Patent Description:
Medical students as well as experienced doctors learning new surgical techniques must undergo extensive training before they are qualified to perform surgery on human patients. The training must teach proper techniques employing various medical devices for cutting, penetrating, clamping, grasping, stapling, cauterizing and suturing a variety of tissue types. The range of possibilities that a trainee may encounter is great. For example, different organs and patient anatomies and diseases are presented. The thickness and consistency of the various tissue layers will also vary from one part of the body to the next and from one patient to another. Different procedures demand different skills. Furthermore, the trainee must practice techniques in various anatomical environs that are influenced by factors such as the size and condition of the patient, the adjacent anatomical landscape and the types of targeted tissues and whether they are readily accessible or relatively inaccessible.

Numerous teaching aids, trainers, simulators and model organs are available for one or more aspects of surgical training. However, there is a need for models or simulated tissue elements that are likely to be encountered in and that can be used for practicing endoscopic and laparoscopic, minimally invasive, transluminal surgical procedures. In laparoscopic surgery, a trocar or cannula is inserted to access a body cavity and to create a channel for the insertion of a camera such as a laparoscope. The camera provides a live video feed capturing images that are then displayed to the surgeon on one or more monitors. At least one additional small incision is made through which another trocar/cannula is inserted to create a pathway through which surgical instruments can be passed for performing procedures observed on the video monitor. The targeted tissue location such as the abdomen is typically enlarged by delivering carbon dioxide gas to insufflate the body cavity and create a working space large enough to accommodate the scope and instruments used by the surgeon. The insufflation pressure in the tissue cavity is maintained by using specialized trocars. Laparoscopic surgery offers a number of advantages when compared with an open procedure. These advantages include reduced pain, reduced blood and shorter recovery times due to smaller incisions.

Laparoscopic or endoscopic minimally invasive surgery requires an increased level of skill compared to open surgery because the target tissue is not directly observed by the clinician. The target tissue is observed on monitors displaying a portion of the surgical site that is accessed through a small opening. Therefore, clinicians need to practice visually determining tissue planes, three-dimensional depth perception on a two-dimensional viewing screen, hand-to-hand transfer of instruments, suturing, precision cutting and tissue and instrument manipulation. Typically, models simulating a particular anatomy or procedure are placed in a simulated pelvic trainer where the anatomical model is obscured from direct visualization by the practitioner. Ports in the trainer are employed for passing instruments to practice techniques on the anatomical model hidden from direct visualization. Simulated pelvic trainers 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, tying knots, suturing, stapling, cauterizing as well as how to perform specific surgical procedures that utilized these basic skills.

Organ models for use with simulated pelvic trainers on which surgeons can train surgical techniques are needed. These organ models need to be realistic so that the surgeon can properly learn the techniques and improve their skills. Examples of known synthetic tissue structures are disclosed in patent documents <CIT>, <CIT>, <CIT> and <CIT>.

Currently, most simulated tissue structures are made of silicone. On the one hand, silicone is very elastic and when cut and silicone rebounds quickly. On the other hand, real tissue does not rebound fully when manipulated. Furthermore, silicone will tear fairly easily in the presence of a cut or a hole, but it resists tearing if there are no defects present. On the other hand, real tissue dissects easily. Also, adhering tissue surfaces poses further difficulties, such as excessive tackiness, when desiring a realistic interface. Therefore, challenges exist to making simulated tissue structures out of silicone that not only appear real, but also, function with the feel of real tissue when dissected and manipulated surgically. The present invention provides such a simulated tissue structure.

According to a first aspect of the present invention there is provided a simulated tissue structure as claimed in claim <NUM> of the attached claims.

According to a second aspect of the invention there is provided a method of manufacturing a simulated tissue structure as claimed in claim <NUM> of the attached claims.

A simulated tissue structure <NUM> is shown in <FIG>. The structure <NUM> includes a first layer <NUM> and a second layer <NUM> having an upper surface <NUM>, <NUM> and lower surface <NUM>, <NUM>, respectively. The first layer <NUM> and the second layer <NUM> are interconnected by a third layer <NUM> defining a gap <NUM> therebetween. The simulated tissue structure <NUM> may further optionally include inclusions <NUM> located between the first and second layers <NUM>, <NUM>. The inclusions <NUM> include simulated vessels, veins, tumors, ducts, vasculature, nerves, fat deposits, pathologies or other anatomical structures. The inclusions <NUM> are typically made of silicone but may also be made of other polymers or other suitable material and realistically shaped, colored and configured.

