Simulated tissue construct compositions and methods of use for surgical training

Abstract

A simulated tissue construct and method for its manufacture are provided. The simulated tissue construct is fabricated to be cuttable with conventional electrosurgical instruments while having sufficient longitudinal strength to withstand manipulation and movement when used with a simulated surgical training model. The simulated tissue construct has first and second inner layers encompassed by an outer layer. A portion of the first inner layer is connectable with other simulated organs to simulate conditions for training laparoscopic procedures.

Description

[Technical Field]

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application Serial No. 63 / 249,692, entitled "Simulated Tissue Structure Composition and Use for Surgical Training," filed September 29, 2021, which is incorporated herein by reference in its entirety.

[0002] This application relates generally to surgical training tools, and more particularly, but not exclusively, to simulated tissue structures and models for teaching and practicing various surgical techniques and procedures associated with laparoscopic, endoscopic, and minimally invasive surgery. [Background technology]

[0003] Medical students, as well as experienced physicians learning new surgical techniques, must undergo extensive training before they are qualified to operate on human patients. This training must teach proper techniques using a variety of medical devices to cut, penetrate, clamp, grasp, staple, cauterize, and suture various types of tissue. The range of possibilities trainees encounter is wide, including the presentation of various organs, patient anatomies, and diseases. The thickness and consistency of various tissue layers also vary depending on the body region and patient. Different procedures require different techniques. Furthermore, trainees must practice procedures in a variety of anatomical environments influenced by factors such as the patient's size and condition, the adjacent anatomical landscape, the type of target tissue, and whether the tissue is easily or relatively inaccessible.

[0004] Numerous teaching materials, 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 can be used to practice endoscopic and laparoscopic, minimally invasive, transluminal surgical procedures that are likely to be encountered. In laparoscopic surgery, a trocar or cannula is inserted to access a body cavity and create a channel for the insertion of a camera, such as a laparoscope. The camera provides a live video feed that captures images that the surgeon displays on one or more monitors. At least one additional small incision is made through which another trocar / cannula can be inserted to create a passageway through which surgical instruments can be passed to perform the procedure, which is observed on the monitor. The location of the target tissue, such as the abdomen, is typically enlarged by insufflating the body cavity with carbon dioxide gas, creating a working space large enough to accommodate the surgeon's scope and instruments. Pneumoperitoneal pressure within the tissue cavity is maintained using specialized trocars. Laparoscopic surgery offers many advantages over open procedures. These benefits include reduced pain, less bleeding, and faster recovery time due to smaller incisions.

[0005] Laparoscopic or minimally invasive endoscopic surgery requires a higher level of skill than open surgery because the clinician does not directly observe the target tissue. The target tissue is viewed on a monitor that displays a portion of the surgical site accessed through a small opening. Clinicians must therefore practice visual judgment of tissue planes, three-dimensional depth perception on a two-dimensional display screen, instrument handover, suturing, precision cutting, and tissue and instrument manipulation. Typically, models simulating specific anatomical structures or procedures are installed in a simulated pelvic trainer, where the anatomical model is not directly visible to the practitioner. Ports in the trainer are used to pass instruments to practice techniques on the anatomical model hidden from direct visualization. The simulated pelvic trainer provides a functional, inexpensive, and practical means for training surgeons and residents in basic skills and typical procedures used in laparoscopic surgery, such as grasping, manipulation, cutting, knot tying, suturing, stapling, and cauterization, as well as how to perform specific surgical procedures utilizing these basic skills. The simulated pelvis trainer is also an effective sales tool for realizing the medical devices required to perform these laparoscopic procedures.

