Surgical training equipment

Abstract

1. A surgical training device comprising a housing and a cassette, wherein the housing comprises a synthetic layer for simulating skin, the cassette for holding one or more organ models in anatomical relationship to one another, the cassette being substantially surrounded by the housing and thereby engageable with the housing to define a body cavity, and the cassette comprising synthetic bony anatomical features as landmarks.

Description

[Technical Field]

[0001] Related to surgical training devices. [Background technology]

[0002] To obtain realistic surgical experiences, surgical trainees have traditionally used human cadavers or live animals. While cadavers have realistic tissues, they are chemically preserved and therefore do not offer sufficient fidelity, and surgical training using live animals poses serious ethical challenges. Both of these traditional approaches are expensive, and none offer the ability to simulate various surgical conditions requiring repair. Furthermore, once a robotic surgical system is used on a cadaver or animal, it cannot subsequently be used for human surgery. Such robotic surgical systems are too expensive to be limited solely to such training uses.

[0003] Alternative synthetic surgical training models have been developed. To date, these have included silicone- or hard-resin-based models, but lack the ability to mimic human tissue to provide an accurate surgical training experience. These models have typically been used to train laparoscopic and robotic surgeries, using hard-plastic "dome trainers" with pre-formed holes for inserting surgical instruments, as disclosed in recently filed U.S. Patent Application Nos. US20230386366 and US20230343243.

[0004] There is a continuing need for surgical training models that provide anatomically, pathologically, and procedurally accurate simulations for various surgical techniques and procedures. Additionally, there is a need for such training systems to be easily reusable.

[0005] The reference to any prior art in this specification is not, and should not be construed as, an admission or in any way suggestion that the prior art forms part of the publicly known art. Summary of the Invention

[0006] According to one aspect of the present invention, a surgical training device is provided, comprising a housing for substantially defining a human or animal body cavity and at least one organ model, the housing having an exterior surface that allows surgical access to the organ model. The surgical access means accesses the body cavity or organ in a manner that would be performed in a real surgical procedure on a living body. This may involve an incision or may mean the insertion of one or more trocars or endoscopic devices (any surgical instrument used in endoscopic procedures). Those embodiments that include the use of one or more endoscopic devices may include maintaining an airtight exterior surface surrounding the one or more endoscopic devices.

[0007] Some embodiments include a cassette for reversible engagement with a housing, where the organ model is reversibly engageable with a support within the cassette, the cassette configured to be inserted into the housing to form a body cavity for surgical access to the organ model through the housing. In some embodiments, the cassette is engageable with the housing such that it forms an airtight seal within the body cavity. The airtight seal may be formed in any suitable manner. The housing may include a seal for airtight engagement with the cassette. The cassette may include a seal for airtight engagement with the housing.

[0008] In some preferred embodiments, the exterior surface of the housing is shaped to mimic portions of the human or animal anatomy, allowing surgical trainees to practice using anatomical landmarks to identify suitable sites for surgical access and to practice other portions of the procedure.

[0009] In some preferred embodiments, the cassette is slidably engageable with the housing, which allows the organ model to be easily positioned in an anatomical position within the cassette before the cassette is slid into the housing. In some embodiments, this is further facilitated when the cassette is substantially drawer-shaped for slidable engagement within the housing.

[0010] Various other anatomical features may be part of the training device to further facilitate the simulated environment. Some embodiments include openings positioned to simulate the locations of anatomical holes. In some embodiments, the openings may be accessible as part of one or more surgical procedures. Some embodiments include structures positioned to anatomically simulate underlying bone. Such structures may help provide anatomical landmarks for use by trainees and may help maintain other components, such as organ models, in the correct anatomical relationship. In some embodiments, such structures provide, at least in part, structures to simulate portions of human or animal anatomy relative to the shape of the external surface.

[0011] Additional features can be added to various embodiments to further improve the simulation of surgery. For example, some embodiments include electrical pathways to allow electrocautery devices to be used during training. Some embodiments include fluid pathways to allow simulated blood to be used during training.

[0012] Throughout this specification (including any claims which follow), unless the context specifically requires a different meaning, the word "comprise" and variations such as "comprises" and "comprising" are understood to mean the inclusion of a stated integer or step or group of integers or steps, but not the exclusion of any other integer or step or group of integers or steps. [Brief explanation of the drawings]

[0013] [Figure 1A] FIG. 1A is a top perspective view of an exemplary adult female surgical training device according to the present invention. [Figure 1B] FIG. 1B is a top perspective view of an exemplary mold for a housing cover for a female surgical training device according to the present invention. [Figure 1C] FIG. 1C is a top end perspective view of an exemplary mold for a housing cover for a female surgical training device according to the present invention. [Figure 1D] FIG. 1D is a top side perspective view of an exemplary mold for a housing cover for a male surgical training device according to the present invention. [Figure 2A] 2A is a top side view of the housing of the adult female surgical training device of FIG. 1. FIG. [Figure 2B] FIG. 2B is a top side view of an exemplary housing for an adult male surgical training device. [Figure 2C] FIG. 2C is a top side view of an exemplary housing for a further adult male surgical training device. [Figure 2D] FIG. 2D is a top side view of an exemplary housing for yet another adult male surgical training device. [Figure 3] 3 is a top end view of the housing of the adult female surgical training device of FIG. 1. FIG. [Figure 4] FIG. 4 is a top side view of the cassette of the adult female surgical training device of FIG. 1 with the addition of a pelvic model and a thoracic model. [Figure 5] FIG. 5 is a top side view of an exemplary cassette of a surgical training device according to the present invention. [Figure 6] FIG. 6 is a top side view of the cassette of FIG. 5 with a pelvis model inserted. [Figure 7] FIG. 7 is a top side view of the cassette of FIG. 6 with the pelvic fat base model inserted. [Figure 8] FIG. 8 is a top side view of the cassette of FIG. 7 with the uterus model inserted. [Figure 9]FIG. 9 is an enlarged top side view of the lower end of the cassette of FIG. 8 to show more detail of the organ model. [Figure 10] FIG. 10 is a side view of an exemplary cassette according to the present invention. [Figure 11] FIG. 11 is a top side view of the cassette of FIG. 6 with an additional organ model inserted. [Figure 12] FIG. 12 is a top perspective view of an exemplary pediatric surgical training device according to the present invention with the cassette open. [Figure 13] FIG. 13 is another top perspective view of a pediatric surgical training device similar to that of FIG. [Figure 14] 14 is a top perspective view of the pediatric surgical technique training device of FIG. 12 with the cassette closed. [Figure 15] 15 is a top perspective view of the exemplary pediatric surgical training device of FIG. 13 with the cassette removed. [Figure 16] 16 is a top perspective view of the pediatric surgical training device of FIG. 13 with the cassette partially open. [Figure 17] FIG. 17 is a top perspective view of the pediatric surgical training device of FIG. 13 with the abdominal organs removed. [Figure 18] FIG. 18 is a top perspective view of the surgical training device of FIG. 17 with the organs and spare stomach individually assembled. [Figure 19] FIG. 19 is a top perspective view of a cassette according to the present invention having a pelvis and ribs. [Figure 20] FIG. 20 is a top perspective view of the cassette of FIG. 20 with a vertebra and inguinal hernia model inserted. [Figure 21] FIG. 21 is a top perspective view of the cassette of FIG. 21 from a different angle. [Figure 22] FIG. 22 is a top perspective view of an assembled pelvis, vertebrae, and inguinal hernia model according to the present invention. [Figure 23] FIG. 23 is a photographic image of the surgical training device of the present invention in use. [Figure 24A]FIG. 24A shows an exemplary exterior door configuration for a cassette according to the present invention. [Figure 24B] FIG. 24B shows the internal door structure from the cassette door of FIG. 24a. DETAILED DESCRIPTION OF THE INVENTION

[0014] It is convenient herein to describe the invention in terms of particularly preferred embodiments. However, it should be understood that the invention is applicable to a wide range of embodiments, and that other configurations and arrangements are also considered to be within the scope of the invention. Various modifications, alterations, variations, and / or additions to the configurations and arrangements described herein are also considered to be within the sphere and scope of the invention.

