Gynecologic pathology surgery simulation model and system for surgical training

Abstract

Embodiments of the present invention provide GYN pathology simulation models for surgical training. These models are energy compatible models that emulate tissue-based diseases of the female reproductive system that allow surgical trainees and surgeons to practice advanced OB / GYN surgical skills. One simulated GYN model includes an elongated conductive tube enclosing a mass of non-conductive material. The elongated tube has a sidewall including an inner surface and an outer surface extending between a proximal end and a distal end. The sidewall is configured to have a cavity of a specific volume that creates an external bulge when filled with the mass of non-conductive material. Another simulated GYN model includes a fluid-filled cyst enclosed within a conductive bulbous hollow structure. The fluid-filled cyst is selectively adhered to the bulbous hollow structure in at least one or more regions to form a plane for combined blunt and sharp dissection.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63 / 227,502, entitled "Ectopic Pregnancy Model," filed on July 30, 2021, and U.S. Provisional Patent Application Serial No. 63 / 227,530, entitled "Ovarian Cyst Torsion Model," filed on July 30, 2021, which are hereby expressly incorporated by reference in their entireties for all purposes.

[0002] The present invention relates generally to surgical training tools and, in particular, but not exclusively, to a gynecological (GYN) pathology surgical simulation model and system for teaching and practicing various surgical techniques and procedures associated with laparoscopic, endoscopic and minimally invasive surgery. [Background technology]

[0003] Ectopic pregnancy and ovarian torsion both represent surgical emergencies. An ectopic or extrauterine pregnancy is a pregnancy that occurs when a fertilized egg implants and develops outside the main cavity of the uterus. In over 90% of cases, the egg implants in the fallopian tube, also called a tubal ectopic pregnancy. In the remaining cases, the egg implants in the cervix, ovary, abdomen, or uterine muscle. Ectopic pregnancy remains the number one cause of death in early pregnancy, accounting for approximately 3-4% of all pregnancy-related deaths. Laparoscopic surgery remains the cornerstone of treatment for tubal ectopic pregnancy. Surgical approaches for ectopic pregnancy have evolved from radical surgery (salpingectomy) to conservative treatment (salpingostomy). Salpingectomy is the surgical removal of one or both fallopian tubes. Salpingostomy, on the other hand, is a procedure in which the contents of the fallopian tube are removed by making a tubal incision across the pregnancy site. This procedure is considered the surgical procedure of choice when a woman is found to have an unruptured tubal pregnancy, with the aim of preserving the fallopian tubes for future pregnancies.

[0004] On the other hand, ovarian torsion, also called adnexal pedicle torsion, refers to a complete or partial rotation of the adnexal supporting organ, often resulting in partial or complete blockage of the blood supply to the ovary. This condition occurs mainly when the ovaries and sometimes the fallopian tubes twist on the ligament-like tissue that supports and holds these organs in place. Ovarian torsion can affect women of all ages, including premenopausal and postmenopausal women. In more than 80% of cases, ovarian torsion occurs due to an ovarian cyst or mass larger than 5 cm in diameter. Of these, approximately 20% of ovarian torsion cases occur in pregnant women. Noncystic ovarian torsion is more common in young children, whose ovaries are prone to torsion due to developmental abnormalities. Early diagnosis of ovarian torsion is necessary to preserve ovarian function and prevent other complications.

[0005] As with ectopic pregnancy, surgery is the mainstay of treatment for ovarian torsion. It is also the only way to confirm torsion. Regardless of the appearance of the ovary, a minimally invasive surgical approach to detorsion and preserve the adnexal structures is recommended. The majority of benign ovarian cystectomies and ovarian detorsion procedures can be performed laparoscopically. Prior to laparoscopic surgery, baseline workup for ovarian malignancy risk assessment should be completed. Conservative treatment is considered the treatment of choice for ovarian detorsion and ovarian cystectomy. However, in cases where tissue is necrotic, definitive procedures such as surgical removal of the ovaries (oophorectomy) or both the ovaries and fallopian tubes (salpingo-oophorectomy) may be the treatment of choice.

[0006] Ovarian torsion is a rare but surgical emergency that requires rapid diagnosis and laparoscopic intervention to ensure preservation of ovarian function. However, this condition is considered to be rarely encountered during medical training. On the other hand, ectopic pregnancy is also rarely encountered during medical training, even though it is increasing worldwide. Thus, there is a growing concern among OB / GYN trainees about the insufficient training opportunities for minimally invasive gynecologic surgery. There is also a growing common concern regarding the adequacy of surgical training, especially laparoscopic surgery, during the traditional four-year OB / GYN residency. This is problematic for trainees who need realistic and easy-to-follow training before entering the operating room. There are also few options for high-fidelity, energy-compatible simulation models that allow surgical trainees to practice laparoscopic removal of ectopic masses and / or detorsion and removal of ovarian cysts. The organs in the model must not only be simulated to closely resemble living organisms, but also be able to move and manipulate as if they were in the body. Additionally, the organs on the model must be attached to the model so that they can be moved and positioned into the optimal surgical position.

[0007] Additionally, many surgical procedures use energy-based surgical instruments, such as electrosurgical graspers, scissors, tweezers, blades, probes, or dissectors. These instruments provide surgeons with the convenience of nearly instantaneous thermal hemostasis to reduce blood loss while cutting and dissecting tissue with little force. Such instruments have become standard within the surgical community and are routinely used in a variety of procedures. Thus, there is a need for an organ model, simulated tissue element, or training module that includes the ability to train in the use of energy-based or electrosurgical surgical instruments. Thus, it may be apparent that there is a need for a realistic organ model in conjunction with a simulated pelvis trainer on which surgeons can train their surgical skills. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Pat. No. 8,764,452 Summary of the Invention [Means for solving the problem]

[0009] According to various embodiments, GYN (gynecological) pathology surgery simulation models or systems for surgical training are provided. These models or systems are energy-compatible models that simulate tissue-based diseases of the female reproductive system to allow surgical trainees and surgeons to practice advanced OB / GYN surgical skills such as salpingostomy, ovarian cystectomy, ovarian cystectomy and detorsion, as well as other basic OB / GYN surgical skills such as suturing. In various embodiments, a monopolar electrosurgical instrument is used to deliver RF energy to the simulated surgical site to incise the simulated target tissue and remove and / or sever the simulated abnormality.

[0010] According to one aspect of the present invention, a gynecological pathology surgery simulation system is provided. The GYN pathology surgery simulation system can include a tubular structure defining a central lumen extending between a proximal end and a distal end along a longitudinal axis, and an adhesive material enclosed within a cavity formed along at least a portion of the central lumen to produce an external bulge when filled with the adhesive material. The adhesive material according to an embodiment of the present invention can include a water-insoluble material and a non-conductive material. In various embodiments, the adhesive material is heterogeneous and formed from a fibrous material or a liquid fiber mixture.

[0011] According to a second aspect of the present invention, there is provided a method of manufacturing a gynecological pathology surgery simulation system, the method including the steps of providing a mandrel, suspending the mandrel within a two-part mold cavity, applying a layer of conductive material onto the mandrel, curing the layer of conductive material to form a thin-walled tubular structure defining a central lumen, providing an adhesive material, and encapsulating the adhesive material within a cavity formed along a portion of the thin-walled tubular structure.