[0006] One such procedure is a hysterectomy, which involves removing the uterus. A hysterectomy can be performed either transvaginally, through the vaginal canal, or abdominally, through a small abdominal incision. Vaginal hysterectomies have historically been difficult to train due to their limited field of view. Unlike laparoscopic procedures, there is no camera to project the procedure onto a screen, and unlike open procedures, there is no large incision that multiple people can view. Therefore, the best way to teach vaginal hysterectomies is through a simulated model. Therefore, a model for training the hysterectomy procedure is needed. Furthermore, simulated models can also be configured to provide additional teaching scenarios, such as simulating the removal of the uterus through an abdominal approach. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 8,764,452 Summary of the Invention

[0008] According to various embodiments, simulated tissue constructs are described herein. In particular, the simulated tissue constructs can be used to simulate one or more different types of ligaments. The simulated tissue constructs described herein have a first inner layer, a second inner layer, and an outer layer surrounding both the first and second inner layers. The first and second layers provide longitudinal strength to the simulated tissue construct when used in a surgical simulation.

[0009] According to various embodiments of the present invention, a method for creating a simulated tissue construct is described herein. The method includes providing a mold having a proximal end, a distal end, and a cavity extending between the proximal and distal ends. The method also includes using a mesh fabric and a thread. The mesh fabric is first placed within the mold and conforms to the shape of the mold cavity. After the mesh fabric is placed, the mold is partially filled with silicone that covers at least a portion of the mesh fabric within the cavity. The thread is then placed over the silicone. The mold is then further filled with silicone that covers the thread. The silicone within the mold is then allowed to harden, thereby encapsulating both the mesh fabric and the thread and forming a silicone construct with enhanced longitudinal strength for use in surgical simulations.

[0010] According to various embodiments, a simulated tissue structure is described herein. The simulated tissue structure can be used, for example, to simulate various types of ligaments. The simulated tissue structure has a first layer, a second layer, and an outer layer surrounding both the first and second inner layers. The first layer, the second layer, and the outer layer are each made from a different material. Depending on the materials used for the first and second layers, different longitudinal strengths can be provided to the simulated tissue structure.

[0011] According to various embodiments, a simulated tissue structure is described herein. The simulated tissue structure has a first layer, a second layer, and an outer layer surrounding both the first and second inner layers. The outer layer has a weaker longitudinal strength than either the first layer or the second layer.

[0012] The present invention can be understood by reference to the following description taken in conjunction with the accompanying drawings, in which like reference numerals refer to like elements throughout the drawings. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a rear view of a simulated surgical training model according to various embodiments of the present invention. [Figure 2] FIG. 1 is a top view of a simulated surgical training model according to various embodiments of the present invention. [Figure 3] FIG. 1 is a side view of a simulated surgical training model according to various embodiments of the present invention. [Figure 4] FIG. 1 is a rear view of a portion of a simulated surgical training model according to various embodiments of the present invention. [Figure 5] FIG. 1 is a rear view of a simulated surgical training model according to various embodiments of the present invention. [Figure 6] FIG. 1 is a rear view of a simulated surgical training model with portions of the model removed, according to various embodiments of the present invention. [Figure 7] FIG. 1 is a side view of a portion of a simulated surgical training model according to various embodiments of the present invention. [Figure 8] 1 is a side view of a simulated tissue structure according to various embodiments of the present invention. FIG. [Figure 9] 1A-1C are cross-sectional views of simulated tissue constructs according to various embodiments of the present invention. [Figure 10] 1 is a perspective view of a surgical training device according to various embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] According to various embodiments of the present invention, a simulated surgical training model is provided. The simulated surgical training model comprises one or more artificial or simulated tissue constructs comprising interlaced planar thread materials, continuous lengths of fibers or filaments, and / or curable silicone. The simulated tissue constructs are connectable to artificial or simulated organs, bones, tissue layers, and / or any combination thereof. The simulated tissue constructs have sufficient column or longitudinal strength to withstand manipulation and movement within a simulated surgical training procedure, while also being cuttable with conventional surgical scissors, scalpels, and the like. The simulated tissue constructs are suturable, i.e., capable of withstanding and holding up to the processes or manipulations involved in suturing the simulated tissue construct to itself and / or another simulated organ or tissue.