[0015] In some embodiments, the present invention provides a life-size, insufflable torso into which a hydrogel synthetic tissue organ model can be inserted. The hydrogel model is inserted into a custom cassette that can have a base anatomical structure embedded in it. The cassette can have ports for electrical current access / connection and tubular access inserts to allow for simulated blood flow. The cassette can be sealed, for example, with a mechanical locking device. This allows surgeons to train for surgical procedures without animal harm, cadavers, or patient training, eliminating the need for dedicated robotic equipment for training.

[0016] A wide variety of versions of the training device can be manufactured in accordance with the present invention, for example, a pediatric model for neonatal hernia repair, an adult female model (lower torso) with and without a vaginal and / or anal opening for training gynecological surgeons in total hysterectomy and other procedures, a male anatomy (e.g., lower torso) with an anal opening and penis replica for training partial nephrectomy, prostatectomy, inguinal hernia repair, cholecystectomy, and other procedures.

[0017] The device of the present invention creates a simulated environment in which multiple hydrogel organs can be used, enabling surgical experience at various stages of surgical procedures, representing different levels of difficulty, and aiming for gradual surgical skill development.

[0018] The training device of the present invention typically includes three main structures: an internal cassette, an internal skeletal frame structure to provide structural integrity for the cover and organ model, and an external housing with a cover such as a skin layer.

[0019] The cassette may have a hermetically sealable door and another hermetically sealed hole at the other end. In some embodiments, an air seal may be custom constructed using a silicone seal around the door. A preferred method is to use a silicone gasket. The clip used to seal the door may be a mechanical clamp to maintain internal pressure during insufflation. Sealed ports for electrical current and perfusion may be embedded in the door.

[0020] The cassette may include three sections, for example, the pelvis, abdomen, and chest. Each section may have a treatment model inserted into it. The pelvic section may be attached to the front of the cassette using an airtight ring, which may be used to lock both the pelvis and the cassette together, as well as to attach a uterus (for example) to create an airtight space. A hydrogel pelvic fat pad may be inserted around the pelvic structure to provide additional anatomical realism and allow electrical current to connect with the hydrogel tissue. The other sections may be made of silicone (not hydrogel) and may contain surgical landmarks and other anatomical organ structures to provide realism.

[0021] The present invention also includes an internal skeletal framework insert that includes a stand and a pelvic section that holds the organs in place, which is also used to hold the treatment model in the correct anatomical position.

[0022] According to one aspect of the present invention, there is provided a surgical training device comprising a housing and a cassette, the housing comprising a synthetic layer for simulating skin, the cassette for holding one or more organ models in anatomical relationship to one another, the cassette engageable with the housing such that the cassette is substantially enclosed by the housing thereby forming a body cavity therewith, and the cassette comprising synthetic bony anatomical features as landmarks.

[0023] The cassette may include a drawer slidably engageable with the housing. The cassette may be for holding one or more organ models in anatomical relationship with each other and with the exterior surface of the housing. The housing may be substantially covered on the operable surface by a cover including a synthetic layer for simulating skin. Synthetic anatomical features may provide structural integrity for the cover and anatomical positioning and support for the organ models. The housing may be contoured to mimic a life-size torso. The cassette may include the synthetic anatomical features as landmarks. The housing may include a sidewall and a closed end, the closed end of the housing including a cassette engagement end defining an opening for receiving the cassette. The synthetic skin is preferably sufficiently flexible to form an airtight seal around a laparoscopic instrument passing therethrough. The engagement between the housing and the cassette provides an airtight seal within the body cavity, preferably by means of a mechanical locking device.

[0024] In some embodiments, the synthetic skin is heat-healable, sufficiently elastic to allow suturing, sufficiently distensible, and sufficiently stretchable to allow bio-like expansion when pressure is applied via insufflation into a body cavity while maintaining said airtight condition, the body cavity comprising a hydrogel synthetic pelvic fat pad disposed on a pelvic model.

[0025] In some embodiments, the synthetic bony anatomical features include one or more of a pelvis model, a rib model, and a vertebra model, and a hydrogel synthetic pelvic fat pad placed on the pelvic model is adhered to a diathermy (electrocautery) pad, the pelvic fat pad enhancing anatomical realism and providing a pathway for connecting the hydrogel tissue and electrical current during electrocautery.

[0026] In some embodiments, the cassette comprises a drawer having an inner end, a support for holding the organ model, and an outer end, the outer end comprising a handle, and the engagement between the housing and the cassette further comprises a seal on the housing and / or a seal on the cassette.

[0027] In some embodiments, the body cavity comprises one or more additional organ models selected from thoracic organs, lungs, heart, thymus, abdominal organs, stomach, small intestine, large intestine, colon, gallbladder, rectum, liver, pancreas, spleen, kidneys, adrenal glands, urinary bladder, female reproductive tract, male reproductive tract, lymph nodes, peritoneal tissue, omentum, and mesentery.

[0028] In some embodiments, the engagement between the housing and the cassette further includes a seal on the housing and / or a seal on the cassette, each seal optionally including a silicone gasket, each seal optionally contained within a channel around the respective engaged portions of the housing and the cassette, and the cassette door comprising a hermetically sealed port for passage of an electrical cable to provide current access for ablation and a hermetically sealed port for passage of one or more tubes to provide simulated blood flow path access.

[0029] In some embodiments, the housing further comprises a tray and sidewalls, the housing having an exterior shape simulating a life-size torso, the manipulable surface being substantially covered by a cover comprised of one or more synthetic layers for simulating a body wall, the synthetic layers comprising synthetic skin and optionally muscle, connective tissue, and fat, each layer being adhered to the other layers, the cover comprising one or more of elastomers, thermoplastic elastomers, silicones, room temperature vulcanizing silicones, platinum cure room temperature vulcanizing silicones, saturated fatty acids, pigments, foams, cellular or high density polyethylene foams, high density ethylene vinyl acetate (EVA) foams, foams containing cells providing a cellular or tissue texture, reduced polynomial hyperelastic materials, urethane polymers, silicone fluids, damping agents for softening silicone components, platinum cure silicone additives, silicone oils, alcohol, commercially available synthetic skin products, the synthetic skin being sufficiently flexible; a periphery seal can be created when laparoscopic instruments such as trocars are passed therethrough, and engagement between the housing and the cassette provides an airtight seal within the body cavity by means of a mechanical locking device comprising one or more of a clasp, clip, clamp or rotary airlock; the cassette includes synthetic bony anatomical features as landmarks, which provide structural strength to the cover and anatomical positioning and support for the organ model; the pelvic model includes engagement means having slots for providing releasable engagement with struts on the inner wall of the organ model support; and the pelvic model includes a cap for securing the synthetic peritoneal tissue in place.

[0030] In some embodiments, the closed end of the housing defines an opening for passage of a portion of the organ model to simulate the anatomical orifice, the internal end of the drawer defines an opening for passage of the organ model to simulate the anatomical orifice, the opening defined by the closed end of the housing and the opening defined by the internal end of the cassette are arranged to form a continuous opening for passage of the organ model to simulate the anatomical orifice, the housing and cassette of the surgical training device together define an opening shaped to receive the organ model having the opening to simulate the anatomical orifice, the organ model optionally further including a simulated internal anatomical structure associated with the opening, the opening being selected from an organ lumen, an anal orifice, a vaginal orifice, and the organ model having the opening, the housing, and the cassette together form an airtight seal around the simulated orifice to allow insufflation into the body cavity while maintaining the orifice and its associated internal anatomical features (optionally including the organ lumen).

[0031] In some embodiments, the hermetic seal around the simulated hole includes a flange on the organ model having an opening, the flange being positioned within the body cavity and inside the opening defined by the inner wall of the cassette, and the hermetic seal further comprises one or more annular members on the insert designed for hermetic mating engagement with the organ model from outside the body cavity and outside the opening, the insert including the annular members for hermetic mating engagement with the external organ model, which may be a synthetic skin model or the like for simulating an external opening, and the external hole is optionally the anus, vulva, or penis, and the external hole is continuous with the hole of the organ model having an opening in the body cavity.

[0032] In some embodiments, the cassette comprises a length of about 450-600 mm, preferably 500-550 mm, more preferably 520-530 mm, more preferably about 526 mm, and a height of 200-400 mm, preferably 250 mm-350 mm, more preferably 280-300 mm, more preferably about 291 mm, and the cassette-engaging end of the housing comprises a first layer for adhering to the cover, a second layer for defining an opening for inserting the cassette, and a third layer including a seal for hermetically engaging the outer end of the cassette.

