Surgical simulation system and method

Abstract

To provide a surgical simulation system.SOLUTION: The system includes at least one simulated body organ placed upon a base of an organ tray, and at least one covering layer placed over the simulated body organ. At least one of the simulated body organ and the covering layer includes electro-conductive gel that is operably severable under application of electrical current to simulate electrosurgery in a training environment. The training environment comprises a top cover connected to and spaced apart from a base to define an internal cavity that is partially covered from a trainee's direct observation. The tray, simulated body organ and covering layer are placed inside the internal cavity for the practice of laparoscopic surgical procedures.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61 / 771,316, entitled "Advanced surgical simulation constructions and methods," filed March 1, 2013, which is incorporated herein by reference in its entirety.

[0002] This application relates generally to surgical training tools, and more particularly to anatomical models that simulate organs or tissues for teaching and practicing various surgical techniques and procedures. [Background technology]

[0003] Medical students learning new surgical techniques, as well as experienced physicians, must undergo extensive training before being qualified to perform surgery on human patients. Training must teach proper technique using a variety of medical devices to cut, penetrate, crimp, grasp, staple, and suture various tissue types. The range of possibilities a trainee may encounter is vast, presenting different organs, patient anatomies, and diseases. The thickness and consistency of various tissue layers will vary from one part of the body to the next and from one patient to another. Consequently, the techniques and instrument skills required will also vary. Furthermore, trainees must practice their techniques in easily accessible open surgical and laparoscopic locations.

[0004] Many teaching aids, trainers, simulators, and model organs are available for one or more aspects of surgical training. However, there is a need for model organs or simulated tissue elements that are likely to be encountered in endoscopic, laparoscopic, transanal, minimally invasive, or other surgical procedures involving the removal of tumors or other tissue structures. For example, there is a need for realistic model organs for repeatable practice of removing tumors or other unwanted tissue, followed by closure of the target area by suturing or stapled anastomosis as part of the same surgical procedure. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Serial No. 13 / 248,449 Summary of the Invention [Problem to be solved by the invention]

[0006] In light of the above, it is an object of the present invention to provide a surgical training device that realistically simulates those specific situations encountered during surgery. The medical training and simulation system and device of the present invention provides users with visual, tactile, and technical attributes that emulate the real-life situations present in live surgical procedures. Emulation is a technique that attempts to equal or exceed the conditions or effects of actual surgery in a surgical simulation.

[0007] To simplify training and minimize the use of cadavers for dissection in surgical training and practice, the present invention contemplates the use of synthetic materials formulated, configured, and combined to emulate the properties, responses, and characteristics of human or animal tissue in response to the actions of surgical instruments under surgical conditions, including incision, penetration, dissection, closure, anastomosis, approximation, and resection.

[0008] Many surgical procedures involve the use of energy-based surgical instruments, such as electrosurgical scalpels, electrosurgical probes, electrosurgical scissors, electrosurgical graspers, and electrosurgical dissectors. Electrosurgery is generally considered to be the application of high-voltage, radiofrequency electrical energy to tissue for the purpose of cutting or destroying. Electrocautery is a type of electrosurgery in which resistive heating is generated within the instrument that is high enough to apply an electrical current to the tissue to cut or destroy it. Additionally, many procedures utilize radiofrequency sound-based energy devices. These instruments offer surgeons the convenience of nearly effortless cutting and dissection, as well as nearly instantaneous thermal hemostasis. Such instruments have become standard in surgical societies and are in common use.

[0009] It is readily apparent that any mock organ, organ simulation module, or training module must include the ability to train using energy-based surgical instruments. Many existing training or simulation modules require the use of harvested animal tissue, synthetic materials that must be wetted or infiltrated with saline solution, or materials that are conductive and have embedded metal particles to be suitable for energy-based surgical skill training. Most preferred synthetic materials, such as silicone rubber, latex, vinyl, polyester, and polyurethane, do not meet the demands of energy-based surgical instruments and devices to train users to use these instruments in actual surgical procedures. Therefore, one aspect of the present invention is to provide a combination of synthetic materials, some of which have dielectric properties and some of which are conductive, that nevertheless mimic the physical attributes of natural tissue and the behavior of energy-based surgical instruments and devices. Additionally, the present invention provides a method for providing realistic synthetic samples for constructing various body parts, ducts, organs, cysts, tumors, and the like. [Means for solving the problem]

[0010] According to one aspect of the present invention, a surgical simulation system is provided. The surgical simulation system includes a tray having a base, a perimeter, and one or more anatomical receptacle portions formed by at least one upstanding wall configured to substantially cooperate and match in size and shape with one or more simulated body organs positioned within the one or more receptacle portions. The system includes one or more simulated body organs positioned on the base within the one or more receptacle portions. At least one cover layer is positioned over the one or more simulated body organs. The cover layer is attached to the one or more simulated body organs at at least one location. To simulate electrosurgery in a training environment, at least one of the one or more simulated body organs and the cover layer includes a conductive gel that is operably cut under the application of an electric current.

[0011] According to another aspect of the present invention, a surgical simulation system for practicing electrosurgical operations is provided. The surgical simulation system includes a simulated tissue structure including an inner layer adjacent to and in contact with an outer layer. The inner layer includes a foam material, and the outer layer includes an elastic hydrogel. The inner layer defines an interior cavity, and the inner and outer layers together define the shape of at least a portion of a uterus. The surgical simulation system also includes a simulated lesion positioned adjacent to or embedded in the inner layer. The simulated lesion is removable from the simulated tissue structure. The elastic hydrogel is electrically conductive such that it is operably cuttable under the application of an electric current to simulate electrosurgery in a training environment.