[0012] According to a third aspect of the present invention, a gynecological pathology surgery simulation system is provided. The gynecological pathology surgery simulation system can include a simulated fallopian tube having a sidewall including an inner surface and an outer surface extending between a proximal end and a distal end and defining a central lumen along a longitudinal axis. The sidewall of the simulated fallopian tube according to embodiments of the present invention is configured to encapsulate a simulated ectopic mass or embryo at a location along the longitudinal axis such that the location of the simulated ectopic mass or embryo is identifiable from outside the simulated fallopian tube. The simulated ectopic mass or embryo in various embodiments is formed of a non-aqueous and non-conductive material and the simulated fallopian tube is formed of a conductive material. In various embodiments, the simulated ectopic mass or embryo is formed of a batting mixture of single-part platinum-cured silicone thermoset in a ratio of 9 grams to 2 cm by 2 cm.

[0013] According to a fourth aspect of the present invention, a surgical simulation system is provided. The surgical simulation system may include an ectopic pregnancy model and a surgical training device configured to mimic a torso. The ectopic pregnancy model according to various embodiments includes a simulated fallopian tube having a tubular structure defining a central lumen extending between a proximal end and a distal end along a longitudinal axis, the tubular structure being formed of a conductive material, and an adhesive material encapsulated within a cavity formed along at least a portion of the central lumen to produce an external bulge when filled with the adhesive material. The surgical training device according to an embodiment of the present invention may include a base and a top cover, the top cover being connected to and spaced apart from the base to define an internal cavity between the top cover and the base. The internal cavity of the surgical training device is partially hidden from direct observation by a user, and the top cover includes an aperture or penetrable simulated tissue area for accessing the internal cavity. The ectopic pregnancy model in various embodiments is configured to be placed on a ground pad contained within a GYN pathology tray configured to be insertable within the internal cavity of the surgical training device.

[0014] According to various embodiments, a gynecological pathology surgery simulation system is provided. The gynecological pathology surgery simulation system may include an elongated tube having a central lumen extending between a proximal end and a distal end along a longitudinal axis, and an encapsulated curved body attached to the elongated tube and extending in a transverse direction relative to the longitudinal axis and larger than the elongated tube. In various embodiments, the elongated tube is or represents one or more portions of a simulated fallopian tube and / or a simulated ovarian cyst capsule. In various embodiments, the encapsulated curved body is or represents a simulated uterus. In various embodiments, only a portion of the encapsulated curved body is formed of a conductive material. In various embodiments, a portion of the elongated tube is raised relative to the encapsulated curved body. The gynecological pathology surgery simulation system further includes a conductive pad removably attached to the encapsulated curved body. In various embodiments, the conductive pad is electrically / conductively attached to only a portion of the encapsulated curved body formed of a conductive material.

[0015] According to another aspect of the present invention, a gynecological pathology surgery simulation system is provided. The gynecological pathology surgery simulation system can include a fluid-filled cystic body enclosed within a bulbous hollow structure having a proximal extension at a proximal end and a distal extension at a distal end. In various embodiments, the fluid-filled cystic body is selectively adhered to the bulbous hollow structure at least in one or more regions of an interface between the fluid-filled cystic body and the bulbous hollow structure to provide a plane for combined blunt and sharp dissection.

[0016] According to another aspect of the present invention, a gynecological pathology surgery simulation system is provided. The gynecological pathology surgery simulation system may include a tubular structure defining a central lumen extending between a proximal end and a distal end along a longitudinal axis, a bulbous hollow structure enclosing a fluid-filled cystic body, and / or an ultra-thin sheet cut into a desired pattern and / or having a thickness of 1 mm or less. The bulbous hollow structure further includes a proximal extension at the proximal end and a distal extension at the distal end. The ultra-thin sheet and the tubular structure in various embodiments are appendages arranged to facilitate twisting and untwisting of the bulbous hollow structure around at least one of the proximal extension and the distal extension.

[0017] According to yet another aspect of the present invention, there is provided a method of manufacturing a gynecological pathology surgery simulation system, the method including the steps of providing a fluid-filled cyst, coating the fluid-filled cyst with a thickening agent, providing a two-piece molded cavity having a shape conforming to the shape of the fluid-filled cyst having a proximal extension at a proximal end and a distal extension at a distal end that is longer than the proximal extension, and encapsulating the thickening agent-coated fluid-filled cyst in a conductive material.

[0018] According to yet another aspect of the present invention, there is provided a gynecological pathology surgery simulation system that may include a simulated ovarian cyst capsule having a bulbous structure with a proximal extension at a proximal end and a distal extension at a distal end, and a simulated fallopian tube defining a central lumen extending along a longitudinal axis between the proximal and distal ends. The simulated ovarian cyst capsule and simulated fallopian tube are attached to the simulated mesasalpinx sheet using a flexible adhesive technique to allow twisting and untwisting of the ovarian cyst with or without the simulated fallopian tube.

[0019] According to yet another aspect of the present invention, a surgical simulation system is provided. The surgical simulation system can include an ovarian cyst pedicle torsion model and a surgical training device configured to mimic a torso. The ovarian cyst torsion model according to various embodiments can include a simulated ovarian cyst capsule having a bulbous structure with a proximal extension at a proximal end and a distal extension at a distal end, a simulated fallopian tube having a sidewall including an inner surface and an outer surface extending between the proximal and distal ends and defining a central lumen along a longitudinal axis, and a simulated mesasalpinx sheet cut into a desired pattern to connect to the simulated ovarian cyst capsule and the simulated fallopian tube. The surgical training device according to an embodiment of the present invention can include a base and a top cover, the top cover connected to and spaced from the base to define an interior cavity between the top cover and the base. The interior cavity of the surgical training device is partially hidden from direct observation by a user, and the top cover includes an aperture or penetrable simulated tissue area for accessing the interior cavity. The ovarian cyst pedicle torsion model in various embodiments is configured to be placed on a ground pad contained within a GYN pathology tray configured to be insertable within the interior cavity of the surgical training device.

[0020] Many of the attendant features of this invention will become readily appreciated as the same becomes better understood by reference to the above and following descriptions and by consideration of the accompanying drawings in which like reference characters refer to like parts throughout.

[0021] The present disclosure will now be described with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 illustrates a top view of an ectopic pregnancy model according to an embodiment of the present invention. [Diagram 2] FIG. 1 illustrates an exploded top view of an ectopic pregnancy model in accordance with an embodiment of the present invention. [Diagram 3] FIG. 1 illustrates an ectopic pregnancy model placed on a ground pad in a GYN pathology tray, according to an embodiment of the present invention. [Figure 4] FIG. 13 shows images of an ectopic mass after removal from a simulated fallopian tube. [Diagram 5] FIG. 1 illustrates a top view of an ovarian cyst pedicle torsion model according to an embodiment of the present invention. [Figure 6] FIG. 1 illustrates an exploded top view of an ovarian cyst pedicle torsion model in accordance with an embodiment of the present invention. [Figure 7] FIG. 1 illustrates an ovarian cyst pedicle torsion model placed on a ground pad in a GYN pathology tray, according to an embodiment of the present invention. [Figure 8] FIG. 1 illustrates a top perspective view of a laparoscopic trainer for use with an ectopic pregnancy model, in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] In the accompanying figures, similar components and / or features may have the same reference label. Furthermore, various components of the same type may be distinguished by following the reference label with a dash and a second label that distinguishes between the similar components. When only a first reference label is used in this specification, the description applies to any one of the similar components having the same first reference label, regardless of the second reference label.

