Cutting open may simulate tissue

Abstract

To provide a simulated dissectible tissue model for surgical skills.SOLUTION: A simulated tissue comprises a simulated anatomical structure, such as a simulated rectum or one or more artificial vessels, embedded with a silicone gel layer between two silicone layers. The simulated dissectible tissue, with or without a simulated anatomical structure, is connected to one or more artificial organs via a fiberfill layer. The fiberfill layer includes a plurality of entangled fibers embedded in between two adjacent silicone layers. The fiberfill layer creates a dissection plane that permits the one or more artificial organs to be removed by spreading apart and selectively dissecting the chains of entangled fibers.SELECTED DRAWING: Figure 24

Description

Technical Field

[0001] The present invention relates to surgical training tools, particularly to simulated tissue structures and models for teaching and practicing surgical procedures.

[0002]

Description of Related Applications

Background Art

[0003] Laparoscopic colectomy involves the removal of the intestine at various locations. Depending on the location of the intestine, the colectomy is called a right hemicolectomy, a left hemicolectomy, a sigmoid colectomy, or a total colectomy. A right hemicolectomy is the removal of the entire ascending colon, including a portion of the transverse colon, and this right hemicolectomy is the most common colectomy procedure. A crucial step in the right hemicolectomy procedure is the ability to identify important anatomical landmarks and vascular systems to enable the mobilization of the colon by crossing (incising laterally) the appropriate vessels and attachments. The surgeon's first step in this procedure is to identify and cross the ileocolic vessels. The ileocolic vessels are pulled down with the patient in the Trendelenburg position, with the right side facing upward. This position helps to move the omentum and small intestine out of the way. The ileocolic vessels are typically located adjacent to the duodenum, and these vessels are enclosed within the mesentery, which is composed of two peritoneal layers. During this step, the surgeon uses the duodenum as a structural landmark to locate the ileocolic vessels. When transecting the ileocolic vessels, either a medial-lateral or lateral-medial incision of the mesentery layer may be performed. This incision is made by blunt cutting using laparoscopic tools or energy-adaptive instruments that can cut and seal the small vascular or vascular systems and lymph nodes enclosed within the mesentery layer. With a medial-lateral incision, the duodenum and fascia gellota are moved anteriorly toward the mesenteric roots attached to the cecum and ileum. If the surgeon moves laterally-medially, the incision is made at the ileocecal junction and moves medially, in which case the duodenum and fascia gellota remain in an anterior position. Once the cecum and ileum are mobilized, the surgeon raises the White Line of Toldt to reach the right colic flexure of the colon. The White Line of Toldt is an avascular plane connected to the abdominal lateral wall via a lateral or lateral attachment. The surgeon typically dismantles the attachment and the White Line of Toldt using energy- and adaptable laparoscopic scissors or other laparoscopic instruments. Dismantling the White Line of Toldt involves removing the attachment along the right colic flexure, with the aim of enabling extracorporeal mobilization and transverse transsection of the intestine.When the intestine is cut transversely, the surgeon performs an external anastomosis, thereby reconnecting the remaining portion of the intestine.

[0004] Since there are several procedural steps for right hemicolectomy, it is important for surgeons to have a way to learn and practice this surgical procedure. The model must be anatomically accurate and include the important landmarks and / or vascular system required for the right hemicolectomy procedure. The model should be compatible with any variation of the procedural steps. For example, it should be possible to perform either a medial-lateral or lateral-medial incision on the model. Furthermore, the model should simulate the tactile sensations that surgeons observe during the procedure. For example, if an incision of the mesenteric layer is made, the differences when advancing through the mesenteric layer to reach large blood vessels should be clear. The blood vessels should be able to be grasped, cut, and clipped. Although several procedural steps exist, for the majority of this procedure, the intestine is mobilized by various incision techniques, and therefore, developing an accurate incision model is crucial for simulation. Organs in the model should be simulated to be moved and manipulated so that they are positioned within the body. Furthermore, the organs on the model should be mounted in such a way that they can be moved in the correct direction when the model is being positioned in the Trendelenburg or reverse Trendelenburg position. Anatomical models that address these issues are needed.

[0005] Furthermore, surgical residents and practicing surgeons undergo extensive training before they are qualified to perform surgery on human patients. This training may include instruction on various aspects of surgery, such as developing specific skills, practicing specific surgical procedures, or practicing with certain surgical instruments. There is a need for integrated simulated models to facilitate training for surgeons. Specifically, there is a need for simulated tissues that closely resemble the response of human tissue being dissected. The ability to make incisions between planes or to skeletonize vascular systems from surrounding anatomical structures is a skill observed in surgical procedures. In particular, when laparoscopic procedures are performed, the manipulation of instruments for making incisions is a learnable skill, and such skills enable non-traumatic procedures that minimize trauma. This invention relates to such simulated tissues. [Overview of the project]

[0006] According to one aspect of the present invention, an incisible dummy tissue for surgical training is provided. The incisible dummy tissue has a first layer made of silicone and having an inner and outer surface, with a defined thickness between the inner and outer surfaces. The incisible dummy tissue has a second layer made of silicone and having an inner and outer surface, with a defined thickness between the inner and outer surfaces. The incisible dummy tissue has a third layer containing a silicone gel placed between the first and second layers. The silicone gel is sealed by the first and second layers. The first and second layers are incisible, and the third layer elastically adheres the first and second layers to each other, so that the first and second layers are separable by a blunt instrument.

[0007] According to another aspect of the present invention, a dissectable dummy tissue for surgical training is provided. The dissectable dummy tissue has an outer shell made of silicone and configured to form an internal cavity. A filler is placed in the internal cavity and sealed. The sealed filler contains a silicone gel, and the outer shell is separable at the location of the filler to mimic surgical skeletonization.

[0008] According to another aspect of the present invention, a method for producing an incisable simulated tissue for surgical training is provided. The method includes the steps of: preparing a first layer of silicone; curing the first layer; preparing a mold having a central cavity; placing the first silicone layer on the mold so that the first layer covers the central cavity; preparing a silicone gel; applying the uncured silicone gel onto the first layer; preparing a second layer of silicone; placing the second layer on the silicone gel and the first layer; curing the silicone gel; and curing the second layer.

[0009] According to another aspect of the present invention, a method is provided for producing an incisable simulated tissue having one or more outer layers enclosing an inner layer. The method includes the step of selecting a material for the outer layer. The step of selecting a material for the outer layer includes the step of selecting one of silicone and a mixture of silicone and deadener. The method includes the step of selecting a material for the inner layer. The step of selecting a material for the inner layer includes the step of selecting one of silicone gel and a mixture of silicone gel and deadener.

[0010] According to another aspect of the present invention, an incisible simulated tissue structure for surgical training is provided. The incisible simulated tissue structure includes a first silicone tubular body having an outer and inner surface defining a first lumen. The incisible simulated tissue structure further includes a second silicone tubular body having an outer and inner surface defining a second lumen, and a third silicone tubular body having an outer and inner surface defining a third lumen. The incisible simulated tissue structure further includes a fourth polyfill tubular body positioned between the third tubular body and the second tubular body. A frame is provided that defines the interior and exterior. The first tubular body, the second tubular body, the third tubular body and the fourth tubular body are suspended within the frame, with the first tubular body positioned within the second tubular body, and the second tubular body positioned within the third tubular body.

[0011] According to another aspect of the present invention, an incisible simulated tissue structure for surgical training is provided. The incisible simulated tissue structure has a silicone apex layer having an upper and lower surface that defines the thickness of the apex layer, a silicone bottom layer having an upper and lower surface that defines the thickness of the bottom layer, and an intermediate layer disposed between the apex layer and the bottom layer. At least one simulated blood vessel of silicone is disposed within the intermediate layer. The incisible simulated tissue structure further has a second silicone layer having an upper and lower surface, with a defined thickness between the upper and lower surfaces. The incisible simulated tissue structure further has a third polyfill layer disposed between the second layer and the bottom layer.

