is made 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 employed in the insert material <NUM> as a support layer <NUM> between two muscle layers <NUM>, <NUM> advantageously provides a realistic haptic response when penetrated by the surgeon using an obturator. The closed cell polyethylene foam layer provides a tactile pop when penetrated. Because endoscopic surgery relies on the visualization of the operative field via an endoscope where the image may be obscured by tissue, blood, fluids and moisture condensation, the surgeon trainee learns to develop a keen haptic sense when certain bodily tissues are handled or penetrated with surgical instruments. The insert material provides an effective way for teaching the surgeon to develop that haptic sense. Similarly, the eighth layer <NUM> that simulates the peritoneum is also made of closed cell polyethylene foam that advantageously provides a realistic haptic feedback to the surgeon trainee that the peritoneum has been penetrated. Because the eighth layer <NUM> is closer to the bottom of the insert the haptic response is more pronounced compared to the haptic response generated by the polyethylene layer, such as the fifth layer <NUM>, that is cushioned or surrounded by more layers on either side which muffle the haptic response.

The support ring <NUM> is an optional means to provide support for the insert material <NUM> and serves to prevent the insert material <NUM> from being pushed through the opening in bottom ring <NUM> when an instrument is being inserted. The support ring <NUM> also provides a degree of compression to the insert material <NUM> when inserted into the ring structure to simulate the resiliency of real tissue. A support ring <NUM> is interchangeable and may be substituted with another support ring <NUM> of different thickness as required to simulate different areas of the body to be penetrated. For example, a thinner insert material <NUM> representing a thinner tissue layer may necessitate a thicker support ring <NUM> inserted into the ring structure. Hence, the overall thickness of the second insert is advantageously kept constant whereas the thicknesses of the insert material and support ring may vary as required to simulate the desired tissue characteristics. The support ring <NUM> provides a thickness adjustment layer for insert material <NUM> of different thicknesses. The multiple layers of the insert material <NUM> are connected with glue or other means such as by one or more plastic price tag holders <NUM> as shown in <FIG> that are typically I-shaped and passed through all of the layers to keep them together. In another variation, the multiple layers of insert material <NUM> are captured in a heat shrink plastic sleeve having an open top and bottom.

A user may select an appropriate insert material <NUM> and associated support ring <NUM> for the part of the body to be penetrated. The support ring <NUM> is first inserted into the bottom ring <NUM>, then, the insert material <NUM> is placed on top of the support ring <NUM> either layer-by-layer or as a single biscuit having all the layers connected together with, for example, one or more price tag holders <NUM> as shown in <FIG>. The top ring <NUM> is then connected to the bottom ring to capture the insert material <NUM> and support ring <NUM> there between. The second insert <NUM> can then be disposed in a corresponding aperture in the top cover <NUM> of the trainer <NUM> and connected thereto by threaded, snap-fit, compression-fit or other means known to one having ordinary skill in the art. A user may then demonstrate, practice or teach various procedures using various instruments penetrating the insert material <NUM> and observing the penetration and procedures via the camera/scope with video images displayed on the video monitor <NUM>. After multiple penetrations of the insert material <NUM> with the same or different instruments, the user may then remove the second insert <NUM> from the top cover <NUM>, unscrew the top ring <NUM> from the bottom ring <NUM>, remove and discard the insert material <NUM> and insert a new insert material <NUM> into the ring structure for another demonstration or more practice. The user may carry multiple insert layers <NUM> of different combinations of constituting layers and reconstruct the second insert <NUM> as desired without necessitating reconstruction of a larger insert or having to send the insert <NUM> to the manufacturer to be reconstructed. Of course, in another variation, the entire second insert <NUM> may be avoided and the first insert <NUM> fashioned in the same manner as the second insert <NUM> just described to provide for a larger simulated tissue region.

Referring back to <FIG>, there is shown a top cover supported above the base by five legs. In one variation, a sixth leg is provided as shown in <FIG>. The trainer <NUM> may be assembled with an optional sixth support structure or leg <NUM> which is configured for simulating transanal endoscopic micro-surgery (TEMS) also known as transanal minimally invasive surgery (TAMIS).