The third layer <NUM> comprises a plurality of one or more non-aligned, randomly arranged, nonwoven fiber <NUM> connected to the first layer <NUM> and/or second layer <NUM> at one or more location along the length of the fiber(s) <NUM>. The fiber <NUM> is connected to one or more of the first layer <NUM> and the second layer <NUM> by being embedded into the one or more of the first layer <NUM> and the second layer <NUM> during the manufacturing process which will be described in greater detail below. Each fiber may be in the form of a strand, filament, yarn, micro-fiber and the like and has a length and a first free end and a second free end. Adhesive is not used to connect the fiber. The fiber of the third layer <NUM> is resident within the gap <NUM> in a randomly arranged fashion. One strand of fiber <NUM> may be connected to the first layer <NUM> at one location and then connected to the first layer <NUM> again at another location along the length of the fiber or to the second layer <NUM> and its free ends may or may not be embedded in the first or second layer. Some strands of fiber <NUM> may not be connected to the first layer <NUM> or second layer <NUM> and are freely disposed between the first layer <NUM> and the second layer <NUM>. Some strands of fiber <NUM> are entangled and intertwined with other strands in a loose fashion such that the strands may move relative to other strands. The fiber may span the gap <NUM> to be connected to the opposite or second layer <NUM> at one or more location along the length of the fiber. It is possible to use a single fiber strand instead of a plurality of fiber strands to comprise the third layer <NUM>. The single fiber strand would be longer in length to fill and create a gap <NUM> between the layers <NUM>, <NUM> compared to the use of shorter strands to fill the same gap. The fibers are selected from any suitable material such as polyester, polyamide, acrylic, acetate, polyolefin, cotton, fiberfill, batting, polyethylene terephthalate, polyethylene naphthalate, nylon, polyfill, fiberfill, polymer, plastic, spandex or other suitable fiber, natural fiber, non-absorbent fiber, synthethic fiber or fiber-like material. The material may be woven, not woven or partially woven. Fiberfill is typically made by garnetting in which a garnet machine takes fibers and combs them into a batt form. The garnet machine may then fold and chop the fibers to make strands that are shorter and clumped together. The fibers mat together entangle and bunch.

One or more of the first layer <NUM> and second layer <NUM> has a substantially uniform thickness between its upper surface <NUM>, <NUM> and its lower surface <NUM>, <NUM> defining a substantially planar configuration. In one variation, the first layer <NUM> and the second layer <NUM> have a substantially uniform thickness between its upper surface <NUM>, <NUM> and its lower surface <NUM>, <NUM>. The lower surface <NUM> of the second layer <NUM> faces the upper surface <NUM> of the first layer <NUM>. In the location where the fibers <NUM> are attached to one of the first layer <NUM> and second layer <NUM>, the layer <NUM>, <NUM> has a reduced thickness because part of the thickness is taken by the thickness of the fiber itself. The first and second layers <NUM>, <NUM> are made of any suitable elastomeric material such as silicone. Room temperature vulcanization silicone is used in one variation.

The method, in accordance with a second aspect of the invention, of manufacturing the simulated tissue structure <NUM> will now be described with reference to <FIG>. A casting dish <NUM> having a textured surface <NUM> is provided. In another variation, the casting dish <NUM> has a smooth surface. Uncured room temperature vulcanization silicone is provided and applied evenly onto the textured surface <NUM> of the casting dish <NUM> as shown in <FIG> to form a thin first layer <NUM>. A spatula may be used to calendar the silicone evenly into a thin first layer <NUM>. While the silicone of the first layer <NUM> is in an uncured state, the third layer <NUM> is applied. In particular, a layer of polyester fibers <NUM> is placed onto the upper surface <NUM> of the first layer <NUM> while the first layer <NUM> is still wet. The polyester fibers <NUM> are arranged in a desired shape, thickness and density. The fibers <NUM> are then tamped down into the first layer <NUM> to help embed the fibers into the first layer <NUM> in a random fashion. Some parts of the fibers <NUM> are embedded in the silicone and most are exposed to the air and remain available to embed in a subsequent silicone casting.

Any optional inclusions <NUM> are placed onto or in juxtaposition with the upper surface <NUM> of the first layer <NUM>. The inclusions <NUM> are placed before the polyester fibers <NUM> are applied. In another variation, the inclusions <NUM> are placed after the polyester fibers <NUM> are applied. If the inclusions <NUM> are placed before the polyester fibers <NUM>, the inclusions <NUM> will become adhered to the first layer <NUM> as the silicone cures. If the inclusions <NUM> are placed after the polyester fibers <NUM>, only portions of the inclusions <NUM> that are in direct contact with the wet silicone of the first layer <NUM> will become adhered to the first layer <NUM> as the silicone cures. Thereby, the inclusions may be selectively adhered to either the first layer and/or the second layer to provide a realistic scenario for practicing the removal of an inclusion in a simulated surgical excision of the inclusion <NUM> with the surgeon employing careful and selective dissection. Also, only portions of the fibers <NUM> that are in contact with the wet silicone of the first layer <NUM> will become adhered to the first layer <NUM>. The silicone of the first layer <NUM> is allowed to cure fully embedding parts of the fibers into the first layer <NUM>. In one variation, the inclusions <NUM> are placed onto the first layer <NUM> after the first layer <NUM> has cured, thereby, not being embedded therein. Similarly, the fiber third layer <NUM> is placed onto a cured first layer <NUM> and, thereby, not becoming bonded thereto.