[0024] The following description merely illustrates an example embodiment(s) and is not intended to limit the scope, applicability, or configuration of the present disclosure. Rather, the following description of the example embodiment(s) is intended to provide one of ordinary skill in the art with an enabling description for implementing the example embodiments of the present disclosure. It should be understood that various changes can be made in the function and arrangement of elements without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0025] The present disclosure relates generally to simulated tissue structure and organ models. In particular, the present disclosure relates to gynecological (GYN) pathology surgery simulation models and systems, such as an ectopic pregnancy model and an ovarian cyst pedicle torsion model, to assist surgical trainees and surgeons in acquiring full surgical skills before entering the operating room.

[0026] To this end, an ectopic pregnancy model for laparoscopic surgery according to an embodiment of the present invention is provided. The model is an energy-compatible model that simulates an ectopic pregnancy and allows surgical trainees to practice the corresponding surgical procedure. To simulate the anatomy involved in the procedure, the simulated ectopic mass emulates the fragility of a blood clot to realistically simulate a semi-solid mass that may break when subjected to excessive force. The simulated fallopian tube also encapsulates the simulated ectopic mass and is compatible with an electrosurgical device. The model also includes other appendages, such as a simulated uterus. The ectopic pregnancy model according to an embodiment of the present invention allows surgical trainees to train in bimanual dexterity, tissue handling, use of electrosurgical instruments, and / or camera orientation.

[0027] First, an embodiment of an ectopic pregnancy model 100 is shown in Figs. 1-2. In this regard, Fig. 1 is a top view of the ectopic pregnancy model 100, and Fig. 2 is an exploded top view. As shown in these figures, the ectopic pregnancy model 100 can include a simulated ectopic mass or embryo 120. According to an embodiment of the present invention, the simulated ectopic mass or embryo 120 has a viscous and is not aqueous. In various embodiments, the simulated ectopic mass or embryo 120 is formed of a non-aqueous and non-conductive material. In some embodiments, the simulated ectopic mass or embryo 120 includes a fibrous material and / or uncured silicone. According to various embodiments, the simulated ectopic mass or embryo 120 of the present invention is formed from a mixture of a one-part platinum-cured silicone thermoset and a batting. It is noted that this mixture does not include any aqueous or water-soluble material, which solves the problem of absorption by surrounding conductive tissue. To emulate the fragility and consistency of a human embryo, 9 grams of one part SORTA-Clear™ silicone part A or part B is used with a 2 cm x 2 cm batting. This ratio has proven effective in recreating an embryonic-like consistency. Other one-part platinum-cure silicone thermosets, such as Ecoflex®, Dragon Skin®, etc., can also be used to achieve similar properties.

[0028] Colorants can also be added to the above mixture to closely emulate the natural color of the human embryo. In some embodiments, food colorings such as red food coloring (310 uL) and blue food coloring (15.5 uL) are added to the mixture of one-part platinum-cured silicone thermoset and 2 cm x 2 cm batting to maximize realism and anatomical accuracy. In other embodiments, acrylic inks can be added to the mixture to mimic a realistic appearance. In select embodiments, dry mineral pigments such as non-aqueous colorants are used as the colorants of choice in the mixture of one-part platinum-cured silicone thermoset and 2 cm x 2 cm batting. This avoids potential color leaching throughout the fallopian tube, thus extending the shelf life of the product. By way of example and not limitation, dry mineral pigments for red colorants can include 1,2-dihydroxyanthraquinones such as Alzarin Red Lake, organic synthetics, quinacridones such as Primary Red, and carbon and calcium phosphates such as Ivory Black. For brown colorants, iron oxide (Fe2O3), which may also include manganese silicate or manganese dioxide, may be used as the colorant of choice, depending on the shade of brown selected.

[0029] In various embodiments, the filling can be formed from any suitable fibrous material. Examples of such materials can include cotton (e.g., wool) and gluten fibers (e.g., seitan). In some embodiments, the filling can be formed from a felt fabric made from natural fibers. In other embodiments, the filling can be formed from a natural sponge made from vegetable fiber sponge and / or animal fiber sponge. In select embodiments, the filling can be formed from a foam.

[0030] According to various embodiments, the simulated ectopic mass or embryo 120 can be formed with mineral oil gel compositions and batting. By way of example and not limitation, such compositions can include HYNAP® HT100 and KRATON® G1651 at a dilution ratio of (12-13:1). In some embodiments, a high purity silicone gel, such as Nusil® silicone-based gel, can be used with the batting. In optional embodiments, the batting can be used with a mixture of sodium polyacrylate and gelatin, or a mixture of sodium polyacrylate, glue, and borax. In one embodiment, a petroleum jelly, such as Vaseline® jelly, can be used with the batting suspension. In another embodiment, a mixture of a combination of soft wax and oil can be used with the batting. In yet another embodiment, a ballistics gelatin with dilatant fluid can be used with the batting, if desired. In other embodiments, any suitable conductive material may be used with the batting. Other suitable products, compositions and / or solutions may be used with the batting. Examples of such products may include coagulated blood products, costume "blood" products, and food products.

[0031] As further described above and also shown in FIGS. 1-2, an ectopic pregnancy model 100 according to an embodiment of the present invention may further include a simulated fallopian tube 140. The organ model may be dissected using an electrosurgical instrument while encapsulating a simulated ectopic mass or embryo 120. The location of the embryo should also be identifiable from the outside of the organ model to assist a user in identifying items of interest, such as the location of the simulated ectopic mass or embryo 120. In various embodiments, the simulated fallopian tube 140 of the present invention is a hollow structure formed of a conductive material or tissue. As can be seen more clearly in FIG. 2, the simulated fallopian tube 140 may include a tubular structure defining a central lumen extending between a proximal end and a distal end along a longitudinal axis. The central lumen gradually expands from the proximal end toward the distal end to form a frustoconical sidewall having an outer surface and an inner surface extending between the proximal end and the distal end. In some embodiments, the proximal end of the sidewall may be closed.

[0032] According to various embodiments, a thin-walled structure is formed by suspending a mandrel within a two-part molded cavity. The thin-walled structure can have a thickness of 2 mm or less. The mandrel according to embodiments of the present invention has the shape of a real fallopian tube to provide a realistic appearance and cavity size. To determine the volume of space required for the embryo, the mandrel is modified at a location along its longitudinal axis. Specifically, a portion of the mandrel is modified to have a larger diameter along the longitudinal axis compared to the remainder of the mandrel. This larger diameter creates a space or cavity that allows for the placement of the simulated ectopic mass or embryo 120. Thus, according to various embodiments, the simulated fallopian tube 140 is molded to have a cavity of a specific volume that creates a realistic external bulge or bulge when the simulated ectopic mass 120 is inserted therein (as shown in FIG. 3). This external bulge or bulge makes this feature useful for the function of the model 100 by helping to identify the location of an ectopic pregnancy.