The TEMS or TAMIS leg <NUM> includes a flat plate <NUM> having an inner surface for facing toward the interior of the trainer and an outer surface for facing outwardly towards the user. The plate <NUM> has an aperture <NUM> passing through the plate <NUM> from the inner surface to the outer surface. As shown in <FIG> and <FIG>, the plate <NUM> also includes means such as tabs <NUM> or a U-shaped channel <NUM> for inserting to connect the TEMS or TAMIS leg <NUM> to the top cover <NUM> and to the base <NUM> to help support and space apart the top cover <NUM>. The TEMS or TAMIS leg <NUM> is provided with a sphincter insert <NUM> to simulate an anus. The sphincter insert <NUM> is typically made of silicone to provide a realistic tissue-like interface. The sphincter insert <NUM> is insertable into the aperture <NUM> of the leg <NUM> and includes an aperture <NUM> coaxial with the plate aperture <NUM>. In another variation, the insert <NUM> is glued or over molded to the leg <NUM> such that the insert <NUM> substantially faces outwardly toward the user. On the inner surface of the leg <NUM>, a tube <NUM> is connected such that the lumen of the tube <NUM> is in communication with the aperture <NUM> of the leg <NUM> and if a sphincter insert <NUM> is utilized, the lumen of the tube <NUM> is connected such that it is in communication with the aperture <NUM> in the sphincter insert <NUM>. In another variation, a connector (not shown) is attached to the inner surface of the leg <NUM>. The connector is a cylindrically-shaped extension having a radially-extending distal flange. The connector is configured for attaching the tube <NUM> to the connector by pulling the tube <NUM> over the distal flange and over the connector which has a connector diameter larger than a relaxed tube diameter to keep the tube <NUM> secured to the leg <NUM>. The tube <NUM> may be suspended from the under surface of the top cover <NUM> with tethered clips <NUM> connected to the under surface of the top cover <NUM> as shown in <FIG>. The tube <NUM> may be made of inanimate tissue such as a calf colon. Alternatively, the tube <NUM> is designed to simulate a bowel, intestine or colon and is made of silicone. Artificial tumors <NUM> illustrated in <FIG> are also disposed on the tube <NUM> so that the user may practice locating and removing them. In one variation, the artificial tumors <NUM> are darker in color than tube and located inside the tube lumen. At the outer surface of the plate <NUM>, an access device <NUM> may be provided and inserted into the sphincter insert <NUM> and into the aperture <NUM> as shown in <FIG>. The access device <NUM> seals the proximal opening of the tube <NUM> at the leg <NUM> and provides an insufflation port <NUM> for delivering insufflation fluid into the tube <NUM> to expand the tube <NUM> and create a working space inside the tube <NUM> to simulate an actual TEMS/TAMIS procedure. If insufflation is employed, a tube <NUM> with a sealed distal end is provided to contain the insufflation gasses. Simulated insufflation in which a tube <NUM> is configured to simulate an already inflated colon may be employed without the use of pressurization or gas. Such a tube <NUM> is configured to be larger and distended as if it were insufflated with gas. The leg <NUM> advantageously provides a lateral approach to the body cavity of the trainer <NUM> for yet another range of procedures that require a lateral or anal approach. The leg <NUM> and accompanying tube attachment is particularly useful for users to practice closing incisions in the tube <NUM> with sutures performed through the top cover <NUM> or laterally through the leg <NUM>. A silicone tube does not tear as easily as other materials when closing an incision therein with sutures and provides an ideal practicing environment and medium. Lighting such as LEDs (not shown) attached to the under surface of the top cover <NUM> is provided to illuminate the body cavity. The trainer <NUM> is suitable for simulations that are not limited to practicing or demonstrating laparoscopic procedures including gynecological and urological procedures but may also be employed for other surgical procedures requiring a lateral approach including orthopedic applications.

Turning now to <FIG>, here there is disclosed a surgical training device <NUM> in accordance with the present invention, having a top cover <NUM> that angulates with respect to the base <NUM>. This training device <NUM> includes two legs <NUM>, <NUM> that connect and separate the top cover <NUM> and the base <NUM>. The legs <NUM>, <NUM> are configured to permit the angle of the top cover <NUM> with respect to the base <NUM> to be adjusted. The angulation of the trainer advantageously simulates a patient in a Trendelenburg or reverse Trendelenburg position. In the Trendelenbury position the body is tilted such that it is laid flat on the back with the feet higher than the head or vice versa. The Trendelenburg position allows better access to the pelvic organs as gravity pulls the intestines away from the pelvis to thereby prevent encroachment of the intestines upon the pelvic operating field to provide more working space inside the abdominal cavity in which the surgeon can more easily manipulate organs. The degree of tilt of the trainer is approximately <NUM> to ± <NUM> degrees. The selected angulation is locked by tightening thumbscrews provided on the legs <NUM>, <NUM>. A tray for holding simulated or live tissue inside the simulated cavity is configured to angulate independently with respect to the base as well or connected to the top cover <NUM> such that angulation of the top cover <NUM> simultaneously angulates the tissue tray. While <FIG> show only the top cover <NUM> angulating with respect to the base <NUM>, another variation provides for angulation of the entire trainer <NUM> with respect to a table top. Such trainer <NUM> is provided with tilting means such as one or more jack screws or other height adjustment mechanisms known to a person skilled in the art. The jack screws, for example, are provided in each corner of the base <NUM> and are adjustable for custom angulation of the entire trainer <NUM> with respect to a table top. Although <FIG> depict the trainer <NUM> angulating forwardly and backwardly, the trainer <NUM> may also be configured to angulate side to side.

Claim 1:
A surgical training device (<NUM>) comprising:
a base (<NUM>); and
a top cover (<NUM>) connected to and spaced apart from the base (<NUM>) by at least one leg (<NUM>, <NUM>) to define an internal cavity between the top cover and the base, the top cover (<NUM>) having an opening and an insert (<NUM>) sized and configured to be removably fitted into the opening of the top cover and connected thereto; characterised in that the at least one leg (<NUM>, <NUM>) is configured to allow angulation of the top cover with respect to the base,
wherein an angle between respective planes of the top cover and the base is selectably adjustable so as to simulate a patient in a Trendelenburg position or a reverse Trendelenburg position, the selectable angle between the top cover and the base being adjustable within a range of <NUM> ° to <NUM> °.