Patent ID: 12243441

DETAILED DESCRIPTION OF THE INVENTION

A surgical training device10that is configured to mimic the torso of a patient such as the abdominal region is shown inFIG.1. The surgical training device10provides a body cavity12substantially obscured from the user for receiving simulated or live tissue or model organs or training models of the like described in this invention. The body cavity12is accessed via a tissue simulation region14that is penetrated by the user employing devices to practice surgical techniques on the tissue or practice model found located in the body cavity12. Although the body cavity12is shown to be accessible through a tissue simulation region, a hand-assisted access device or single-site port device may be alternatively employed to access the body cavity12. An exemplary surgical training device is described in U.S. patent application Ser. No. 13/248,449 entitled “Portable Laparoscopic Trainer” filed on Sep. 29, 2011 and incorporated herein by reference in its entirety. The surgical training device10is particularly well suited for practicing laparoscopic or other minimally invasive surgical procedures.

Still referencingFIG.1, the surgical training device10includes a top cover16connected to and spaced apart from a base18by at least one leg20.FIG.1shows a plurality of legs20. The surgical training device10is configured to mimic the torso of a patient such as the abdominal region. The top cover16is representative of the anterior surface of the patient and the space12between the top cover16and the base18is representative of an interior of the patient or body cavity where organs reside. The surgical trainer10is a useful tool for teaching, practicing and demonstrating various surgical procedures and their related instruments in simulation of a patient undergoing a surgical procedure. Surgical instruments are inserted into the cavity12through the tissue simulation region14as well as through pre-established apertures22in the top cover16. Various tools and techniques may be used to penetrate the top cover16to perform mock procedures on simulated organs or practice models placed between the top cover16and the base18. The base18includes a model-receiving area24or tray for staging or holding a simulated tissue model or live tissue. The model-receiving area24of the base18includes frame-like elements for holding the model (not shown) in place. To help retain a simulated tissue model or live organs on the base18, a clip attached to a retractable wire is provided at locations26. The retractable wire is extended and then clipped to hold the tissue model in position substantially beneath the tissue simulation region14. Other means for retaining the tissue model include a patch of hook-and-loop type fastening material (VELCRO®) affixed to the base18in the model receiving area24such that it is removably connectable to a complementary piece of hook-and-loop type fastening material (VELCRO®) affixed to the model.

A video display monitor28that is hinged to the top cover16is shown in a closed orientation inFIG.1. The video monitor28is connectable to a variety of visual systems for delivering an image to the monitor. For example, a laparoscope inserted through one of the pre-established apertures22or a webcam located in the cavity and used to observe the simulated procedure can be connected to the video monitor28and/or a mobile computing device to provide an image to the user. Also, audio recording or delivery means may also be provided and integrated with the trainer10to provide audio and visual capabilities. Means for connecting a portable memory storage device such as a flash drive, smart phone, digital audio or video player, or other digital mobile device is also provided, to record training procedures and/or play back pre-recorded videos on the monitor for demonstration purposes. Of course, connection means for providing an audio visual output to a screen larger than the monitor is provided. In another variation, the top cover10does not include a video display but includes means for connecting with a laptop computer, a mobile digital device or tablet and connecting it by wire or wirelessly to the trainer.

When assembled, the top cover16is positioned directly above the base18with the legs20located substantially around the periphery and interconnected between the top cover16and base18. The top cover16and base18are substantially the same shape and size and have substantially the same peripheral outline. The internal cavity is partially or entirely obscured from view. In the variation shown inFIG.1, the legs include openings to allow ambient light to illuminate the internal cavity as much as possible and also to advantageously provide as much weight reduction as possible for convenient portability. The top cover16is removable from the legs20which in turn are removable or collapsible via hinges or the like with respect to the base18. Therefore, the unassembled trainer10has a reduced height that makes for easier portability. In essence, the surgical trainer10provides a simulated body cavity12that is obscured from the user. The body cavity12is configured to receive at least one surgical model accessible via at least one tissue simulation region14and/or apertures22in the top cover16through which the user may access the models to practice laparoscopic or endoscopic minimally invasive surgical techniques.

A model30for practicing hysterectomies and, in particular, for practicing vaginal hysterectomies according to the present invention is shown inFIG.2. The model30is configured to be placed inside the surgical training device10described above or other similar surgical trainer. The model30includes a simulated uterus32connected to a frame34with a first sheet36and a second sheet38. The simulated uterus32includes a bulbous portion40defining a hollow simulated uterine cavity42. The bulbous portion40is connected to a tubular portion44defining a vaginal canal46having an opening48. The simulated uterus32further includes a simulated cervix50(shown inFIG.4A) located inside the simulated uterus32in a location substantially between the uterine cavity42and the vaginal canal46. The simulated cervix50includes a slit52. The simulated cervix50is made of a solid, high durometer silicone.

The simulated uterus32further includes simulated fallopian tubes54connected to ovaries56. The simulated uterus32, fallopian tubes54and ovaries56are made of silicone or other elastomeric material and may include other material such as foam material combined with the silicone. The simulated uterus32is made of silicone or lighter foam such as urethane or silicone foam or a combination of the two. The silicone construction imparts the simulated uterus32with a more realistic weight when the attached simulated cervix50is being pulled and manipulated. The simulated uterus32made of foam makes the simulated uterus32easier to suspend inside the simulated pelvic cavity. Also, when removing the simulated uterus32the lightweight foam flexes more easily than a simulated uterus32made of higher durometer silicone allowing a larger simulated uterus32to be placed into the model30and still be removed. The foam uterus32would compress and flex as it is being removed through the vaginal opening48similar to an actual surgery. The simulated uterus32is approximately 300-500 grams and the simulated uterus32is composed of a selected durometer foam to accurately represent the size and weight of a real uterus that could normally be removed vaginally without significant morcellation. The use of foam for the artificial uterus provides a realistic resistance during vaginal hysterectomy, proper bulk density and realistic morcellation properties along with an overall muscular-like feel without collapsing during removal. In another variation, the simulated uterus32is a combination of silicone and foam to give a more realistic look to the simulated uterus32while still having the flexibility of the foam. The foam can be cast and then the silicone can be applied over the foam such as, for example, on a rotational mold in an over-molding method. This variation advantageously results in not having to put mesh reinforcement along the entire length of the artificial uterus and allows the artificial uterus to be manipulated while having a smooth realistic finish that permits the color to be changed by using different colored silicone and/or foam. The simulated uterus32is generally pink in color and the fallopian tubes54and ovaries are clear or white in color. Furthermore, the simulated uterus32may include embedded tumors, cysts and/or ectopic pregnancies in the fallopian tubes54. The model30may further include simulated vasculature58such as blood vessels. The simulated vasculature58is made of solid or hollow tubular silicone or other suitable elastomer. Liquid may be included inside the hollow tubing of the simulated vasculature58. The simulated vasculature58that simulates blood vessels may be red in color. The model30may also include simulated ligaments59such as the uteralsacral ligament59and made of silicone material as seen inFIGS.2and4E. The model30may further include the round and tubo ovarian ligaments61attached to the frame34shown inFIG.2.