[0012] According to another aspect of the present invention, an incisible simulated tissue structure is provided. The incisible simulated tissue structure has a simulated organ made of silicone. One or more fasteners are connected to the simulated organ. The incisible simulated tissue structure has a tray made of a rigid material. The tray has a base and a support platform. The support platform is located above the base, separated from the base. The tray has one or more fastener placement locations. The simulated organ is connected to the tray by the connection of one or more fasteners to one or more fastener placement locations. One or more fasteners are detachably connectable to one or more fastener placement locations. [Brief explanation of the drawing]

[0013] [Figure 1] This is a top-down perspective view of a laparoscopic training device. [Figure 2] This is a plan view of the right colon model of the present invention. [Figure 3] This is a plan view of a model of the right colon with the reticular layer retracted according to the present invention. [Figure 4] This is a plan view of the large intestine in the right colon model of the present invention. [Figure 5] This is a plan view of the aorta in the right colon model of the present invention. [Figure 6] This is a plan view of a simulated tissue structure of the present invention, for example, the mesenteric layer. [Figure 7A] This is a schematic diagram illustrating the steps of the manufacturing process for a simulated tissue structure of the present invention, such as the mesenteric layer. [Figure 7B] This is a schematic diagram illustrating the steps of the manufacturing process for a simulated tissue structure of the present invention, such as the mesenteric layer. [Figure 7C] This is a schematic diagram illustrating the steps of the manufacturing process for a simulated tissue structure of the present invention, such as the mesenteric layer. [Figure 7D] This is a schematic diagram illustrating the steps of the manufacturing process for a simulated tissue structure of the present invention, such as the mesenteric layer. [Figure 7E] This is a schematic diagram illustrating the steps of the manufacturing process for a simulated tissue structure of the present invention, such as the mesenteric layer. [Figure 8A] This figure shows a list of compositional variations of the simulated tissue structure of the present invention, for example, the outer layer of the mesenteric layer. [Figure 8B] This figure shows a list of compositional variations of the simulated tissue structure of the present invention, for example, the intermediate or inner layer of the mesenteric layer. [Figure 9A] This is a flowchart illustrating the compositional variations of the simulated tissue structure of the present invention, for example, the mesenteric layer. [Figure 9B] This is a flowchart illustrating the compositional variations of the simulated tissue structure of the present invention, for example, the mesenteric layer. [Figure 10A] This is a plan view of the first layer of the incisable simulated tissue of the present invention. [Figure 10B] This is a plan view of a mold and template for manufacturing the incisable simulated tissue of the present invention. [Figure 10C] This is a plan view of the first layer of incisable simulated tissue on the top of the mold and template of the present invention. [Figure 10D] This is a plan view of the first layer, template, and top of the mold of the present invention, showing a simulated vascular system and a simulated tumor. [Figure 10E] This is a plan view of the simulated vascular system, simulated tumor, first layer, template, and second layer made of gel on top of the mold according to the present invention. [Figure 10F]A plan view of the second layer made of gel, the simulated vascular system, the simulated tumor, the first layer, the template, and the third layer on top of the mold according to the present invention. [Figure 10G] A perspective view from above of a model of a dissectible simulated tissue attached to a peg of the simulated tissue platform according to the present invention. [Figure 10H] A plan view of a model of a dissectible simulated tissue attached to a peg of the simulated tissue platform according to the present invention. [Figure 11] A plan view from above of a dissectible simulated tissue in a state where an incision provided in the outer layer exposes the inner gel layer according to the present invention. [Figure 12] A cross-sectional perspective view of an organ model according to the present invention. [Figure 13] An exploded assembly view of an organ model according to the present invention. [Figure 14A] A plan view of an organ model with an incision made according to the present invention. [Figure 14B] A plan view of an organ model with an incision retracted according to the present invention. [Figure 15] A perspective view from above of an organ model with an incision retracted according to the present invention. [Figure 16] A partial schematic view of an organ model according to the present invention. [Figure 17] A cross-sectional view taken along the line A-A in FIG. 16 of a part of an organ model according to the present invention. [Figure 18A] A plan view of two layers of silicone during the formation of the white line of the tortoise according to the present invention. [Figure 18B] A plan view of two layers of silicone connected to each other by the white layer of silicone during the formation of the white line of the tortoise according to the present invention. [Figure 18C] A cross-sectional view taken along the line B-B in FIG. 18B of two layers of silicone and the white line of the tortoise according to the present invention. [Figure 19] A cross-sectional side view of the simulated mesentery layer according to the present invention. [Figure 20] A cross-sectional side view of the simulated mesentery layer and the fascia of the simulated tortoise according to the present invention. [Figure 21] This is a cross-sectional side view of the simulated mesenteric layer and simulated Tort's fascia of the present invention. [Figure 22] This is a cross-sectional side view of the simulated mesenteric layer and simulated Tort's fascia of the present invention. [Figure 23] This is a top-down perspective view of a simulated aorta equipped with a simulated nerve bundle according to the present invention. [Figure 24] This is a cross-sectional view taken along the midline of the pelvic region of the model of the present invention. [Modes for carrying out the invention]

[0014] One or more simulated organ and tissue tray models are ideal for training and practicing laparoscopic procedures and techniques when placed inside a simulated laparoscopic training device such as the SIMSEI laparoscopic training system manufactured by Applied Medical Resources Corporation, California. The laparoscopic training device 10 is shown in Figure 1. The laparoscopic training device 10 is described in concurrently pending U.S. Patent Application No. 13 / 248,449 (Title of Invention: Portable laparoscopic trainer), filed by Pravong et al. on 29 September 2011, assigned to Applied Medical Resources Corporation, and published as U.S. Patent Application Publication No. 2012 / 0082970, which is incorporated herein by reference and the entirety of which is incorporated herein by reference. The laparoscopic training device 10 has a top cover 12, which is connected to a base 14 by a pair of legs 16 that separate the top cover 12 from the base 14. The laparoscopic training device 10 is configured to mimic the torso of a patient, for example, the abdominal region. The top cover 12 represents the anterior surface of the patient, and the space formed between the top cover 12 and the base 14 represents the inside of the patient, or body cavity, or cavity 18 where organs are located. The laparoscopic training device 10 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and their associated instruments in a patient-like state. Surgical instruments are inserted into the cavity 18 through pre-formed holes 20 in the top cover 12. These pre-formed holes 20 may have seals that simulate trocars or simulated tissues that simulate the patient's skin and abdominal wall portion. The top cover 12 can be penetrated using various tools and methods, thereby enabling full-scale procedures on a model organ, such as the right colon model of the present invention, placed between the top cover 12 and the base 14.When placed within the cavity 18 of the training device 10, the organ model is generally obscured from the user's field of view, allowing the user to practice the surgical procedure laparoscopically by indirectly observing the surgical site via a video feed displayed on the video monitor 22.

[0015] A video display monitor 22, hinged to the top cover 12, is shown in an open orientation in Figure 1. The video monitor 22 can be connected to various visual systems for sending images to the monitor 22. For example, a laparoscope, inserted through one of the pre-formed holes 20 or a webcam provided in the cavity and used to observe simulated procedures, can be connected to the video monitor 22 and / or a mobile computer calculator to provide images to the user. In another variation, the top cover 12 does not have a video display 22, but supports a laptop computer, mobile digital device, or tablet, and has means to connect it to the training device 10 by wire or wirelessly.

[0016] When assembled, the top cover 12 is positioned directly above the base 14, with the legs 16 positioned substantially around it and interconnected between the top cover 12 and the base 14. The top cover 12 and the base 14 are substantially identical in shape and size and have substantially identical peripheral contours. The training device 10 does not have side walls, but the legs 16 partially conceal the internal cavity from view from the end-open training device 10. The laparoscopic training device 10 has a top cover 12 angled relative to the base 14. The legs 16 are configured to allow adjustment of the angle of the top cover 12 relative to the base 14. Figure 1 shows the training device 10 adjusted to an angle of approximately 30 to 45° relative to the base 14. The inclination of the training device 10 advantageously simulates a patient in the Trendelenburg or inverted Trendelenburg position. In the Trendelenburg position, the patient's body is tilted so that it lies flat on its back with the feet higher than the heart or the opposite position. The Trendelenburg position allows for good access to the pelvic organs as gravity pulls the intestines away from the pelvis, thereby preventing intestinal intrusion into the pelvic surgical field and providing a large working space within the abdominal cavity that allows the surgeon to easily manipulate the organs. The selected angular position of the top cover 12 is locked by indicating the wing nuts provided on the legs 16. The angle of the top cover 12 of the training device 10 relative to the base 14 or the horizontal plane, for example, the angle of the top cover 12 relative to the tabletop, is particularly advantageous for training and practicing right hemicolectomy with the colon model of the present invention inserted into the cavity 18 of the training device 10.