[0012] According to another aspect of the present invention, a method for surgical simulation is provided. The method includes providing an organ tray having a base on which one or more simulated body organs are placed. A cover layer is placed over the one or more simulated body organs. The cover layer includes a first planar layer of non-conductive material and a second planar layer of conductive gel. The cover layer is placed over the one or more simulated body organs such that the second layer is adjacent to the one or more simulated body organs. The organ tray is placed within an internal cavity of a surgical training device such that the organ tray is at least partially shielded from direct visual observation by a trainee. The surgical training device includes a top cover spaced from a base. The internal cavity is defined between the top cover and the base. The surgical training device includes an opening or a penetrable simulated tissue region in the top cover. The method further includes inserting a scope configured to capture video of the internal cavity into the internal cavity of the training device through the opening or the penetrable simulated tissue region. At least one instrument is inserted into the interior cavity of the training device through the opening or penetrable simulated tissue region. The method includes separating the first layer from the second layer using the at least one instrument.

[0013] According to one aspect of the present invention, a method for making a simulated tumor is provided. The tumor is made by mixing uncured silicone rubber with untreated fumed silicon dioxide. The mixture is then molded and cured to form the simulated tumor.

[0014] According to one aspect of the present invention, a simulated tissue structure for surgical training is provided, the structure including an organ tray, a simulated organ placed on the tray, and a cover layer, the cover layer including a translucent sheet of silicone rubber.

[0015] In accordance with one aspect of the present invention, a simulated tissue structure for surgical training is provided, the structure including an organ tray, a simulated organ placed on the tray, and a cover layer, the cover layer including a translucent sheet of silicone rubber and a translucent sheet of hydrogel material.

[0016] According to one aspect of the present invention, a method for forming a cover layer for a tray containing simulated tissue includes mixing a conductive material, such as platinum or tin, into liquid silicone. The mixture is spread onto a first layer of polyethylene foam. A second layer of polyethylene foam is placed on top of the silicone layer. A textured roller or stamping device is moved over the surface of the second layer of foam to calendar the silicone material between the foam layers. The silicone layer is then removed from between the foam layers.

[0017] According to another aspect of the present invention, there is provided a simulated organ model of a uterus, the model comprising an outer shell of soft silicone and an inner layer of foam, with a simulated tumor positioned between the outer shell and the inner layer.

[0018] According to another aspect of the present invention, there is provided a simulated organ model of a uterus, the model comprising an outer shell of soft silicone and an inner layer of foam, with a simulated tumor positioned inside the inner foam layer.

[0019] According to another aspect of the present invention, there is provided a simulated organ model of a uterus. The model includes a silicone fallopian tube containing a conductive material. The fallopian tube includes a lumen extending between a first end and a second end, and a bulbous portion near the second end that transitions to a funnel shape at the second end and has multiple axial cuts within the funnel portion. At least a portion of the lumen includes a soft fibrous material.

[0020] Another aspect of the present invention provides a simulated organ model of a uterus. The model includes a silicone fallopian tube containing a conductive material. The fallopian tube includes a lumen extending between a first end and a second end, and a bulbous portion near the second end that transitions to a funnel shape at the second end and has multiple axial cuts within the funnel portion. At least a portion of the lumen includes a soft fibrous material, and a simulated ectopic pregnancy is positioned inside the bulbous portion. The simulated ectopic pregnancy is made of silicone rubber and untreated fumed silicon dioxide.

[0021] According to another aspect of the present invention, there is provided a simulated organ model of a stomach. The model includes a hollow stomach-shaped pouch having a proximal opening and a distal opening. The model includes a predetermined path for practicing resection of at least a portion of the stomach along the predetermined path. The predetermined path is defined by two opposing inner surfaces of the stomach model that are joined together.

[0022] According to another aspect of the present invention, there is provided a tray for receiving a model organ, the tray including a bottom surface and at least one receptacle portion for receiving at least one organ, the at least one receptacle portion being formed by an upstanding wall having a height and shape that substantially matches the height, shape, and size of the organ to be placed therein. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 is a side view of a surgical training device with model organs according to the present invention. [Figure 2A] 1 is a side cross-sectional view of a simulated tissue structure according to the present invention. [Figure 2B] 1 is a side cross-sectional view of a simulated tissue structure from which a tumor has been excised in accordance with the present invention. [Figure 2C] FIG. 1 is a side cross-sectional view of a simulated tissue structure having an open suture in accordance with the present invention. [Figure 2D] FIG. 1 is a side cross-sectional view of a simulated tissue structure having a closed suture in accordance with the present invention. [Figure 3A] FIG. 2 is a top view of a defect layer having a circular defect according to the present invention. [Figure 3B] FIG. 2 is a top view of a defect layer having elongated defects according to the present invention. [Figure 3C] FIG. 2 is a top view of a defect layer having amorphous defects according to the present invention. [Figure 3D] FIG. 2 is a top view of a defect layer having a two-part defect according to the present invention. [Figure 3E] FIG. 2 is a top view of a defect layer having multiple defects according to the present invention. [Figure 3F]FIG. 2 is a top view of a defect layer having multiple defects in accordance with the present invention. [Figure 4] FIG. 1 is a top view of a simulated tissue structure according to the present invention. [Figure 5] 1 is a side cross-sectional view of a simulated tissue structure according to the present invention. [Figure 6A] 1 is a perspective view of a modular tissue structure and support according to the present invention; [Figure 6B] 1 is a perspective view of a modular tissue structure and support according to the present invention; [Figure 7] 1 is a cross-sectional view of a simulated tissue structure configured to mimic a human uterus in accordance with the present invention. FIG. [Figure 8] FIG. 1 is a top view of a modular organizational structure according to the present invention. [Figure 9] FIG. 1 is a side view of a modular organizational structure according to the present invention. [Figure 10A] 1 is a perspective view of a simulated tissue structure according to the present invention; [Figure 10B] 1 is a perspective view of a simulated tissue structure according to the present invention; [Figure 11A] 1 is a perspective view of a simulated tissue structure according to the present invention; [Figure 11B] 1 is a perspective view of a simulated tissue structure according to the present invention; [Figure 12] 1 is a perspective view of a suture needle and a simulated tissue structure according to the present invention. [Figure 13] 1 is a schematic diagram of a model of the anatomy of a female uterus with tumor placement according to the present invention. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0024] FIG. 1 shows a surgical training device 10 configured to simulate a patient's body, such as the abdomen. The surgical training device 10 provides a simulated body cavity 18, substantially shielded from the user, for receiving model organs, simulated tissue, or live tissue 20. The body cavity 18 is accessed through a tissue simulation region 19, through which the user penetrates with the device to practice surgical techniques on the tissue or organ 20 that can be visualized as being placed therein. While the body cavity 18 is shown as accessible through the tissue simulation region 19, a hand-assisted access device or single-site port device can alternatively be used to access the body cavity 18, as described in U.S. patent application Ser. No. 13 / 248,449, entitled "Portable Laparoscopic Trainer," filed September 29, 2011, and incorporated herein by reference in its entirety. The surgical training device 10 is particularly well-suited for practicing laparoscopic or other minimally invasive surgical procedures.