[0033] After determining the fallopian tube cavity size and embryo volume ratio, according to various embodiments, the simulated ectopic mass or embryo 120 is encapsulated or otherwise positioned within the simulated fallopian tube cavity. In one embodiment, the simulated ectopic mass or embryo 120 can be injected and encapsulated within the simulated fallopian tube cavity using a syringe. To this end, the syringe is first filled with the simulated embryo material and then injected through the distal end of the simulated fallopian tube 140 into the space formed for the embryo within the simulated fallopian tube cavity. The filling and injection steps can be repeated multiple times to complete the encapsulation process. Care should be taken to ensure that any air is expelled during the encapsulation process. Once the simulated embryo material is fully injected into the designated space within the simulated fallopian tube cavity, the simulated ectopic mass or embryo 120 is encapsulated within the simulated fallopian tube 140, for example, using a conductive tissue cap (not shown). In some embodiments, the conductive tissue cap is glued in place using an adhesive such as Loctite® adhesive.

[0034] In various embodiments, the conductive material of the simulated fallopian tube 140 can be formed from a double network hydrogel (DN gel). The ionic structure of this type of hydrogel creates a realistic response to electrosurgical instruments, allowing electrosurgical instruments, such as monopolar / bipolar surgical instruments, to be used with the model. Electrosurgical instruments, such as monopolar / bipolar surgical instruments, can be used to incise the thin wall of the fallopian tube to access and remove the simulated ectopic mass or embryo 120. In some embodiments, hydrogel fibers can be used to form the simulated fallopian tube 140. Examples of these hydrogel fibers include a fibrous structure saturated with saline or vinegar solution, and a fibrous structure with a surface coated with Surgilube® lubricant. In other embodiments, a fibrous fabric coated with a conductive solution can be used to form the simulated fallopian tube 140.

[0035] With further reference to FIGS. 1-2, the ectopic model 100 may further include a simulated uterus 160. The simulated uterus 160 according to an embodiment of the present invention serves as an attachment point for the simulated fallopian tubes 140 and provides a large surface area for electrical grounding purposes. This configuration provides a reference point for surgical trainees and surgeons to interact with the simulated fallopian tubes 140 while simultaneously training in bimanual dexterity and tissue handling. In various embodiments, the simulated uterus 160 may have a solid, monolithic, or hollow structure. In various embodiments, the simulated uterus 160 is a solid structure or portion thereof formed of an electrically conductive material or tissue. The electrically conductive material forming the simulated uterus 160 may include an electro-conductive hydrogel formulation. In one embodiment, the simulated uterus 160 is formed of a metal puck. In another embodiment, the simulated uterus 160 is formed of a natural or synthetic sponge saturated with an electrolyte solution.

[0036] In various embodiments, the simulated uterus 160 is shaped as a half uterus with half or various portions / volumes of the uterus located adjacent to a grounding pad formed of, for example, conductive material to increase surface area for electrical grounding purposes and reduce overall costs associated with manufacturing. Attaching the simulated fallopian tube 140 to the simulated uterus 160 by conventional techniques, such as using adhesives, may not provide consistent electrical current flow. To ensure a continuous electrical pathway between the simulated organs, the simulated fallopian tube 140 according to an embodiment of the present invention is overmolded into the simulated uterus 160. Means for grounding the ectopic pregnancy model 100 or any other GYN pathology simulation model are described in more detail below.

[0037] 3, an ectopic pregnancy model 100 is shown disposed within a GYN pathology tray 50 according to an embodiment of the present invention. The GYN pathology tray 50 ("tray 50") is configured to receive the ectopic pregnancy model 100 and is configured to house or include a grounding pad 10 that is removably connectable to an electrosurgical generator (not shown). The grounding pad 10 is configured to contact the ectopic pregnancy model 100 or a portion thereof and is disposed between the model 100 and the tray 50. As shown in FIG. 3, a simulated uterus 160 according to various embodiments is disposed and attached to the grounding pad 10 of the present invention to provide a connection to ground between the simulated fallopian tube 140 and the grounding pad 10. In some embodiments, the simulated uterus 160 can be attached to the grounding pad 10 using an adhesive. The grounding pad 10 and one side of the tray 50, such as the left side, are further provided with a ground connection 12 for connection of a ground wire.

[0038] In various embodiments, the tray 50 can include a flat, planar surface having a channel or cavity. The cavity can extend circumferentially along and near the edge of the tray. The cavity is configured to collect liquid or viscous materials, such as substances expelled from the simulated organ model. The tray 50, or a portion thereof, is configured to be impermeable. The tray 50 is configured to direct liquids into the circumferential cavity. The tray 50 can include a central top that is raised or elevated above the circumferential portion of the tray, the circumferential cavity, or a portion thereof. One or more tapered surfaces can extend from the raised central top toward the circumferential cavity. In one embodiment, the tray 50 can include upper and lower surfaces that are both planar and disposed parallel to one another. The lower surface, the upper surface, or both of these surfaces can include one or more protrusions or projections, such as upper and / or lower surface supports, attached to or integral with the respective surfaces, and disposed between the upper and lower surfaces to form the raised central top of the tray. The tray 50 may further include one or more slots disposed about the circumferential cavity and outer edge or periphery of the tray, the one or more slots configured to receive a model support configured to connect to a portion of the simulated organ model.

[0039] In various embodiments, the model 100 includes an elongated tube formed of a conductive material having a central lumen extending between a proximal end and a distal end along a longitudinal axis, and an encapsulating flexure that is larger than the elongated tube and that is attached to the elongated tube and extends in a direction transverse to the longitudinal axis. In various embodiments, only a portion of the encapsulating flexure is formed of a conductive material. In various embodiments, a conductive pad is removably attached to the encapsulating flexure. In various embodiments, a conductive pad is electrically / conductively attached to only a portion of the encapsulating flexure formed of a conductive material. In various embodiments, the elongated tube is not in direct contact with the conductive pad. In various embodiments, a monopolar electrosurgical instrument is positioned to transmit RF energy between the elongated tube that is not in direct contact with the conductive pad and the encapsulating flexure that is in direct contact with the conductive pad. In various embodiments, the encapsulating flexure does not include access to the interior of the encapsulating flexure.

[0040] In various embodiments, a non-conductive material mass is disposed within the elongated tube. In various embodiments, the non-conductive material mass is heterogeneous and semi-solid and disposed within a cavity within a central lumen of the elongated tube. In various embodiments, the non-conductive material mass has a higher viscosity than the elongated tube or the encapsulating flexure. In various embodiments, the non-conductive material mass comprises a liquid fibrous mixture. In various embodiments, the non-conductive material mass comprises a fibrous material. In various embodiments, the non-conductive material mass is disposed such that it is removable from the elongated tube through a break in the elongated tube. In various embodiments, the non-conductive material mass has a width that is greater than a diameter of a portion of the elongated tube connected to the encapsulating flexure. In various embodiments, the non-conductive material mass has a length that is less than a length of the elongated tube.