[0017] Referring next to Figure 2, a right colon model 26 of the present invention is shown, which is particularly suitable for training and practicing the right hemicolectomy procedure among the procedures in a laparoscopic environment, for example, the laparoscopic training device 10 described above with reference to Figure 1. The simulated organ is typically made of silicone or thermoplastic elastomer (TPE) and placed in a tray 28. The tray 28 is configured to accommodate the model organ placed within the tray 28. The tray 28 has a base and at least one side wall formed around the base. Additional side walls are formed inside this periphery to define the location specific to the anatomical structure, and such additional side walls are configured to accommodate the simulated structure and tissue. These additional side walls act as lateral supports in response to forces applied by the physician while the physician manipulates the simulated organ using instruments inserted through the top cover 12 of the training device 10 with the model 26 placed in the cavity 18. Figure 2 shows a simulated reticular layer 32, which includes the respective vascular systems 34, positioned above a model liver 30 and other organs made of silicone, arranged along the top of tray 28.

[0018] Referring to Figure 3, the reticular layer 32 is shown pulled back to expose the underlying simulated organs, which include at least a portion of the large intestine 36 (shown alone in Figure 4) attachable to the appendix 42 and sigmoid colon, at least a portion of the small intestine 38, the liver 30 including the gallbladder aggregate, the stomach, duodenum, kidney, ureter, aorta 40 (shown alone in Figure 5), blood vessels 44 representing arteries and veins, and connective tissue layers including the peritoneum, Gerota's fascia, and mesenteric layer 46 (shown alone in Figure 6). The organs are assembled to represent the accurate anatomical positioning and location of organs present in the human body for surgical training using various laparoscopic instruments. The right colon model 26, sometimes also called the right intestine model 26, is assembled using a silicone simulated organ with modifications to highlight important landmarks and features for surgical training in right hemicolectomy.

[0019] A base tray 28 is provided. The base tray 28 is made of yellow or red foam and is sized and shaped to be insertable into the cavity 18 of the training device 10. In a variation, the base tray 28 may have a liner made of yellow or red foam that fits directly into the base tray 28, and the base tray 28 can be inserted into the laparoscopic training device 10 together with this liner. It is preferable to add an additional foam portion to the left side of the foam base, for the purpose of simulating the right side wall. Another model base is provided to enable the simulation of various body positions during simulated surgical procedures. For example, the right colon model base 28 or liner may be made of vacuum-formed plastic so as to have an inclination angle at one end of the model 26. This angle can simulate the patient's inverted Trendelenburg position during surgical procedures. Furthermore, Model 26 is preferably made on a vacuum-formed plastic base to have a curved shape molded to mimic the shape of the pelvis, with the pelvic shape extending proximally to form the curved shape of the abdominal lateral wall.

[0020] A sheet made of silicone is attached to the top of the model base 28 to assist in the attachment and assembly of the simulated organs. A list of silicone organ simulates and their colors can be seen in Table 1 below. The colon 36, aorta 40, and mesentery 46 may remain substantially as shown in Figures 2 and 3, or they may be shortened or reduced to better fit the base of the laparoscopic training device 10. These anatomical structures are attached to the top of the foam base tray 28 in a manner that precisely represents their accurate relative anatomical positioning. Table 1: Organs and their colors TIFF0007860284000001.tif103168

[0021] The mesenteric layer 46 encloses the arteries and veins 44, and this mesenteric layer is configured to be grasped and incised using a laparoscopic dissection instrument. Dissection between tissue layers has properties that cannot be simulated with silicone alone. Therefore, to solve this problem, several modifications of incisable simulated tissue suitable for simulating actual anatomical structures, such as the mesentery 46, have been developed. The incisable simulated tissue suitable for simulating the mesentery 46 consists of three layers stacked on top of each other at the apex. The three layers include an apex layer 48, a bottom layer 50, and an intermediate layer 54. The apex layer 48 and bottom layer 50 are suitable for representing the peritoneal layer, and the intermediate layer 54, made of gel, is suitable for representing the connective tissue surrounding the blood vessels 44, which is made of incisable silicone.

[0022] Next, with reference to Figures 7A to 7E, the composition of the incisable simulated tissue of the present invention, which can be used exemplary as the mesenteric layer 46, will now be described. As can be seen, the incisable simulated tissue 47 of the present invention is not limited to use as the mesenteric layer 46, and such incisable simulated tissue can form at least part of any simulated tissue structure. The composition of the incisable simulated tissue 47 involves an initial step of making two separate thin silicone sheets, one sheet for the top layer 48 and the other sheet for the bottom layer 50, and these two silicone layers are fully cured as shown in Figure 7A. Once the sheets are fully cured, thin silicone gel layers 58a and 58b are spread onto the unpatterned sides of the silicone sheets 48 and 50, respectively, using a spatula or similar tool, as shown in Figure 7B. A simulated vascular system 44 containing silicone blood vessels is placed on either the uncured gel layer 58a or 58b. Figure 7C shows a simulated vascular system 44 placed on an uncured gel layer 58a on a sheet of top layer 48. Next, the silicone sheets 48, 50 are fully cured together with the gel layers 58a, 58b to adhere the simulated vascular system 44 to the top layer 48. Once the gel lining layers 48, 50 have cured, a third or intermediate layer 54 made of new silicone gel is prepared and poured onto one of the layers 48, 50. In one modification, new silicone gel is poured onto the silicone sheet 48 so that the silicone vessels 44 are positioned. The gel is spread to completely cover the simulated vessels of the vascular system 44. Next, the second layer 50 is placed on top of the first layer 48, covering the intermediate layer 54, while the silicone is still an uncured gel and is extruded to the edges so that air pockets form a sandwich structure. As a result of this process, the use of a three-layered dissectable simulated tissue 47 allows for the simulation of a mesenteric assembly 46, for example, shown in Figure 6, which is particularly suitable and compatible for laparoscopic dissection and skeletonization of the enclosing vascular system 44 located between these layers. The provision of multiple layers provides an accurate and realistic feel and function for the dissectable simulated tissue structure. Furthermore, the dissectable simulated tissue 47 advantageously creates various tissue planes, through which physicians can hone their dissection skills.Model 26 not only provides the ability to incise layers, but also allows physicians to correctly identify tissue planes or layers 44, 48, 50, 54, 58a, 58b, which is an important skill to learn for each individual procedure. In one modification, the incisable simulated tissue 47 is composed without the vascular layer 44, and such incisable simulated tissue can also be used to perform incisions.