With additional reference toFIGS.3A-3D, the frame34comprises a cylindrical-like shape defining an interior/lumen60. The frame34includes a first surface62interconnected to a second surface64defining a thickness therebetween. The first surface62defines the inner surface of the cylindrical-like shape of the frame34and the second surface64defines an outer surface of the cylindrical-like shape of the frame34. The frame34is made of flexible foam material that is also slightly compressible. The frame34includes one or more cutouts66extending between the first surface62and the second surface64to define an outer perimeter and apertures. In one variation, the frame34is made of a sheet of foam material that is cut according to a pattern shown inFIG.3D.FIG.3Dillustrates the outer perimeter having a top68and a bottom70interconnected by a first side and a second side72,74. The top68includes two curved portions76a,76binterconnected at a first protrusion78along a vertical axis. The two curved portions76a,76brepresent the left and right ilium/iliac crest. The bottom70includes a second protrusion80along the vertical axis. The first protrusion78represents the sacrum of a human pelvis and the second protrusion80represents the coccyx. The first side72includes a first lower lobe82having a first aperture86and the second side74includes a second lower lobe84having a second aperture88. The first and second lower lobes82,84represent the left and right ischium and the first aperture86and the second aperture88represent the obturator foramen of the human pelvis. A piece of foam having a thickness is cut to have the flat pattern shape shown inFIG.3D. Then the piece of foam is curved such that the first lower lobe82and second lower lobe84join together in a cylinder-like configuration. Where the two lobes82,84are joined, represent the pubic bone/pubis/pubis symphysis. The two lobes82,84can be joined by adhesive or connected in another suitable manner. In another variation, the two lobes82,84are not joined together but remain spaced apart in a semi-cylindrical-like or split cylinder configuration. The frame34is bendable and may be made of a material that retains its shape after bending such as aluminum. Also, the clips26and wire that are connected to the trainer10may be used to hold the two lobes82,84in an upward orientation and in a cylindrical-like configuration while inside the trainer10. The anatomy of the pelvis is shown inFIG.7.

The frame34is made of soft, compressible, semi-rigid foam that can be die cut and then formed into the correct shape with adhesive. If the frame34is made of harder plastic, it could be a thin thermoform that is initially formed into the correct shape or a thicker plastic that is cut into the pelvis shape and then formed into a cylindrical shape with heat. The frame34may also be made of deformable metal that holds its shape. The frame34is not a perfect replica of the anatomy and need only include certain features selected to practice certain procedures that require those specific features as anatomical reference points or visual landmarks for the practitioner. For example, for practicing a vaginal hysterectomy, the important features of the pelvis are the restriction of the pelvic inlet and the attachments to the pelvic sidewall. For practicing a transanal total mesolectal excision (taTME), the L-shape of the sacrum is an important landmark. For hernia procedures, the pubic tubercle is an important landmark. The frame34can be made to have all anatomically correct features or only the ones needed for the specific procedure. As such, the frame34and model30can be used for the simulation of a vaginal hysterectomy, abdominal hysterectomy, colectomy, hernia, taTME, and other pelvic procedures. In another variation, the frame34forms a conical shape or frusto-conical shape having an open proximal and open distal ends.

With reference back toFIG.2, the model30may further include a simulated bladder90. The simulated bladder90is a hollow, air-filled component typically made of silicone or other elastomeric material. In another variation, the simulated bladder contains liquid. The simulated bladder90is connected to the frame34with adhesive or other means. It is connected to the first surface62or inner surface of the frame34. The simulated bladder90is attached in alignment with the vertical axis in the location of where the two lobes82,84are in juxtaposition in a location representative of the pubis. When connected the simulated bladder90extends into the lumen60of the frame34. The simulated bladder90may further include a simulated ureter94. In one variation, the simulated ureter94is connected to the simulated bladder90. The simulated ureter is made of solid or hollow tubular silicone.

Still referencingFIG.2, the model30may further include a simulated colon92or bowel portion. The simulated colon92is a tubular structure that includes a lumen. The simulated colon92is laid on the first surface62inside the interior60of the frame34and substantially along the vertical axis and against the second protrusion80of the frame34. Adhesive may be used to attach the simulated colon92to the frame34. The simulated colon92is made of silicone or other suitable elastomeric material and colored pink or other suitable color and may or may not include simulated tumors.

The first sheet36is a thin layer of clear silicone material having a top surface96and a bottom surface98and a first end100and a second end102. The first sheet36is transparent and at least one of the top surface96and the bottom surface98is textured in one variation. The first sheet36is attached to the simulated uterus32. In particular, the bottom surface98of the first sheet36near the first end100is attached along at least a portion of the length of simulated uterus32to one or more of the bulbous portion40and tubular portion44as shown inFIG.2. The first sheet36is then folded back toward the top of the model30and toward the first end100of the first sheet36creating a fold near the tubular portion44of the simulated uterus32. At least a portion of the first sheet36near the second end102of the first sheet36is attached to the frame34such that the bottom surface98of the first sheet36is adhered to the frame34in the general location of where the two lobes82,84are in juxtaposition to create a cylinder-like configuration for the frame34. The attachment of the first sheet36may also serve to hold the frame34in the cylindrical-like configuration. Adhesive is used to attach the bottom surface98of the first sheet36to the frame34. The bottom surface98of the first sheet36is attached to the first surface62or inner surface of the frame34and then folded around a portion of the first side72and second side74of the frame34. If a simulated bladder90is employed in the model30, then the second end102of the first sheet36is also attached with adhesive to the outer surface of the simulated bladder90capturing the simulated bladder90between the frame34and the first sheet36. A portion of the second end102of the first sheet36is folded around the edge of the frame34and attached to the second surface64of the frame34such that at least part of the second end102of the first sheet36is resident above the second or outer surface64of the frame34as visible inFIG.4D. The first sheet36is sized and configured to suspend the simulated uterus32inside the interior60of the frame34. Simulated vasculature58may be attached to the top surface96or bottom surface98of the first sheet36. The configuration of the first sheet36forms a pocket-like structure wherein the top surface96of the first sheet36is folded and at least in part facing itself. The first sheet36creates a webbing of suspension that simulates the peritoneum layer.

The second sheet38is a thin layer of clear silicone material having a top surface104and a bottom surface106and a first end108and a second end110. The second sheet38is transparent and at least one of the top surface104and the bottom surface106is textured in one variation. The second sheet38is attached to the simulated uterus32. In particular, the bottom surface106of the second sheet38near the first end108is attached along at least a portion of the length of simulated uterus32to one or more of the bulbous portion40and tubular portion44on a side opposite from where the first sheet36is attached. The first sheet36is attached to the anterior side of the model30which is also the anterior side of the simulated uterus32. The second sheet38is attached to the posterior side of the model30which is also the posterior side of the simulated uterus32. After being attached to the posterior side of the simulated uterus32, the second sheet38is then folded back toward the top of the model30and toward the first end108of the second sheet38creating a fold near the tubular portion44of the simulated uterus32. At least a portion of the second sheet38near the second end110of the second sheet38is attached to the frame34such that the bottom surface106of the second sheet38is adhered to the frame34in the general location of the second protrusion80. Adhesive is used to attach the bottom surface106of the second sheet38to the frame34. The bottom surface106of the second sheet38is attached to the first surface62or inner surface of the frame34and may be folded around the edge of the frame34such that at least part of the second end110of the second sheet38is connected to second or outer surface64of the frame34. If a simulated colon92is employed in the model30, then the second end110of the second sheet38is also attached with adhesive to the outer surface of the simulated colon92or at least overlaying and not attached with adhesive such that at least a portion of the simulated colon92is captured or located between the frame34and the second sheet38. The second sheet38is sized and configured to suspend the simulated uterus32inside the interior60of the frame34if the model30is turned over. Simulated vasculature58may be attached to the top surface104or bottom surface106of the second sheet38. The configuration of the second sheet38forms a pocket-like structure wherein the top surface104of the second sheet38is folded and at least in part facing itself. The second sheet38creates a suspended webbing that simulates the peritoneum layer.