[0041] The steps involved in performing a surgical procedure to remove an ectopic pregnancy are described in more detail below. A trainee practices laparoscopic salpingostomy by placing an ectopic pregnancy model 100 in a simulated laparoscopic environment, such as a laparoscopic surgical training device or laparoscopic trainer. For this purpose, the model 100 is first connected to the ground pad 10 of a GYN pathology tray 50 and then inserted into the internal cavity of the laparoscopic trainer. The tray 50 can also be fastened to the bottom of the laparoscopic trainer using fastening means. In one embodiment, the model 100 can be attached to the internal cavity of the laparoscopic trainer using a hook-and-loop type fastening means below the tray 50, such as below the lower surface of the tray. The trainee then grasps and manipulates the fallopian tube to orient it in the optimal surgical position. A scalpel or other electrosurgical instrument is used to make a longitudinal incision in the fallopian tube wall. The trainee then grasps and extracts the simulated ectopic or embryo 120 from the fallopian tube 140. An examination is then performed to remove any remaining remnants of the embryo, after which the incision in the fallopian tube is either sutured closed or left open in place.

[0042] 4 shows an image of an ectopic mass after removal from a simulated fallopian tube 140 according to an embodiment of the present invention. For the surgery to be considered successful, the embryo must be completely removed from the fallopian tube. The removal according to an embodiment of the present invention consists of one "main" lesion and several smaller lesions. In a laparoscopic salpingectomy, both the ectopic pregnancy and the fallopian tube are removed.

[0043] In another embodiment, the ectopic pregnancy model 100 is formed as part of another, larger model or tissue structure. By way of example, the ectopic pregnancy model 100 according to an embodiment of the present invention can be part of an abdominal organ model or a pelvic model that is sized and configured to be placed inside a laparoscopic surgical training device, which is described in more detail below.

[0044] According to another aspect of the present invention, an ovarian cyst pedicle torsion model for laparoscopic surgery is also provided. The model is an energy-compatible model that simulates an ovarian cyst, such as an ovarian torsion, that can be partially or fully twisted around a ligament to allow surgical trainees and surgeons to practice the corresponding surgical procedure. To simulate the anatomy involved in the procedure, the simulated cyst is filled with fluid, while the plane between the simulated fluid-filled cyst and the simulated ovarian tissue is untwistable when subjected to realistic surgical forces. To enhance the training experience, the model also includes other accessory organs. Examples of other accessory organs include the fallopian tube, mesalpingeal ligament-like tissue, and uterus. To further enhance the training experience, flexible adhesive techniques are used to connect the organs involved in the torsion. The ovarian cyst pedicle torsion model according to an embodiment of the present invention allows surgical trainees and surgeons to train in intraoperative decision-making, bimanual dexterity, tissue handling, use of electrosurgical instruments, and / or camera orientation.

[0045] 5-6 show one embodiment of an ovarian cyst pedicle torsion model 200. In this regard, FIG. 5 is a top view of the ovarian cyst pedicle torsion model 200, and FIG. 6 is an exploded top view. As shown in these figures, the ovarian cyst pedicle torsion model 200 can include a simulated ovarian cyst capsule 240, 240-1 and a simulated mesosalpinx 260. The simulated ovarian cyst capsule 240 can include a bulbous hollow structure having a proximal extension at a proximal end and a distal extension at a distal end. The proximal extension has a tubular structure with a first lumen, and the distal extension has a tubular structure with a second lumen. Both the first lumen and the second lumen have a substantially constant diameter profile along their length. In some embodiments, the proximal extension and the distal extension can have substantially the same diameter. In other embodiments, the proximal extension and the distal extension can have different diameters. In various embodiments, the proximal extension is shorter than the distal extension. The proximal and distal extensions according to various embodiments represent ligaments that hold the ovary in place.

[0046] As shown in FIG. 6, the simulated ovarian cyst capsule 240 can include a simulated cyst body or cyst 220 that is entirely encapsulated within the conductive material of the simulated ovary. In various embodiments, the simulated cyst body or cyst 220 is formed using a mandrel having a spherical shape of a desired size, for example, 3-5 cm. The simulated cyst body or cyst 220 according to embodiments of the present invention can be filled with any type of liquid or fluid. According to various embodiments, the simulated cyst body or cyst 220 of the present invention can be a pouch formed of a platinum cured silicone thermoset. In various embodiments, the platinum cured silicone thermoset has flexibility and / or elasticity similar to natural human tissue and / or has a Shore hardness of 0010 or less. One example of a suitable platinum cured silicone thermoset is Smooth-On Dragon Skin® 0010 silicone. Other platinum cured silicone thermosets can also be used to arrive at similar durometers and tear strengths.

[0047] A platinum curing silicone thermoset with a certain dilution ratio is used to emulate the fragility of a cyst wall with realistic durability. In various embodiments, the simulated cyst body or cyst 220 is cast from a solution formed with silicone and Novocs® silicone solvent with a dilution ratio of (e.g., 90 g:12 mL). This ratio of Dragon Skin® silicone to Novocs® silicone solvent, according to various embodiments, has proven effective in forming a durable cyst wall that is realistically difficult to penetrate. Different ratios of silicone to Novocs® with smaller amounts of each component (e.g., between about 3-12 g:1 mL-5 mL and / or about 2-3 to 1 ratios) can also be used to achieve different cyst wall fragility. In some embodiments, the simulated cyst body or cyst 220 can be formed from any other suitable composition, such as, for example, urethane rubber, rubber, and polyisoprene rubber (e.g., water balloons). In one embodiment, the simulated cyst or sac 220 may be formed from KRATON polymer or ultragel. In alternative embodiments, the simulated cyst or sac 220 may be formed from any suitable hardened conductive material or tissue.

[0048] According to various embodiments, the simulated cyst or sac 220 of the present invention may include a cyst opening that defines a fluid outlet for fluid injection. To form a fluid-filled cyst, a fluid-filled syringe may be used to fill the simulated cyst or sac 220 of the present invention. In various embodiments, the simulated cyst or sac 220 is filled with water. In some embodiments, the cyst opening is provided with a self-closing silicone cap (not shown) that allows for the injection of liquids such as water without leakage. In various embodiments, the cyst opening is sized and configured to fit and receive the self-closing silicone cap in a flush manner. Optionally, various colorants may be added to the fluid to mimic a realistic appearance. Other fillers may be used to fill the simulated cyst or sac 220. Examples of such fillers may include polyethylene glycol (PEG), propylene glycol (PG), glycerin, one-part silicone, and food products.

[0049] In one aspect of the present invention, a dissection plane is provided between the simulated cyst and the ovarian tissue so that the simulated cyst or cyst 220 can be dissected by blunt dissection without rupturing the simulated cyst or cyst. This dissection plane is achieved by adding a layer of thickening material between the two materials, the simulated cyst and the simulated ovary. In various embodiments, the simulated cyst or cyst 220, such as a fluid-filled cyst, can be coated with a thickening material. By way of example and not limitation, thickening materials used for this purpose can include cornstarch. According to an embodiment of the present invention, a thickening material such as cornstarch at the interface between the simulated ovary and the simulated cyst forms a weak adhesion in one or more areas for blunt dissection.