[0025] The surgical training device 10 includes a base 12 and a top cover 14 connected to and spaced from the base 12, defining an internal body cavity 18 between the top cover 14 and the base 12. At least one leg 16 interconnects and spaces the top cover 14 and the base 12. A model organ or simulated tissue 20 is placed within the body cavity 18. The model organ 20 shown in FIG. 1 is a partial colon or intestine, shown suspended from the top cover 14 by a tether 22 and connected to at least one leg 24. The at least one leg 24 has an opening (not shown) that faces the internal body cavity 18. The model colon 20 includes a tube 26 having a proximal end and a distal end. The proximal end of the tube 26 is interconnected with the opening in the leg 24 such that the opening provides an access port to the lumen of the tube 26. In FIG. 1 , the access port and opening are shown plugged with an access device 28 that, in combination with the sealed distal end of tubing 26, supplies a model organ 20 adapted for suction with a deliverable fluid through suction port 30. An optional insert 32 made of a soft material, such as silicone, creates a realistic interface to the access port. The distal end of tubing 26 extends into and is suspended within body cavity 18. The interior of tubing 26 of the simulated organ 20 is accessible through an access port in leg 24 or through tissue simulation region 19 or instrument insertion port 34. An endoscopic camera inserted into body cavity 18 or organ 20 through the access port generates live images for display on a folding video screen 36, shown in a closed position in FIG. 1 . An endoscope is a visualization device used to observe hollow structures. While the simulated organ 20 of FIG. 1 is ideal for performing procedures related to transanal minimally invasive surgery, any simulated organ or tissue section can be used. One particular aspect of the organ 20 is that at least one tumor or defect 38 is provided and connected to the organ. As shown in Figure 1, the tumor 38 is connected to the wall of the organ tube 26.

[0026] Turning now to FIG. 2A, a partial cross-sectional side view of a portion of a simulated organ 20 containing a tumor 38 is shown. The simulated organ or tissue 20 includes a base layer or organ wall 40. The organ wall 40 is made of a material, such as silicone or other polymer, configured to mimic real, living tissue and appropriately stained. One or more base layers 40 of various thicknesses and color schemes can be used to construct the entire wall 40. In one variation, the organ wall 40 is rigid and made of a polymeric material. Above the base layer 40 is a second layer or defect layer 42. The defect layer 42 may be the same size as the base layer 40 or smaller, providing a raised platform for the tumor 38. The defect layer 42 may be integrally formed with the base layer 40 as a single unit and may be connected to the base layer 40 by adhesive or other means known to those skilled in the art. The defect layer 42 is made of silicone to blend into the background of the base layer 40, and in one variation, is made of the same color as the base layer 40. The defect layer 42 includes at least one defect or gap 44. In one variation, the defect 44 is a prefabricated tear in the defect layer 42 that mimics an incision, gap, or other void in real tissue resulting from a tear, cut, removal, or other surgical procedure and requiring surgical attention, such as with suturing and stapling, to close the defect. Such a situation most often arises during tumor 38 removal, where the tumor 38 is removed along with surrounding tissue to ensure the entire tumor is prophylactically removed, leaving a residual defect in the tissue. The defect 44 includes two opposing sides or surfaces that define a gap therebetween. While the adjacent sides or surfaces are shown as being perpendicular to the base layer 40, the invention is not so limited, and the juxtaposed surfaces or sides can have any shape, for example, curved. The defect 44 can have any shape, as discussed below with respect to FIGS. 3A-3F.

[0027] Turning now to FIG. 3A, a top view of a defect layer 42 is shown having a circular defect 44. FIG. 3B shows a defect layer 42 having an elongated, oval, or elliptical defect 44. As shown in FIG. 3C, the defect 44 can be amorphous or of any shape. The defect layer 42 can be multi-part, as shown in FIG. 3D, and includes two or more adjacent defect layer portions 42a, 42b juxtaposed to create at least one defect 44 therebetween. FIG. 3E shows another multi-part defect layer 42 having multiple adjacent defect layer portions 42a, 42b, and 42c forming one or more defects 44 therebetween. Of course, the defect layer 42 can include multiple defects 44a, 44b, and 44c, as shown in FIG. 3F. The defects 44 can all be the same or have different shapes, as shown in FIG. 3F. The defect shapes, thicknesses, and sizes allow trainee surgeons to practice suturing both sides of defects with varying degrees of difficulty. In one variation, the defect layer 42 is not of uniform thickness. Instead, the thickness of the defect layer 42 varies at the location of the defect 44 to increase the difficulty of suturing or closing the defect.