[0023] During the process of preparing the incisable simulated tissue 47, several additives are introduced to ensure that various desired properties and repeatability of the incisable simulated tissue 47 are obtained. A list of various components for the outer first and second layers 48, 50 and the inner or intermediate layer 54 of the incisable mesenteric layer 46 is shown in Table 2, and such a list is described in a summarized form in the flowcharts of Figures 8A and 8B. A flowchart for determining the optimal incisable sheet based on the desired properties of Figures 8A and 8B is shown in Figures 9A and 9B. In Figures 9A and 9B, the mesenteric layer is used as an illustrative application of the incisable simulated tissue of the present invention, and the flowcharts of Figures 9A and 9B are not limited to applications for creating only a simulated mesenteric layer, but include applications in any simulated tissue structure. Furthermore, the blood vessels shown in Figures 9A and 9B are not limited to simulated blood vessels, but may include any simulated anatomical structure or tissue in an implanted state, such as tumors, pathological lesions, organs, tubes, cartilage, etc., but are not limited to these. The silicone outer layers 48, 50 are conventionally made of two parts in a 1:1 ratio of room temperature vulcanized (RTV) silicone, or a 1:1 ratio of RTV silicone and a deadener additive, or a 2:1 ratio of RTV silicone and a deadener additive. RTV includes, but is not limited to, platinum-cured room temperature vulcanized silicone (PCRTVS). Silicone deadener belongs to the silicone fluid chemistry family, which includes (but is not limited to) silicone oil, and this silicone deadener is a platinum-cured silicone additive. An example of deadener is called SLACKER, manufactured by Smooth-On, Inc., located in MacKandsee, Pennsylvania. Deadening agents, used as additives, soften silicone to mimic the feel of skin or human tissue, making it appear more realistic. Silicone deadeners are silicone additives that can soften silicone and alter the resulting "feel" as well as the rebound properties of cured silicone. These additives belong to a chemical family of silicone fluids, including silicone oils.Silicone fluids and silicone oils have a range of uses depending on the viscosity and chemical structure of the fluid. Silicone deadener is a type of silicone oil that is miscible with platinum-curable, room-temperature vulcanized silicone.

[0024] The durometer of conventional silicones used for shaping organs ranges from 00-10 Shore to 10A Shore. Thus, as a result of adding deadener, different properties are obtained when it is added to silicones of different durometers. As a result of adding deadener to a silicone that is soft in terms of durometer, a gel-like composition is obtained upon complete curing. However, as a result of adding a deadening agent to a silicone with a high durometer, the desired characteristics of a soft-feeling silicone are obtained, and such a soft-feeling silicone easily reaches its deformation fracture point upon complete curing. Thus, the combination of silicone and deadening agent can provide the tactile characteristics of the outer layers 48,50 constituting the mesentery 46, such as the peritoneal layer.

[0025] Modifications of the intermediate layer include (1) a gel containing a deadener or deadening agent, (2) a gel containing alcohol, (3) a gel containing alcohol and heated, or (4) a gel containing a deadener or deadening agent and alcohol and heated. Isopropyl alcohol is used. The addition of each additive to the sealing gel layer 54 reduces the magnitude of the pressure and force used to cut the layer and facilitate the cutting of the layer. The gel is a platinum-cured silicone rubber gel that can be used as an intermediate layer 54 in the mesenteric assembly 46. In another modification to facilitate the cutting of the intermediate layer 54, alcohol is added to thin the gel, thus facilitating penetration into the gel. Further degradation of the gel layer 54 can further increase the ease with which the intermediate layer 54 can be cut. The mixture of alcohol and gel is heated to about 70°C to accelerate the curing time and create a porous intermediate layer 54 resulting from the evaporation of the alcohol. A porous intermediate layer 54 composed of gel, alcohol, and heat reduces the inherent stickiness of the gel, making it easier to penetrate and incise the mesenteric layers 48, 50, 54. In another modification, deadner is added to the silicone gel, resulting in a formulation with lower elasticity but increased stickiness upon complete curing. To mitigate the stickiness of the cured gel mixture, alcohol is added to the mixture of silicone gel and deadner in the same ratio. The resulting properties, upon complete curing, are less sticky compared to the gel mixture alone and the gel and deadner, but these properties also provide the desired cuttable feel when using laparoscopic dissection instruments. In this case as well, adding heat to the mixture creates a porous intermediate layer 54 with the characteristics listed above for another modification of the cuttable layer. Modifications of the intermediate cuttable layer 54 composed of gel and various additives advantageously provide a feel for moving through tissue and incising free blood vessels contained between the two outer layers 48, 50 within the mesenteric layer 46. Furthermore, the compounded gel modifications provided herein give layer 54 a realistic wet appearance that provides gloss or sheen, which is particularly advantageous in laparoscopic procedures where the cavity is surrounded and illuminated by a laparoscope. Table 2: Layers and Materials TIFF0007860284000002.tif40161

[0026] The vascular system 44 present in the right colon model 26 is made of silicone or KRATON polymer tubing manufactured by Kraton Polymers, located in Houston, Texas. The blood vessels are housed within the simulated mesenteric layer 46 described above. The vascular system 44 is anatomically positioned and attached to the peritoneal layers 48, 50 by a gel intermediate layer 54. Furthermore, although the incisable tissue containing the vascular system 44 has been described in relation to a model for right hemicolectomy, this manufacturing method can be used in any tissue simulation model by similar means or as a standalone model for a simulated tissue platform.

[0027] Another component of the right colon tray is the omentum 32. The omentum 32 is attached to the large intestine 36, and this omentum hangs over the top of the model 26. Several variations of the omentum 32 have been developed. The first variation is a textured silicone cast omentum 32 that can be easily hung over the top of the model 26. However, to simulate the weight and feel of the omentum 32, this omentum is also better formed by casting using soft silicone foam. The omentum 32 made of foam is colored yellow, which appears to occupy a large space in the abdominal cavity, but can be hung over the top of the model 26. The vascular system 34 is present on both variations of the omentum 32 to simulate its appearance so that the omentum 32 is visible inside the body.

[0028] Referring back to Figure 3, the presence of an attachment 64 on the model connecting the ascending colon 60 to the abdominal wall 62 is an important feature for training in the right hemicolectomy procedure. Several identical models are made to work with the abdominal wall 62. The first model of the abdominal wall 62 is made by attaching a long, thin piece of foam, approximately 2 inches (5.08 cm) high, to the side of a base 28, which is also preferably made of foam. The abdominal lateral wall 62 is also preferably incorporated into the base 28 through the curvature of the molded base and lateral wall described above. Finally, the abdominal lateral wall 62 is preferably made of a curved, rigid, and hard cast material that extends to the length of the foam base 28 and attaches to the foam base 28. An external attachment 64 can be attached to any of the abdominal walls 62 described above. The external attachment 64 is made by using two textured silicone sheets that attach to the top of any of the abdominal walls 62 described above. Tort's linea alba is present between two sheets attached to the abdominal wall 62. Several models exist for Tort's linea alba. The first model simulates Tort's linea alba with rope fiber. Strands of white cotton rope are used in model 26 to mimic the appearance of the vascular plane of Tort's linea alba. Tort's linea alba can also be simulated by creating white stripes or streaks of silicone to represent anatomical landmarks. Tort's linea alba is attached between two layers of silicone sheets, then these layers are attached to each other along the edges, and then attached to the ascending colon 60. The resulting structure is an lateral attachment that connects to the lateral wall 62, which includes the intestine 36.

[0029] In another aspect of the present invention, the incisable simulated tissue 47 is composed of at least two distinct layers. The first layer is composed of a silicone layer, and the second layer is composed of a silicone gel. Using the incisable simulated tissue 47, it is possible to create synthetic tissue and organ models with anatomical similarity, and such incisable simulated tissue 47 can be used as a simulated training model for training in incisions and other surgical procedures. The incisable simulated tissue 47 of the present invention is an assembly composed of at least one outer silicone layer and a gel layer enclosed by one or more outer silicone layers, resulting in a structure that closely resembles an incision observed by a surgeon. One or more silicone layers of the incisable simulated tissue are made of two-part RTV10A durometer silicone mixed with a silicone deadener that accounts for 33% of the total weight, thereby the ratio of total silicone to deadener used is 2:1. The deadener is a silicone oil that softens the properties of the cured silicone to which it is added. As a result, 10A durometer silicone to which deadener is added hardens to become durometer silicone of less than 10A. The amount of deadener added is proportional to the change in the properties of the durometer to which it is added. A silicone pigment is added to the mixture of silicone and deadener, thereby casting the silicone to create a viscous mixture with the pigment corresponding to the anatomical structure represented thereby. The silicone mixture is optionally cast onto a sheet of foam with texture or onto a sheet containing a texture made of gypsum material. If foam is used, the cast silicone mixture is hardened at room temperature for about 45 minutes, or if foam is not used, at a temperature of about 70°C in an oven for about 25 minutes. The sheet size should preferably have a length and width that gradually changes depending on the size of the plane or surface being cut.