With reference now toFIGS.4A-4E, the model30is shown placed inside a surgical training device10of the like described with respect toFIG.1. The model30is shown inside the body cavity12and oriented such that the top68of the frame34is in the cephalad direction of the simulated training device10and the vaginal opening48of the simulated uterus32faces the caudal direction of the simulated training device10. The model30can be connected to the surgical training device10with the clips26attached to the trainer10. The retractable clips26can be pulled out and the clips26attached to any portion of the model30such as to the frame34of the model30. Also, the second or outer surface64of the model30may include a hook-and-loop type fastener configured to attach to a complementary portion of hook-and-loop type fastener connected to the base18of the trainer10. Together with one or more fasteners such as the clips26and/or hook-and-loop type fasteners, the model30is securely attached to the trainer10such that it can be manipulated in simulated surgery without dislodging the model30from the body cavity12of the trainer10. The model30is further connected to the trainer10via a transvaginal adapter112that is sized and configured to connect between the top cover16and the base18as an additional leg20positioned at the caudal direction of the surgical training device10.

Turning now toFIGS.5A-5B and6A-6B, there is shown a transvaginal adapter112. With reference also back toFIG.1, there is shown a top cover supported above the base by five legs20. In one variation, a sixth leg20is provided as shown inFIGS.4A-4Din the form of the transvaginal adapter112. The trainer10may be assembled with an optional sixth support structure or leg which is configured for simulating transvaginal surgery including transvaginal hysterectomies.

The transvaginal adapter112includes a flat plate114having an inner surface116for facing toward the interior of the trainer and an outer surface118for facing outwardly towards the user. The plate114has a rectangular shape and includes an aperture120passing through the plate108from the inner surface116to the outer surface118. In one variation, the aperture120is circular in shape. In another variation, the aperture120is elongate elliptical oval-like in shape and oriented vertically along the longitudinal axis of the adapter112. In another variation, the aperture120is elongate elliptical oval-like in shape and oriented perpendicularly to the longitudinal axis of the adapter. As shown inFIGS.5A-6B, the plate114also includes means such as tabs122or a U-shaped channel for inserting to connect the transvaginal adapter112to the top cover16and to the base18to help support and space apart the top cover16. The transvaginal adapter112is located between the top cover16and the base18and provides a side access aperture16lateral to the trainer10or substantially perpendicular to the top cover16and the base18. The plate114further includes a plurality of molding apertures124surrounding or encompassing the main aperture120configured for overmolding a soft simulated vaginal tissue interface made of silicone or the like. In another variation the interface is insertable into the aperture120of the transvaginal adapter112. The tissue interface (not shown) includes an aperture that is substantially coaxial with the plate aperture120. At the inner surface of the transvaginal adapter112, a tubular extension126is integrally provided and extends into the simulated body cavity12of the trainer10. The tubular extension126is longer inFIGS.6A-6Bin comparison to the tubular extension126ofFIGS.5A-5B. The tubular extension126is sized and configured such that the tubular portion44of the simulated uterus32can be stretched around the extension126and secured to the transvaginal adapter112such that the vaginal canal46is supported in an open configuration, coincident with and accessible through the aperture120of the adapter112as shown inFIGS.4A-4D. The tubular extension126serves as a connector connecting the model30with the trainer10in a manner that permits the interior of the uterus to be accessed as in real surgery. In one variation, the tubular extension126is a cylindrically-shaped extension having a radially-extending distal flange128that extends around at least a portion of the extension128to help secure and retain the model30attached to the trainer10. The tubular portion44of the model20is attached to the tubular extension126by pulling the tubular portion44over the distal flange128, if one is provided, and over and around the tubular extension126the outer diameter of which is the same or slightly larger than the relaxed inner diameter of the tubular portion126to keep the tubular portion44secured to the transvaginal adapter112. The transvaginal adapter112can be made of flexible or rigid material. If the adapter112is made of rigid material it will tend to simulate an already retracted vaginal canal46. If the adapter112is made of flexible material or soft material, the adapter112is suited for practicing retraction. In another variation, the transvaginal adapter112has a tubular extension126that is made of soft flexible material and plate114made of rigid material or surrounded by rigid material to keep the top cover16of the trainer10supported which would still allow the practitioner to practice retraction at the opening of the vaginal canal46at the adapter112.

In use, the model30is placed inside the surgical training device10and held in place with a hook-and-loop type fastener and/or retracting clips26. The tubular portion44is attached to the transvaginal adapter112by stretching the vaginal opening48over the tubular extension126of the adapter112. A curtain may be employed that is placed around the sides of the trainer30to further conceal the model30such that the only visualization is through the simulated vaginal canal46. The vaginal canal46is then retracted using a surgical retractor. The vaginal canal46is made of a flexible thermoplastic elastomer (TPE). The TPE provides resistance as it is retracted and wants to spring back to its original shape which permits the user to practice realistic retraction. The transvaginal adapter112ofFIGS.6A-6Bhaving a longer tubular extension126is used to simulate an already retracted vaginal canal. Hence, the transvaginal adapter112permits the practitioner to practice the hysterectomy procedure without needing extra-hands and assistance to perform the retraction. If the transvaginal adapter112ofFIGS.5A-5Bhaving the shorter tubular extension126is used, the practitioner will practice retracting the vaginal canal46with retractors and the help of extra hands during the procedure. The transvaginal adapter112can be made of rigid or flexible material or rigid and flexible material as described above and selected for the purpose of practicing retraction of the vaginal canal46or not. Next, the simulated cervix50is grasped and pulled towards the opening48of the vaginal canal46. The simulated cervix50is made of high durometer silicone relative to the surrounding tubular portion44. The simulated cervix50is also made as a solid component which allows it to be grasped with real surgical tools and pulled on without fear of the silicone ripping or tearing. The simulated cervix50is incised circumferentially and the practitioner is able to practice carefully dissecting the vaginal mucosa off of the simulated cervix50. A sheet of cotton or other webbing-like substance can be included in the model30between the vaginal canal46and the simulated bladder90. As described above, the simulated bladder90is a hollow, air-filled component. If the practitioner cuts to high while dissecting the simulated vaginal mucosa and the simulated bladder90is accidentally incised, the simulated bladder90could pop and give immediate feedback to the practitioner especially if the simulated bladder90contains fluid.