[0015] 1-9, a simulated surgical training model 100 having one or more simulated tissue structures is provided. In various embodiments, the simulated surgical model 100 includes a simulated pelvic frame 12. The frame 12 includes a top cover 121 and a base 122 connected to each other by side walls 123, 124, collectively defining a cavity 125. The frame 12 is tapered, with a proximal end that is smaller than the distal end. Attached to the frame 12 are simulated tissue structures, such as simulated organs, simulated tissue layers, and connective tissue and / or vasculature, including ligaments, blood vessels, and the like. As shown in the illustrated embodiment, a simulated bladder 14, a simulated uterus 20, and a simulated colon 22 are all disposed within the cavity 125 of the frame 12. The simulated bladder 14 is a hollow, air-filled component that may be made of silicone or any other type of elastomeric material. The simulated bladder 14 is connected to the top cover 121 of the frame 12, and the simulated colon 22 is connected to the base 122 of the frame 12. In various embodiments, the simulated bladder 14 is a closed receptacle with an outer membrane made of pink silicone. The interior of the simulated bladder 14 can be filled with air, polyfilm, or other material to maintain its shape. In some embodiments, the simulated bladder 14 can also be filled with a liquid.

[0016] The simulated uterus 20 is positioned between the simulated bladder 14 and the simulated colon 22, and the simulated uterus 20 is suspended within the frame 12. In various embodiments, the simulated uterus 20 has a bulbous portion defining a hollow simulated uterine cavity (not shown). The bulbous portion is connected to a tubular portion defining a vaginal canal. The simulated uterus 20 may also include simulated fallopian tubes connected to simulated ovaries, which are oval structures filled with silicone. In various embodiments, the simulated uterus 20 is made of silicone and / or foam. The simulated uterus 20 is connected to and suspended from the frame 12 via a simulated vasculature 16. The simulated vasculature 16 may be made of solid or hollow tubular silicone or other suitable elastomer. The hollow tubular body of the simulated vasculature 16 may contain a fluid. Proximate to the simulated vasculature 16 are simulated fallopian tubes 18 connected to and extending from the simulated uterus 20. The simulated fallopian tube 18 has a tubular / cylindrical shape and can be made of silicone or other elastomeric material, or can include a material such as foam combined with silicone. A simulated peritoneal layer 24 is positioned between the simulated uterus 20 and the simulated colon 22. The simulated peritoneal layer 24 covers the simulated colon 22. A simulated pelvic floor 26 is positioned below the simulated colon 22 and connected to the base 122 of the frame 12. The simulated colon 22 is a tubular structure with a lumen extending longitudinally therethrough. In various embodiments, the simulated colon / rectum 22 is a tubular structure made of silicone with molded transverse folds, and in various embodiments, the simulated peritoneal layer 24 and / or the simulated pelvic floor 26 comprise a flat, planar layer of silicone material. The simulated colon 22 can be made of silicone or other elastomeric material and can be pink or another suitable color.

[0017] Connected at its proximal end to the simulated uterus 20 is at least one simulated tissue structure, which in the illustrated embodiment comprises a simulated uterosacral ligament 32 or 34. The simulated uterosacral ligament 32 or 34 comprises continuous lengths of fibers or filaments embedded in interlaced planar thread material and silicone. In various embodiments, the simulated uterosacral ligament 32 or 34 comprises an elongated monolithic structure of mesh fabric and silicone with threads embedded therein. In various embodiments, the simulated uterosacral ligament 32 or 34 comprises a first inner layer 131 and a second inner layer 132 in close proximity, both of which are surrounded or contained within an outer layer 133. The first inner layer 131 and the second inner layer 132 are made of different materials and have different longitudinal and / or transverse strengths relative to one another. In various embodiments, the first inner layer 131 has a greater length and / or a greater thickness than the second inner layer 132. The outer layer 133 has a shorter length and / or weaker longitudinal and / or transverse strength than the first inner layer 131 and / or the second inner layer 132.