After the first layer <NUM> is cured, the textured first layer <NUM> is removed from the casting dish <NUM>. Typically, very thin sheets of silicone are difficult to remove from a casting dish <NUM> even with a layer of mold release coating the casting dish. However, the presence of fibers <NUM> that are attached to the first layer <NUM> upon curing of the silicone enable extremely thin layers of silicone to be removed from a casting dish without resulting in the layer tearing or being damaged. The interconnected embedded fibers <NUM> help to gently pull the thin layer away from the casting dish. Hence, the fiber layer <NUM> makes the tissue structure <NUM> more resilient to tearing and advantageously enables extremely thin layers of silicone to be casted and safely removed without tearing from the casting dish. The textured casting dish <NUM> advantageously provides locations of reduced thickness as wet silicone will pool in the locations where the casting dish is deeper. In one variation, the texture of casting dish <NUM> creates a multitude of small holes throughout the layer. The holes are relatively unrecognizable because advantageously the fiber layer provides a visual of glistening tissue as light is reflected in many directions from the shiny fiber mimicking wet live tissue. Furthermore, the holes act as points of origin for tears in the first layer <NUM> of silicone which is advantageous for simulating dissection, because, as mentioned previously, defects in the silicone help overcome the large and often unrealistic resistance to tearing of silicone. However, as the first layer <NUM> of silicone is made thinner, it become more difficult to de-mold and remove. The added fibers <NUM>, which are placed on top of the uncured silicone while in the casting dish <NUM>, form a composite with the silicone and make it possible to de-mold extremely thin sheets. Furthermore, advantageously, the presence of fibers <NUM> atop and in connection with the first layer <NUM> while the silicone of the first layer <NUM> is still uncured creates a capillary action or absorbency depending upon the type of material used in making the fiber that pulls silicone into the fibers <NUM> and away from the casting dish <NUM>. This capillary action results in extremely thin spots and even small holes in the casting of the first and second layers <NUM>, <NUM> which are easy and realistic to dissect using surgical instruments. This capillary action allows for the formation of sheets on un-textured, smooth casting dishes with the same desirable end results wherein the layers <NUM>, <NUM> have locations of reduced thickness of silicone. The isolated spots of reduced thickness in the silicone layer <NUM>, <NUM> act as points of origin for tears that mimic real dissection with a scalpel. The capillary-like action takes place when the fibers <NUM> are placed on the silicone when it is in an uncured state and results in at least part of the fiber strand becoming coated with the polymer or silicone polymer. The silicone bonds well to the micro-fibers and advantageously reduces friction when the fibers are moved against each other creating a slick, almost wet-like interface. In one variation, all of the fibers are coated before being embedded in one or more of the first and second layers. The fibers <NUM> of the third layer <NUM> are not ordered or aligned but randomly tangled. This tangled configuration resist the silicone's natural rebound, greatly enhancing the realistic feel of the tissue structure <NUM>, especially when performing blunt dissection as in laparoscopic surgery, as the fibers can slide/move relative to each other dampening the resiliency of the silicone. Also, the tangled configuration of the fibers <NUM> make separation of the first layer <NUM> and the second layer <NUM> a function of pulling tangled fibers instead of pulling layers that are adhered with silicone or other adhesive. In a sense, the fibers act as an adhesive layer or mechanical linkage between the first layer <NUM> and the second layer <NUM>. The adhesion being defined by the tangled fibers of the third layer <NUM> and the degree of their adhesion to the layers <NUM>, <NUM>. Separating the tangled fibers when pulling the first and second layers apart permit the surgeon to employ and practice respect for tissue techniques instead of using larger forces merely because the model is made of silicone, with adjoining layers firmly adhered with adhesive and the like. Therefore, the present invention is highly effective for making dissectible tissue models.

The method of manufacturing the simulated tissue structure <NUM> includes providing a second layer <NUM> of silicone. The second layer <NUM> of silicone is applied to a smooth or textured casting dish to create a thin layer of silicone. A spatula may be used to calendar the silicone evenly into a thin second layer <NUM>. While the silicone of the second layer <NUM> is in an uncured state, the combination of the first layer <NUM> and the third layer <NUM> previously made is applied onto the lower surface <NUM> of the second layer <NUM> while the silicone of the second layer <NUM> is in an uncured state. In particular, the third layer <NUM> of polyester fibers <NUM> is placed onto the lower surface <NUM> of the second layer <NUM>. The fibers <NUM> are then tamped down onto the second layer <NUM> to help embed the fibers <NUM> into the second layer <NUM>. Any optional inclusions <NUM> may be optionally provided onto the lower surface <NUM> of the second layer <NUM>. The inclusions <NUM> are placed before the polyester fibers <NUM> are applied. The inclusions <NUM> together with the fiber layer may become adhered to the second layer <NUM> as the silicone cures. In one variation, the second layer <NUM> is allowed to cure before the first layer <NUM> and third layer <NUM> are overlaid onto the second layer <NUM> if adhesion of fiber only to the first layer <NUM> is desired.

In one variation, a frame is provided having a central window of a desired shape. The frame (not shown) is applied against the lower surface <NUM> of the first layer <NUM> and pressed down toward the second layer <NUM> to bring the perimeter of the first layer <NUM> into sealing contact with the uncured silicone of the second layer <NUM> capturing the third layer <NUM> in between creating a pocket of fibers <NUM> with or without inclusions <NUM>. The perimeter areas of the first and second layers <NUM>, <NUM> are without fibers, in one variation, ensuring that the first and second layers <NUM>, <NUM> come into direct contact with each other to create and substantially seal the pocket. In another variation, the pocket is not created and the sides of the simulated tissue structure <NUM> are left open as shown in <FIG>. The silicone of the second layer <NUM> is allowed to cure fully resulting in the third layer being attached and embedded in the upper surface <NUM> of the first layer <NUM> and the lower surface <NUM> of the second layer <NUM> in sandwich-like fashion. One of the first layer <NUM> and second layer <NUM> may have a greater thickness than the other. In another variation, both the first layer <NUM> and the second layer <NUM> have the same thickness.

The most basic variation of the simulated tissue structure <NUM> is a first layer <NUM> sheet of silicone with fibers <NUM> on one side. This basic variation can be combined with other processes to create models of increasing complexity having additional layers of silicone, fiber and inclusions provided on outer or inner surfaces. After the first layer <NUM> of silicone with fibers <NUM> added to one side is cured and removed from the casting dish <NUM>, the second layer <NUM> of silicone can be applied to the same casting dish <NUM> and the previously made first layer <NUM> together with attached third layer <NUM> can be placed fiber-side down onto the uncured second layer <NUM>. This results in a sandwich with thin sheets of silicone on the exterior and micro fibers and inclusions in the interior having various degrees and locations of being embedded and/or adhesion. This assembly can then be used alone or as a component to a larger and more complex model. The thickness of the first and second layers is approximately between <NUM> millimeter and <NUM> millimeters and, preferably, between <NUM> millimeters and <NUM> millimeters. The third layer is approximately between <NUM> millimeters to <NUM> millimeters.