[0033] In one aspect of the present invention, there is provided a surgical training device comprising a housing and a cassette: the housing includes a tray, a sidewall, and a closed end; the closed end of the housing defines an opening for passing a portion of the organ model to simulate an anatomical hole, and the closed end of the housing includes a cassette engagement end defining an opening for receiving the cassette; the housing has an exterior shape simulating a life-size torso, the manipulable surface being substantially covered by a cover including one or more synthetic layers for simulating a body wall, the synthetic layers including synthetic skin and optionally one or more of muscle, connective tissue, and fat, each layer being adhered to the other layers; the cassette for holding one or more organ models in anatomical relationship to each other and to the exterior surface of the housing; The cassette has a length of about 520-530 mm, preferably about 526 mm, and a height of 280-300 mm, preferably about 291 mm; the cassette includes a drawer slidably engageable with the housing and substantially surrounded by the housing, thereby defining a body cavity therewith; the cover comprises one or more of a thermoplastic elastomer, a silicone, a room temperature vulcanizing silicone, a platinum cure room temperature vulcanizing silicone; a saturated fatty acid; a pigment, a foam, a cellular or high density polyethylene foam, a high density ethylene vinyl acetate (EVA) foam, a foam containing cells that provide a cellular or tissue texture, a reduced polynomial hyperelastic material, a urethane polymer, a silicone fluid, a damping agent that softens the silicone component, a platinum cure silicone additive, a silicone oil, an alcohol; a commercially available synthetic skin product; the synthetic skin is sufficiently flexible to form an airtight seal around laparoscopic instruments as they are passed therethrough, is heat-healable, has sufficient elasticity to allow suturing, and is sufficiently stretchable to allow bio-like expansion when pressure is applied via insufflation from within the body cavity while maintaining the airtight seal; the cassette-engaging end of the housing includes a first layer for adhering to a cover, a second layer for defining an opening for inserting the cassette, and a third layer comprising a seal for sealingly engaging an outer end of the cassette; the cassette includes a drawer having an inner end, a support for holding an organ model, and an outer end, the outer end including a handle, the inner end defining an opening for passage of the organ model simulating an anatomical orifice; the opening is defined by the closed end of the housing, and the opening is defined by the inner end of the cassette arranged to form a continuous opening for passage of an organ model to simulate an anatomical orifice; the engagement between the housing and the cassette provides an airtight seal within the body cavity by means of a mechanical locking device, the engagement between the housing and the cassette further comprising a seal on the housing and / or a seal on the cassette, the seal including a silicone gasket and housed within a channel around the engaged portion of the housing and the cassette, respectively; the cassette includes synthetic bony anatomical features as landmarks, the synthetic bony anatomical features providing structural integrity for the cover and anatomical placement and support for the organ model; the synthetic bone anatomical features include a pelvis model, a rib model, and a vertebral model, the pelvis model having an engagement means with a slot for providing detachable engagement with a support post of the inner wall of the organ model support, and the pelvis model including a cap for fixing the synthetic peritoneal tissue in place; the cassette door comprises a hermetically sealed port for passage of an electrical cable to provide current access for cauterization and a hermetically sealed port for passage of one or more tubes to provide simulated blood flow access; the housing and cassette of the surgical training device together define an opening shaped to receive an organ model having an opening for simulating an anatomical orifice, the organ model further including a simulated internal anatomical structure associated with the orifice including an organ lumen, the orifice being selected from an anal orifice, a vaginal orifice, and a penile orifice; the organ model having the opening, the housing, and the cassette together form an airtight seal around the simulated hole, allowing air to be insufflated into the body cavity while maintaining the hole and associated internal anatomical features; the hermetic seal around the simulated hole includes a flange on an organ model having an opening, the flange being disposed within the body cavity and inside the opening defined by the inner wall of the cassette, the hermetic seal further comprising one or more annular members on an insert designed to be in airtight mating engagement with the organ model on the outside of the body cavity and the outside of the opening; the insert comprises an annular member for mating engagement with a cover including a synthetic skin model for simulating an external orifice selected from an anus, a vulva, or a penis, the external orifice being continuous with the orifice of an organ model having the opening within the body cavity; the body cavity includes a hydrogel synthetic pelvic fat pad positioned on the pelvic model and adhered to an electrocautery pad, the pelvic fat pad enhancing anatomical realism and providing a pathway for connecting hydrogel tissue and electrical current during electrocautery; The body cavity includes one or more additional organ models selected from thoracic organs, lungs, heart, thymus, abdominal organs, stomach, small intestine, large intestine, colon, gallbladder, rectum, liver, pancreas, spleen, kidneys, adrenal glands, urinary bladder, female reproductive tract, male reproductive tract, lymph nodes, peritoneal tissue, omentum, and mesentery.

[0034] In some embodiments, the present invention provides a surgical training device including a plurality of anatomical landmarks for use during a procedure, the anatomical landmarks including synthetic skin covering anatomical structures. In some preferred embodiments, the surgical training device is for training surgical procedures involving a body cavity. In some embodiments, it is for training laparoscopic surgical techniques. In some embodiments, the synthetic skin of the present invention includes one or more anatomical structures. These may include, for example, skin surface features, optionally including one or more of nipples, wrinkles, hair, navel, breasts, vagina, and penis. In some embodiments, the synthetic skin of the present invention includes multiple additional layers to simulate one or more of muscle, fat, and mesentery.

[0035] FIG. 1A is a top perspective view of an exemplary adult female surgical training device according to the present invention, generally designated 10. This particular example includes a female torso training device, which in general terms includes a housing 20 and a cassette 30. It can be seen that the pelvis and ribs are shown superimposed at 25, which in some embodiments may be used to provide structural integrity to, for example, the external torso and / or internal organs. In some embodiments, the bone structures are 3D printed. The housing 20 is generally shaped to simulate the contours of an adult female, preferably including a cover itself comprising a synthetic material capable of simulating skin. The housing 20 comprises a sidewall 28, a closed end 53, and a cassette-engaging end 54. In this embodiment, the closed end 53 is located at the anatomical lower end of the torso model, and the cassette-engaging end is located at the anatomical upper end. It will be understood that in some embodiments, the cassette-engaging end could be located at the anatomical lower end of the anatomical model, and the closed end of the housing 20 could be located at the anatomical upper end of the model.

[0036] Cassette 30 includes an inner end (not shown), a support 32, and an outer end 34. The outer end 34 includes attachment points 33 for a handle. Support 32 holds organ models of interest within cassette 30 so that surgical training can be performed. In this embodiment, support 32 has a drawer-like structure, allowing the associated organ models to be placed within the drawer-like structure. However, it is not necessary for support 32 to have a drawer-like configuration. For example, support 32 may take the form of a series of devices that secure the organ models in intended anatomical relationships relative to one another for the purposes of the intended surgical training procedure.

[0037] In this embodiment, cassette engagement end 54 includes a seal 52 that abuts and engages exterior end 34 of cassette 30. In some embodiments, this engagement is airtight, allowing the interior chamber defined by cassette 30 and housing 20 to be insufflated, thereby better replicating surgical conditions and providing the surgeon with an opportunity to practice the techniques required for insufflation. Some embodiments of the invention may not have an airtight seal, in which case insufflation practice is not possible.

[0038] In this exemplary embodiment, cassette 30 includes an abdominal organ model 40, including a small intestine 42, a liver 44, and female reproductive organs 46. In this embodiment, cassette engaging end 54 includes three layers: a first layer for adhering synthetic skin-like tissue, a second layer for an open door structure to allow the cassette to be inserted, and a third layer for inserting the cassette door and providing an airtight fit. Cassette engaging end 54 includes a wall 56 that helps provide a structure for engaging with exterior end 34 of cassette 30. As mentioned above, in some embodiments, this engagement is airtight, and may be clamped, for example.

[0039] The cover of housing 20 can include multiple layers to simulate anatomical layers of a body wall, such as the abdominal wall, and thus these layers can include one or more layers to simulate muscle, connective tissue, fat, and skin. The cover of some embodiments of a torso trainer according to the present invention includes the following: a skin layer, an umbilical pedicle, a fat layer, an anterior rectus sheath layer, a first rectus abdominis muscle layer, a second rectus abdominis muscle layer, a third rectus abdominis muscle layer, a posterior rectus sheath layer, a transverse abdominis fascia layer, and a peritoneal tissue layer. One or more of these layers can optionally be made from a hydrogel.