[0018] According to various embodiments, a simulated cervix 21 is connected to the simulated uterus 20, and simulated uterosacral ligaments 32, 34 are connected to the simulated cervix 21. The simulated cervix 21 includes an opening that extends into the cavity defined by the simulated uterus 20. A simulated vaginal canal (not shown) connects the simulated uterus 20 and the simulated cervix 21 to a simulated vaginal opening 28 that surrounds and is attached to the proximal end of the frame 12. The simulated vaginal canal (not shown) is a tubular structure having a proximal end and a distal end. The simulated vaginal canal is made of silicone and, in various embodiments, may optionally include an embedded mesh layer to assist in the connection and / or suspension of the simulated uterosacral ligaments. The simulated vaginal canal is connected to the simulated uterus 20 at one end and has a simulated vaginal opening 28 located at the opposite end of the simulated vaginal canal. The simulated cervix 21 is a tubular structure made of silicone and has an opening at the proximal end. In various embodiments, the simulated cervix 21 has a mesh material for reinforcement. The ends of the simulated uterosacral ligaments 32 or 34, i.e., the ends not connected to the simulated cervix 21, are connected to the simulated pelvic floor 26, for example, via an adhesive. The simulated pelvic floor 26 is connected to the base 122 of the frame 12, for example, via an adhesive. In various embodiments, the simulated vaginal canal (not shown) is a tubular structure made of silicone.

[0019] In various embodiments, the frame 12 is configured to simulate a pelvis and functions as a box-like container for housing multiple simulated organs and tissue structures. The frame 12 comprises multiple semi-rigid plastic elements with portions connected to each other with fasteners and / or adhesive. The area of ​​a central lumen or cavity 125 in a cross section perpendicular to the longitudinal axis gradually increases from the proximal end to the distal end. The frame 12 has a base 122 and can be placed upright on a flat surface. The frame 12 can include apertures for the passage of fasteners and / or the connection of tissue structures, such as simulated blood vessels 16, through which they can be looped and suspended from the frame 12. Like other portions of the simulated surgical training model, the frame 12 includes a portion representing a pelvis, which is not anatomically correct, but provides the benefits necessary to simulate laparoscopic procedures at the expense of the realism of an anatomically correct pelvis. The physical contraction of the organs at the proximal end creates a more rigid response of the organs when manipulated by surgical instruments compared to the distal end, where the organs placed there contract less, swing freely, and react more fluidly to manipulation by surgical instruments. Like other parts of the simulated surgical training model, or models in general, the frame 12 according to various embodiments is an intended simplification of the pelvis, combining the variable resistance of the organs along the length of the longitudinal axis of the central lumen. The small opening to the central lumen at the proximal end of the frame 12 is where the opening to the vaginal canal would be located when organs are placed within the frame 12. The distal end of the frame 12 is where the simulated uterus 20 can be located. Other simulated tissue structures or portions thereof can also be included at or near the distal end of the frame 12, such as the ovarian ligament, ovarian blood vessels, ureter, peritoneum, colon, and fallopian tubes. In various embodiments, the ovarian ligament, ovarian blood vessels, ureter, and fallopian tube are tubular structures with circular cross-sections and are made of silicone, which facilitates connection to other silicone-based structures via silicone-silicone connections. Additionally, the ovarian ligament, ovarian vessels, ureters, and fallopian tubes may be partially or entirely hollow or solid. The central lumen of the frame 12 is elongated, expanded, and angled outward toward the distal end.This taper of the box-like frame relaxes and expands the organs positioned therein, while the narrow proximal end constricts and supports the organs more tightly, thereby relatively restricting the organ's range of motion.

[0020] In various embodiments, the simulated pelvic floor 26 serves as a location for easy silicone-to-silicone attachment, whereas silicone-to-plastic attachment is more difficult to achieve. Silicone adheres easily to silicone, and the simulated pelvic floor 26 simplifies removal of silicone organ structures from the frame 12. The simulated pelvic floor 26 is not an anatomically correct component. Therefore, the model is not an exact reproduction of human anatomy. Nevertheless, the appearance of the model maintains anatomical integrity for the user during procedural training employing laparoscopic procedures. The simulated pelvic floor 26 creates a background for the user. This background does not detract from the realism important to the user, such as simulated organs placed on or attached to the background of the simulated pelvic floor 26.