[0028] Referring again to FIG. 2A , the tumor 38 is placed on the defect layer 42. Preferably, the tumor 38 is a different color than the base layer 40, the defect layer 42, or both so that it is easily identifiable by the trainee. Preferably, the tumor 38 is made of silicone or other polymeric material and is red, black, or dark brown in color. Generally, the tumor 38 is a darker or otherwise contrasting color than the base layer 40 or the defect layer 42 when viewed through a scope. In one variation, the tumor 38 is connected to the defect layer 42 by adhesive or other means known to those skilled in the art. In another variation, the tumor 38 is not connected or attached to the defect layer 42 but is removably positioned thereon.

[0029] 2A , the simulated tissue configuration 20 includes a cover layer 46 positioned over the tumor 38. In one variation, the cover layer 46 overlies the tumor 38, the defect layer 42, and the base layer 40. Preferably, the cover layer 46 is transparent or translucent in color and made of a polymeric material such as silicone. In another variation, the cover layer 46 is the same color as the base layer 40 or the defect layer 42. The cover layer 46 is at least as thick as the base layer 40 or the defect layer 42; in one variation, it is thinner than the defect layer 42; and in another variation, it is thinner than the base layer 40. The cover layer 46 is sized to cover the entire area of ​​the tumor 38 and the defect layer 42, and in one variation, it is large enough to contact the base layer 40. In another variation, the cover layer 46 is sized to cover the entire area of ​​the tumor 38 and the defect layer 42 and to contact the defect layer 42. The cover layer 46 is connected to the base layer 40, the defect layer 42, the tumor 38, or more than one of these three layers using adhesive or other means known to those skilled in the art. In another variation, the cover layer 46 is smaller and connected only to the defect layer 42. In yet another variation, the cover layer 46 is connected to both the defect layer 42 and the base layer 40 using adhesive or other means known to those skilled in the art. The cover layer 46 can be any shape or size and can be configured to provide the surgeon with a smooth surface instead of a layered surface for placement of the artificial tumor. In one variation, the cover layer 46, the tumor 38, the defect layer 42, or the base layer 40 includes a surface texture. Additionally, the cover layer 46 helps keep the tumor 38 and the defect layer 42 sandwiched between the cover layer 46 and the base layer 40, which is advantageous over variations in which the tumor 38 is not adhered to the defect layer 42. A top plan view of the base layer 40, the defect layer 42, the cover layer 46, and the tumor 38 is shown in FIG. 4. In one variation, any one or more of the base layer 40, defect layer 42, and cover layer 46 are formed of silicone molded onto a textile, fibrous, or mesh material, such as nylon or cheesecloth, so that the layer of silicone has an integral mesh structural support or other type of reinforcement.Any one or more of these layers 38, 40, 42, 46 may include a fiber or mesh reinforcement combined with a resilient polymer such as silicone. The mesh support helps prevent the suture, staple, or needle from tearing at least one of the layers, particularly the defective layer 42, when the suture is pulled to close the gap 44.

[0030] In FIG. 2B, the tumor 38 and a portion of the cover layer 46 are shown being excised from the base layer 40. This excision is performed by a trainee using a scalpel or other medical instrument to remove the tumor 38. The trainee will then incise the cover layer 46 around the tumor 38, isolate the tumor 38, and lift and remove the tumor 38 away from the site to expose the underlying defect 44, as shown in FIG. 2B. Now, as shown in FIG. 2C, the trainee will use surgical sutures to close the defect 44 and join the lips or edges of the defect layer 42, as shown in FIG. 2D, thereby practicing closure of the gap or wound created by the surgical removal of the tumor 38. The steps of cutting at least one layer to create an opening, removing the artificial tumor, and suturing the gap are performed while the simulated tissue structure is placed inside the simulated body cavity 18 of the surgical training device so that it is at least partially obscured from the user's view.

[0031] Turning now to FIG. 5 , another variation is shown in which there is no pre-formed gap or defect in the second layer or defect layer 42. Instead, a defect is created by the user in one or more of the cover layer 46, defect layer 42, base layer 40, and any remaining tumor portion not removed by the user when excising the tumor 38. The user then practices suturing the defect created in any of these layers 38, 40, 42, 46. In one such variation, one of the defect layer 42 or base layer 40 is omitted from the configuration. In another variation, the tumor 38 is placed on the base layer 40, and the defect layer 42 is placed on the tumor 38, such that the defect layer 42 is above the tumor 38. In such a variation, the cover layer 46 may or may not be included. If the cover layer 46 is included, it may be integrally formed with the defect layer as a separate, single layer. In any of the configurations described above with respect to Figures 2-5, the configuration can be flipped upside down, the layers can be arranged in reverse order, or the configuration can otherwise be made accessible to the user from either the top or bottom, with layer thicknesses and colors adjusted accordingly as needed to simulate the effect of real tissue.