[0050] During the molding operation, the final step to form the simulated ovarian cyst capsule 240 is the encapsulation process. For this purpose, a two-part molded cavity is used. To achieve complete encapsulation, the simulated fluid-filled cyst of the present invention is overmolded with a conductive material to form the simulated ovarian tissue. The formation of the simulated ovarian tissue is achieved using a two-step casting process. In the first step, a first ovarian half is formed to allow for the placement of the cyst. In the second step, a second ovarian half is formed to allow for complete encapsulation of the cyst. Prior to the second step, an additional material, such as a conductive material, can optionally be cast in one or more locations on the coated cyst to aid the surgical trainee and surgeon in locating the cyst.

[0051] To further enhance the training experience, adhesive may also be selectively applied onto the simulated cyst or cyst 220 during the encapsulation process. It should be noted that in various embodiments, the base of the simulated cyst should exhibit stronger adhesion to the surrounding tissue compared to the remainder of the simulated cyst. This adhesion is achieved using a high strength adhesive that is applied to the base of the simulated cyst to form a single strong adhesion site that can be separated using sharp dissection. Thus, during the molding operation, a high strength adhesive is applied to a predetermined location on the fluid filled and coated cyst prior to placement of the cyst. This predetermined location is then placed adjacent the proximal extension of the mold. To form a single strong adhesion site, care must be taken to ensure proper adhesion. The molding process then proceeds to the final step of completely encapsulating the cyst. According to embodiments of the present invention, a suitable adhesive such as Loctite® 454 adhesive may be used to form a single strong adhesion site. Other such adhesives may also be used for this purpose. In another embodiment, a low adhesive strength glue can be applied to at least one or more areas of the remaining portion of the simulated cyst body or cyst 220 to form multiple weak adhesion sites that can be separated using blunt dissection. One suitable example of an adhesive for blunt dissection can be Elmer's Glue-All™ glue. This selective adhesion allows surgical trainees and surgeons to separate the simulated cyst body or cyst 220 from the ovarian tissue using a combination of blunt and sharp dissection as in a real surgical setting.

[0052] In various embodiments, the conductive material of the simulated ovary can be formed from a double network hydrogel (DN gel). The ionic structure of this type of hydrogel creates a realistic response to electrosurgical instruments, allowing, for example, monopolar and / or bipolar electrosurgical instruments to be used with the model. A monopolar surgical instrument can be used to cut open the ovarian cyst capsule 240-1 to access and remove the simulated cyst body or cyst 220 of the present invention. In some embodiments, textiles coated with a conductive agent, such as hydrogel fibers, can be used to form the ovarian tissue. By way of example and not limitation, such compositions can include a textile structure saturated with saline or vinegar solution and a textile structure coated with Surgilube® lubricant.

[0053] As further described above, according to various embodiments, the ovarian cyst pedicle torsion model 200 further includes a simulated mesalpinx 260. This organ model acts as an appendage that allows for the twisting and untwisting of the simulated ovarian cyst capsule 240. To achieve realistic torsion, an extremely thin sheet is molded for this organ model. The sheet should be thin and pliable enough to allow for the twisting / untwisting of the simulated ovarian cyst capsule 240. Thus, according to embodiments of the present invention, a 2-plate mold is used to cast a sheet that is thin enough to simulate a mesalpinx ligament-like tissue. In various embodiments, the simulated mesalpinx 260 can have a thickness of about 1 mm or less. Once the thin sheet is manufactured, a custom pattern (shown in FIG. 6) can be developed for cutting the thin sheet to the desired size and shape. In some embodiments, a manual tracing and cutting process can be used to create the desired size and shape. In various embodiments, a die-cutting process is used to cut the thin sheet to the desired pattern. This desired pattern aids in optimal positioning of the simulated ovarian cyst capsule 240 during adhesion. In some embodiments, petrolatum, such as Vaseline® jelly, can be applied onto the simulated mesosalpinx 260 to avoid self-adhesion during torsion.

[0054] A further feature of the ovarian cyst pedicle torsion model 200 of the present invention is to aid the user in realistic tissue manipulation and assessment of any accidental damage to surrounding biological structures during the use of energy-based surgical instruments. Thus, the simulated mesalpinx 260 according to an embodiment of the present invention is formed of a conductive material or tissue. In various embodiments, the conductive material of the simulated mesalpinx 260 can include a double or twin network hydrogel (DN gel). In an optional embodiment, the simulated mesalpinx 260 can be formed of silicone. In some embodiments, a fiber fabric, optionally coated with a conductive solution, can be cut to the desired size and shape. In other embodiments, a mixture of KRATON polymer and oil can be used to form the simulated mesalpinx 260. In this embodiment, a solution of KRATON polymer in tetrahydrofuran (THF) allows for a solvent casting process that results in the formation of a very thin film. Multiple layers can be formed to achieve the desired thickness.

[0055] Continuing with reference to FIGS. 5-6, the ovarian cyst pedicle torsion model 200 further includes a simulated fallopian tube 140. Similar to the simulated mesasalpinx 260, the simulated fallopian tube 140 also functions as an accessory organ that allows for torsion and detorsion of the simulated ovarian cyst capsule 240. This organ model also serves to simulate surgical cases in which the fallopian tube is involved in torsion along with the ovary (as shown in FIG. 7). In various embodiments, the simulated fallopian tube 140 is a hollow structure formed of conductive material or tissue. In this embodiment, a thin-walled structure is formed by suspending a mandrel within a two-part molded cavity. The mandrel according to an embodiment of the invention has the shape of an actual fallopian tube to provide a realistic appearance and cavity size. In various embodiments, the conductive material of the simulated fallopian tube 140 can include a double or twin network hydrogel. The ionic structure of this material serves to provide realistic tissue handling and assessment of any accidental damage to the surrounding biological structures during the use of energy-based surgical instruments. In some embodiments, hydrogel fibers can be used to form the simulated fallopian tube 140. Examples of these hydrogel fibers include textile structures saturated with saline or vinegar solutions and textile structures having a surface coated with Surgilube® lubricant. In an optional embodiment, the simulated fallopian tube 140 may be formed from silicone. In another embodiment, a textile fabric coated with a conductive solution may be used to form the simulated fallopian tube 140.

[0056] A chitosan-based adhesive is used to connect the simulated organs involved in torsion. Many adhesives prevent the transfer of energy between the connected simulated organs. A flexible conductive adhesive can be used to create a continuous conductive path with minimal interference resistance between the connected components. In various embodiments, 4% chitosan diluted in 2% acetic acid is used as an adhesive to bond the simulated mesosalpinx 260 to the simulated ovarian cyst capsule 240 and the simulated fallopian tube 140. In this embodiment, a medium molecular weight chitosan is used to increase the viscosity, thereby preventing or reducing the migration of the adhesive. In other embodiments, different ratios of chitosan and acetic acid can be used to prepare the adhesive. Cross-linking reagents can also be added to achieve higher viscosity. One suitable example of a cross-linking reagent can be collagen. In some embodiments, a UV-curable adhesive can be used as the adhesive. In another embodiment, a hot melt adhesive (HMA) can be used as the adhesive. In one embodiment, a natural adhesive such as tree sap can be used as the adhesive. In an optional embodiment, an uncured hydrogel can be cast to form a joint to overmold and attach the simulated organ.