[0030] Once cured, the silicone sheet is placed on a mold having a rectangular cavity, which is smaller than the size of the silicone. The silicone sheet is positioned on the mold such that its central region is within the cavity and its outer periphery lies flat on the surface of the mold. This setup configuration facilitates the gel encapsulation process while minimizing gel leakage. Within the central cavity, a silicone vascular system and pathological lesion, such as a tumor, are attached to the portion of the sheet located within the cavity using a silicone adhesive. The placement of the vascular system and pathological lesion is analogous to anatomical tissue where incisions are typically made. Once the silicone adhesive has cured and the vascular system and pathological lesion remain intact, an intermediate gel layer is formed. The present invention is not limited to the implantation of a vascular system, but also includes other anatomical landmarks and structures, such as vascular systems, tumors, pathological lesions, organs, and tissue structures, and their constituent materials include, but are not limited to, any polymer material, silicone, KRATON, etc.

[0031] In one modification, the encapsulating gel present in the dissectable simulated tissue consists of silicone gel, deadener, and isopropyl alcohol. To make the gel, two parts of silicone gel are placed in a mixing cup in equal parts by weight and volume. Deadener is added in an amount equal to the total volume of silicone added. Isopropyl alcohol is added in an amount equal to the volume of deadener. The mixture is mixed until a homogeneous solution is obtained. Silicone pigment is added as needed to create a pigment that closely resembles the human tissue to be dissected. Once the solution is thoroughly mixed, it is cast onto the top of the outer silicone sheet placed in the cavity of the mold to form a gel layer. The gel is encapsulated and does not pass through the top of the cavity, because if it did, gel leakage would occur, which is detrimental to the overall tissue model. Silicone gel is a silicone elastomer. However, extremely soft is platinum-cured silicone rubber. The durometer of silicone gels is below the Shore hardness scale of 00, resulting in gel-like softness, tackiness, and low tear resistance. An example of a gel used in incisable tissues is ECOFLEX gel, manufactured by Smooth-On, which has a hardness of 000-35.

[0032] At this stage of manufacturing, there are two distinct methods for completing the dissectable simulated tissue model. For example, the dissectable simulated tissue can be consumed as a component in an organ tray focused on surgical procedure training, as described with reference to Figures 1-6. In such cases, when the dissectable simulated tissue is consumed as a component in a tray, the gel layer is enclosed using a second silicone sheet having the same size and the same silicone, deadener, and pigment properties as the first silicone sheet. The second silicone sheet is placed on top of the first sheet containing the gel. The layers are pressed so that air pockets are pushed out to the sides of the sheet and released into the atmosphere. Silicone adhesive is used to line the cavity between the two silicone sheets, thereby creating a seal between the two silicone layers and preventing gel leakage. The gel is cured between the two silicone sheets at room temperature. Once cured, the dissectable simulated tissue can be removed from the casting mold. The dissectable simulated tissue can be attached to various silicone organs in the organ tray using the periphery of the silicone sheets. The incisable simulated tissue 47 is particularly suitable for use in simulated organ training trays for training on right hemicolectomy procedures, as shown in Figures 2 to 6.

[0033] In another example, the incisible simulated tissue 46 can be used on a small platform to practice only the incision technique. In this case, the gel layer is poured into the cavity and then cured in an oven at approximately 60°C for approximately 35 minutes. Once the gel has cured, a 10A durometer silicone mixture is prepared with the same pigment as the outer silicone sheet of the incisible simulated tissue. To form a second silicone sheet layer, the silicone mixture is cast onto the gel and the outer silicone sheet layer and then cured in an oven at approximately 60°C for approximately 30 minutes. The resulting incisible simulated tissue model is a standalone model that can be used to practice incision skills. This model of the incisible simulated tissue is a one-sided model, in which case only one side of the outer layer is made of soft silicone with properties similar to human tissue. The outer layer, composed of 10A durometer silicone, serves as a taut support for the model when placed within a suturing platform of the type described, for example, U.S. Patent Application No. 14 / 037,005, filed September 25, 2012 (Title of Invention: Surgical training model for laparoscopic procedures), which is cited by reference and whose entire contents are incorporated herein by reference.

[0034] The addition of a damping agent as an additive during the fabrication of the outer silicone layer makes the cured silicone softer and more realistic in feel to skin or human tissue. As a result of the addition of the damping agent, different properties are obtained when added to silicones with different durometers. Adding a damping agent to a durometerally soft silicone results in a gel-like composition upon complete curing. However, adding a damping agent to a durometerally high silicone results in the desired soft-feeling silicone, which readily reaches its deformation fracture point upon complete curing. Thus, the combination of silicone and damping agent can provide the tactile characteristics of human tissues constituting the mesentery, such as the peritoneal layer.

[0035] The intermediate gel layer contains a deadener, alcohol, and a heated gel. The addition of each additive to the sealing gel layer reduces the pressure and force required for incision, thereby facilitating the incision. The gel is a platinum-cured silicone rubber gel that can be used as an intermediate cuttable layer in cuttable simulated tissue. Adding alcohol thins the gel, making the intermediate layer easier to cut and penetrate. Furthermore, degradation of the gel layer can further enhance the cuttable properties of the intermediate layer. Heating the alcohol and gel mixture accelerates the curing time and creates a porous intermediate layer through alcohol evaporation. The porous intermediate layer, composed of gel and alcohol, reduces the gel's inherent stickiness and allows it to penetrate and easily cut the sealing gel layer. In another modification, deadener is added to the silicone gel, resulting in a formulation with lower elasticity but increased stickiness upon complete curing. To mitigate the stickiness issues of the cured gel mixture, alcohol is added to the silicone gel and deadener mixture in the same ratio. The resulting properties, upon complete curing, exhibit reduced tackiness compared to the gel mixture itself and the gel-deadner, but also provide the desired cuttable feel when using laparoscopic dissection instruments. In this case, too, applying heat to the mixture creates a porous intermediate layer with the characteristics listed above for another variation of the cuttable layer. The configuration of the intermediate cuttable layer, composed of the gel and various additives, provides the feel of moving through tissue and dissecting the mesentery layer or other tissue structures or free blood vessels within organs. Furthermore, the use of the gel's gloss or sheen provides a realistic wet appearance similar to that of real tissue, which is particularly useful when viewed on a video monitor during laparoscopic skills training.

[0036] Modifications in fabricating the outer silicone layer include changing the silicone's durometer. RTV platinum-cured silicone, useful for creating simulated organ models, is available in 00-10 durometer and 10A durometer, and the silicone outer layer can be fabricated using either of these silicones. Additionally, adding deadener to the silicone can soften its cured state. The change in the silicone's softness and elasticity is directly proportional to the amount of deadener added. Figure 8A shows a flowchart of the outer silicone layer forming a resectable simulated tissue.

[0037] The intermediate gel layer consists of a base silicone gel to which additives including deadener and alcohol are added and then heated to cure. By separately removing each of the additives, variations are given at each step, resulting in properties for each form. Figure 8B shows variations of each gel layer composition containing additives in specific ratios and possessing the properties exhibited by these additives. Throughout this specification for all embodiments, the ratios for the outer layer are preferably based on either volume or weight, because the densities of silicone and deadener are approximately equal. The ratios of the gel layer, deadener, and alcohol are based on volume.

[0038] Modifications in the assembly of a dissectable simulated mesenteric layer may include the use of silicone gel to attach the vascular system. The construction of this assembly involves the initial step of creating two separate sheets of silicone containing a deadener and curing them completely as shown in Figure 7A. Once the sheets are completely cured, thin layers of silicone gel 58a, 58b are spread onto the unpatterned sides of the respective silicone sheets 48, 50 using a spatula or similar tool, as shown in Figure 7B. The vascular system 44 made of silicone vessels is placed on the uncured gel layer 58a on one of the sheets, as shown in Figure 7C. The silicone sheets 48, 50, including the gel layers 58a, 58b, are completely cured. Once the gel lining layers have cured, a new silicone gel 54 is prepared and cast onto the silicone sheet 48 on which the silicone vessels 44 are placed. The gel 54 is spread so that it completely covers the vessels 44, as shown in Figure 7D. Next, the second silicone sheet 50 is placed on the uncured gel, and air pockets are pushed out to the edges. As a result of this process, the multilayered mesentery can be compatible with laparoscopic incisions as shown in Figure 7E.