An example of the simulated tissue structure <NUM> being employed in a larger model is shown in <FIG> illustrates a pelvic model <NUM> with the simulated tissue structure <NUM>. The pelvic model <NUM> includes a portion of a simulated pelvis <NUM>. The simulated tissue structure <NUM> includes only a first layer <NUM> and a third layer <NUM> of fibers <NUM> without a second layer <NUM> of silicone. The upper surface <NUM> of the first layer <NUM> faces toward the simulated pelvis <NUM> such that the fibers <NUM> are located between the first layer <NUM> and the simulated pelvis. The simulated pelvis <NUM> serves as an armature on which the simulated tissue structure of the present invention is attached. The simulated tissue structure <NUM> is placed over the simulated pelvis <NUM> that is shown to include other anatomical features including but not limited to ducts <NUM> and a defect <NUM> interior to the first layer <NUM>. The edges of the first layer <NUM> are adhered to the backside of the simulated pelvis <NUM> as shown in <FIG> and optionally at other selected areas along the first layer <NUM>. When the pelvic model <NUM> is approached by a surgeon employing a laparoscope, the lower surface <NUM> of the first layer <NUM> will be visualized first. Because of the textured surface of the first layer <NUM> and because of the varying placement and arrangement of the third layer <NUM> beneath the thin first layer <NUM>, the model <NUM> will appear more realistic than a uniform layer of silicone without texturing or without the underlying fiber layer <NUM>. If simulated anatomical structures and/or inclusions <NUM> are employed, the fiber layer <NUM> will advantageously serve to obscure portions of the structures/inclusions making them more difficult to discern making the dissection practice more realistic and difficult for the practitioner. Thicker areas of the third layer <NUM> from having more fiber will obscure underlying structures/inclusions <NUM> more than thinner areas of the third layer <NUM> having less fiber thickness. Also, the first layer <NUM> may vary in thickness itself permitting different degrees of visualization of the underlying structures/tissues. The first layer <NUM> may be dyed red or pink. The lightcolored or white fibers <NUM> will make the overlaying first layer <NUM> appear lighter in color in certain locations. With the underlying third layer <NUM> of fiber, the first layer <NUM> will appear lighter red or lighter pink in certain areas relative to other locations where there is no fiber or less fiber. The surgeon will then practice making an incision <NUM> with a scalpel or a blunt surgical instrument. An incision <NUM> is shown in <FIG> and <FIG>. Upon making the incision <NUM>, the first layer <NUM> will not rebound due to the elasticity of the silicone itself which would resulting in the incision <NUM> appearing to close at an unrealistically fast rate or response. Instead, the incision <NUM> will remain substantially open as shown as a result of the fiber layer <NUM> dampening or holding back resiliency of the silicone itself. Also, the ability to mold very thin layers of silicone with the help of the fiber layer, the resulting thinner layer of silicone will have less thickness and reboundability. Under laparoscopic observation, the polyester fibers <NUM> appear to glisten as the fibers <NUM> reflect light in various directions advantageously making the simulated tissue structure <NUM> appear wet or moist as real tissue without the help of any liquid being present in the model. In laparoscopic simulations, the simulated tissue structures may appear unrealistic outside of a simulator or outside of a laparoscopic simulation environment and when observed with the naked eye, but because visualization takes place via a scope in a cavernous trainer that is artificially illuminated, certain liberties can be taken to achieve realistic advantages that could not be achieved for organs suitable for open procedures used outside the a laparoscopic simulation environment. In essence, the fibers <NUM> of the third layer <NUM> may appear very unrealistic as an organ or tissue simulation when observed with the naked eye but appear and behave very realistically in a laparoscopic training environment which will be described in greater detail below. After the incision <NUM> is made, the inclusions <NUM> including the ducts <NUM> and underlying artificial tissue structures <NUM> are exposed.

Turning now to <FIG>, there is shown another example in which the simulated tissue structure <NUM> is employed in an organ model. <FIG> illustrates an abdominal organ model <NUM> that includes simulated bowels <NUM> atop a simulated mesentery or omentum layer <NUM> that comprises the simulated tissue structure <NUM>. The bottom surface <NUM> of the structure <NUM> is facing up and vasculature <NUM> is included as an inclusion <NUM> attached to the first layer <NUM>. The vasculature <NUM> was attached to the first layer <NUM> before the third layer <NUM> of fiber <NUM> was embedded. Hence, the vasculature is clearly visible through the first layer <NUM>. The simulated mesentery layer <NUM> is made of silicone that is dyed yellow and the vasculature is red in color and made of silicone.