[0040] Such layers may be fabricated from a single mold or may be adhered to one another by techniques including, for example, adhesives or welding, compression during molding, thermal annealing, lamination techniques, etc. In some embodiments, simply curing one or more layers in contact with one or more other layers will provide sufficient adhesion or bonding therebetween. Preferably, the layers are adhered to one another, which prevents gaps between the layers and provides a more realistic simulation.

[0041] Preferably, the synthetic skin used in the present invention is realistic in texture, color, and elasticity, easily simulating human tissue for procedures such as incision, suturing, stapling, and port insertion. In practice, a surgeon using the training device can preferably identify the correct location for the incision based on the device's anatomical landmarks. In some preferred embodiments, the skin is sufficiently flexible to form an airtight seal around laparoscopic instruments such as trocars. In some preferred embodiments, the skin is healable by applying heat to the skin surface, so that the skin can be reused for multiple surgical training sessions. Once surgical practice is complete, the skin can be thermally repaired or "healed" by applying heat to the incision site, which can re-bond or re-melt and re-bond the edges of the incision. Preferably, heat from a hair dryer is sufficient for this purpose. In some embodiments, a heat gun is used. In some embodiments, the skin is sufficiently elastic to allow suturing without tearing. In some embodiments, the cover skin (and any underlying layers) is sufficiently stretchable to allow its surface to undergo biological expansion when pressure is applied from within the body cavity via insufflation of air.

[0042] The synthetic skin used in the present invention can be made from any suitable material. The cover layer is desirably shaped to achieve precise anatomical features, such as the umbilical stalk, navel, or nipple. The cover and / or skin can include any one or more of the following: Elastomers such as thermoplastic elastomers - Room temperature vulcanizing silicones, such as platinum curing room temperature vulcanizing silicones ·Saturated fatty acids Pigments Foams, such as cellular or high-density polyethylene foam or high-density ethylene vinyl acetate (EVA) foam, some of which contain air bubbles to provide a cellular or tissue texture Reduced polynomial type hyperelastic material Urethane polymer Silicone fluids, such as platinum-cured silicone additives or damping agents for softening silicone components such as silicone oils ·alcohol Additionally, commercially available products can be used to create any one or more of the cover layers, including the skin, such as Dragon Skin FX Pro. Such products can be molded into the required shape and used as part of the cover for housing 20.

[0043] Examples of molds and molding processes FIG. 1B is an upper top perspective view of an exemplary mold for a housing cover for a female surgical training device according to the present invention. Mold 70 has an outer shell 64 partially constructed over an inner portion of mold 65. In this embodiment, outer shell 64 includes multiple sections 66, 67, 68, etc. It will be understood that outer shell 64 can include any number of sections suitable for forming a useful housing cover 20. The multiple sections can be joined together, for example, as shown where flanges 72 meet. Flanges 72 have corresponding openings 73 that can be used to hold the multiple sections in sealing engagement with fasteners 74, which in this embodiment are simple nuts and bolts.

[0044] Since this is a female surgical training device, it includes pads 57 used to simulate the shape of breast tissue for molding. It also includes a circular section 58 used to mold the genital area. The shape of the pelvis is formed using sections 59, and in particular the iliac wings are formed using protrusions 60. The shape of the ribs is simulated using rib sections 63. The skin preparation is poured in liquid form to fill the space between the inner layer 61 and the outer shell 64. End sections 62 are provided to seal the ends of the mold.

[0045] 1C and 1D are upper end and side perspective views of an exemplary mold for a housing cover for a female surgical training device according to the present invention, and an exemplary mold for a housing cover for a male surgical training device according to the present invention, respectively.

[0046] example Smooth-On Inc.'s Dragon Skin FX-Pro is a soft, stable platinum silicone rubber specifically designed for creating silicone makeup appliances and skin effects. It has a Shore hardness of 2A and can be combined with a softener (such as Slacker from Smooth-On) to create a soft silicone gel for filling encapsulated silicone pieces. Selected skin colors and surface effects can be achieved by adding silicone pigments and painting as needed. Its softness, Shore 2A hardness, allows for softer appliances with less softener required. Its low viscosity, combined with its long working time, reduces air bubbles and makes it easier to pour. It cures in a dry state, preventing leaching of the silicone fluid. It has a long working time of 10 to 12 minutes, which is important for larger volume pouring and injection molding, such as the skin cover of the present invention. It cures within 40 minutes and has a gel phase that allows the material to be more easily added to the mold.

[0047] method 1. Prepare the mold, for example, by adding inserts to simulate breast tissue or foam pad(s) to simulate muscle and fat layers. These layers should be positioned so that the liquid polymer mixture will fill over them and form a mechanical bond with them, thereby forming the cover of the housing 20. 2. Thoroughly premix Part B. Pour the required amounts of Parts A and B (1A:1B by volume or weight) into a mixing vessel and mix thoroughly, scraping the sides and bottom of the mixing vessel several times. 3 Pour into a 3D resin printing mold (e.g., printed from Siraya Fast Grey resin). Pour the mixture into a single spot at the lowest point of the container. Allow the rubber to naturally spread out and level evenly. An even flow helps minimize trapped air. 4 Allow the rubber to cure for 40 minutes at room temperature (73°F / 23°C) before removing from the mold. Do not cure the rubber below 65°F / 18°C. 5 To finish the model once it has been removed from the mold, heat it with a heat gun and use a skin-textured silicone pad to remove any imperfections or air bubbles.

[0048] FIG. 2A is a top side view of the housing of the adult female surgical training device of FIG. 1. It can be seen that the pelvis and ribs are shown superimposed at 25, which in some embodiments may be used to provide structural integrity to, for example, the external torso or internal organs. Some embodiments include additional bony features to enable further landmarks and realism. For example, some embodiments include additional appendicular skeletal landmarks, such as those from the scapula, clavicle, etc. Some embodiments include limb joints to which artificial limbs can be attached. This additional realism may extend training opportunities not only to surgeons but also to other support staff, such as scrub nurses, nursing assistants, or anesthesiologists. Some embodiments include one or more limbs attached to the torso in anatomically correct positions. In some of these embodiments, the limbs are adapted for a life-like range of motion. Providing training devices with additional features, such as the limbs or neck and head, can create a more realistic operating room training environment. This may include, for example, training patient positioning on a table relative to a robot and / or training access to the patient by operating room staff while avoiding the robot and surgeon.

[0049] The exterior surface or cover 230 of the housing 20 is generally shaped to simulate that of an adult female, preferably comprising a synthetic covering capable of simulating skin. The housing 20 comprises a tray 29, sidewalls 28, a closed end 53, and a cassette-engaging end 54. The tray 29 and sidewalls 28 function to provide an enclosed space for the cassette 30 to reside within, thereby simulating normal anatomy and facilitating ensuring that the space is airtight. The exterior surface 230 of the closed end 53 of the housing 20 includes an opening 220 in the shape of an anatomical orifice (in this case, the vulva). In this embodiment, the closed end 53 is located at the anatomically lower end of the torso model, and the cassette-engaging end is located at the anatomically upper end. This embodiment also includes a block 200 attached to the cassette-engaging end 54. The block 200 facilitates attachment of a clamp between it and the cassette's outer end 34 to provide an airtight seal. Flange 210 is part of the attachment of cassette 30 to outer end 34 of the cassette.

[0050] FIG. 2B is a top side view of an exemplary housing for an adult male surgical training device. It can be seen that the pelvis and ribs are shown superimposed at 25, which in some embodiments may be used to provide structural integrity to, for example, the external torso or internal organs. The exterior surface 230 of the housing 20 is generally shaped to simulate that of an adult male and is preferably covered with a synthetic material capable of simulating skin. The housing 20 comprises a tray 29, sidewalls 28, a closed end 53, and a cassette-engaging end 54. The tray 29 and sidewalls 28 function to provide an enclosed space for the cassette 30 to reside within, thereby simulating normal anatomy and facilitating ensuring that the space is airtight. The exterior surface 230 of the closed end 53 of the housing 20 includes an opening 220 in the shape of an anatomical orifice (in this case, the urethral orifice of the penis). In this embodiment, the closed end 53 is located at the anatomical lower end of the torso model, and the cassette-engaging end is located at the anatomical upper end.