The model30advantageously includes a second sheet38forming a fold between the simulated uterus32and the frame34. Also, the suspension of the simulated uterus32within the frame34advantageously creates a realistic response when the simulated uterus32is being incised and manipulated. Also, in the variation in which the simulated uterus is made of lighter foam material, the simulated uterus will remain suspended, hang and swing in response to being manipulated with surgical instruments. At least portions of the simulated uterus and simulated vagina are held in suspension inside the enclosure defined by the pelvic frame and connected thereto or directly connected to the enclosure defined by the trainer. The suspension advantageously permits the fold of the second sheet to be accessed to practice posterior colostomy into the posterior cul-de-sac incision by incising the peritoneum forming the recto-uterine fold. The suspended simulated uterus32allows for the existence of the recto-uterine peritoneum fold. As previously described, the simulated uterus32is pendent inside the frame34made of foam material that mimics a human pelvis. The simulated uterus32is suspended by a folded first sheet of silicone material on the anterior side of the simulated uterus32and a folded second sheet of silicone material on the posterior side of the simulated uterus32. The frame34can be made of any material such as plastic or harder foam material. The frame34serves as an attachment area for the various simulated portions of the anatomy including the broad ligament, ovaries56and fallopian tubes54. The elasticity of the silicone of these anatomical components allows the simulated uterus32to be pulled and manipulated and still remain attached to the frame34. A frame34made of semi-rigid foam may also move as the simulated uterus is being manipulated. A more rigid frame34would move less. The practitioner then divides the uteralsacral ligaments59. The practitioner then performs an anterior colostomy into the anterior cul-de-sac by incising the first sheet38simulating the peritoneum forming the vesico-uterine fold. The practitioner divides the tubo ovarian and round ligaments61on each side of the simulated uterus32. Due to the foam frame34, the round and tubo ovarian ligaments59remain realistically attached to the frame34after they have been divided from the simulated uterus32. The simulated uterus32is then freed and removed. The practitioner then practices to suture the vaginal cuff closed by passing a needle and suture through the tubular portion44of the model32to close the vaginal canal46opening. Suturing the vaginal cuff in real surgery is another difficult part of the vaginal hysterectomy due to the space limitations. The tubular portion44that is made of TPE holds the suture without tearing and limits the space allowed for instruments during the suturing process. The model30allows the practitioner to practice numerous difficult procedures on one model.

Turning now toFIGS.7-8, a hysterectomy model200will now be described. The model200includes a plurality of simulated organ structures202connected to and located inside a frame204.

Turning now toFIG.9, there is shown a frame204according to the present invention. The frame204is configured to simulate a pelvis and serve as a box-like encasement for housing the plurality of simulated organ structures202. The frame204includes a top frame portion206connected with fasteners210to a bottom frame portion208. The assembled frame204forms a base and a top interconnected by two upstanding sidewalls and defines a central lumen with an open proximal end and an open distal end. The frame204has a flat base permitting it to be placed and stand on a flat surface.

Turning now toFIGS.10-11, there is shown the top frame portion206.FIG.10illustrates the top frame portion206in a flat arrangement. The bottom side includes curvatures representative of the bony structure of the human pelvis and form the sidewalls and top of the frame204. From the flat arrangement, the top frame portion206is folded to form the folded arrangement shown inFIG.11. The top frame portion206includes a plurality of apertures212configured to receive fasteners for connecting the plurality of simulated organ structures202to the frame204. Other apertures212are configured to pass the simulated organ structures through the apertures212and into the frame204for supporting the various simulated organ structures such as simulated vasculature with respect to the frame204as will be described in greater detail below.

Turning now toFIGS.12-13, there is shown a bottom frame portion208.FIG.12illustrates the bottom frame portion208in a flat arrangement andFIG.13illustrates it in a folded arrangement. The bottom frame portion208defines the base of the frame204and includes curved ends that simulate the bony anatomy of the human pelvis. The bottom frame portion208also includes a plurality of apertures212configured to connect the plurality of simulated organ structures202to the frame204with fasteners passed through the apertures and/or by passing the simulated organ structures directly through the apertures212as will be described in greater detail below.

Turning now toFIGS.14-15, the plurality of simulated organ structures202and its connection to the frame204will now be described. The plurality of simulated organ structures202includes a simulated bladder214, a simulated uterus216, a simulated vaginal canal218, a simulated rectum220, a first sheet222, a second sheet224, a dissecting layer226and a plurality of fasteners210. The plurality of organ structures202are interconnected as shown inFIG.14and in turn connected to the frame204. Tubular shaped vasculature, ducts, arteries and the like in addition to other simulated organs structures not mentioned herein may be included in this model in an anatomically correct or anatomically similar arrangement for the same or different anatomical location of the body. Each simulated organ structure will now be described.

The simulated bladder214forms a closed receptacle with an outer membrane made of pink-colored silicone. The interior of the simulated bladder214may be stuffed with polyfil or other material to maintain its shape. The simulated bladder214has a proximal end240and a distal end242. The simulated uterus216is also made of silicone. The simulated uterus216has a proximal end260and a distal end262. The simulated vaginal canal218is a tubular structure made of silicone and may optionally contain an embedded mesh layer230. The simulated vaginal canal218has a proximal end256and a distal end258. The simulated rectum220is a tubular structure made of silicone with molded transverse folds. The simulated rectum220has a proximal end244and a distal end246. Each of the first sheet222and the second sheet224comprises a large flat planar layer of silicone material. Both sheets222,224represent the peritoneum. The first sheet222has a first surface232and a second surface234and a proximal end248and a distal end250. The second sheet224has a first surface236and a second surface238and a proximal end252and a distal end254.

With continued reference toFIGS.14-15, the assembly, configuration and connection of the plurality of simulated organ structures202will now be described. The distal end of the bladder242is attached to the first surface232of the first sheet222with adhesive approximately midway between the proximal end248and the distal end250of the first sheet222such that the first sheet222wraps around the distal end242of the simulated bladder214from the top of the simulated bladder to the bottom of the simulated bladder214. The first surface232is attached to a fastener210near the distal end248of the first sheet222. The first sheet222is folded in an approximate U-shape such that the distal end250of the first sheet222and, in particular, the first surface232of the first sheet222, is attached to the simulated uterus216and attached to the simulated vaginal canal218via the dissecting layer226using adhesive.

The dissecting layer226is a construct comprising a silicone layer228interconnected with a fiber layer229. While the silicone layer228is uncured, a fiber layer229is embedded to form the dissecting layer226. The dissecting layer226is attached to the simulated vaginal canal218in pieces or strips while the silicone of the simulated vaginal canal218is still wet and uncured on a mandrel. When the dissecting layer226is applied to the uncured simulated vaginal canal218, the uncured silicone of the uncured simulated vaginal canal218is allowed to cure to attach the dissecting layer226, in particular, to attach the fiber layer229of the dissecting layer226to the simulated vaginal canal218sandwiching the fiber layer229between two layers of silicone. The dissecting layer226may be sectional around the simulated vaginal canal218or completely tubular in shape to surround the circumference of the simulated vaginal canal218. Although the dissecting layer226is shown with the same reference number, two dissecting layers226may be provided on either side of the simulated vaginal canal218as shown in the figures. Also, as shown inFIGS.14-15, the dissecting layer226is attached to distal end258of the simulated vaginal canal218. The dissecting layer226is described in detail in co-pending International Patent Application Serial No. PCT/US2016/041852 entitled “Simulated dissectible tissue” filed on Jul. 12, 2016 incorporated herein by reference in its entirety.