Although a method of forming a substantially flat or pocket-like simulated tissue structure <NUM> was described previously hereinabove, a method of forming a tubular-shaped simulated tissue structure <NUM> according to the present invention will now be described. Uncured silicone is provided and applied evenly to a rotating mandrel to create the first layer <NUM>. While the silicone of the first layer <NUM> is still wet, the polyester fiber layer is applied to form a third layer <NUM> of fibers <NUM>. The fibers may be randomly or evenly applied or strategically applied forming areas where more or less fiber is intentionally located to effect a desired simulation outcome. The first layer <NUM> of silicone is allowed to cure to embed the fibers <NUM> into the first layer <NUM>. The cured first layer <NUM> is taken off the mandrel and has a cylindrical shape with the lower surface <NUM> of the first layer <NUM> forming the interior of the cylinder and defining the cylinder lumen. The cylindrical shape of the first layer <NUM> and the third layer <NUM> may be inverted to place the fiber layer <NUM> inwardly and the lower surface <NUM> of the first layer <NUM> forming a smooth outer surface of the cylinder. Inclusions <NUM> may be applied to the outer surface of the cylinder either after inversion or prior to forming the first layer <NUM>. In another variation, the cylinder is not inverted. A first strip of uncured silicone is applied onto a surface. The first strip has a length approximately equal to the length of the tubular first layer <NUM>. The tubular first layer <NUM> and third layer <NUM> is aligned with the first strip and laid down onto the first strip with the fiber side of the combination facing the uncured first strip and tamped down to embed fibers <NUM> into the first strip. The first strip is allowed to cure to embed the fibers <NUM> of the third layer <NUM> into the first strip. A second strip of uncured silicone is applied to a surface. The second strip has a length approximately equal to the length of the tubular first layer <NUM>. The tubular first layer <NUM>, third layer <NUM> and first strip is laid onto the second strip while the silicone of the second strip is still wet to embed the fibers <NUM> of the third layer <NUM>. The tubular first layer <NUM> is applied to the second strip offset from the first strip so that an adjacent portion of exposed fibers of the third layer <NUM> come in contact with the wet second strip, preferably adjacent to the first strip and slightly overlaying the first strip to form an almost continuous second layer <NUM>. This process is repeated to form the second layer <NUM> from a plurality or any number of silicone sections or strips. The strips may be rectangular, triangular or any other shape to suitably cover the cylindrical surface and embed the third layer into the second layer <NUM>. Different organ models such as bowels can be formed with the simulated tissue structure <NUM> having a tubular shape and any inclusions <NUM> can be provided directly to either side of the first layer <NUM> prior to the application of the fiber layer <NUM> or after the fiber layer <NUM> or directly to the second layer <NUM>. In another variation, the second layer <NUM> is not applied and the simulated tissue structure includes the first and second third layer and any inclusions <NUM>.

In another variation, the simulated tissue structure <NUM> by itself or formed as part of another larger model or tissue structure such as the abdominal organ model <NUM> or pelvic model <NUM> described above with respect to <FIG> and <FIG> is sized and configured to be placed inside a simulated laparoscopic environment such as a surgical training device <NUM> of the like shown in <FIG>. Of course, the simulated tissue structure may also be used to practice open surgical procedures.

A surgical training device <NUM> that is configured to mimic the torso of a patient such as the abdominal region is shown in <FIG>. The surgical training device <NUM> provides a body cavity <NUM> substantially obscured from the user for receiving simulated or live tissue or model organs or training models of the like described in this invention. The body cavity <NUM> is accessed via a tissue simulation region <NUM> that is penetrated by the user employing devices to practice surgical techniques on the tissue or practice model found located in the body cavity <NUM>. Although the body cavity <NUM> is shown to be accessible through a tissue simulation region, a hand-assisted access device or single-site port device may be alternatively employed to access the body cavity <NUM>. An exemplary surgical training device is described in U. Patent Application, publication number <CIT>. The surgical training device <NUM> is particularly well suited for practicing laparoscopic or other minimally invasive surgical procedures.

Still referencing <FIG>, the surgical training device <NUM> includes a top cover <NUM> connected to and spaced apart from a base <NUM> by at least one leg <NUM>. <FIG> shows a plurality of legs <NUM>. The surgical training device <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 <NUM> between the top cover <NUM> and the base <NUM> is representative of an interior of the patient or body cavity where organs reside. The surgical trainer <NUM> is a useful tool for teaching, practicing and demonstrating various surgical procedures and their related instruments in simulation of a patient undergoing a surgical procedure. Surgical instruments are inserted into the cavity <NUM> through the tissue simulation region <NUM> as well as through pre-established apertures <NUM> in the top cover <NUM>. Various tools and techniques may be used to penetrate the top cover <NUM> to perform mock procedures on simulated organs or practice models placed between the top cover <NUM> and the base <NUM>. The base <NUM> includes a model-receiving area <NUM> or tray for staging or holding a simulated tissue model or live tissue. The model-receiving area <NUM> of the base <NUM> includes frame-like elements for holding the model (not shown) in place. To help retain a simulated tissue model or live organs on the base <NUM>, a clip attached to a retractable wire is provided at locations <NUM>. The retractable wire is extended and then clipped to hold the tissue model in position substantially beneath the tissue simulation region <NUM>. Other means for retaining the tissue model include a patch of hook-and-loop type fastening material affixed to the base <NUM> in the model receiving area <NUM> such that it is removably connectable to a complementary piece of hook-and-loop type fastening material affixed to the model.

A video display monitor <NUM> that is hinged to the top cover <NUM> is shown in a closed orientation in <FIG>. The video monitor <NUM> is connectable to a variety of visual systems for delivering an image to the monitor. For example, a laparoscope inserted through one of the pre-established apertures <NUM> 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 screen larger than the monitor is provided. In another variation, the top cover <NUM> does not include a video display but includes means for connecting with a laptop computer, a mobile digital device or tablet 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. The internal cavity is partially or entirely obscured from view. 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. In essence, the surgical trainer <NUM> provides a simulated body cavity <NUM> that is obscured from the user. The body cavity <NUM> is configured to receive at least one surgical model accessible via at least one tissue simulation region <NUM> and/or apertures <NUM> in the top cover <NUM> through which the user may access the models to practice laparoscopic or endoscopic minimally invasive surgical techniques.