[0032] 6A and 6B, in any of the variations herein, the simulated tissue configuration may be modular, such that it is not integrally formed with the entire simulated organ 20, but instead is configured as removable and replaceable modules 50. One or more modules 50 are supported or contained within a module support 52. The module support 52 includes a first surface 51, a second surface 53, and one or more tumor module receiving portions 54, 56, 58 formed within the support 52. The tumor support 52 may be rigid or flexible and may be made of a polymeric material. The tumor support 52 may include a sheet of elastomeric material. Each of the module receiving portions 54, 56, 58 is sized and configured to receive a correspondingly sized and configured module 50. While FIG. 6 shows the module 50 and module receiving portions 54, 56, and 58 as being circular, the tumor module 50 can be any shape with complementary shaped receiving portions formed in the module support 52. The support 52 can have different thicknesses, providing configurations with tumor module 50 positions at various depths. The module receiving portions 54, 56, and 58 can include a bottom wall upon which the tumor module 50 can rest. Alternatively, the tumor receiving portions 54, 56, and 58 extend between an opening in the first surface 51 and an opening in the second surface 53, and the tumor 38 is connected between the openings in any of the surfaces 51, 53, or connected to one of these openings, or suspended within the tumor receiving portion. In one variation, a single tumor module 50 includes one or more tumors 38. One or more tumor modules 50 are loaded onto the module support 52, and the simulated tissue construct 20 is inserted into the body cavity 18, frame, or other body model of the surgical training device 10. The simulated tissue construct 20 can be placed on the base 12 of the training device 10 or suspended within the body cavity 18 of the training device 10.The simulated tissue construct 20 and / or the training device may be provided with attachment mechanisms such as clips, fasteners, wires, hook and loop fasteners, etc. for positioning, suspending, or connecting the simulated tissue construct 20 to the training device 10 .

[0033] With particular reference to FIG. 6B, a modular support 52 including more than one layer is shown. The modular support 52 of FIG. 6B includes a first layer 57 connected to a second layer 55. In one variation, the first layer 57 is made of an elastomeric material sheet, and the second layer 55 is made of any suitable polymeric material, such as a low-density resilient foam. The second layer 55 serves as support for the first layer 57. The second layer 55 also advantageously provides depth to the modular support 52, allowing the tumor 38 in the module 50 to be positioned deeper within the modular support 52 relative to the first surface 51. The modular receiving portions 54, 56, 58 are formed in one or more of the first layer 57 and the second layer 55. The modular receiving portions 54, 56, 58 formed in the second layer 55 can have a different shape than the same modular receiving portions 54, 56, 58 have in the first layer 57. In one variation, the tumor module 50 includes only at least a simulated tumor 38 incorporated or embedded inside the second layer 55, with at least one of the first layer 57 or the second layer 55 constituting a defect layer against which a user can practice closure. Alternatively, the first layer 57 does not include a module receiving portion, but instead serves as a cover layer against which a user can practice incision to access a tumor 38 positioned in the tumor receiving portion formed within the second layer 55. In such a variation, the first layer 57 can be a sheet of elastomeric material such as silicone, and the second layer 55 is a layer of low-density resilient foam. The module support 52 can be planar, as shown in FIGS. 6A and 6B, or alternatively, can be shaped to mimic a portion of human anatomy, tissue, or organ.

[0034] For example, FIG. 7 shows a support 52 shaped to mimic a human uterus. The support 52 includes a first layer 57 connected to a second layer 55. In one variation, the first layer 57 is made of any suitable polymeric material, such as an elastomeric sheet, and the second layer 55 is made of any suitable polymeric material, such as a low-density resilient foam. The second layer 55 serves as a support for the first layer 57, allowing a tumor 38 within the module 50 or a free-standing tumor 38 to be advantageously connected to the support 52, realistically extending deep within the support 52, and dispersing in various positions and orientations throughout the support 52, including being embedded within the first layer 57 as shown in FIG. 7. A tumor or module receiving portion 61 is formed in at least one of the first layer 57 and the second layer 55. The tumor receiving portion 61 can be a pre-formed pocket in the second layer 55, or can be formed by a user by cutting a slit in the second layer 55. In one variation, the tumor 38 is configured to mimic fibroids commonly found in the human uterus. Examples of fibroids that may be simulated by the tumor 38 placed on the support include, but are not limited to, one or more of the following types of fibroids: pedunculated submucosal fibroids, subserosal fibroids, submucosal fibroids, pedunculated subserosal fibroids, and intramural fibroids. A user can access the support 52 from the first side 51 or the second side 53 through an access channel or opening 63 to remove the simulated tumor 38. In one variation, the opening 63 serves as the only opening to the hollow portion 59, or alternatively, the support 52 can have a substantially C-shaped planar configuration with user access available from above or below the planar C-shaped structure.

[0035] In one variation, the modular support 52 in any of the variations is not flat, but is given contours including curved or other structures, peaks and valleys, and various textures. The different contours provide the user with varying degrees of difficulty in accessing each tumor location, requiring the user to navigate around artifacts and features that may obscure the tumor location. These structural artifacts in the tumor support 52 can be integrally formed with the tumor support 52 or can be modular in structure, similar to the tumor module 50, to allow anatomical contour modules to be removable and replaceable. The tumor module 50 can be replaced with a non-tumor module that includes features and artifacts or textures made of silicone or other materials extending outward or inward from one or more of the upper and lower surfaces 51, 53 of the modular support 52, for example. The features in such non-tumor modules can have various shapes to mimic anatomical structures, including the structure or tissue of adjacent organs. For example, the non-tumor module can include a tubular form of silicone to mimic the intestine. The non-tumor module and tumor module 50 are removably connected to the module support 52 by any means known to those skilled in the art, allowing the user to discard a module after use and then continue practicing by replacing the discarded module, moving it to an adjacent module 50 within the module support 52, or swapping the tumor module 50 for another tumor module 50 with different features or difficulty level.