The second sheet224is attached between the simulated uterus216and the simulated rectum220. In particular, the first surface236at the distal end252of the second sheet224is attached near the distal end262of the simulated uterus216. The second sheet224is attached along the length of the simulated uterus216toward the proximal end260using adhesive. The second sheet224is attached to the dissecting layer226. In particular, the first surface236of the second sheet224is attached to the silicone layer228of the dissecting layer226using adhesive. Then, the second sheet224is folded to extend back towards the distal end of the simulated rectum220and attached along the top side and outer surface of the simulated rectum220such that the distal end254of the second sheet224is near the distal end246of the simulated rectum220. The top side of the simulated bladder214is connected to a fastener210and this fastener210is passed through an aperture212in the top frame206of the frame204. The proximal end248of the first sheet222is also attached to a fastener210which is also passed through an aperture212in the top frame206of the frame204to attach the plurality of the simulated organ structures202to the frame204in a suspended manner. While suspended from the top frame204, the interconnected plurality of simulated organ structures202advantageously pendulate and move together in a realistic fashion wherein the point of contact with instruments and the like will move most and simulated organs distal to the point of contact with instruments move to a lesser degree. The bottom side of the simulated rectum220is attached to at least two fasteners210as shown inFIGS.14-15. The two fasteners210are passed through apertures212in the bottom frame208to secure the plurality of simulated organ structures202to the frame202. Hence, the plurality of simulated organs structures is spanned across the central opening of the frame202with the first sheet222and second sheet224forming an interconnecting webbing. The proximal end260of the simulated uterus216is inserted into the distal end258of the simulated vaginal canal218and joined together with adhesive. A simulated cervix is provided made of silicone and located inside the simulated uterus216at the proximal end260.

Turning now toFIG.16, the fastener210will now be described in greater detail. The fastener210has a dual-pronged, hooked, deflectable end264connected to a planar surface end266. The two prongs of the rivet-like fastener210extend from the planar surface266. The two prongs are resiliently deflectable toward and away from each other such that when passed through a smaller aperture, the prongs flex inwardly when ramped against the aperture and then spring back outwardly when the widest portion of the prongs has passed through the aperture, thereby, snapping and hooking into the aperture wall. The fastener210is not limited to having a two-prong arrangement. Instead, a single prong may be employed having a bulbous portion for example that is configured to snap through an aperture. A looped layer268of looped-sided VELCRO hook-and-loop type fastener is attached to the planar end266with cyanoacrylate glue270. After the layer of looped-side VELCRO hook-and-loop type fastener is attached, a silicone layer272is applied while uncured to the looped layer268making sure that the wet silicone is spread into the loops of the looped layer268. Then, the silicone layer272is allowed to dry. Instead of a silicone layer272, a layer of silicone adhesive may be used. The fastener210is easily attached to a silicone organ structure with adhesive or by putting a layer of wet silicone onto the organ structure at a location where the fastener210is desired to be located. The fastener210is then placed on the patch of wet uncured silicone and the patch is allowed to dry, adhering the silicone embedded in the looped layer268to the silicone organ structure. In another variation, the silicone layer272is part of the silicone organ structure as a patch of wet silicone or part of a cured silicone component of the organ structure and attached with silicone glue. The fasteners210are removable with respect to the frame204by pressing the prongs together and/or pushing the fastener210out of the apertures212making the plurality of simulated organ structures202removable and replaceable with a new plurality of simulated organ structures202for continued practice and training of surgical procedures. The apertures212and fasteners210may be color-coded to make attachment of the plurality of simulated organ structures202to the frame204quick and easy.

Upon attachment, simulated vasculature274, ducts, fallopian tubes, ureters or other anatomical or non-anatomical structure having a tubular/cylindrical form and typically made of silicone are pulled through appropriately-sized apertures212as shown inFIGS.7-8to further support the connected simulated tissue structures. These tubular structures have a free end and another end that is attached to other simulated tissue structures. The free end is passed through an aperture in the frame and can be secured with adjustable length to adjust the tension on the simulated tissue structures to which it is connected. For example, a loose tension may be created by securing the tubular structure with more slack between the frame and other simulated tissue structure. Alternatively, tension on the simulated tissue may be increased by pulling the tubular structure taunt with respect to the frame to create a relatively less pendulating simulated tissue construct within the frame. The tubular rope-like structure can be tied into a knot along its length to adjust the tension. The knot diameter is made larger than the aperture in frame in order to secure the larger tissue structure to the frame. The knots may be untied to remove the simulated tissue structure or re-tied to provide a different tension level. In another variation, the tubular silicone simulated vasculature274, ducts, fallopian tubes, ureters or other anatomical or non-anatomical structure having a tubular/cylindrical form are provided with rivets at their distal end. The rivets include a distal end for connection with the frame and a proximal portion embedded or swaged into the ends of the silicone tubular structure to make a mechanical connection. The rivet-like fastener210serves as an interface connection between the soft, pliable silicone of the simulated tissue structures and the rigid plastic frame. The simulated tissue structures are often made from room temperature vulcanized (RTV) silicone elastomers. As a result, the simulated tissue structures are delicate and may tear easily if not reinforced. This makes it difficult to connect such artificial tissue structures to the frame. The fastener has a rigid portion for connecting with the rigid frame and an interfacing layer located between the rigid portion of the fastener and the attaching simulated tissue structure. In one variation, the interfacing layer is a fiber layer that wet, uncured silicone may interpenetrate and when cured adhered securely thereto along the area of the interfacing layer. The uncured silicone layer may be a patch on the artificial tissue structure such that when cured, the patch becomes integrally connected to the artificial tissue structure and to the interfacing layer. This type of fastener advantageously minimizes stress concentrations that would result in the fastener tearing away from the simulated tissue structure permitting the simulated tissue structures to be manipulated aggressively. The fasteners also permit a quick assembly of the simulated tissue structure inside the frame by simply snapping the fasteners through a plurality of apertures in the frame. Disassembly is also facilitated and the frame is reusable after a simulated tissue structure is consumed with practiced and replaced with another simulated tissue model that is the same or different from the discarded model. Advantageously, no additional tools or adhesive is required for assembly. As an alternative to the fastener shown inFIG.16, the first, second and/or third sheets222,224and225may be attached to the frame directly with adhesive. Although rivets are described any suitable fastener adapted to secure the simulated tissue structure to the frame is within the scope of the present invention.

Turning now toFIGS.17-18, a transvaginal adapter280will now be described. As described above, the transvaginal adapter280is formed as a leg20configured to support the top cover of the trainer10. It is configured for simulating transvaginal surgery including transvaginal hysterectomies. The transvaginal adapter280includes a flat plate282having an inner surface284for facing toward the interior of the trainer and an outer surface286for facing outwardly towards the user. The plate280has a rectangular shape and includes an aperture288passing through the plate280from the inner surface284to the outer surface286. In one variation, the aperture288is circular in shape. In another variation, the aperture288is elongate elliptical, oval-like in shape and oriented vertically along the longitudinal axis of the adapter280. In another variation, the aperture288is elongate elliptical, oval-like in shape and oriented perpendicularly to the longitudinal axis of the adapter. The plate280also includes means such as tabs290or a U-shaped channel for inserting to connect the transvaginal adapter280to the top cover16and to the base18to help support and space apart the top cover16. The transvaginal adapter280is located between the top cover16and the base18and provides a side access aperture288lateral to the trainer10or substantially perpendicular to the top cover16and the base18. The plate280further includes a plurality of molding apertures292, shown inFIGS.23-28, surrounding or encompassing the main aperture288configured for overmolding a soft simulated vaginal tissue interface294made of silicone or the like. The method of forming the overmolded soft simulated vaginal tissue interface294will now be described.