Turning now to <FIG>, a simulated rectum model <NUM> comprising a composite of simulated tissue structures <NUM> will now be described. The simulated rectum model <NUM> includes a first tube <NUM> made of silicone. The first tube <NUM> may include an embedded mesh material such that the first tube <NUM> is capable of retaining sutures such that they do not pull out or tear through the silicone. The first tube <NUM> defines a first lumen <NUM> extending between a proximal end and a distal end.

The simulated rectum model <NUM> further includes a second tube <NUM> defining a second lumen <NUM> and extending between a proximal end and a distal end. The second tube <NUM> is made of yellow urethane foam. A layer of foam is formed and then folded into a cylindrical shape and the ends adhered to form a tube. The anterior end of the urethane foam second tube <NUM> is thinner as shown in <FIG>. The second lumen <NUM> is dimensioned to receive the first tube <NUM> inside the second lumen <NUM> in a concentric-like fashion. The second tube <NUM> is adhered to the first tube <NUM> using cyanoacrylate glue.

The model <NUM> further includes a third tube <NUM>. The third tube <NUM> is simulated tissue structure <NUM> of the like described above having a first layer <NUM>, a second layer <NUM> and a third layer <NUM> of polyfill fiber <NUM> that is formed into a cylindrical tube to define a third lumen <NUM>. The first layer <NUM> of the third tube <NUM> is yellow in color and the second layer <NUM> is white in color. The third layer <NUM> is made of white polyfill fiber. The diameter of the third lumen <NUM> is dimensioned to receive the second tube <NUM> inside the third lumen <NUM> in an eccentric fashion. The third tube <NUM> is adhered to the second tube <NUM> with adhesive such as cyanoacrylate glue.

The simulated rectum model <NUM> further includes a fourth tube <NUM>. The fourth tube <NUM> is simulated tissue structure <NUM> of the like described above having a first layer <NUM> and a third layer <NUM> of polyfill fiber <NUM> but does not have a second layer <NUM> that is formed into a cylindrical tube to define a fourth lumen <NUM> such that the third layer <NUM> of free polyfill fibers faces the fourth lumen <NUM>. The second layer <NUM> is pink in color. The third layer <NUM> is made of white polyfill fiber. In one variation, the fourth tube <NUM> includes a second layer <NUM> that is white in color. The diameter of the fourth lumen <NUM> is dimensioned to receive the third tube <NUM> inside the fourth lumen <NUM> in a concentric-like fashion. The fourth tube <NUM> is adhered to the third tube <NUM> with adhesive in select areas.

The simulated rectum model <NUM> further includes a simulated prostate system <NUM> located between the third tube <NUM> and the fourth tube <NUM>. The simulated prostate system <NUM> is located at the anterior side of the model <NUM>. The simulated prostate system <NUM> includes a simulated prostate, simulated seminal vesicles, simulated bladder, simulated urethra, and simulated vas deferens. The simulated urethra and simulated vas deferens are made of silicone formed into a solid tube. The simulated seminal vesicles are made of urethane foam over molded onto the simulated vas deferens. The simulated prostate is made of urethane foam over molded onto the simulated urethra.

The simulated rectum model <NUM> further includes additional polyfill material located between the fourth tube <NUM> and the third tube <NUM> at the anterior side of the model <NUM> and surrounding the simulated prostate system <NUM>.

The simulated rectum model <NUM> is fantastically suited for practicing transanal total mesorectal excision (TaTME) for cancer located in the lower rectum. In such a surgical procedure the cancerous simulated rectum is approached through the anus via a sealable port connected to a channel that is inserted into the simulated rectum. A purse-string suture seals off the cancerous portion of the rectum. The purse-string suture is a type of suture technique that the user of the model <NUM> can practice. It involves suturing around the circumference of the rectum and pulling it tight to seal off the area of the rectum that includes the tumor. The first tube <NUM> includes mesh embedded in the silicone layer of the tube to hold the purse-string suture in place. The silicone layer of the first tube <NUM> allows the purse-string suture to be pulled tight. Then, the surgeon will cut down posteriorly through the second tube <NUM> which represents the mesorectum. The surgeon will continue to dissect through the first layer <NUM> of the third tube <NUM> and then dissect circumferentially around in the third layer <NUM> of the third tube <NUM> being careful not to penetrate the second layer <NUM> of the third tube <NUM> because doing so would endanger the adjacent simulated prostate system <NUM>. The first layer <NUM> of the third tube <NUM> is yellow, which is the same color as the simulated mesorectum, second tube <NUM>, making it hard to distinguish apart from the second tube <NUM>. While dissecting circumferentially around in the third layer <NUM>, care must be taken not to penetrate the second layer <NUM>, because the third layer <NUM> is made of white polyfill and the second layer <NUM> is made of white silicone making them difficult to distinguish, thereby, teaching the practitioner to exercise due care. The fourth tube <NUM>, and in particular, the second layer <NUM> of the fourth tube <NUM> is red, representing the muscle and the pelvic floor. Accidental dissection into the second layer <NUM> of the fourth tube <NUM> and circumferential progression of dissection in this location would possibly lead to intersection with the simulated prostate system <NUM> which this model <NUM> teaches the surgeon to avoid. Dissection within the third layer <NUM> of the third tube <NUM> leads to a safe excision of the simulated prostate system <NUM>. After dissecting posteriorly, anterior dissection begins by dissecting through the thinner section of the simulated mesorectum (second tube <NUM>) until the third tube <NUM> is reached. When in the third tube <NUM>, and in particular, the third layer <NUM> of the third tube <NUM>, dissection proceeds circumferentially until the dissection meets the posterior dissection. The simulated mesorectum (second tube <NUM>) has an area of reduced thickness and the third tube <NUM> is attached to the second tube <NUM> and indistinguishably colored when comparing the yellow first layer <NUM> with the yellow second tube <NUM>. The simulated prostate system <NUM> is located on top of the third tube <NUM> as shown in <FIG> and it is surrounded with polyfill fiber <NUM> which makes it harder to distinguish from the polyfill fiber of the third layer <NUM> of the third tube <NUM> while dissecting in the third tube <NUM>. Dissection proceeds until the pelvic cavity is breached.