[0021] In various embodiments, the simulated tissue construct is connected to the frame 12 via adhesion to a support structure. In various embodiments, openings in the frame 12 are used to form a mechanical connection between the simulated tissue construct and the frame 12, utilizing tissue sheets and / or silicone as mechanical links. The portions of the tissue sheets or silicone involved in such connections may not be anatomically corrective and may be used solely for structural and / or aesthetic purposes. In various embodiments, the top cover or roof of the frame 12, positioned opposite the base and / or pelvic floor, does not include openings or holes on either side of the roof adjacent to the frame's sidewalls or at or near the bends, thereby increasing the durability and / or robustness of the roof and the connection therebetween to, for example, reduce potential breakage or shearing during shipping.

[0022] Referring to FIG. 10 , a laparoscopic surgical training device 200 according to various embodiments is shown. The laparoscopic surgical training device 200 provides an internal cavity 208, substantially hidden from the user, for receiving simulated tissue, live tissue, model organs, or training models as described herein. The body cavity 208 is accessed through a tissue simulation region 210 that is penetrated by a user utilizing the device to practice surgical techniques on tissue found to be located within the body cavity 208 or on a training model. While the body cavity 208 is shown accessible through the tissue simulation region 210, a hand-assisted access device, trocar, or single-site port device may alternatively be utilized to access the body cavity 208. An exemplary laparoscopic surgical training device is described in U.S. Patent No. 8,764,452, entitled “Portable Laparoscopic Trainer,” filed September 29, 2011, and incorporated herein by reference in its entirety. The laparoscopic training device 200 is particularly suited for practicing laparoscopic or other minimally invasive surgical procedures.

[0023] The laparoscopic surgical training device 200 includes a top cover 202 connected to and spaced from a base 204 by a plurality of legs 206. The laparoscopic surgical training device 200 is configured to simulate a patient's torso, such as the abdominal region. The top cover 202 represents the front of the patient, and the space between the top cover 202 and the base 204 represents the patient's interior or body cavity in which organs reside. The laparoscopic surgical training device 200 is a useful tool for teaching, practicing, and performing various surgical procedures and associated devices in a simulated patient undergoing a surgical procedure. Surgical instruments are inserted into the cavities through pre-drilled openings 212 in the top cover 202 as well as the tissue simulation area 210. Various instruments and techniques can be used to penetrate the top cover 202 and perform the simulated procedure on the simulated organ or training model disposed between the top cover 202 and the base 204. The base 204 includes a model receiving area 214 or tray (not shown) for staging or holding a simulated tissue model or biological tissue. To aid in holding the simulated tissue model, the tissue model may include a patch of hook-and-loop fastening material attached to the base 204 at the model receiving area 214, allowing it to be removably connected to a complementary hook-and-loop fastener attached to the tissue or organ model. A video display monitor 216 is hinged to the top cover 202 (shown in a closed orientation in FIG. 10 ). The video monitor 216 can be connected to various vision systems for delivering images to the monitor. For example, a laparoscope inserted through one of the pre-established apertures 212, or a webcam placed within the cavity and used to observe the simulated procedure, can be connected to the video monitor 216 and / or a mobile computing device to provide images to a user.

[0024] When assembled, the top cover 202 is positioned directly above the base 204, with the legs 206 positioned substantially near the periphery and interconnected between the top cover 202 and the base 204. The top cover and base are substantially the same shape and size and have substantially the same peripheral contours. The internal cavity is partially or fully concealed. In the illustrated embodiment, the legs include openings to allow ambient light to illuminate the internal cavity and / or to provide lightweight portability. The top cover is detachable from the legs, which are detachable or foldable relative to the base via hinges or the like. The surgical trainer 200 provides a simulated body cavity 208 that is hidden from the user. The internal cavity or body cavity 208 is configured to receive at least one simulated surgical training model, allowing a user to access the model to practice laparoscopic or endoscopic minimally invasive surgical techniques.