Turning now toFIG.19, a mold298is provided. The mold298includes a well298encompassing an elongated center post300. In another variation, the center post300is oval or circular in shape. The circular or oval shape will result in an opening having the same shape and suitable for a TATME application in which the adapter is connectable to a simulated rectum and, thereby, serves as a transanal adapter instead of a transvaginal adapter. A pre-made silicone tube302is placed over the center post300as shown inFIG.20. Next, turning toFIGS.21-22, uncured silicone is poured into the well298to form the outer interface304. Next, turning toFIGS.23-24, the transvaginal adapter280is placed on top of the uncured silicone located inside the well298. The uncured silicone of the outer interface304is allowed to cure. Turning now toFIGS.25-26, a backing mold306is placed around the silicone tube302and inside the aperture288. Uncured silicone is then poured between the backing mold306and the inside of the aperture288and into the molding apertures292and onto the inner surface284and allowed to cure to form the inner interface308as shown inFIGS.27-28. The mold296and the backing mold306are removed. The resulting transvaginal adapter280is shown inFIGS.17-18. At least part of the flat plate282of the transvaginal adapter280is sandwiched between the inner interface308and the outer interface304as the wet silicone of the inner interface308adheres to the cured silicone of the outer interface304through the aperture288and the molding apertures292. The inner interface308and the outer interface304provide a soft and realistic tissue appearance and feel. The transvaginal adapter280is connected between the top cover16and base18of the trainer10. The model200is placed inside the body cavity12of the trainer10and connected to the transvaginal adapter280such that the silicone tube302faces the interior of the cavity12and is inserted into the proximal end256of the simulated vaginal canal218. The elongated center post300of the mold296creates an elongated entry way leading into the model200.

In use, a practicing surgeon may approach the simulated uterus216with surgical instruments and retractors through the transvaginal adapter280to perform a transvaginal hysterectomy. Alternatively, the simulated uterus216may be approached through the simulated abdominal wall of the top cover16of the trainer10. The user will practice laparoscopic surgical skills, employing a trocar and scope to examine the anatomy and perform the simulated surgical hysterectomy. The procedure involves making key incisions to detach the uterus and then remove it. In particular, the model200advantageously provides the one or more dissecting layer226that includes fibers embedded in silicone that make the incisions and separation of the simulated uterus216realistic. The user may further practice suturing the simulated vaginal canal218after removal of the simulated uterus216. For this purpose, the simulated vaginal canal218is provided with an embedded mesh that makes it possible for the silicone to hold sutures without easily tearing. After use, the model200is removed from the trainer10and the plurality of simulated organ structures202is removed from the model200by releasing the fasteners212from the frame204. A new plurality of simulated organ structures202is then connected to the frame204and inserted into the trainer10for continued practice.

Turning now toFIGS.29-30, another variation of the hysterectomy model200will now be described. The model200is similar to the model200described with respect toFIGS.7-28and like numbers will be used to describe like parts. The model200includes a plurality of simulated organ structures202connected to and located inside a frame204.

Turning briefly now toFIG.31, there is shown a frame204according to the present invention. The frame204is configured to simulate a pelvis and serve as a box-like encasement for housing the plurality of simulated organ structures202. The frame204includes a top frame portion206connected with fasteners210to a bottom frame portion208to form a top planar surface and a bottom planar surface interconnected by two upstanding sidewalls. The top planar surface and the bottom planar surface are parallel with each other and form corners with the sidewalls that are approximately 90 degrees. The sidewalls are angled towards each such that at the proximal end the distance between the sidewalls is close and increases progressively with increasing distance toward the distal end where the sidewalls are farther apart from each other. The assembled frame204having a base and a top interconnected by two upstanding sidewalls defines a central lumen with an open proximal end and an open distal end. The area of the central lumen in cross-section taken perpendicular to the longitudinal axis increases progressively with increasing distance from the proximal end toward the distal end. The outer shape of the frame204can be dissimilar from the shape of the central lumen. Another example of a tapered frame that has a central lumen with increasing area and that does not have corners is a frame that forms a frusto-conical shape. The central lumen of one such variation has a frusto-conical shape. The outer shape of the frame may also match the tapered shape of the central lumen. The frame204has a flat base permitting it to be placed and stand on a flat surface. In one variation, the bottom frame portion208includes a first level and a raised second floor209that raises the level of the model inside the frame204to be in line with the transvaginal adapter280. The frame204may include apertures212for passing of fasteners210and/or connecting tissue structures, such as vasculature, by passing them through the apertures and suspending them in the frame204. In various embodiments, the apertures212include a first set of apertures and a second set of apertures aligned with the first set of apertures to form the box-like shape. The frame204ofFIG.31is similar to the frame204shown inFIGS.7-13in which the frame204is comprised of folded plastic that is transparent and/or translucent. The folding of the plastic components of the frame204results corners that are representative of a pelvis that is not anatomically correct yet provides advantages needed in simulating laparoscopic procedures in exchange for the realism of an anatomically correct pelvis. These advantages include the mechanical constriction of organs located in the tapered proximal end having the smallest luminal cross-sectional area. The physical constriction of organs at the proximal end creates a more rigid response in the organs when manipulated by surgical instruments relative to the distal end where organs located therein are less constricted and freer to pendulate and more fluidly respond to manipulations with surgical instruments. The frame204of the present invention is an intentional simplification of the pelvis that combines variable resistance in the organs along the length of the longitudinal axis of the central lumen. The smaller opening to the central lumen at the proximal end of the frame is where the opening to the vaginal canal would be positioned when the organs are placed inside the frame. The proximal end of the frame is also oriented toward the transvaginal or transanal adapted for connection therewith. The distal end of the frame204is the location of the artificial uterus216. The central lumen of the frame expands, widens and angles outwardly towards the distal end. This taper of the box-like frame widens relaxing the organs located therein and the narrow proximal end constricts the organs, limiting the range of motion of the organs relatively more as a result of supporting the organs in closer confines.

With reference back toFIGS.29-30, the plurality of simulated organ structures202and its connection to the frame204will now be described. The plurality of simulated organ structures202includes a simulated bladder214, a simulated uterus216, a simulated vaginal canal218, a simulated rectum220, a first sheet222, a second sheet224, a third sheet225and a plurality of fasteners210. The plurality of organ structures202are interconnected as shown inFIG.29and in turn connected to the frame204. Alternatively, the first sheet222, second sheet224and third sheet225are connected as shown in dotted lines inFIG.29. In this variation, the first sheet22extends proximally along the top of the simulated bladder214and around the proximal end of the simulated bladder214downwardly and toward the distal end of the simulated bladder214. In this variation, the simulated bladder214is not suspended with a fastener210as shown inFIG.29. The third sheet225commences at the proximal end of the simulated bladder214and extends downwardly and is connected to the first sheet222at a location360that in this variation comprises a location of adhesive connecting the first sheet222and the third sheet225. The second sheet224in this alternative variation follows approximately the same path but includes slit to pass the simulated uterus216through such that the second sheet224extends upwardly as shown with the dotted line. Tubular shaped vasculature, ducts, arteries and the like in addition to other simulated organs structures not mentioned herein may be included in this model in an anatomically correct or anatomically similar arrangement for the same or different anatomical location of the body. Each simulated organ structure will now be described.

The simulated bladder214forms a closed receptacle with an outer membrane made of pink-colored silicone. The interior of the simulated bladder214may be stuffed with polyfil or other material to maintain its shape. The simulated bladder214has a proximal end240and a distal end242.