The proximal end of the simulated rectum model <NUM> may be attached to a transanal adapter. The transanal adapter is a leg <NUM> used to space apart the top cover <NUM> from the base <NUM> of a surgical trainer <NUM> to provide access into the model <NUM> from the side of the surgical trainer. The transanal adapter includes an opening that is connected to the first lumen <NUM> of the first tube <NUM>. Surrounding the opening of the transanal adapter, soft silicone is provided to simulate an anus. The practice of the surgical TaTME procedure is performed through the opening of the transanal adapter with a circumferential purse string suture placed proximal to the transanal adapter with the simulated prostate system located distal to the transanal adapter.

The simulated rectum model <NUM> is manufactured by first placing a mesh sheath on a mandrel and paining uncured silicone over the mesh. The second tube <NUM> (simulated mesorectum) is made of urethane foam that is cast into a flat sheet. The foam is cast to have a thinner section. The simulated mesorectum is wrapped into a cylinder around the first tube <NUM> to create the second tube <NUM>. Cyanoacrylate glue is used together with a primer to adhere the thicker portions of the second tube <NUM> together on the posterior side of the simulated rectum <NUM>. To form the third tube <NUM>, a thin planar sheet of yellow silicone is cast onto foam to create the first layer <NUM>. While the silicone of the first layer <NUM> is still wet, a layer of polyfill is evenly placed on top to create the third layer <NUM> of polyfill. After the first layer <NUM> cures, it is de-molded. A new layer of white-colored or clear silicone is cast on the foam to form the second layer <NUM>. The previously-cured first layer <NUM> together with the polyfill third layer <NUM> is placed on top with the polyfill third layer <NUM> touching the wet silicone of the second layer <NUM>. The assembly is demolded and wrapped around the second tube <NUM> to form a cylindrical third tube <NUM> which is adhered to the second tube <NUM> using cyanoacrylate glue. The fourth tube <NUM> is formed in a similar fashion as the third tube <NUM>.

To form the fourth tube <NUM>, a thin planar sheet of white or clear silicone is cast onto foam to create the first layer <NUM>. While the silicone of the first layer <NUM> is still wet, a layer of polyfill is evenly placed on top to create the third layer <NUM> of polyfill. More polyfill fiber is added to create an area where the third layer <NUM> is thicker as shown in <FIG>. After the first layer <NUM> cures, the third layer <NUM> is adhered and the combination of the first layer <NUM> and the third layer <NUM> is de-molded. A new layer of redcolored silicone is cast on the foam to form the second layer <NUM> of the fourth tube <NUM>. The previously-cured first layer <NUM> together with the polyfill third layer <NUM> is placed on top with the polyfill third layer <NUM> touching the wet silicone of the second layer <NUM>. Once cured, the assembly is demolded and wrapped around the third tube <NUM> to form a cylindrical fourth tube <NUM> which is adhered to the third tube <NUM> using cyanoacrylate glue or silicone dots. The simulated prostate system <NUM> is previously formed and located between the third tube <NUM> and the fourth tube <NUM>.

Turning now to <FIG>, there is shown a casting dish <NUM> that has a textured molding surface. The surface may vary in thickness. To create a simulated tissue structure in accordance with the first aspect of the present invention, a first layer <NUM> of uncured silicone is poured into the casting dish <NUM>. Before it is allowed to cure, a third layer 44a of fiber is placed on top of the first layer <NUM> such that fibers on one side of the third layer 44a are embedded into the first layer <NUM>. The first layer <NUM> is allowed to cure. After curing, the first layer <NUM> is removed from the casting dish <NUM> with the help of the third layer 44a. The third layer 44a and the first layer <NUM> are pulled up from the casting dish <NUM>. Because the third layer 44a adhered to the first layer <NUM>, pulling up on the third layer 44a allows the fibers of the third layer 44a to distribute the removal force and advantageously prevent the thin first layer <NUM> from tearing during removal. After the combination of the first layer <NUM> and the third layer 44a is removed, it is inverted and placed in juxtaposition to a second casting dish <NUM> with a second layer <NUM> of wet silicone as shown in <FIG>. A fourth layer 44b of fiber is placed onto the second layer <NUM> of wet silicone. Inclusions <NUM> are placed over the fourth layer 44b. Part of the inclusions <NUM> are placed in contact with the second layer <NUM> and remains embedded in the second layer <NUM> when the second layer <NUM> finishes curing. The third layer 44b also is embedded into the second layer <NUM>. In one variation, the inclusions <NUM> are not embedded in the second layer <NUM> and are located between the third and fourth layers 44a, 44b. When the first layer <NUM> with the third layer 44a are placed over the second layer <NUM>, the inclusions <NUM> and the fourth layer 44b, the construct is completed. In another variation, the first layer <NUM> is placed into contact with the second layer <NUM> while the second layer <NUM> is still uncured to adhere the first layer <NUM> and create a pocket that includes the inclusions <NUM> and third and fourth layers 44a, 44b. In another variation, portions of the third layer 44a are also embedded into the second layer <NUM> while the silicone is still wet to embed the third layer 44a into the second layer <NUM>. The inclusions <NUM> shown in <FIG> are vasculature made of silicone; however, the invention is not so limited and the inclusions <NUM> may be any inclusion, anatomical structure, landmark, organ, nerves, tissue, tumors and the like.