[0025] In use, in various embodiments, for example, the simulated surgical training model 100 is placed within the laparoscopic trainer 200. In various embodiments, the inserted model is accessible through a vaginal opening and is configured to simulate transvaginal surgery, including, in various embodiments, a transvaginal hysterectomy. In various embodiments, the aperture at the vaginal opening is circular. In various other embodiments, the aperture is an elongated oval-like shape and is oriented perpendicular or orthogonal to the longitudinal axis of the vaginal opening.

[0026] In various embodiments, a user of the simulated surgical model can access the simulated uterus 20 with surgical instruments and retractors through the vaginal opening to perform a transvaginal hysterectomy. Alternatively, the simulated uterus 20 can be accessed through the simulated abdominal wall of the top cover 202 of the trainer 200. The user can practice laparoscopic techniques, inspect the anatomical structures using trocars and a scope, and perform a simulated surgical hysterectomy. In various embodiments, this procedure involves making a critical incision to remove the uterus and remove it. In various embodiments, an incision can be made within the simulated vaginal canal around the simulated cervix 21 to begin mobilization of the simulated uterus. Simulated uterosacral ligaments 32 or 34, which have sufficient longitudinal and lateral strength, can be manipulated and excised from either side of the simulated cervix 21, sutured to hold them to the outside of the frame 12, and later sutured to the simulated vaginal canal to prevent collapse of the simulated vaginal canal. The simulated uterus 20 can then be detached from the other simulated tissues and exteriorized through the simulated vaginal canal. The simulated uterosacral ligaments 32 or 34, which have sufficient longitudinal and transverse strength, can again be manipulated and sutured to the simulated vaginal canal.

[0027] According to various embodiments, a method for creating simulated tissue structures, such as connective tissue and / or vasculature, e.g., ligaments, blood vessels, etc., and simulated uterosacral ligaments 32, 34, is provided. The method includes providing a mold having a proximal end, a distal end, and a cavity extending between the proximal and distal ends. The method includes providing at least one mesh fabric and at least one thread. In various embodiments, the mesh fabric has a predetermined width and length, and the thread has a length and thickness greater than that of the mesh fabric. The method includes positioning and / or conforming the mesh fabric along the cavity of the mold. In various embodiments, the mesh fabric is curved or arcuately disposed along its length, thus having a curved cross-section. The method further includes filling or injecting silicone into the mold with the mesh fabric inserted into the cavity. The silicone is filled to cover the mesh fabric without filling the entire cavity of the mold. The method further includes positioning the thread on the silicone, centering the thread relative to the cavity, and adding or injecting additional silicone over and around the thread. The silicone is cured or allowed to cure. In various embodiments, the threads and mesh fabric are thereby encased, embedded, or encapsulated within the silicone. In this manner, according to various embodiments, simulated tissue structures such as connective tissue and / or vasculature, including ligaments, blood vessels, etc., can be created that provide enhanced longitudinal and transverse strength. In various embodiments, the proximal or distal portions of the threads are not covered or encased in silicone, and / or in various embodiments, the proximal / distal portions of the threads extend beyond the proximal / distal ends of the mold. In various embodiments, a conductive material, such as a conductive hydrogel, can be used in addition to or instead of silicone.

[0028] According to various embodiments, exposed threads of the simulated tissue construct, e.g., threads not covered by silicone, are inserted into a simulated organ mold, e.g., a cervix mold. According to various embodiments, one or more simulated tissue constructs are inserted into one or more openings or channels in the simulated organ mold. The simulated organ mold is filled with silicone to cover and seal the inserted portions of the one or more simulated tissue constructs. The silicone is cured or allowed to harden, thereby connecting the simulated organ or portion thereof, e.g., the simulated cervix, to one or more simulated tissue constructs, e.g., the simulated uterosacral ligaments. In various embodiments, another simulated organ or portion thereof is provided and connected to one or more simulated organs and / or tissue constructs. For example, a preformed uterus is inserted into the cervix mold along with the inserted portions of one or more simulated tissue constructs and the silicone. The silicone is cured or allowed to harden, thereby connecting the simulated organ or portion thereof to one or more simulated tissue constructs. For example, a simulated uterus, simulated cervix, and simulated uterosacral ligaments are connected.