[0039] The incisible simulated tissue of the present invention possesses the mechanical properties of a representative tissue to be incised, including low tear resistance, elasticity, toughness, color, and texture. It is preferable to use laparoscopic tools, such as a Maryland incision container or laparoscopic scissors, within this tissue to incise or cut each section. The use of the gel incisible tissue imparts a unique luster to the material, thereby allowing it to have a realistic wet appearance. Since the gel used to construct this incisible tissue is primarily composed of silicone, it can be bonded to various other silicone models or organs already manufactured, such as silicone blood vessels. Furthermore, the viscosity of the gel allows blood vessels made of other thermoplastic elastomers, such as KRATON polymer, to adhere to the outer silicone layer of the silicone gel.

[0040] The incisable simulated tissue of the present invention is incisable and possesses several advantageous properties that closely resemble human tissue. The simulated tissue mimics the mechanical properties of human tissue, such as elasticity, toughness, color, and texture. Furthermore, the simulated tissue has low tear resistance or tear strength, which advantageously allows for the propagation of tissue separation. The low tear resistance of the simulated tissue facilitates blunt incision with minimal force using a laparoscopic Maryland incision container or laparoscopic scissors. The simulated tissue may also include anatomical landmarks or structures of representative anatomical structures that require incision. These anatomical landmarks or structures include, but are not limited to, organs, vascular systems embedded between mesenteric layers, or pathological lesions that need to be resected, such as peritoneal sheets surrounding a tumor. The anatomical landmarks or structures can be grasped using a non-traumatic laparoscopic grasper or Maryland incision container, or cut using laparoscopic scissors. Furthermore, the incisable simulated tissue of the present invention allows for the manipulation and procedure of anatomical structures upon completion of the incision. The movement of these structures closely resembles the movement of anatomical structures in human tissue upon completion of the incision. In addition, the incisable simulated tissue is consistently manufacturable. The simulated tissue can be molded to take the shape of a human organ or membrane. The incisable simulated tissue can also be bonded to various silicones and thermoplastics. Preferably, any and all of the silicone layers of the present invention are translucent or transparent so that the underlying implanted pathological lesions, tumors, vascular systems, etc., are slightly visible through one or more of the layers. Examples

[0041] Referring to Figures 10A to 10H, an example of manufacturing a biased simulated tissue model having a composition of incisible simulated tissue will now be described. Prepare 10A durometer silicone containing two parts, namely part A and part B. Mix approximately 5 grams of part A of 10A durometer silicone with approximately 5 grams of part B of 10A durometer silicone. Add approximately 5 grams of silicone deadener. Add yellow silicone pigment. Mix the silicone, deadener and pigment thoroughly. Cast the mixture onto a textured mold and cure it to form a first layer sheet 66 as shown in Figure 10A. Prepare a rectangular mold 68 with a central cavity 70 about 0.125 inches (3.175 mm) deep as shown in Figure 10B. The depth of the central cavity 70 can be changed according to the desired incisible thickness. Place a vascular template 72 in the central cavity of the rectangular mold as shown in Figure 10B. The template 72 shows lines 74 in which silicone vessels should be positioned for accurate anatomical structures. The template 72 further includes markings of the anatomical locations 76 in which a particular pathological lesion should be positioned. While the vascular system template 72 is disclosed, the invention is not limited thereto, and templates 72 of any anatomical feature can be used oriented towards the locations in which a particular structure, pathological lesion, organ, tumor, and other tissue, as well as anatomical landmarks, should be positioned. Next, the first layer sheet 66 is placed on the mold 68 so as to align with the outer edge of the mold 68, as shown in Figure 10C. The first layer sheet 66 is transparent so that the template 72 can be seen through the first layer sheet 66. Next, as shown in Figure 10D, the simulated vascular system 78 and the simulated tumor 80 are attached to the first silicone sheet layer 66 using a silicone adhesive and positioned in the locations shown on the template 72 placed underneath. The simulated vascular system 78 is positioned on the lines 74 of the template 72. It is best to further color the lines 74 or other shapes on template 72 and place the correspondingly colored blood vessels and / or organs in their precise anatomical locations. Mix approximately 3.3 grams of part A silicone gel with approximately 3.3 grams of part B silicone gel.Approximately 6.67 millimeters of silicone deadener and 5.27 grams of isopropyl alcohol are added to the silicone gel and mixed together. By volume or volume measurement, these are quantitatively approximately 3.3 milliliters of Part A silicone gel, approximately 3.3 milliliters of Part B silicone gel, 6.67 milliliters of silicone deadener, and 6.67 milliliters of isopropyl alcohol. The yellow and white silicone content is added and mixed. The mixture is poured into the central cavity to surround the simulated vascular system 78, but without leakage over the cavity, thereby forming an intermediate gel layer 82 as shown in Figure 10E. All components are cured in an oven at approximately 60°C for approximately 35 minutes. The intermediate gel layer 82 is also transparent when cured, so that the simulated blood vessels 78 and simulated tumors 80 can be seen through the intermediate gel layer 82. Mix approximately 35 grams of Part A and 35 grams of Part B of 10A durometer silicone. Silicone is cast onto the cured gel and the sides of the model to form a second outer layer 84. The model is then cured in an oven at approximately 60°C for approximately 25 minutes. The second outer layer 84 is also transparent, allowing embedded landmarks in the combination of the gel layer 82 and the outer layer 84, such as a simulated tumor 80 and simulated blood vessels 78, to be visible through the layers 66, 82, 84. The excess of the silicone sheet sandwich is trimmed around the perimeter so that the model dimensions are approximately 4 inches x 5 inches (10.16 cm x 12.7 cm) and the intermediate gel layer 82 is enclosed by the two surrounding outer layers 66, 84. The perimeter of the model is made of two outer layers 66, 84 joined together with no intermediate gel layer 82 between them to prevent leakage of the gel layer 82 from the model. The outer layers 66, 84 help to seal and enclose the gel intermediate layer 82. Referring to Figures 10G and 10H, four holes 86 are made in the corners of the rectangular model, and the model is placed on upright pegs 88 of the simulated tissue platform 90 to suspend it like a trampoline, allowing for practice of incisions.The simulated tissue models in Figures 10A to 10H are models of the vascular system near the gallbladder and can be considered partial gallbladder models, which may or may not include a simulated gallbladder. For use, the model is suspended on a platform 90 or forms part of a larger organ model or organ tray and placed in a surgical simulation device and / or training device for a physician to practice surgical procedures on the model. The model may also be used outside the simulation device and / or training device. Referring further to Figure 11, the physician cuts into the second outer layer 84 and enters the intermediate gel layer 82. The physician spreads the second outer layer 84 apart from the first outer layer 66, thereby accessing the embedded structure, simulated blood vessels 78 and simulated tumor 80. In doing so, the physician may need to separate or incise the intermediate gel layer 82. The intermediate gel layer 82 is soft, glossy, and elastic. When the second outer layer 84 is lifted, the soft elastic gel of the intermediate layer 82 preferably resembles a fibrous membrane when the gel is stretched when the second outer layer 84 is moved away from the first outer layer 66. When the intermediate gel layer 82 is stretched, it preferably opens into a deep pocket with the strands of gel 92 remaining interconnected between the two layers, allowing the surgeon to practice cutting these strands of gel. A blunt or sharp incision of the soft silicone gel follows, creating a space through the intermediate gel layer 82 and forming an incision plane between the first outer layer 66 and the second outer layer 84. The anterior layer may also be cut and divided, thereby further enhancing the visibility of structures such as a simulated vascular system 78 embedded within the intermediate gel layer 82, thereby mimicking skeletonization.