[0051] FIG. 2C is a top side view of an exemplary housing for an adult male surgical training device. It will be appreciated that people have different body types, which in themselves can present various additional surgical challenges. For example, identification of anatomical landmarks (such as bony prominences) can be hindered, and subcutaneous fat can bulge into the surgical site and obstruct the passage of surgical instruments. Thus, in this exemplary embodiment, the male torso has the characteristics of a mildly obese adult male. In this embodiment, the pelvic bones and ribs are not superimposed and are not shown. The exterior surface 230 of the housing 20 is generally shaped to simulate the anatomy of a slightly obese adult male and is preferably covered with a synthetic material capable of simulating skin. The housing 20 includes a tray 29, sidewalls 28, a closed end 53, and a cassette-engaging end 54. The tray 29 and sidewalls 28 function to provide an enclosed space for the cassette 30 to reside within, thereby simulating normal anatomy and facilitating ensuring that the space is airtight. This embodiment includes a block 200 attached to the cassette engaging end 54. The block 200 facilitates attachment of a clamp between it and the cassette outer end 34 to provide an airtight seal. The outer surface 230 of the closed end 53 of the housing 20 includes an opening 220 in the shape of an anatomical orifice (in this case, the urethral orifice of the penis). In this embodiment, the closed end 53 is located at the anatomical lower end of the torso model, and the cassette engaging end is located at the anatomical upper end.

[0052] FIG. 2D is a top side view of yet another exemplary housing for an adult male surgical training device. In this exemplary embodiment, the male torso has the characteristics of an obese individual. In this embodiment, the pelvic bones and ribs are not superimposed and are not shown. The exterior surface 230 of the housing 20 is generally shaped to simulate the contours of an obese adult male and is preferably covered with a synthetic material capable of simulating skin. The housing 20 includes a tray 29, sidewalls 28, a closed end 53, and a cassette-engaging end 54. The tray 29 and sidewalls 28 function to provide a sealed space for the cassette 30 to reside within, thereby simulating normal anatomy and facilitating ensuring that the space is airtight. The exterior surface 230 of the closed end 53 of the housing 20 includes an opening 220 in the shape of an anatomical orifice (in this case, the urethral orifice of the penis). In this embodiment, the closed end 53 is located at the anatomical lower end of the torso model, and the cassette-engaging end is located at the anatomical upper end.

[0053] Figure 3 is a top end view of the housing of the adult female surgical training device of Figure 1. In this view, cavity 315 of housing 20 is clearly visible within bottom surface 310 and wall 28. Cavity 315 is clearly visible in this view and is defined by closed end 53, opening 320 in cassette engaging end 54, wall 28, and bottom surface 310. Wall 56 of cassette engaging end 53 defines opening 320 into which a cassette (which can be pre-loaded with an organ model during use) can be loaded.

[0054] FIG. 4 is a top side view of the unattached housing exterior 230 of the adult female surgical training device of FIG. 1. In this view, the housing 20 includes 3D printed pelvic bones and ribs 25, but no other organs. The closed end 53 includes an opening 400 so that a female reproductive tract organ model can be attached if desired. It will be understood that the opening 400 is continuous through the opening 220, as shown in FIG. 2, to simulate an anatomical opening (vulva opening). Preferably, the opening 400 can be airtightly engaged with such an organ model, so that the training device can be used to practice insufflation techniques.

[0055] Cavity 315, clearly shown in FIG. 4, is defined by closed end 53, opening 320 at cassette engagement end 54, wall 28, and bottom surface 310 of tray 29. The roughly rectangular parallelepiped shape of cavity 315 in this embodiment is conveniently designed to broadly simulate anatomical structures and simplify the operation of attaching and detaching various organ models. The angle of closed end 53 represents a cut-away torso shape with the legs removed to simulate the pelvis. It will be understood that in some embodiments, such as the present example, cavity 315 more closely simulates the internal three-dimensional shape of the thoracic and abdominal cavities of an adult female.

[0056] FIG. 5 is a top side view of an exemplary cassette of a surgical training device according to the present invention. Cassette 30 includes support 32, inner wall 530, and outer wall 34. Support 32 is designed to be reversibly engageable with an organ model within the cassette. In this embodiment, support 32 is configured as a roughly rectangular parallelepiped-shaped container defining an internal cavity 550 into which an organ model can be placed for surgical training. Cavity 550 is defined at the outer end 34 of cassette 30 by a support bottom 520, inner wall 530, and outer wall 560. Inner wall 530 defines an opening 510, through which, in this example, a female reproductive tract organ model can be attached, if desired. It will be understood that opening 510 is continuous with opening 400 (see FIG. 4) in housing 20 to simulate an anatomical opening (the vulva), and opening 400 is continuous with opening 220 as shown in FIG. 2. Preferably, openings 400 and 510 are capable of sealingly engaging such an organ model so that the trainer can be used to practice insufflation techniques. Exterior end 34 of cassette 30 also includes panel 540, which can be used to sealingly engage cassette-engaging end 54 of housing 20, for example, via seal 52.

[0057] It will be appreciated that support 32 may be designed in a variety of ways, provided that it is reversibly engageable with the organ models within cassette 30. For example, it may include one or more elements that grasp and hold one or more organ models in a predetermined anatomical relationship relative to one another and to cassette 30 and housing 20. Thus, in some embodiments, cassette 30 may not have a generally rectangular parallelepiped shape. Similarly, while cassette 30 is substantially drawer-shaped in this embodiment, it will be appreciated that this shape is not required to fulfill its function of providing a structure for removably positioning one or more organ models within housing 20 so as to be surgically accessible therethrough.

[0058] FIG. 6 is a top side view of the cassette of FIG. 5 with a pelvis model inserted. In this embodiment, the pelvis model 600 is positioned to anatomically simulate the underlying bones or bony structures of the pelvis. The pelvis model 600 is positioned so that the shape of the outer surface 230 provides a structure that simulates a portion of the human or animal anatomy (see item 25 in FIGS. 1, 2, and 3). The pelvis model 600 includes an engagement means 630 that provides a releasable engagement with the support 32. In this embodiment, the engagement means 630 abuts the wall 530, which has struts 633 to increase the wall's rigidity, inhibit movement, and ensure airtightness. In this embodiment, the engagement means 630 provides a slidable engagement between the support 32 and the pelvis model 600. However, other forms of simple mechanical engagement, such as a keyhole type, a latch type, a screw type, a snap type, or a latch and hook type, are equally applicable.

[0059] The engagement between the wall 620 and the pelvic support 610 provides a removable yet stable positioning within the support 32. The pelvic support 610 is designed to assist in the positioning of caps that can be placed on the pelvic model 600 to secure the artificial peritoneal tissue in place. The pelvic support 610 also assists in aligning fasteners, such as bolts, that secure or clamp the peritoneal tissue in the correct position. As used herein, the term "peritoneal tissue" may include any one or more of the peritoneum (or peritoneal lining), omentum, mesentery, or other intra-abdominal tissue. The wall 620 ensures that the pelvis abuts the inner wall 530, locating the correct position for the bolts and also providing rigidity for airtightness. In this embodiment, the engagement means 630 comprises struts 633 on the inner wall 530 and slots 632 on the pelvic model 600.

[0060] The struts 633 also provide wall rigidity to reduce movement and ensure airtightness. The pelvis model 600 can be manufactured by any suitable means, for example, molded from plastic or printed with a three-dimensional printer. Preferably, it is constructed of a hard material, such as plastic or a metal alloy, so as to simulate bone and provide a rigid structure for the abdominal organs to be placed in anatomical positions within the support 32. More preferably, the bone structure comprises a hard plastic, and optionally one or more of PVC, resin, polycarbonate, polypropylene, etc.

[0061] FIG. 7 is a top side view of the cassette of FIG. 6 with a pelvic fat base model 700 inserted. It can be seen that the pelvic fat base model 700 is inserted into the pelvic cavity to simulate anatomical fat in this region. The model 700 is preferably made from a conductive and flexible material that simulates fat in its handling characteristics. In a preferred embodiment, the model 700 connects hydrogel organs with diathermy leads to allow for electrocautery. Additional features for the model 700 include aesthetic and anatomical realism.