[0029] In various embodiments, a simulated tissue structure, such as a simulated uterosacral ligament 32 or 34, is provided and comprises interlaced planar thread material and continuous lengths of fibers or filaments embedded in silicone. In various embodiments, a simulated tissue structure, such as a simulated uterosacral ligament 32 or 34, is provided and comprises a first inner material or layer 131, a second inner material or layer 132, and an outer layer or material 133. In various embodiments, the first inner material or layer 131, the second inner material or layer 132, and the outer material or layer 133 are different or not the same material. In various embodiments, the first inner material or layer 131 comprises thread, twine, cord, strand, fiber, cable, and / or any combination thereof. In various embodiments, the second inner material or layer 132 comprises a mesh fabric, Tulle®, Kevlar®, fiberglass mesh, neoprene mesh, netting, webbing, grid, screen, and / or any combination thereof. In various embodiments, the outer material or layer 133 comprises a non-conductive silicone, a conductive hydrogel, or other conductive material, and / or any combination thereof.

[0030] In various embodiments, mesh fabrics and threads are embedded in silicone to provide durability or enhanced material strength for ligaments, vasculature, and / or other anatomical or surgical models used in various simulated surgical procedures. According to various embodiments, artificial or simulated tissue constructs include one or more thread portions extending through or embedded in the simulated tissue construct to enhance the longitudinal strength of the simulated tissue construct. According to various embodiments, simulated tissue constructs include one or more mesh portions extending through or embedded in the simulated tissue construct to enhance the longitudinal and lateral strength of the simulated tissue construct.

[0031] Various portions of various embodiments of the simulated organ and / or vasculature system can be made from one or more organic-based polymers, including, but not limited to, inorganic-based polymers such as hydrogels, single-polymer hydrogels, multi-polymer hydrogels, rubber, latex, nitrile, proteins, gelatin, collagen, soy, thermoplastic elastomers, KRATON polymers, silicones, foams, silicone-based foams, urethane-based foams, and ethylene vinyl acetate foams. One or more fillers can be used with any of the base polymers, including, for example, cloth, woven or nonwoven fibers, polyester, nylon, cotton and silk, graphite, platinum, silver, gold, copper, miscellaneous additives, gels, oils, cornstarch, glass, dolomite, carbonate minerals, alcohols, deadeners, silicone oils, pigments, foams, poloxamers, collagen, gelatin, and the like. Adhesives that can be employed include, but are not limited to, cyanoacrylates, silicones, epoxies, spray adhesives, rubber adhesives, and the like.

[0032] The simulated surgical training model, according to various embodiments, is not anatomically correct, yet includes portions of simulated tissue structures, layers, and / or organs, etc., that provide necessary or useful structures in simulating surgical, e.g., laparoscopic, procedures, e.g., at the expense of anatomical accuracy. Similarly, the simulated surgical training model, according to various embodiments, provides intentional simplification, e.g., not including tissues, organs, or the like, typically found in a patient, to emphasize and / or provide a repeatable, consistent, and practical surgical training model to aid in the simulation, training, and evaluation of surgical procedures.

[0033] The above description is provided to enable any person skilled in the art to make and use the invention and to practice the methods described herein, and describes the best mode contemplated by the inventors for carrying out the invention. However, various modifications will still be apparent to those skilled in the art. These modifications are contemplated to be within the scope of the present disclosure. Different embodiments or aspects of such embodiments may be shown in the various figures and described throughout the specification. However, it should be noted that each embodiment and aspect thereof, although shown or described separately, can be combined with one or more of the other embodiments and aspects thereof, unless expressly stated otherwise. The fact that each combination has not been explicitly specified is solely for the sake of readability of the specification.