Turning now to <FIG> with particular reference to <FIG>, there is shown a casting dish <NUM> having two channels <NUM> for receiving uncured silicone. Although two channels <NUM> are shown any pattern can be employed to receive uncured material and form a desired structure including but not limited to anatomical structures and landmarks, tissues, nerves, vasculature, tumors, organs and the like. The material may include uncured silicone, uncured urethane foam, uncured silicone foam and the like. In one variation, wet uncured urethane foam is poured into the channels <NUM> to create a first inclusion 48a as shown in <FIG>. A first fiber layer 44a is placed on top of the uncured foam 48a inside the channels <NUM> to embed the fiber layer 44a into the uncured foam. The uncured foam 48c inside the channels <NUM> is allowed to cure and as a result become attached to the first fiber layer 44a. The first fiber layer 44a together with the formed inclusions 48a are removed from the casting dish <NUM> and placed in juxtaposition to a first layer <NUM> of uncured silicone as shown in <FIG>. The first fiber layer 44a with the attached first inclusions 48a are pressed into the first layer <NUM> while the silicone is still wet to embed the first inclusions 48a and the first fiber layer 44a into the first layer <NUM> as shown in <FIG>. The first inclusions 48a are configured to depict and mimic nerves; however, the first inclusions 48a can be any type of inclusion suitable for the simulated tissue structure. A second fiber layer 44b made of fiber is provided together with one or more second inclusion 48b. The second inclusions 48b are attached to the second fiber layer 44b in the same manner as described above with respect to the first fiber layer 44a and first inclusions 48a and may be made of silicone, silicone foam, urethane foam and the like. A casting dish is provided that is configured with a pattern for molding the one or more second inclusion 48b. The pattern is filled with wet silicone, for example, and while uncured, the second fiber layer 44b is overlaid onto the casting dish and wet silicone of the second inclusions 48b to embed and attach the second inclusions 48b to the second fiber layer 44b along a first side of the second fiber layer 44b. The second side of the second fiber layer 44b is embedded into a second layer <NUM> while the second layer <NUM> is still uncured. When the second inclusions 48b and the second layer <NUM> are cured the second fiber layer 44b and the second layer <NUM> together with the second inclusions 48b are removed from the respective casting dishes and placed on the first fiber layer 44a, first layer <NUM> and first inclusions 48a to create the sandwich-like simulated tissue construct. The second inclusions 48b are configured to mimic vasculature or any other anatomical structure, tissue, organ, nerve, tumor and the like. One or more of the first fiber layer 44a and second fiber layer 44b, create ideal dissection pathways for skeletonizing any one or more of the inclusions 48a, 48b wherein the dissection pathway through the fiber creates a realistic look and feel with the fibers being capable of being cut and/or spread apart to separate and expose the layers and inclusions for removal.

Any portion of the model <NUM> can be made of one or more organic base polymer including but not limited to hydrogel, single-polymer hydrogel, multi-polymer hydrogel, rubber, latex, nitrile, protein, gelatin, collagen, soy, non-organic base polymer such as thermo plastic elastomer, Kraton, silicone, foam, silicone-based foam, urethane-based foam and ethylene vinyl acetate foam and the like. Into any base polymer one or more filler may be employed such as a fabric, woven or non-woven fiber, polyester, non-absorbent fiber, nylon, mesh, cotton and silk, conductive filler material such as graphite, platinum, silver, gold, copper, miscellaneous additives, gels, oil, cornstarch, glass, dolomite, carbonate mineral, alcohol, deadener, silicone oil, pigment, foam, poloxamer, collagen, gelatin and the like. The adhesives employed may include but are not limited to cyanoacrylate, silicone, epoxy, spray adhesive, rubber adhesive and the like.

Claim 1:
A simulated tissue structure for surgical training, comprising:
a first (<NUM>) layer of silicone polymer with an upper surface and a lower surface;
a second layer (<NUM>) of silicone polymer with an upper surface and lower surface; the second layer (<NUM>) being spaced apart from the first layer (<NUM>) such that the upper surface of the first layer faces the lower surface of the second layer, characterized in the simulated tissue structure further comprising:
a third layer (44a) made of a plurality of nonwoven, randomly arranged entangled fibers located between the first layer (<NUM>) and the second layer (<NUM>), the third layer (44a) being embedded in the first layer at the upper surface of the first layer;
a fourth layer (44b) made of a plurality of nonwoven, randomly arranged entangled fibers located between the first layer (<NUM>) and the second layer (<NUM>), the fourth layer (44b) being embedded in the second layer (<NUM>) at the lower surface of the second layer; and
at least one inclusion (<NUM>) located between the third layer (44a) and the fourth layer (44b),
wherein the plurality of entangled fibers of the third and fourth layers (44a, 44b) create a dissection plane for practice of surgical excision of the at least one inclusion (<NUM>).