[0062] Figure 8 is a top side view of the cassette of Figure 7 with a uterus model 800 inserted. The uterus model 800 includes a uterine body portion 810, a uterine horn portion 820, and a vaginal portion 830. The vaginal portion 830 includes an engagement portion for engaging with portions of the cassette 30 and housing 20 that define openings 400 and 510. It may also engage with opening 220 in outer surface 230 and a portion of the pelvic model 600 (e.g., engagement means 630).

[0063] FIG. 9 is an enlarged view of the cassette of FIG. 8 to show more detail of the organ model. This view particularly provides more detail regarding the engagement portion 900 of the vaginal portion 830 of the uterus model 800. It will be appreciated that the opening 910 of the insert 950, i.e., the opening 910 of the uterus organ model 800, like openings 510, 400, and 220, maintains continuous contact with the interior cavity of the uterus model 800, thereby enabling simulation of the interior cavity of the female reproductive tract from the housing 20, through the pelvic model 600, through the cassette 30, and to the uterus model 800. Engagement of the engagement portion 900 of the vaginal portion 830 with the opening 510 (and in some embodiments, the corresponding portion of the pelvic model 600) may be by any suitable means capable of providing sufficient compatibility for the purpose. For example, in some embodiments, it must be capable of providing a watertight seal, and in some, it must be capable of providing an airtight seal. In some, structural soundness without a seal may be sufficient. In this embodiment, the engagement portion 900 of the vaginal section 830 of the uterus model 800 includes a flange 930 and an insert 950. The flange 930 abuts the opening-defining portion 631 of the pelvic model engagement means 630 to restrict outward movement of the uterine organ model 800 through the opening 510. The insert 950 includes a ring portion 920 that abuts the outer surface of the inner wall 530 and is inserted into the vaginal section 830 through the flange 930 in close engagement. The close abutment of the ring portion 920 against the outside of the inner wall 530 ensures that the uterine organ model 800 cannot slide inward into the cavity 550 or slide away from the opening 510. The insert 950 further includes a secondary ring portion 940 that can matingly engage with the outer surface 230, allowing the opening 910 to continue into the opening 220. In an alternative embodiment, opening 910 and flange 930 can be replaced with a ring-shaped annulus without an internal opening, providing an airtight seal to the torso, preventing air leakage through the vaginal opening, and allowing air to be insufflated into the abdominal cavity. If the pelvis is not in the model, the single ring annulus allows other alternative cartridges to be inserted.

[0064] FIG. 10 is a side view representation of an exemplary cassette according to the present invention in accordance with FIG. 8. This figure provides suggested dimensions of a portion of a surgical training device for a typical human adult female torso. A cassette length of approximately 520-530 mm, preferably approximately 526 mm, and a cassette pull-out height of 280-300 mm, preferably 291 mm, have been found to be beneficial for ease of manufacture and ease of use in surgical training. It will be understood that other dimensions commensurate with the normal range of anatomical dimensions of the simulated surgical patient are appropriate.

[0065] FIG. 11 is a top-side view of the cassette of FIG. 6 with additional organ models inserted, specifically the small intestine 42, large intestine 1110, stomach 1120, and liver 44. It can be seen from FIG. 11 that variations in the support 32 can achieve more accurate anatomical relationships between the various organ models. For example, a minor modification to the currently illustrated embodiment would be to shape the support bottom surface 520 to simulate the posterior shape of the abdominal and thoracic cavities. In another exemplary embodiment, the entire cavity 550 is shaped to simulate the abdominal cavity. In yet another exemplary embodiment, the support 32 may include one or more devices for holding each organ model in a specific anatomical position.

[0066] FIG. 12 is a top perspective view of an exemplary pediatric surgical training device according to the present invention, shown generally at 1210 with the cassette in an open position. Generally, this embodiment includes a housing 1220 and a cassette 1230. The housing 1220 is generally shaped to simulate the shape of a pediatric patient and is covered with a synthetic material that can simulate skin, for example. The housing 1220 includes a tray 1229, sidewalls 1228, a closed end 1253, and a cassette-engaging end 1254. The tray 1229 and sidewalls 1228 provide an enclosed space for the cassette 1230 to rest within, functioning to simulate normal anatomy and make it easier to ensure an airtight seal. In this embodiment, the closed end 1253 is at the anatomical lower end of the torso model, and the cassette-engaging end is at the anatomical upper end. It will be appreciated that in some embodiments, the cassette engagement end may be located at the lower end of the anatomical model and the closed end of the housing 1220 may be located at the anatomical upper end of the model.

[0067] The cassette 1230 includes an inner end (not shown), a support 1232, and an outer end 1234. The outer end 1234 includes a handle 1233. In this embodiment, the handle 1233 is shaped to facilitate manipulation of an airlock wheel to form an airtight cavity within the housing. The support 1232 holds selected organ models within the cassette 1230 so that surgical training can be performed. In this embodiment, the support 1232 includes a drawer-like structure that allows associated organ models to be added and positioned within the drawer-like structure. However, it is not necessary for the support 1232 to have a drawer-like configuration. For example, the support 1232 may take the form of a series of devices that secure the organ models in intended anatomical relationships relative to one another for the purposes of the envisioned surgical training procedure.

[0068] In this embodiment, cassette engagement end 1254 includes a seal 1252 that abuts and engages with outer end 1234 of cassette 1230. Channel 1255 provides a channel-shaped cavity for receiving an air seal, which may comprise, for example, a soft plastic, rubber, or similar material, such as silicone. Frame 1252 is an internal door frame structure that facilitates the hermetically sealed engagement. In some embodiments, this engagement is airtight, allowing the internal chamber defined by cassette 1230 and housing 1220 to be insufflated, which can better replicate surgical conditions and provide surgeons with an opportunity to practice the techniques required for insufflation. Some embodiments of the invention may not have an airtight seal, in which case insufflation practice is not possible.

[0069] In this exemplary embodiment, cassette 1230 includes an abdominal organ model 1240 including a small intestine 1242, a liver 1244, and a large intestine 1243. In this embodiment, cassette engagement end 1254 includes three layers: a first layer for adhering synthetic skin-like tissue, a second layer for an open door structure to allow the cassette to be inserted, and a third layer for the cassette door to be inserted and provide an airtight fit. This particular embodiment includes a mechanical airlock integrated into the space between inner wall 1260 and outer door 1234 of cassette 1230. Rotation of handle 1310 (see FIG. 13 ) rotates teeth on gear 1262, which engages the airlock using teeth 1266 and 1264. FIG. 13 is another top perspective view of the pediatric surgical training device of FIG. 12 .

[0070] Figure 14 is a top perspective view of a pediatric surgical training device similar to that of Figure 12 with the cassette closed. It will be appreciated that in this embodiment, the handle 1410 on the outer end 1234 of the cassette 1230 comprises a simple knob. Any suitable handle can be used for this purpose, provided it can be easily grasped for inserting and removing the cassette 1230 from the housing 1220. Figure 14 also shows the fasteners 1420 used to secure the cassette 1230 to the housing 1220 in a tight, and in some embodiments airtight, fashion.

[0071] Figure 15 is a top perspective view of the exemplary pediatric surgical training device of Figure 13 with the cassette removed. Figure 15 shows brackets 1510 with fasteners 1420 engaging to secure cassette 1230 to housing 1220. Figure 15 also shows organ models 1520 that are constructed from different materials than those previously shown, as evidenced by their appearance. They include a liver 1530, a stomach 1540, a large intestine 1550, and a small intestine 1560.

[0072] Figure 16 is a top perspective view of the pediatric surgical training device of Figure 13 with the cassette partially open. Figure 17 is a top perspective view of the pediatric surgical training device of Figure 15 with the abdominal organs removed. Figure 17 shows bony structures 1710, in this example showing the approximate shape of a pelvic girdle, that provide structure for the organ models and help maintain them in approximate anatomical positions relative to each other when they are inserted into cassette 1230.

[0073] Figure 18 is a top perspective view of the surgical training device of Figure 17 with the organs individually assembled and with a spare stomach 1810. This embodiment provides an insert 1820 that helps position and maintain the organ model in approximately correct anatomical relationships. The insert 1820 can be easily engaged and positioned with the support 1232, which in this example means being placed within the cassette 1230.