[0036] 8 and 9 show a variation of the tumor module 50. The tumor module 50 includes a simulated tissue portion 60 connected to a support 62. In the variation shown, the support 62 includes an upper frame 64 connected to a bottom frame 66. At least one of the upper frame 64 and the bottom frame 66 includes a window. FIG. 8 shows the upper frame 64 with a window 68. The bottom frame 66 may or may not include a window. When windows are provided in both the upper and bottom frames 64 and 66, the windows are at least partially aligned. The support 62 is sized and configured to receive the simulated tissue portion 60 between the upper and bottom frames 64 and 66. The upper frame 64 may be formed from a single simulated tissue portion 60 or multiple layers and, in one variation, is connectable to the bottom frame 66 to capture the severable simulated tissue portion 60. In one variation, the frames 64, 66 are spaced apart from one another using a spacer 70. Additionally, at least one of the top frame 64 and the bottom frame 66 includes one or more connection features 72 configured to secure the tumor module 50 to the tumor support 52 (not shown). In Figure 9, the connection features 72 are shown as extended pegs that provide a snap-fit ​​engagement for insertion into corresponding holes formed in the tumor support 52. Other fastening or connection means, such as friction fit means or hook-and-loop materials, can be used on the module 50 and module support 52 to removably connect the module 50 to the support 52.

[0037] 8 and 9, the simulated tissue portion 60 can have any of the configurations described above with reference to FIGS. 2-5. The use of windows formed in both the first frame 64 and the second frame 66 allows access to the simulated tissue portion 60 from either side of the module 50. Any of the layers described above as cover layers can function as top or bottom layers depending on which side or direction the simulated tissue portion 60 is accessed from. For example, the base layer can also function as top or bottom layers depending on which side or direction the simulated tissue portion 60 is accessed from. In such a bidirectional configuration, the thickness and color of the layers can be adjusted accordingly to provide the desired simulated effect.

[0038] The simulated tissue portion 60 of FIG. 9 includes a first layer 74 and a second layer 76. The first and second layers 74, 76 are made of a polymeric material, such as silicone or other polymers, configured to mimic real, living tissue and may include one or more dyes of an appropriate color, or mesh, fabric, or other reinforcement. Each of the layers 74, 76 includes a tumor receiving portion 78, 80, respectively. Each tumor receiving portion 78, 80 is a recess, depression, semi-pocket, or location of small thickness formed within the layer 74, 76. The tumor receiving portions 78, 80 are substantially aligned to form a pocket for the tumor 38. While FIG. 9 shows each layer 74, 76 having a tumor receiving portion 78, 80, in one variation, a single tumor receiving portion is formed within at least one of the first and second layers 74, 76. The tumor 38 is placed within a pocket formed by one or more tumor receiving portions 78, 80 formed within one or more layers 74, 76. The tumor 38 can be attached to either layer 74, 76 or suspended within the pocket. A tumor receiving portion formed within a layer, as shown in FIG. 9, can be considered a type of defect, and a variation of FIG. 9 illustrates a simulated tissue configuration including two defect layers sandwiching a tumor. As the user approaches the simulated tissue portion 60, the user will view the target tumor location. Visualization of the target tumor 38 is improved by the thinning of the layers provided by the recess or pocket, resulting in a reduced thickness of the tumor receiving portion compared to the remainder of the layer. The user will then make a cut at the approximate tumor location, making an incision within at least one of the layers 74, 76 to remove the tumor 38. Creating a gap or complete defect is completed by dissecting one or more layers, and the user can then practice suturing or otherwise closing it. In another variation, there is no tumor receiving portion formed within layers 74, 76. In such a variation, at least one tumor is positioned between two layers 74, 76, which have a substantially uniform thickness, and the tumor 38 creates a slight bulge within the layer.

[0039] 10A, 10B, 11A, 11B, and 12, another variation of a simulated tissue segment 86 is shown. As mentioned above, the tissue segment 86 can be unitary or modular. The tissue segment 86 includes a base layer 88 formed of any suitable elastic polymer, such as silicone or other elastic polymer, which may or may not include a reinforcing material or filler, such as fiber, mesh, nylon, or other reinforcing material, that will resist tearing while retaining sutures or being sewn. The base layer 88 is connected to an overlying defect layer 90. The defect layer 90 includes a plurality of protrusions extending upward from the base layer 88. The defect layer 90 can be integrally formed with the base layer 88 or can be a separate layer adhered to the base layer 88. As can be seen in FIGS. 10A, 11A, and 12, the defect layer 90 is configured in a lattice-shaped pattern that protrudes above or protrudes upward from the base layer 88. The grid pattern is exemplary, and the defect layer 90 can form any shape, including multiple adjacent protrusions. These protrusions on the base layer 90 provide the user with a location for a suture needle to act as a platform to elevate the tumors 38a, 38b above the base layer 88 for easier resection. The tumors 38a, 38b can be adhered to the defect layer 90, and in one variation, a cover layer 92 can be included. FIGS. 10A and 11A show the base layer 88, defect layer 90, tumors 38a, 38b, and cover layer 92 in a semi-exploded view of the simulated tissue portion 86, with the cover layer 92 elevated above the other layers. The tumor 38a in FIG. 10a is substantially planar and is shown covered by the cover layer 92 in FIG. 10B. The tumor 38b in Figure 11A has a greater height and is substantially spherical in shape, and Figure 11B shows the spherical tumor 38b covered with a cover layer 92 while leaving a ridge or protrusion in the configuration. Figure 12 shows the tumor 38 being removed while leaving a residual defect 94 in the base layer 88 with the defect accessed under or through the cover layer 92 and a suture needle traversing the gap in the defect 94.