The simulated uterus216is also made of silicone. The simulated uterus216has a proximal end260and a distal end262. The simulated uterus216is made by providing a uterine mold310comprising two halves310a,310bas shown inFIG.32. A mesh fabric layer312is placed inside both halves the mold310a,310b. In one half of the mold310a, the mesh fabric layer312is placed only in the proximal end of the mold310to reinforce that portion that will be subjected to the most force during practice of a surgical technique. The mesh fabric layer312may cover the entire mold in one variation. The mesh fabric layer312includes darts or cutouts to allow the fabric to lay as smoothly as possible in the mold. Uncured silicone foam314is poured over the mesh fabric layer312and into each half310a,310bof the mold310as shown in FIGS.33-34. The wet silicone foam314is spread evenly to contact all of the surfaces to ensure that the silicone foam314will expand uniformly. As shown inFIG.35, a mandrel316is placed onto half310bthe mold310. The two halves310a,310bare placed together and the mold310is clamped as shown inFIGS.36A and36Band the silicone foam314is allowed to expand and cure. Upon curing, the mold310is removed from the cured silicone foam314and the mandrel316is mounted on a motor and the cured silicone foam is rotated and uncured silicone gel is applied evenly onto the silicone foam314to create an outer layer of silicone that encompasses the silicone foam314. The outer layer of silicone is allowed to cure and the mandrel316is removed leaving behind a uterine-like form332shown inFIGS.29-30and43-45. Next, a simulated cervix318is formed and inserted into the proximal end260of the cured foam and cured outer layer of silicone. The simulated cervix318is formed by first providing a cervix mold320having a well322as shown inFIG.37. The cervix mold320is generally made of two pieces that are clamped together to define the well322. A sleeve324of fabric such as KEVLAR synthetic fiber fabric is provided and inverted to create a fold326wherein the thickness of one end of the sleeve324is doubled as shown inFIGS.38A,38B and39. The KEVLAR synthetic fiber reinforcement of the simulated cervix makes the portion of the cervix that is pulled by the surgeon strong and allows the surgeon to use a tenaculum with an ability to puncture and pull the simulated cervix as in real surgery without the model tearing. Also, at the same time, the fabric sleeve is compatible with silicone in that it does not inhibit the curing of room temperature vulcanizing (RTV) silicone elastomers that form the rest of the artificial cervix, uterus and vaginal canal. Because KEVLAR synthetic fiber is porous, it allows for a strong mechanical connection without additional adhesive and can be used with materials other than silicone. Any suitable fiber having a high tensile strength-to-weight ratio may be employed. A post328is inserted into the lumen of the fabric sleeve324such that it protrudes outwardly from the proximal end having the fold326as shown inFIG.39. The cross-section of the post328is elongate and narrow such that a wooden popsicle stick can serve as the post328. The sleeve324with the post328is placed into the well322of the cervix mold320with the fold326and protruding post328being placed into the bottom of the well322as shown inFIGS.40and41B. Wet silicone330is poured into the well322of the mold320such that approximately three quarters of the well322is filled with uncured silicone330full as shown inFIGS.41A and42. The proximal end of the form332comprising the cured silicone foam with a coating of silicone is squeezed to substantially close the hole left by the mandrel316. The form332is squeezed to remove as much air as possible from out of the inside of the form332as shown inFIG.42and while still squeezing the form332, the proximal end of the form332is inserted into the wet silicone330inside the well322of the cervix mold320as shown inFIG.43and released. When the form332is released, a negative pressure is equalized moving wet silicone330into the opening left by the removed mandrel316drawing wet silicone up into the mandrel hole and into and around the fabric sleeve324. The wet silicone330inside the cervix mold320is allowed to cure and adhere to the form332as shown inFIG.44. The cervix mold320is removed leaving behind the simulated uterus216that includes the form332comprising the silicone foam314and overcoat of silicone and the attached simulated cervix334at the proximal end as shown inFIG.45. The post328is removed to define a narrow opening338at the proximal end260of the simulated uterus216that is reinforced with the fabric sleeve324as clearly seen inFIGS.46A and46B. The fabric sleeve324advantageously reinforces that portion of the simulated uterus216that is grasped strongly by the surgeon in practicing a hysterectomy. The fabric sleeve324remains inside the simulated cervix334. The fold326in the sleeve324creates a smooth distal end such that individual threads of the fabric sleeve324do not protrude from the cured silicone at the proximal end260that would increase the chance of the sleeve324ripping when pulled during surgical practice. Any flash is trimmed from the simulated cervix334. In one variation, the well322of the cervix mold320is provided with a circumferential ledge that forms a ridge336on the resulting simulated cervix334. The ridge336is visible inFIG.45and is useful for connection to the vaginal canal218which will be described next.

Turning now toFIGS.47-52, the simulated vaginal canal218will be described. The simulated vaginal canal218is a tubular structure made of silicone and may optionally contain an embedded mesh layer230. The simulated vaginal canal218has a proximal end256and a distal end258. The mesh layer230is formed into a tubular shape having an open proximal end. The mesh layer230in the form of a sock is placed onto a mandrel340and attached with an elastic as shown inFIG.47. Uncured silicone is applied onto the sock-like mesh layer230as the mandrel240is rotated to form a thin layer of silicone that embeds the mesh layer230. The mesh layer230reinforcement advantageously prevents the propagation of a tear in the silicone/and/or foam and makes the artificial uterus pliable and strong and not cut resistant. In one variation, the mesh layer230can be made of KEVLAR para-aramid synthetic fiber or poly-paraphenylene terephthalamide or other substantial equivalent known to a person skilled in the art. The uncured silicone is allowed to cure and the simulated vaginal canal218is removed from the mandrel240as shown inFIG.48. A hole342is punched through the domed distal end258of the simulated vaginal canal218such that the hole342is substantially coaxial with the longitudinal axis of the simulated vaginal canal218. The hole342is visible inFIG.49. The simulated vaginal canal218is attached to the simulated uterus216. In particular, the simulated cervix334is pushed through the hole342of the distal end258of the simulated vaginal canal218as shown inFIG.50. In particular, some adhesive is applied circumferentially around the simulated cervix334in the location of the ridge336and the simulated cervix334is pushed through the hole342until the ridge336just passes through the hole342. The ridge336facilitates holding the simulated cervix334attached preventing it from easily backing out of the hole342. The simulated vaginal canal218is inverted inside out and more adhesive is applied at the interface of the simulated vaginal canal218and simulated cervix334as shown inFIG.51.FIG.52illustrates the resulting attached simulated vaginal canal218and proximal end of the simulated cervix334with the opening338. The simulated vaginal canal218is enlarged to simulate a pre-retracted vaginal canal, allowing the user to practice with additional hands to aid in maintaining the retraction. Furthermore, the domed distal end of the simulated vaginal canal218that includes the hole342will invert as the simulated cervix334is pulled proximally through the lumen of the simulated vaginal canal218due to the dome effect and the adhesive. This feature advantageously closely represents what actually happens anatomically with real tissue.

The distal end262of the simulated uterus216may be provided with simulated ovaries344. The method of manufacturing simulated ovaries344includes the step of providing an ovary mold346which is typically a two-piece mold comprising two halves as shown inFIGS.53and54. The mold346includes a well348that is shaped like an ovary. A cylindrical silicone vessel350is provided inside the well348and inside channels spanning across the mold346. The silicone vessel350may be tied into a knot and the knot placed in the location of the ovary well348to provide more structure to the resulting simulated ovary. The mold346is closed and uncured silicone is then injected into the mold346. The silicone is allowed to cure in the mold and around the silicone vessel350become attached thereto. The mold346is opened and the simulated ovary344is removed and one end of the silicone vessel350is attached with adhesive to the simulated uterus216and other end of the silicone vessel is attached to the frame204by pulling the silicone vessel through one of the apertures212provided in the frame204.