[0074] FIG. 19 is a schematic top perspective view of a cassette 1930 according to the present invention suitable for use as a pediatric training device. It will be appreciated that in this embodiment, a pelvis 1910 and ribs 1920 are pre-attached to the cassette 1930. This can be done in any suitable manner, for example, with adhesive, screws, or clips, or by "snap-fitting" pre-designed sections, or by molding portions of the cassette or support with the bony structures. This embodiment simplifies certain procedures, for example, eliminating the need to insert the pelvis or rib organ models before inserting the other organ models. The pelvis and ribs provide structural integrity to the other organ models, helping to maintain them in more accurate anatomical positions than outlined. It will also be appreciated that simulating such bony structures helps the surgeon simulate actual surgery by presenting them with similar landmarks and obstacles, as well as tactile or other sensory responses, when interacting with the training device.

[0075] Figure 20 is a top perspective view of the cassette of Figure 19 with vertebrae 2030 and an inguinal hernia model inserted. The vertebrae 2030 provide further simulation for proper anatomical organ placement. Structure 2010 is a pelvic cap that slides onto the implanted solid pelvis to create an integrated pelvis. Structure 2020 represents the inguinal ligament beneath which the hernia model rests.

[0076] Figure 21 is a top perspective view of the cassette of Figure 20 from a different angle. In this embodiment, the cassette is designed to fit over an existing fixed pelvis, and the pelvis slides over the cassette like a sheath. This embodiment is custom designed to fit snugly against a solid pelvis to enable a surgical hernia repair procedure.

[0077] 22 is a top perspective view of an assembled pelvis, vertebrae, and inguinal hernia model according to the present invention. To create an inguinal hernia repair training model, the parts can be inserted into a mold and synthetic skin applied around it, resulting in an embedded material with the inguinal hernia defect positioned between the inguinal ligament and the pelvic position.

[0078] 23 is a photographic image of a surgical training device of the present invention in use, shown generally at 2310. Device 2310 comprises a housing 2320 having a closed end 2353 and a cassette engagement end 2354. Visible are the outer end 2334 of the cassette and a fastener 2370 used to hermetically engage and hold the cassette with housing 2320. Housing 2320 is covered with an outer layer intended to simulate skin. A training surgical team surgically accesses an underlying organ model (not shown) through housing 2320 by use of trocar 2360. Light shining by a surgical camera through trocar 2360 beneath the outer layer of housing 2320 is visible at 2380.

[0079] FIG. 24a shows the exterior door structure and silicone-sealed opening 2440 through which the diathermy electrical cable 2540 and perfusion tubing (not shown) can be inserted. FIG. 24b shows the interior door structure of FIG. 24a. The interior end 2450 of the cable 2450 is attached to a diathermy pad 2445, which is preferably adhered to the hydrogel "fat pad" 700 (see FIG. 7) at the base of the pelvis, connecting all synthetic tissue. The exterior end (not shown) of the cable 2540 includes a connection for the diathermy machine socket. Electrical wires 2540 can be seen entering through opening 2440. Tubing (e.g., medical grade) can also be threaded through opening 2440 to perfuse the blood vessels with synthetic blood. The exterior end of the tubing can have a universal connector that can connect a reservoir, such as an IV bag, to provide gravity-fed blood flow. Additionally, a pump can be used to provide higher pressure synthetic blood, for example, to simulate arteries.

[0080] In use, the training device can be prepared by selecting which synthetic model to use for which procedure, opening the cassette drawer, and placing it in the anatomically correct position. Diathermy pads are placed and connected to the fat pad to allow electrical current to flow. Medical tubing is inserted through the opening and connected to the blood vessels to allow perfusion. The inner end of the tubing will be connected to the outer end of the blood vessel protruding from the organ. The cassette will then be closed and latched or locked into position within the housing / pelvic structure.

[0081] The trainee will first make an incision at the umbilicus of the torso and insert a trocar into the abdomen, allowing for the insertion of an insufflation device and camera port that connects to an external machine. The trainee will then activate gas to insufflate the abdominal cavity, thereby creating space for instrument insertion. Using vision from the camera, the trainee will insert trocars in other locations, allowing for safe placement of instrument ports within the abdominal torso. Diathermy is activated to allow electrocautery, and blood flow is initiated to allow perfusion when blood vessels are severed or compromised. The trainee will then proceed to perform the surgical steps according to the procedure and model.

Claims

1. 1. A surgical training device comprising a housing and a cassette, the housing includes a synthetic layer to simulate skin; the cassette holds one or more organ models in anatomical relationship to one another; the cassette is engageable with and substantially surrounded by the housing, thereby defining a body cavity with the housing; The cassette includes synthetic bony anatomical features as landmarks. Surgical training equipment.

2. The surgical training device of claim 1 , wherein the cassette includes a drawer slidably engageable with the housing.

3. 3. The surgical training device of claim 2, wherein the cassette is for holding one or more organ models in anatomical relationship with each other and with the exterior surface of the housing.

4. The surgical training device of claim 3 , wherein the housing has an operable surface substantially covered by a cover including a synthetic layer to simulate skin.

5. The surgical training device of claim 4 , wherein the synthetic bone anatomical features provide structural integrity for the cover and anatomical positioning and support for the organ model.

6. The surgical training device of claim 5 , wherein the housing is contoured to resemble a life-size torso.

7. The surgical training device of claim 6 , wherein the cassette includes synthetic bony anatomical features as landmarks.

8. The surgical training device of claim 7 , wherein the housing includes a sidewall and a closed end, the closed end of the housing including a cassette-engaging end defining an opening for receiving the cassette.

9. 9. The surgical training device of claim 8, wherein the synthetic skin is sufficiently flexible to form an airtight seal around laparoscopic instruments passed therethrough.

10. The surgical training device of claim 9, wherein the engagement between the housing and the cassette provides an airtight seal within the body cavity by means of a mechanical locking device.

11. the synthetic skin is heat-repairable, sufficiently elastic to allow suturing, and sufficiently expandable to expand like a living body when pressure is applied from within the body cavity via insufflation while maintaining the airtight condition; the body cavity includes a hydrogel synthetic pelvic fat pad disposed on the pelvic model; 11. The surgical training device of claim 10.

12. the synthetic bone anatomical features include one or more of a pelvis model, a rib model, and a vertebra model; The hydrogel synthetic pelvic fat pad placed on the pelvic model is adhered to a diathermy pad, the pelvic fat pad, to enhance anatomical realism and provide a pathway for electrical current to connect with hydrogel tissue during electrocautery.

12. The surgical training device of claim 11.

13. the cassette comprises a drawer having an inner end, a support for holding an organ model, and an outer end, the outer end comprising a handle; the engagement between the housing and the cassette further includes a seal on the housing and / or a seal on the cassette; 13. The surgical training device of claim 12.

14. the body cavity comprises one or more additional organ models selected from thoracic organs, lungs, heart, thymus, abdominal organs, stomach, small intestine, large intestine, colon, gallbladder, rectum, liver, pancreas, spleen, kidneys, adrenal glands, urinary bladder, female reproductive tract, male reproductive tract, lymph nodes, peritoneal tissue, omentum, mesentery; 14. The surgical training device of claim 13.

15. the engagement between the housing and the cassette further comprises a seal on the housing and / or a seal on the cassette, each seal optionally comprising a silicone gasket, each seal optionally contained within a channel around the engaging portion of the housing and the cassette, respectively; the cassette door includes a hermetically sealed port for passage of an electrical cable to provide current access for ablation and a hermetically sealed port for passage of one or more tubes to provide simulated blood flow access; 15. The surgical training device of claim 14.