[0042] Next, an organ model 200 as another embodiment of the present invention will be described with reference to Figures 12 to 15. The organ tray model 200 includes all the features described with reference to Figures 2 to 6, and these features are related to the right colon model 26, which further has the features of the left colon model, including one or more of the following simulated anatomical structures: a simulated spleen, a simulated descending colon, a simulated sigmoid colon, a simulated intestine, a simulated transverse colon, a simulated rectum, a simulated left ventral wall, a simulated left linea alba of Tort, a simulated aorta, a simulated left kidney, a simulated pancreas, a simulated nerve, a simulated fascia / space of Tort between the mesentery and retroperitoneal space, a simulated left ureter, a simulated gonadal vessels, a simulated prostate, a simulated seminal vesicle, a simulated urethra, a simulated bladder, a simulated mesentery, a simulated Danone-Villier fascia, a simulated pelvis, a left internal mesenteric vein and vessels, and a plastic base. The simulated anatomical structure 202 is supported on an optional platform 204, which is covered with an outer simulated epidermal layer 208 while positioned within a base 206. The platform 204 has multiple holes 209 for receiving fasteners, such as rivets 226, which are associated with the simulated anatomical structure 202 and are configured to snap into the holes 209 to releasably connect the simulated anatomical structure 202 to the platform 204. The addition of the epidermal layer 208 allows for the simulation of open procedures. An incision 211 is placed in the epidermal layer 208 as shown in Figure 14A, and this incision is then retracted to expose the simulated anatomical structure 202 as shown in Figures 14B and 15. The model 200 allows the user to practice total rectomesectomy (TME) using open or laparoscopic surgical techniques. In the case of simulated laparoscopic surgery, model 200 without the epidermal layer 208 is placed inside the cavity 18 of the training device 10. To practice open procedures, the legs 16 of the training device 10 are removed, and the top cover 12 is placed directly on the base 14, reducing the size and height of the cavity 18 with model 200 positioned between the top cover 12 and the base 14. A silicone wall insert is placed inside the large aperture 20 provided in the top cover 12.In another configuration for practicing open procedures, the legs 16 of the training device 10 are shortened in length, thereby modifying them to reduce the height of the cavity 18 between the top cover 12 and the base 14. In yet another configuration for practicing open procedures, the top cover 12 of the training device 10 is removed, and a silicone sheet is placed on the model 200 positioned inside the base 14. A silicone sheet 208 simulating the epidermal layer is also placed on the base 14 and the side walls of the base 14, as shown, for example, in Figure 12.

[0043] Referring now to Figures 16 and 17, a portion of the simulated intestine 210, including the simulated ascending colon 216, the simulated transverse colon 218, and the simulated descending colon 220, is shown together with the right white line 212 and the left white line 214 of the simulated Tort. Both the right white line 212 and the left white line 214 of the simulated Tort are shown in Figure 16, although Model 200 may include both or only one of the right or left white lines of the Tort. Figure 17 is a cross-sectional view focusing on the left white line 214 of the Tort. The right white line 212 of the Tort is substantially identical on the right side of Model 200. The simulated peritoneal layer 222 is positioned above the intestine 210 and joined to the simulated mesenteric layer 224 from the bottom of the intestine 210 to form the white line 214 of the simulated left tort, and is then connected to the side wall by fasteners, for example 226, inserted through apertures 209 provided on the side wall of the platform 204. At least a portion of the simulated mesenteric layer 224 has a first layer 228 and a second layer 230 of silicone separated from each other by a third layer 232 of polyfil fiber material to form a sandwich layer as described in detail in U.S. Patent Provisional Application No. 62 / 193,143 filed on July 16, 2015.

[0044] The polyfill layer consists of one or more nonwoven fibers randomly arranged in an unaligned manner, and such fibers may or may not be bonded to one or more adjacent silicone layers at one or more locations along the length of the fiber. The fibers are bonded to one or more of the first and second layers by being embedded in one or more of the first and second layers during the manufacturing process described in detail below. Each fiber may be in the form of a strand, filament, yarn, microfiber, etc., and each fiber has a length and has at least a first end and a second end. Adhesives may or may not be used to bond the fibers. The fibers of the third layer are located in a manner randomly arranged within the gap between the first and second layers. For example, one strand of fiber may be joined to the first layer at one point, and then again to the first or second layer at another point along the length of the fiber, and its free end may or may not be embedded in the first or second layer. Several strands of fiber do not have to be joined to the first or second layer, and these strands are freely positioned between the first and second layers. Several strands of fiber are loosely entangled and twisted with other strands so that these strands can move relative to other strands. The fiber may straddle gaps so that it is joined to the opposite or second layer at one or more points along the length of the fiber. A single fiber strand can be used instead of multiple fiber strands to form a third layer. A single fiber strand is longer in length to fill and create gaps between layers compared to using shorter strands to fill the same gaps. Although the term "polyfil" is used throughout the specification, the composition is not limited to polyester.The fibers are selected from any suitable material, such as polyester, polyamide, acrylic resin, acetate, polyolefin, cotton, fiberfill (fiber filler), stuffing, polyethylene terephthalate, polyethylene naphthalate, nylon, polyfill, fiberfill, polymer, plastic, spandex or other suitable fibers, natural fibers, non-absorbent fibers, synthetic fibers or fibrous materials, although such fibers are still called polyfill. Such materials may be woven, unwoven, or partially woven. Fiberfill / polyfill is typically produced by garnetting, in which a garnetting machine receives the fibers and combs them into a butt shape. The garnetting machine then folds and cuts the fibers, thereby creating strands that are short and clumped together. The fibers entangle, intertwine, and bundle together. The fibers, advantageously, provide a glossy tissue appearance, especially when viewed on a video monitor using an image acquisition device with a laparoscope, as light is reflected in many directions from the shiny fibers, mimicking living tissue in a wet state.

[0045] Referring to Figures 18A–18C, the simulated Tort's white lines 212,214 are created by placing two thin layers 234a,234b of flattened silicone on top of each other as shown in Figure 18A. The bottom layer 234b is a polyfill sandwich layer having a third layer 232 of polyfill placed between the first silicone layer 228 and the second silicone layer 230 to simulate Tort's fascia. A narrow strip 236 is removed from both layers 234a,234b by making two juxtaposed cuts as shown in Figure 18A. A layer of white silicone 238 simulating Tort's white lines is applied across the gap created by the removal of the narrow strip 236 and cured as shown in Figure 18B. As a result of this configuration, four layers, each having two first silicone layers 234a and two second silicone layers 234b, are bonded together by a white silicone layer 238 as shown in Figure 18C. The first silicone layer 234a and the second silicone layer 234b located on one side of the white line 238 of the simulated Tort form a simulated peritoneal layer 222 and a simulated mesentery 224, respectively, and these layers 234a,234b are connected to the colon by adhesive, while the first silicone layer 234a and the second silicone layer 234b located on the other side of the white line 234 of the simulated Tort are attached to the side wall of the platform 204 by fasteners, such as plastic rivets 226, inserted into holes 209 provided in the platform 204. Layer 222 may also be attached to the lateral wall on the other side near the right colon using silicone, fasteners, rivets, or cyanoacrylate adhesives.