With reference back toFIGS.29-30, the simulated rectum220is a tubular structure made of silicone with molded transverse folds. The simulated rectum220has a proximal end244and a distal end246. Each of the first sheet222, second sheet224and third sheet225comprises a flat planar layer of silicone material. Both sheets222,224represent the peritoneum and the third sheet225represents a bladder flap or peritoneal reflection. The first sheet222has a first surface232and a second surface234and a proximal end248and a distal end250. A cutout (not shown) may be provided in from the distal end250such that the first sheet222does not overlap a portion of the simulated uterus216. The second sheet224has a first surface236and a second surface238and a proximal end252and a distal end254. A cutout (not shown) may be provided at the proximal end252of the second sheet224such that a portion of the simulated uterus216is not overlapped. The third sheet225has a proximal end352and a distal end354and a first surface356and a second surface358.

With continued reference toFIGS.29-30, the assembly, configuration and connection of the plurality of simulated organ structures202will now be described. The distal end of the bladder242is attached to the first surface232of the first sheet222with adhesive approximately midway between the proximal end248and the distal end250of the first sheet222such that the first sheet222wraps around the distal end242of the simulated bladder214from the top of the simulated bladder to the bottom of the simulated bladder214. The proximal end of the bladder240is attached to the first surface356of the third sheet225with adhesive such that the third sheet225wraps around the proximal end240of the simulated bladder214from the top of the simulated bladder to the bottom of the simulated bladder214. The first sheet222and the third sheet225come together at the bottom of the simulated bladder214to contact a silicone webbing360. In lieu of a silicone webbing360, silicone glue is used to connect the two sheets222,225. The first surface232of the first sheet222is attached to a fastener210near the distal end248of the first sheet222. The first sheet222is folded in an approximate U-shape such that the distal end250of the first sheet222and, in particular, the first surface232of the first sheet222, is attached to the simulated uterus216and attached to the simulated vaginal canal218using adhesive. The third sheet225turns around at point360and backs over itself towards the proximal end creating an overlap. In this location where the third sheet overlaps itself, the sticky silicone of the third sheet225will easily stick onto itself. Advantageously, this overlapping portion is what a surgeon will practice separating when the surgeon approaches point360from the proximal end. In use laparoscopically, the surgeon will practice delicately separating the overlap until point360is approached where a silicone membrane is formed by adhesive or other means. When point360is reached, the surgeon will dissect the silicone membrane360to detach the uterus. In use transvaginally, the surgeon will approach via the lumen of vaginal canal218and make a circumferential incision through the vaginal canal218and then detach the membrane360. In doing so, the surgeon will advantageously not notice the third sheet225which, in essence, is not anatomically correct, because the third sheet225is very thin and is well-adhered to the vaginal canal and bladder. In one variation, the third sheet225does not include surface texturing in order to create a closer adherence to the vaginal canal and bladder. In another variation, the third sheet225is omitted. In such a variation, the bladder240is adhered to the vaginal canal218directly or indirectly via a fiber layer as shown inFIGS.14-15.

The second sheet224is attached between the simulated uterus216and the simulated rectum220. In particular, the first surface236at the distal end252of the second sheet224is attached near the distal end262of the simulated uterus216. The second sheet224is attached along the length of the simulated uterus216toward the proximal end260using adhesive. The second sheet224is folded to extend back towards the distal end of the simulated rectum220and attached along the top side and outer surface of the simulated rectum220such that the distal end254of the second sheet224is near the distal end246of the simulated rectum220. The top side of the simulated bladder214is connected to a fastener210and this fastener210is passed through an aperture212in the top frame206of the frame204. The proximal end248of the first sheet222is also attached to a fastener210which is also passed through an aperture212in the top frame206of the frame204to attach the plurality of the simulated organ structures202to the frame204in a suspended manner. While suspended from the top frame204, the interconnected plurality of simulated organ structures202advantageously pendulate and move together in a realistic fashion wherein the point of contact with instruments and the like will move most and simulated organs distal to the point of contact with instruments move to a lesser degree. The bottom side of the simulated rectum220is attached to at least two fasteners210as shown inFIGS.29-30. The two fasteners210are passed through apertures212in the bottom frame208to secure the plurality of simulated organ structures202to the frame202. Hence, the plurality of simulated organs structures is spanned across the central opening of the frame202with the first sheet222and second sheet224forming an interconnecting webbing. The proximal end260of the simulated uterus216is inserted into the distal end258of the simulated vaginal canal218and joined together with adhesive. The simulated cervix334is provided made of silicone and located inside the simulated uterus216at the proximal end260as described above.

The fastener210is the same fastener210as described above with respect toFIG.16. Turning now toFIGS.55-59, a transvaginal adapter280will now be described. As described above, the transvaginal adapter280is formed as a leg20configured to support the top cover16of the trainer10. It is configured for simulating transvaginal surgery including transvaginal hysterectomies. The transvaginal adapter280includes a flat plate282having an inner surface284for facing toward the interior of the trainer and an outer surface286for facing outwardly towards the user. The plate280has a rectangular shape and includes an aperture288passing through the plate280from the inner surface284to the outer surface286. In one variation, the aperture288is circular in shape. In another variation, the aperture288is elongate elliptical, oval-like in shape and oriented vertically along the longitudinal axis of the adapter280. In another variation, the aperture288is elongate elliptical, oval-like in shape and oriented perpendicularly to the longitudinal axis of the adapter. The plate280also includes means such as tabs290or a U-shaped channel for inserting to connect the transvaginal adapter280to the top cover16and to the base18to help support and space apart the top cover16. The transvaginal adapter280is located between the top cover16and the base18and provides a side access aperture288lateral to the trainer10or substantially perpendicular to the top cover16and the base18. The access aperture288is extra-large to simulate a pre-retracted vaginal canal as described above. The proximal end256of the simulated vaginal canal218is stretched over the access aperture288at the inner surface284to connect the simulated vaginal canal218to the adapter280. The adapter advantageously secures the model in every axial direction and serves as an interface for the surgeon. The adapter is also not anatomically correct but advantageously permits use of real instrumentation.

In use, a practicing surgeon may approach the simulated uterus216with surgical instruments and retractors through the transvaginal adapter280to perform a transvaginal hysterectomy. Alternatively, the simulated uterus216may be approached through the simulated abdominal wall of the top cover16of the trainer10. The user will practice laparoscopic surgical skills, employing a trocar and scope to examine the anatomy and perform the simulated surgical hysterectomy. The procedure involves making key incisions to detach the uterus and then remove it. In particular, the model200advantageously provides the first sheet222and third sheet225and silicone webbing360that make the incisions and separation of the simulated uterus216realistic. Also, the KEVLAR synthetic fiber mesh reinforced simulated cervix334prevents tearing of the silicone when being pulled. The user may further practice suturing the simulated vaginal canal218after removal of the simulated uterus216. For this purpose, the simulated vaginal canal218is provided with an embedded mesh that makes it possible for the silicone to hold sutures without easily tearing. After use, the model200is removed from the trainer10and the plurality of simulated organ structures202is removed from the model200by releasing the fasteners212from the frame204. A new plurality of simulated organ structures202is then connected to the frame204and inserted into the trainer10for continued practice.

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

It is understood that various modifications may be made to the embodiments and variations disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.