16. the housing further comprising a tray and a sidewall; the housing has an exterior shape simulating a life-size torso, the manipulable surface being substantially covered by a cover including one or more synthetic layers for simulating a body wall, the synthetic layers including synthetic skin and optionally one or more of muscle, connective tissue, and fat, each layer being adhered to the other layers; the cover comprises one or more of elastomers, thermoplastic elastomers, silicones, room temperature vulcanizing silicones, platinum cure room temperature vulcanizing silicones; saturated fatty acids; pigments, foams, cellular or high density polyethylene foams, high density ethylene vinyl acetate (EVA) foams, foams containing cells that provide a cellular or tissue texture, reduced polynomial hyperelastic materials, urethane polymers, silicone fluids, damping agents that soften silicone components, platinum cure silicone additives, silicone oils, alcohols; commercially available synthetic skin products; the synthetic skin is sufficiently flexible to form an airtight seal around a laparoscopic instrument, such as a trocar, passing therethrough; the engagement between the housing and the cassette provides an airtight seal within the body cavity by means of a mechanical locking device including one or more of a fastener, a clip, a clamp, and a rotary airlock; the cassette includes synthetic bony anatomical features as landmarks, the synthetic bony anatomical features providing structural integrity for the cover and for anatomical placement and support of the organ model; the pelvis model comprises an engagement means having slots for providing detachable engagement with the struts of the inner wall of the support of the organ model, and the pelvis model comprises a cap for fixing the synthetic peritoneal tissue in place.

16. The surgical training device of claim 15.

17. the closed end of the housing defines an opening for passing a portion of the organ model therethrough to simulate an anatomical orifice; an interior end of the drawer defining an opening for passage of an organ model to simulate an anatomical orifice; the opening is defined by the closed end of the housing, and the opening is defined by the inner end of the cassette arranged to form a continuous opening for passage of an organ model to simulate an anatomical orifice; the housing and cassette of the surgical training device together define an opening shaped to receive an organ model having an opening for simulating an anatomical orifice, the organ model optionally comprising an organ lumen and further including a simulated internal anatomical structure associated with the orifice, the orifice being selected from an anal orifice, a vaginal orifice, and a penile orifice; the organ model with the opening, the housing and the cassette together form an airtight seal around the simulated hole, allowing for insufflation into the body cavity while preserving the hole and associated internal anatomical features, optionally including the organ lumen.

17. The surgical training device of claim 16.

18. the hermetic seal around the simulated hole includes a flange on the organ model having the opening, the flange being disposed within the body cavity and positioned inside the opening defined by the inner wall of the cassette, the hermetic seal further comprising one or more annular members on an insert designed to hermetically engage with the organ model from outside the body cavity and outside the opening; the insert optionally comprises an annular member for close-fitting engagement with an external organ model, such as a synthetic skin model, to simulate an external orifice, the external orifice being an anus, vulva, or penis, the external orifice being continuous with the orifice of the organ model having the opening in the body cavity; 20. The surgical training device of claim 17.

19. the cassette comprises a length of approximately 450-600 mm, preferably 500-550 mm, more preferably 520-530 mm, more preferably about 526 mm, and a height of 200-400 mm, preferably 250-350 mm, more preferably 280-300 mm, more preferably about 291 mm; the cassette-engaging end of the housing includes a first layer for adhering to a cover, a second layer for defining an opening for inserting the cassette, and a third layer comprising a seal for sealingly engaging an outer end of the cassette.

20. The surgical training device of claim 18.

20. 1. A surgical training device comprising a housing and a cassette, the housing includes a tray, a sidewall, and a closed end; the closed end of the housing defines an opening for passing a portion of the organ model to simulate an anatomical hole, and the closed end of the housing includes a cassette engagement end defining an opening for receiving the cassette; the housing has an exterior shape simulating a life-size torso, the manipulable surface being substantially covered by a cover including one or more synthetic layers for simulating a body wall, the synthetic layers including synthetic skin and optionally one or more of muscle, connective tissue, and fat, each layer being adhered to the other layers; the cassette for holding one or more organ models in anatomical relationship to each other and to the exterior surface of the housing; the cassette has a length of about 520-530 mm, preferably about 526 mm, and a height of 280-300 mm, preferably about 291 mm; the cassette includes a drawer slidably engageable with the housing and substantially surrounded by the housing, thereby defining a body cavity therewith; the cover comprises one or more of a thermoplastic elastomer, a silicone, a room temperature vulcanizing silicone, a platinum cure room temperature vulcanizing silicone; a saturated fatty acid; a pigment, a foam, a cellular or high density polyethylene foam, a high density ethylene vinyl acetate (EVA) foam, a foam containing cells that provide a cellular or tissue texture, a reduced polynomial type hyperelastic material, a urethane polymer, a silicone fluid, a damping agent that softens the silicone component, a platinum cure silicone additive, a silicone oil, an alcohol; a commercially available synthetic skin product; the synthetic skin is sufficiently flexible to form an airtight seal around laparoscopic instruments as they are passed therethrough, is heat-healable, has sufficient elasticity to allow suturing, and is sufficiently stretchable to allow bio-like expansion when pressure is applied via insufflation from within the body cavity while maintaining the airtight seal; the cassette-engaging end of the housing includes a first layer for adhering to a cover, a second layer for defining an opening for inserting the cassette, and a third layer comprising a seal for sealingly engaging an outer end of the cassette; the cassette includes a drawer having an inner end, a support for holding an organ model, and an outer end, the outer end including a handle, the inner end defining an opening for passage of the organ model simulating an anatomical orifice; the opening is defined by the closed end of the housing, and the opening is defined by the inner end of the cassette arranged to form a continuous opening for passage of an organ model to simulate an anatomical orifice; the engagement between the housing and the cassette provides an airtight seal within the body cavity by means of a mechanical locking device, the engagement between the housing and the cassette further comprising a seal on the housing and / or a seal on the cassette, the seal comprising a silicone gasket and housed within a channel around the engaged portion of the housing and the cassette, respectively; the cassette includes synthetic bony anatomical features as landmarks, the synthetic bony anatomical features providing structural integrity for the cover and anatomical placement and support for the organ model; the synthetic bone anatomical features include a pelvis model, a rib model, and a vertebral model, the pelvis model having an engagement means with a slot for providing detachable engagement with a support post of the inner wall of the organ model support, and the pelvis model including a cap for fixing the synthetic peritoneal tissue in place; the cassette door comprises a hermetically sealed port for passage of an electrical cable to provide current access for cauterization and a hermetically sealed port for passage of one or more tubes to provide simulated blood flow access; the housing and cassette of the surgical training device together define an opening shaped to receive an organ model having an opening for simulating an anatomical orifice, the organ model further including a simulated internal anatomical structure associated with the orifice including an organ lumen, the orifice being selected from an anal orifice, a vaginal orifice, and a penile orifice; the organ model having the opening, the housing, and the cassette together form an airtight seal around the simulated hole, allowing air to be insufflated into the body cavity while maintaining the hole and associated internal anatomical features; the hermetic seal around the simulated hole includes a flange on an organ model having an opening, the flange being disposed within the body cavity and on the inside of the opening defined by the inner wall of the cassette, the hermetic seal further comprising one or more annular members on an insert designed to be in airtight mating engagement with the organ model on the outside of the body cavity and the outside of the opening; the insert comprises an annular member for mating engagement with a cover including a synthetic skin model for simulating an external orifice selected from an anus, a vulva, or a penis, the external orifice being continuous with the orifice of an organ model having the opening in the body cavity; the body cavity includes a hydrogel synthetic pelvic fat pad positioned on the pelvic model and adhered to an electrocautery pad, the pelvic fat pad enhancing anatomical realism and providing a pathway for connecting hydrogel tissue and electrical current during electrocautery; the body cavity comprises one or more additional organ models selected from thoracic organs, lungs, heart, thymus, abdominal organs, stomach, small intestine, large intestine, colon, gallbladder, rectum, liver, pancreas, spleen, kidneys, adrenal glands, urinary bladder, female reproductive tract, male reproductive tract, lymph nodes, peritoneal tissue, omentum, mesentery; Surgical training equipment.

21. A surgical training device comprising a plurality of anatomical landmarks for use during said surgery, said anatomical landmarks comprising synthetic skin covering anatomical structures.

22. 22. A surgical training device according to claim 21 for training in surgery involving a body cavity.

23. 22. A surgical training device according to claim 21 for training in laparoscopic surgery.

24. 22. The surgical training device of claim 21, wherein the synthetic skin includes one or more anatomical structures.

25. 25. The surgical training device of claim 24, wherein the synthetic skin anatomical structures include skin surface features that are any one or more of the following: nipples, folds, hair, navel, breasts, vagina, and penis.

26. 22. The surgical training device of claim 21, wherein the synthetic skin includes multiple additional layers to simulate one or more of muscle, fat, and mesentery.

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