[0057] With further reference to FIGS. 5-6, the ovarian cyst pedicle torsion model 200 may further include a simulated uterus 160. The simulated uterus 160 according to an embodiment of the present invention serves as an attachment point for the simulated adnexa (Fallopian tube 140 / simulated mesalpinx 260 / ovarian cyst capsule 240) and provides a large surface area for electrical grounding purposes. This configuration provides a reference point for surgical trainees and surgeons to interact with the simulated ovaries and simulated fallopian tubes while simultaneously training in bimanual dexterity and tissue handling. In various embodiments, the simulated uterus 160 may have a solid, monolithic, or hollow structure. In various embodiments, the simulated uterus 160 is a solid structure or a portion thereof formed of a conductive material or tissue. The conductive material forming the simulated uterus 160 may include a conductive hydrogel formulation. In one embodiment, the simulated uterus 160 is formed of a metal puck. In another embodiment, the simulated uterus 160 is formed of a natural or synthetic sponge saturated with an electrolyte solution.

[0058] In various embodiments, the simulated uterus 160 is shaped as a half uterus with half of the uterus or various portions / volumes thereof located adjacent to a grounding pad formed of, for example, a conductive material to increase the surface area for electrical grounding purposes and reduce the overall costs associated with manufacturing. Attaching the simulated adnexa (fallopian tubes 140 / simulated mesosalpinx 260 / ovarian cysts 240) to the simulated uterus 160 by conventional techniques, such as using adhesives, may not provide a consistent current flow. To ensure that a continuous electrical pathway is formed between the simulated organs, the simulated adnexa (fallopian tubes 140 / simulated mesosalpinx 260 / ovarian cysts 240) according to embodiments of the present invention are overmolded into the simulated uterus 160. In various embodiments, a step of adhering the simulated mesosalpinx 260 to the simulated ovarian cyst capsule 240 and the simulated fallopian tubes 140 may be performed before or after this overmolding step.

[0059] 7, an ovarian cyst pedicle torsion model 200 is shown disposed within a GYN pathology tray 50 according to an embodiment of the present invention. The GYN pathology tray 50 ("tray 50") is configured to receive the ovarian cyst torsion model 200 and is configured to house or include a grounding pad 10 that is removably connectable to an electrosurgical generator (not shown). The grounding pad 10 is configured to contact the ovarian cyst pedicle torsion model 200 or a portion thereof and is disposed between the model 200 and the tray 50. As shown in FIG. 3, a simulated uterus 160 according to various embodiments is disposed and attached to the grounding pad 10 of the present invention to provide a connection to ground between the simulated adnexa (fallopian tube 140 / simulated mesasalpinx 260 / ovarian cyst capsule 240) and the grounding pad 10. In some embodiments, the simulated uterus 160 can be attached to the grounding pad 10 using an adhesive. A ground connection 12 is further provided on one side, such as the left side, of the grounding pad and tray for connection of a ground wire.

[0060] As further described above, according to various embodiments, the tray 50 can include a flat planar surface having a channel or cavity. The cavity can extend circumferentially along and near the edge of the tray. The cavity is configured to collect liquid or sticky material, such as material discharged from the ovarian cyst pedicle torsion model 200. The tray 50, or a portion thereof, is configured to be impermeable. The tray 50 is configured to direct liquid to the circumferential cavity. The tray 50 further includes a central top portion that is raised or elevated above the circumferential portion of the tray, the circumferential cavity, or a portion thereof. The tray 50 can further include one or more slots disposed near the circumferential cavity and the outer edge or periphery of the tray. The one or more slots are configured to receive a model support or sidewall 56 configured to connect to a portion of the simulated organ model. Exemplary embodiments of the model support or sidewall 56 are shown in Figures 6-7. The model support or sidewall 56 can be formed from a thermoformable thermoplastic sheet, such as KYDEX. According to an embodiment of the present invention, the KYDEX® thermoplastic sheet is punched with holes to accommodate portions of the simulated organ model. In various embodiments, the ovarian ligaments, such as one or more portions of an ovarian cyst capsule, extend laterally from the simulated uterus 160 and have raised portions relative to the bottom surface of the simulated uterus and / or tray 50. In the embodiment shown in FIG. 7, the model support or side wall 56 is placed in a slot on the right side of the outer edge or periphery of the tray 50 so that it can connect to the simulated ovarian cyst capsule 240-2 of the model 200. In this embodiment, the model support or side wall 56 helps to present the ovarian ligaments, such as one or more portions of an ovarian cyst capsule, in an anatomically correct orientation while placing the ovarian cyst pedicle torsion model 200 in the tray 50. As can be seen in FIG. 7, in various embodiments, the ovarian ligament-like tissue of the model 200 is pulled through the holes in the model support or side wall 56 and glued in place to ensure optimal positioning of the model 200 during the surgical procedure.

[0061] The steps involved in performing a surgical procedure for detorsion and removal of an ovarian cyst are described in more detail below. A trainee practices laparoscopic cystectomy by placing the ovarian cyst pedicle torsion model 200 in a simulated laparoscopic environment, such as a laparoscopic surgical training device or laparoscopic trainer. For this purpose, the model 200 is first connected to the ground pad 10 of the GYN pathology tray 50 and then inserted into the internal cavity of the laparoscopic trainer. The tray 50 can also be secured to the bottom of the laparoscopic trainer using fastening means, such as hook-and-loop fastening means. The trainee then determines the orientation of the twisted anatomy and unwinds the cystic ovary from the surrounding structures. The trainee then places the cystic ovary in an optimal surgical position for removal of the cyst, and then incises the wall of the ovarian cyst 240 using a scalpel or other electrosurgical instrument. The trainee then identifies the dissection plane between the cyst and the ovarian tissue and separates the cyst from the tissue using a combination of blunt and sharp dissection. The tubal incision is then closed with sutures or left open in place.

[0062] In another embodiment, the ovarian cyst pedicle torsion model 200 is formed as part of another, larger model or tissue structure. By way of example, the ovarian cyst pedicle torsion model 200 according to an embodiment of the present invention can be part of an abdominal organ model or a pelvic model that is sized and configured to be placed inside a laparoscopic surgical training device, which is described in more detail below.

[0063] 8 illustrates a laparoscopic surgical training device 300 according to an embodiment of the present invention. The laparoscopic surgical training device 300 provides an internal cavity 308, substantially hidden from a user, for housing simulated or living tissue or model organs, or training models as described herein. The body cavity 308 is accessed through a tissue simulation region 310 that is penetrated by a user using the device to practice surgical techniques on tissue or a training model known to be located within the body cavity 308. Although the internal cavity 308 is shown as being accessible through the tissue simulation region 310, a hand-assisted access device, a trocar, or a single-site port device may alternatively be employed to access the internal cavity 308. An exemplary laparoscopic surgical training device is described in U.S. Patent No. 8,764,452, entitled "Portable Laparoscopic Trainer," filed September 29, 2011, which is incorporated herein by reference in its entirety. Laparoscopic surgery training device 300 is particularly suited for the practice of laparoscopic or other minimally invasive surgical procedures.