[0046] In one embodiment, the simulated mesentery 224 consists of a gel sandwich of three layers: a top layer 48 of silicone, a bottom layer 50 of silicone, and an intermediate layer 54 of gel. The intermediate layer 54 contains simulated blood vessels 44 made of silicone or the like between the top and bottom layers, as described herein and shown in Figure 19. In another embodiment shown in Figure 20, the simulated mesentery layer 224 has a first layer 228 of silicone, a second layer 230 of silicone, and a third layer 232 of polyfil fiber located between the first and second layers. The first layer 228 of silicone is attached to the bottom layer 50 of silicone by an adhesive 240, and this bottom layer 50 of silicone, together with the top layer 48 of silicone, sandwiches the intermediate layer 54 of gel. The intermediate layer 54 is preferably made of silicone and contains simulated blood vessels 44. In yet another embodiment shown in Figure 21, a silicone top layer 48 and a silicone bottom layer 50 sandwich a gel intermediate layer 54, which is preferably used to enclose a simulated blood vessel 44 made of silicone. The bottom layer 50 is combined with a second silicone layer 230, sandwiching a third layer 232 of polyfill fibers between them. In yet another embodiment shown in Figure 22, a first silicone layer 228 is combined with a second silicone layer 230, sandwiching a third layer 232 of polyfill between them. A silicone top layer 48 is provided, and the simulated blood vessel 44 is positioned between the top layer 48 and the first layer 228. The simulated blood vessel 44 is attached to the first layer 228 by adhesive 240, but not to the top layer 48. Furthermore, the top layer 48 is attached to the first layer 228 by adhesive 240 applied to selected areas between the simulated blood vessels 44, as shown in Figure 22, for example. In this embodiment, there is no intermediate layer of gel. In another embodiment, the first layer 228 and second layer 230 of silicone are provided with a third layer 232 of polyfill between them. The silicone top layer 48 has an intermediate layer 54 of polyfill between the top layer 48 and the first layer 228, and the silicone simulated blood vessels 44 are positioned between the top layer 48 and the first layer 228.Furthermore, the bottom layer 50 is preferably provided between the intermediate layer 54 of polyfil and the first layer 228 of silicone. These morphologies shown in Figures 19 to 22 simulate Tort's fascia / cavity between the mesentery and the retroperitoneal space. This cavity is defined by two silicone layers, with a third layer 232 of polyfil located between these two silicone layers. The morphologies in Figures 20 to 22 show the morphology of a combination of Tort's fascia 242 and mesentery 224. Within the fascia layer, it is preferable to arrange a simulated ureter, simulated gonadal vessels, simulated duodenum, and simulated nerve bundles.

[0047] Next, referring to Figure 23, a simulated aorta 40 is shown, preferably made of red-stained silicone. A simulated nerve bundle 244, made of yellow-stained silicone, is provided and attached to the simulated aorta 40 as shown. The simulated nerve bundle 244 has multiple openings 246. In one embodiment, the simulated nerve bundle 244 is fitted over the aorta in the lumen of Tort's fascia 242 within the polyfil region. In one embodiment, the color of the simulated nerve bundle 244 is not yellow.

[0048] Referring next to Figure 24, Model 200 has a lower pelvic portion. After practicing the mobilization of the right or left colon, the user can practice incising into the pelvic region to remove the simulated mesorectal ligament 262. Figure 24 shows an approximate midline cross-section of the pelvic region of Model 200. Model 200 has a plastic sheet 248 positioned anteriorly, configured to simulate the pubic bone. The plastic sheet 248 reduces the workspace the user must practice in. The anatomical structures above the simulated rectum 250 include a simulated prostatic system 252. The simulated prostatic system 252 includes a simulated prostate 254, a simulated seminal vesicle 256, a simulated bladder 258, a simulated urethra, and a simulated vas deferens. The simulated urethra and simulated vas deferens are made of silicone formed into solid or hollow tubes. The simulated seminal vesicle 256 is made of urethane foam or other foam or material coated onto the simulated vas deferens. The simulated prostate 254 is made of urethane foam or other foam or a material covered over a simulated urethra. The simulated prostate system 252 is connected to the plastic sheet 248 by fasteners, such as rivets 226, inserted through holes 209 provided in the plastic sheet 248. A plastic base 260 is provided on the rear side of the model 200. The plastic base 260 creates a confined space for practicing surgical procedures. The simulated rectum 250 has a tubular shape of silicone surrounded by a simulated mesorectal ligament layer 262. Another layer or tube 264 of silicone is provided, which includes an inner layer 266 of polyfill fibers. The surgeon practices cutting the polyfill fiber layer 266 to make a portion of the simulated rectum 250 movable. The simulated rectum 250 is connected to the base 260 by fasteners, such as rivets 226, inserted through holes 209 provided in the plastic base 260. The rivet 226 is attached to the second layer or tube 264 to give the user space to enter the polyfill layer 266 and cut it to remove the simulated rectum 250 and the simulated mesentery 262.

[0049] International application PCT / US2015 / 022774 (Title of invention: Simulated dissectible tissue), filed on 26 March 2015, is incorporated herein by reference in its entirety as part of this specification. International application PCT / US / 2016 / 041852 (Title of invention: Simulated dissectible tissue), filed on 12 July 2016, is incorporated herein by reference in its entirety as part of this specification.

[0050] It goes without saying that various modifications can be made to the embodiments of the incisable simulated tissue disclosed herein. Therefore, the above description should not be construed as limiting the invention, but rather as merely illustrative examples of preferred embodiments. Those skilled in the art will likely conceive of other modifications that fall within the scope and spirit of the invention.

Claims

1. A surgical training incisible simulated tissue structure comprising a lower pelvic region model, the lower pelvic region model is A first silicone cylinder defining the first lumen, A second silicone cylinder defining the second lumen, A third silicone cylinder defining a third lumen, A fourth polyfill cylinder is positioned between the third cylinder and the second cylinder, The model of the lower pelvic region comprises a seat positioned anteriorly and a base positioned posteriorly, defining the interior and exterior of the model. The first, second, third, and fourth tubes are suspended within the lower pelvic region model, with the first tube positioned within the second tube, the second tube positioned within the third tube, and the fourth tube serving as an incisible simulated tissue structure that creates an incision plane for practicing total rectomesectomy (TME).

2. The incisable simulated tissue structure according to claim 1, wherein the rearward-positioned base is provided with a plurality of fastener placement locations, and the simulated rectum is connected to the rearward-positioned base via connections between the plurality of fastener placement locations and the plurality of fasteners.

3. The incisable simulated tissue structure according to claim 2, wherein the simulated rectum comprises a first tube, a second tube, a third tube, and a fourth tube, the second tube representing a simulated rectal mesentery layer.

4. The incisable simulated tissue structure according to claim 2 or 3, wherein the plurality of fasteners are rivets, the locations for the plurality of fasteners are a plurality of holes formed in the rearward-positioned base for receiving the rivets, and the rivets are attached to the third cylindrical body of the simulated rectum.

5. The incisable simulated tissue structure according to any one of claims 1 to 4, wherein the forward-positioned sheet is provided with a plurality of fastener placement locations, and a simulated prostate system is connected to the forward-positioned sheet via connections between the plurality of fastener placement locations and the plurality of fasteners.

6. The anatomically modified prostate system is suspended within the lower pelvic region model, and the anatomically modified prostate system comprises an anatomically modified prostate, anatomically modified seminal vesicles, anatomically modified bladder, anatomically modified urethra, and anatomically modified vas deferens, according to claim 5.

7. The incisable simulated tissue structure according to claim 6, wherein the plurality of fasteners are rivets, and the locations for the plurality of fasteners are a plurality of holes formed in the sheet positioned in front for receiving the rivets.

8. The rivet is attached to the simulated prostate and the simulated bladder of the simulated prostate system, according to claim 7, for the incisable simulated tissue structure.

9. The incisable simulated tissue structure according to claim 6, wherein the simulated urethra and the simulated vas deferens are made of silicone formed into a solid or hollow tube.

10. The incisable simulated tissue structure according to claim 6 or 9, wherein the simulated seminal vesicle is made of urethane foam molded to cover the simulated vas deferens.

11. The incisable simulated tissue structure according to claim 6 or 9, wherein the simulated prostate is made of urethane foam molded to cover the simulated urethra.

12. The incisable simulated tissue structure according to any one of claims 1 to 11, wherein the rearward-positioned base and the frontward-positioned sheet are made of plastic.

13. The incisable simulated tissue structure according to any one of claims 1 to 12, wherein the forward-positioned sheet and the rear-positioned base are configured to simulate the pubic region and the sacral region, respectively.

14. The incisable simulated tissue structure according to any one of claims 1 to 13, wherein the fourth tubular body of polyfill comprises a plurality of nonwoven fibers randomly arranged in an unaligned manner, the nonwoven fibers being connected to one or more adjacent silicone layers at one or more locations along the length of each fiber.

15. The incisable simulated tissue structure according to claim 14, wherein the plurality of nonwoven fibers, one or more of which are randomly arranged in an unaligned state, are partially connected to one or more of the third and second silicone tubular bodies at one or more locations along the length of each fiber.

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