[0040] Synthetic materials that mimic the properties of living tissue can include silicone elastomers, natural latex, polyurethane elastomers, hydrogels, and styrene block copolymers. Generally, elastomeric materials are dielectric materials unless specially treated. Generally, elastomers are any of a variety of polymers with elastic properties similar to those of natural rubber. Generally, hydrogels are hydrophilic polymers containing between 50% and 99% water. Generally, thermoplastics are materials that can be repeatedly softened and hardened by heating and cooling. Thermoplastics are non-conductive and suitable for creating trays or bases, scaffolds, and other similar structures. Generally, thermosetting resins are elastomeric materials that are heated or cured to permanently harden. Thermosetting plastics, such as silicone and polyester, are non-conductive and suitable for forming lesions and tumors. Silicone elastomers are typically very soft, stable, and non-conductive, making them suitable for forming artificial organs, lesions, and other anatomical structures, such as the liver, kidney, spleen, ovaries, gallbladder, stomach, major arteries, colon, intestines, major veins, omentum, and mesentery. Natural latex is highly elastic and non-conductive, making it suitable for forming artificial muscle and cartilage. Polyurethane elastomers and foams are non-conductive, making them suitable for filling hollow structures and bones. Hydrogel SBCs can be conductive, making them suitable for any soft structure operated on by electrosurgery.

[0041] In one variation, a surgical simulation tray insertable into a laparoscopic trainer 10 for practicing surgical techniques, including laparoscopy and electrosurgery, includes a base, an arrangement of anatomical organs, and a cover layer. The base includes a rigid or semi-rigid structure sized and configured to fit within or on the surgical training device 10. Additionally, the base is provided with anatomical support features or receptacle portions formed by upstanding walls that cooperate and match in size and shape with the arrangement of body organs within or on the base. The body organs, made of an elastomeric material, are strategically placed within or on the base according to the specific needs and / or target anatomical structures of the training device. At least one cover layer can be disposed over the entire assembly or over specific sections thereof. The cover layer can be sized and configured to represent one or more of the following: omentum, mesentery, fat, connective tissue, peritoneum, mesothelium, and broad ligament. The cover layer can include a non-conductive silicone elastomer. A non-conductive cover layer is suitable when electrosurgical operation is not to be used on the cover layer. When electrosurgical operation is intended, the cover layer is made of a conductive gel, such as a hydrogel. A combination of a conductive layer and a non-conductive layer is provided when electrosurgical operation is to be directed on one of the layers.

[0042] In addition to the organs placed within or on the base, multiple lesions or defects can be strategically placed relative to the organs or within the simulated organ itself. The lesions or defects can represent tumors, cysts, ectopic pregnancies, etc. For example, as described above with reference to FIG. 7, a uterus can be formed with an outer layer of silicone rubber and a substantially hollow inner layer of soft polyurethane foam. Synthetic fibroids can be placed at various locations between the silicone and foam layers for identification and removal by surgical trainees. One simulated synthetic fibroid configuration includes a small amount of ultra-soft uncured silicone rubber. The uncured silicone rubber is mixed with a certain amount of amorphous, uncured fumed silicon dioxide, which acts as a filler and flow controller. The combination of uncured silicone rubber and silicon dioxide is molded and cured. Once fully cured, this combination results in an irregularly shaped, somewhat fibrous structure resembling a human fibroid. This simulated human fibroid configuration is then placed in a simulated organ model, such as a uterus. This tumor simulation is not limited to use in simulating tumors in gynecological models, but can also be used in other organ models containing tumors to practice tumor removal. This tumor simulation, which includes a hardened mixture of silicone rubber and silicon dioxide, closely resembles real tumors found in the context of gynecological surgery, providing an amorphous, realistic look and feel when practicing surgical techniques. Dark dyes, such as red or black, can be added to the mixture before hardening and mixing throughout. This configuration can be used to create a simulated ectopic pregnancy for insertion into the simulated fallopian tube of a simulated organ placed within the training device 10. The very dry, highly moldable consistency of the silicone and filler mixture advantageously allows for highly creative, easy creation of tumors or other lesions of any size to mimic real-world conditions. Tumors made of silicone and filler are non-conductive and may rupture or tear if not handled properly.

[0043] Next, some examples of organ simulation models including a combination of conductive and non-conductive portions are described. For a liver resection surgical procedure, a simulated organ model for training electrosurgical procedures would have a liver, cystic duct, and mesentery made of conductive hydrogel. These conductive portions of the model are positioned adjacent to non-conductive portions of anatomical structures, including the same or different organs. For example, to practice a cholecystectomy surgical procedure, the organ model would include a cystic duct and mesothelium made of conductive hydrogel, with the liver and gallbladder being non-conductive. For practicing a sleeve gastrectomy, the simulated organ model would include one or more of the blood vessels along the greater curvature of the stomach and the omentum / mesentery made of conductive hydrogel material, and one or more of the stomach, large intestine, and small intestine made of non-conductive material. For practicing gastric bypass surgery, the simulated organ model would include one or more of the short gastric blood vessels along the greater curvature of the stomach and the mesentery / omentum made of conductive hydrogel material, and the stomach made of non-conductive material. In one variation, at least a portion of the jejunum and / or stomach is made of conductive hydrogel. To practice ovarian procedures such as fibroid removal, ectopic pregnancy, ovarian cyst treatment, and hysterectomy, the training model includes both conductive and non-conductive materials. For example, the organ model can include simulations of one or more fallopian tubes, round ligaments, ovarian ligaments, IP ligaments, broad ligaments, bladder valves, uterine arteries / veins, cardinal ligaments, and uterosacral ligaments made of conductive hydrogel, with one or more of the uterus, ovaries, rectum, bladder, ureters, and kidneys being non-conductive. In one variation, locations immediately above and / or below the cervix are made of conductive hydrogel to practice supracervical or total colpostomy. Procedures involving the colon, small intestine, sigmoid colon, or rectum may require certain portions to be conductive. These conductive portions are positioned adjacent to non-conductive portions. For example, to practice transanal minimally invasive surgery for localized resection of a tumor, the organ model would include the colon and / or rectum made of a non-conductive elastomeric material, except for the area surrounding the tumor, which would be made of a conductive hydrogel material, and the tumor.In another variation, at least a portion of the rectum is made of conductive hydrogel, such as for practicing transanal total mesorectal resection. For practicing appendectomy, the simulated organ model can include one or more of the mesentery / mesenteric tract, appendicular artery, and blood vessels made of conductive hydrogel, and one or more of the appendix, cecum, and terminal ileum made of non-conductive elastomeric material. For practicing colectomy, the simulated organ model can include one or more of the mesentery, ileocolic artery, middle colic artery, right colic artery, inferior mesenteric artery, inferior mesenteric vein, left colic artery, sigmoid artery, rectal artery, marginal artery, corresponding veins, omentum, linea alba, mesenteric attachment to the retroperitoneal space, and mesorectum made of conductive hydrogel, and one or more of the colon, liver, spleen, stomach, kidney, duodenum, and retroperitoneal space made of non-conductive material. Hydrogel materials must be hydrated to be sufficiently conductive, and therefore can be difficult to maintain a long useful shelf life.