[0064] The laparoscopic surgical training device 300 includes a top cover 302 connected to and spaced from a base 304 by a number of legs 306. The laparoscopic surgical training device 300 is configured to mimic a patient's torso, such as the abdominal region. The top cover 302 represents the front of the patient, and the space between the top cover 302 and the base 304 represents the patient's interior or body cavity in which the organs reside. The laparoscopic surgical training device 300 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and associated instruments in a simulation of a patient undergoing a surgical procedure. Surgical instruments are inserted into the cavity through the tissue simulation area 310 and through pre-prepared apertures 312 in the top cover 302. Various tools and techniques can be used to penetrate the top cover 302 and perform the simulated procedure on the simulated organ or training model disposed between the top cover 302 and the base 304. The base 304 includes a model receiving area 314 or tray (not shown) for placing or holding a simulated tissue model or living tissue. The model receiving area 314 of the base includes a frame-like element for holding the model in place. Various locations around the periphery of the base 304 include clips attached to retractable wires to aid in holding the simulated tissue model or living organ on the base 304. The retractable wires are stretched and clipped to hold the tissue or organ model in a position substantially below the tissue simulation area 310. Other means for holding the tissue model include patches of hook and loop fasteners attached to the base 204 within the model receiving area 314 that can be removably connected to complementary hook and loop fastener elements attached to the tissue or organ model.

[0065] A video display monitor 316 is hinged to the top cover 302 (shown in a closed orientation in FIG. 8). The video display monitor 316 can be connected to a variety of vision systems that deliver images to the monitor. For example, the video display monitor 316 and / or a mobile computing device can be connected to a laparoscope inserted through one of the pre-prepared apertures 312, or a webcam placed in the internal cavity 308 and used to view the simulated procedure to provide images to the user. Recording or audio distribution means can also be provided and integrated into the laparoscopic surgery training device 300 to provide audio and visual capabilities. Means are also provided for connecting portable memory storage devices such as flash drives, smartphones, digital audio or video players, or other digital mobile devices to record training procedures and / or play pre-recorded videos on the monitor for demonstration purposes. Of course, connection means are also provided to provide audiovisual output on a screen larger than the monitor. In another variation, the top cover 302 does not include a video display monitor, but rather includes means for connecting to a laptop computer, mobile digital device, or tablet to connect it to the trainer, either wired or wirelessly.

[0066] When assembled, the top cover 302 is placed directly above the base 304, and the legs 306 are arranged substantially along the periphery to interconnect the top cover 302 and the base 304. The top cover 302 and the base 304 are substantially the same shape and size and have substantially the same peripheral contour. The internal cavity 308 is partially or wholly hidden from view. The legs 306 include openings to allow the internal cavity to be illuminated by ambient light as much as possible and to keep weight as low as possible for easy portability. The top cover 302 is detachable from the legs 306, and the legs 306 are detachable or foldable, such as via hinges, relative to the base 304. Thus, the unassembled laparoscopic surgical training device 300 has a low height that facilitates portability. In essence, the laparoscopic surgical training device 300 provides a simulated body cavity or internal cavity 308 that is hidden from the user. The internal cavity 308 is configured to accommodate at least one tissue simulation area 310 and / or at least one surgical model accessible via an aperture 312 pre-formed in the top cover 302, through which a user can access the model to practice laparoscopic or endoscopic minimally invasive surgical techniques.

[0067] Any part of the organ or training model may be formed from one or more organic based polymers including, but not limited to, hydrogels, single polymer hydrogels, multipolymer hydrogels, non-organic based polymers such as rubber, latex, nitrile, protein, gelatin, collagen, soy, thermoplastic elastomers, KRATON polymers, silicones, foams, silicone based foams, urethane based foams, and ethylene vinyl acetate foams. Any of the base polymers may also employ one or more fillers such as fabrics, woven or non-woven, polyester, nylon, cotton and silk, conductive fillers such as graphite, platinum, silver, gold, copper, general additives, gels, oils, cornstarch, glass, dolomite, carbonate minerals, alcohol, deadeners, silicone oils, pigments, foams, poloxamers, collagen, and gelatin. Adhesives include, but are not limited to, cyanoacrylate, silicone, epoxy, spray adhesives, and rubber adhesives.

[0068] The above description is provided to enable those skilled in the art to make and use the devices or systems and to perform the methods described herein, and describes the best mode contemplated by the inventors for carrying out the invention. However, various modifications will remain apparent to those skilled in the art. These modifications are intended to be within the scope of the present disclosure. Throughout this specification, different embodiments or aspects of such embodiments may be shown and described in various figures. However, each embodiment and aspect thereof shown or described alone may also be combined with one or more of the other embodiments and aspects thereof, unless expressly stated otherwise. The lack of explicit description of each combination is merely for ease of reading this specification.

[0069] While the principles of the present disclosure have been described above in connection with specific models and apparatus, it is to be clearly understood that this description is made only by way of example and not as a limitation on the scope of the invention. [Explanation of symbols]

[0070] 10 Grounding Pad 12 Ground connection 50 GYN Pathology Trays 100-1 Ectopic Pregnancy Model 140-1 Mock fallopian tube 160 Simulated uterus

Claims

1. A method for manufacturing a gynecological pathology surgical simulation system, comprising: preparing a mandrel; suspending the mandrel in a two-part molding cavity; applying a layer of conductive material onto the mandrel; curing the layer of conductive material to form a thin-walled tubular structure defining a central lumen; preparing an adhesive material; encapsulating the adhesive material within a cavity formed along a portion of the thin-walled tubular structure; A method characterized by including the above steps.

2. The method according to claim 1, wherein the adhesive material is a water-insoluble and non-conductive material.

3. The method according to claim 1, wherein the adhesive material includes a fibrous material and uncured silicone.

4. The method according to claim 1, wherein the adhesive material is formed from a mixture of one-part silicone and cotton wool in a ratio of 9 grams to 2 cm × 2 cm.

5. The step of preparing the mandrel includes preparing a mandrel having a proximal end, a distal end, and a longitudinal axis, which is shaped to mimic at least a part of a human fallopian tube, and a part of the mandrel along the longitudinal axis is modified to have a larger diameter compared to the remaining part of the mandrel along the longitudinal axis.

6. The part of the mandrel having the larger diameter forms a cavity that enables the placement of the adhesive material.

7. The step of encapsulating the adhesive material includes: preparing a syringe; filling the syringe with the adhesive material; injecting the adhesive material into the cavity; repeating the filling step and the injecting step until the cavity is filled with the adhesive material.

8. The method according to claim 7, wherein the step of encapsulating the adhesive material further includes encapsulating the adhesive material within the cavity.

9. The encapsulating step includes preparing a conductive tissue cap and adhering the conductive tissue cap to the adhesive material disposed within the cavity.

10. The conductive tissue cap is adhered in place using an adhesive.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20. Preparing a solid or hollow structure to form a reference point for attaching the thin-walled tubular structure; Overmolding the thin-walled tubular structure within the solid or hollow structure; The method according to any one of claims 1 to 10, further comprising.

12. The solid or hollow structure is formed of a conductive material. The method according to claim 11.

13. The step of preparing the solid or hollow structure includes preparing a solid structure that simulates a part of the uterus. The method according to claim 11.

14. The overmolding step is performed after performing the step of encapsulating the adhesive material. The method according to claim 11.

15. Further comprising the step of preparing a tray and a grounding pad. The method according to claim 11.

16. The step of preparing the tray and the grounding pad further includes placing the grounding pad between the overmolded solid or hollow structure and the tray, and further connecting the grounding pad to an electrosurgical generator. The method according to claim 15.

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