[0034] While the present invention has been described in certain specific aspects, many additional modifications and variations will be apparent to those skilled in the art. It is therefore to be understood that the present invention can be practiced otherwise than as specifically described, including various changes in size, shape, and materials, without departing from the scope and spirit of the invention. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive. [Explanation of symbols]

[0035] 28 Simulated vaginal opening 100 Simulated Surgical Training Models 124 Side wall

Claims

1. A simulated tissue structure, a first inner layer comprising a continuous length of fibers; a second inner layer comprising interlaced planar thread material; an outer layer surrounding the first inner layer and the second inner layer, the outer layer comprising a material different from that of the first inner layer and the second inner layer; Equipped with The simulated tissue structure, wherein the first and second inner layers provide longitudinal strength to the simulated tissue structure.

2. The simulated tissue structure of claim 1 , wherein the outer layer comprises a non-conductive silicone.

3. The simulated tissue structure of claim 2 , wherein a portion of the first inner layer extends beyond the outer layer and is configured to connect with another simulated organ.

4. The simulated tissue structure described in claim 3, wherein the other simulated organ includes a simulated cervix connected to a portion of the first inner layer.

5. The simulated tissue structure of claim 1 , wherein the first inner layer has a greater length than the second inner layer.

6. The simulated tissue structure of claim 1 , wherein the first inner layer has a thickness greater than the second inner layer.

7. The simulated tissue structure of claim 1 , wherein the outer layer comprises an electrically conductive material.

8. A simulated tissue structure described in any one of claims 1 to 7, wherein the first inner layer and the second inner layer have different longitudinal strengths relative to each other.

9. A simulated tissue structure described in any one of claims 1 to 7, wherein the outer layer has a longitudinal strength weaker than that of the first inner layer or the second inner layer.

10. A simulated tissue structure described in any one of claims 1 to 7, wherein the first inner layer has a length and thickness greater than the length and thickness of the second inner layer.

11. A simulated tissue structure described in any one of claims 1 to 7, wherein the first inner layer comprises a thread.

12. A simulated tissue structure described in any one of claims 1 to 7, wherein the second inner layer provides transverse strength to the simulated tissue structure.

13. A simulated tissue structure described in any one of claims 1 to 7, wherein the second inner layer comprises a mesh fabric.

14. A simulated tissue structure described in any one of claims 1 to 7, wherein the first inner layer, the second inner layer, and the outer layer form an elongated monolithic tubular member or tube, with the first inner layer and the second inner layer embedded in the outer layer.

15. A method for producing the simulated tissue structure of claim 1, comprising: providing a mold having a proximal end, a distal end, and a cavity extending between the proximal end and the distal end; providing the first inner layer; providing the second inner layer; conformally placing the first inner layer in the cavity of the mold; partially filling the mold with silicone to cover the second inner layer; disposing the first inner layer over the outer layer; filling the mold with additional silicone over the first inner layer; curing the silicone and the additional silicone in the mold to form the outer layer, the outer layer having the first inner layer and the second inner layer contained therein; A method comprising:

16. The method of claim 15, wherein the first inner layer has a length and thickness greater than the length and thickness of the second inner layer.

17. The method of claim 16, wherein the second inner layer is curved along its length to have a curved cross-section.

18. The method described in claim 17, wherein the first inner layer is positioned centrally relative to the cavity.

19. The method of claim 16, wherein a portion of the first inner layer is not covered by the silicone or the additional silicone.

20. The method of claim 15, wherein a portion of the first inner layer extends beyond the distal end of the mold.

21. 21. The method of claim 20, further comprising inserting a portion of the first inner layer extending beyond the proximal end of the mold into one or more openings in one or more simulated organ molds to connect the simulated tissue construct to another simulated organ.

22. The method of claim 15 further comprising adding a conductive material to the mold along with the silicone.

23. The method of claim 15, wherein the silicone has a longitudinal strength that is weaker than the interlaced planar thread material.

24. A method described in any one of claims 15 to 23, wherein the first inner layer, the second inner layer, and the outer layer are formed as the elongated monolithic tubular member or tube.

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