[0044] With respect to the cardinal ligament, in one variation, the cover layer comprises a thin, translucent sheet of silicone rubber that is calendered or press-formed to have a texture and a finish that appears naturally occurring. Another variation of the cover layer can further comprise a thin, translucent sheet of hydrogel material that is cured from a slurry and develops surface features as it hardens. The hydrogel material becomes conductive upon hydration, enabling the use of electrosurgical devices. A composite structure for the cover layer includes a conductive gel layer sandwiched between two silicone elastomeric, non-conductive layers. In such cases, one or more of the outer non-conductive layers are removed to expose the conductive gel layer. The non-conductive silicone layer advantageously provides a seal against the hydrogel layer and retains the fluid components of the conductive gel.

[0045] In another cover layer variation, a thin film of two-part platinum- or tin-cure liquid silicone is placed on a sheet of textured polyethylene foam. A notched trowel or spreader is then used to spread the silicone material over the surface of the first foam layer, leaving an irregular pattern of material thickness. A second textured polyethylene foam layer is then placed over the first foam layer, leaving silicone between them. A textured roller or stamping device is then moved over the surface of the second foam layer to calendar the silicone material between the foam layers. The resulting silicone sheet, once cured, is tack-free and exhibits properties similar to those of omentum, mesentery, or fat. This sheet advantageously has high-strength and low-strength areas that can be used to demonstrate the use of mechanical dissectors and scissors.

[0046] A specific organ that can be used in the surgical simulation device includes a uterus 100, as shown in FIG. 13. The uterus includes a shell made of soft silicone rubber molded over the uterine form. Once fully cured, the shell is substantially hollow and placed over a molded foam rubber uterine form with walls approximately 7 to 9 millimeters thick. Various lesions can be placed between the silicone shell and the foam wall. Some lesions can be inserted into the foam wall to simulate intramural tumors, fallopian tubes 102, or cysts. Fallopian tubes 104, ovarian ligaments 106, and other ancillary structures can be inserted within the silicone / foam structure and attached with adhesive. An ovarian cyst 124 can be provided and made from the same tumor material. Ancillary structures can include the aorta 114, internal iliac arteries 116, ovarian arteries 118, uterine arteries 120, vaginal arteries 121, and uterosacral ligaments 122. The uterine shell is the primary part of the surgical procedure. In one variant, the uterine shell is made of silicone elastomer, and is therefore suitable for cases where the uterine model is intended to be cut or incised during training. If electrosurgery is being practiced on the uterine model, a uterine model containing conductive gel is selected. Depending on the surgical method, the connecting structures and connecting tubes are made of silicone elastomer or conductive gel.

[0047] The two-part, platinum- or tin-cured silicone fallopian tube 104 includes a first open end, a second open end, and a through lumen. The first open end extends approximately 20 centimeters to form a tubular structure with a diameter of approximately 6.5 millimeters and a very thin wall of approximately 1 to 1.5 millimeters. Toward the end of the tubular structure, a bulbous section is formed with a diameter of approximately 1.5 centimeters and a length of approximately 3 centimeters. The bulbous section transitions to a constricted portion of the tubular structure of approximately 7 millimeters. The constricted tubular structure then gradually expands into a funnel-shaped structure with a final opening diameter of approximately 2 centimeters and a length of approximately 3.5 centimeters. Prior to removing the fallopian tube 104 from the form on which it was created, multiple axial cuts 108 are made in the second enlarged open end. Upon removal from the form, these cuts allow the silicone material to move in a manner similar to human pilus. A lesion 110, such as an ectopic pregnancy, can be inserted into the bulbous portion of the fallopian tube 104 for localization or excision. Additionally, a length of soft fiber thread, used in knitting, can be placed within the lumen to maintain the shape of the thin-walled ductal portion of the fallopian tube when collapsed.

[0048] In this simulated uterus model, the ovary 112 is a hollow, bulbous structure formed from two-part platinum- or tin-hardened silicone. A soft polyurethane foam support is placed within the ovarian structure. The polyurethane support is sized and configured to fit neatly within the ovarian shell and have a nest or receptacle for a lesion, such as an ovarian cyst 124. A trainee can make an incision through the ovarian wall and into the polyurethane foam to remove the lesion and then suture the defect closed. The ovary is made of a non-conductive material and is cut using scissors or a scalpel. In another variation, the ovary is made of a conductive gel and can therefore be cut using electrosurgery. The cyst is made of a non-conductive material.

[0049] In another simulated organ model, the stomach comprises a hollow, stomach-shaped pouch having a first open end, a second open end, and an enlarged central portion. The enlarged central portion is divided by a path extending from near the first open end to near the second open end. This path includes a silicone adhesive area strategically placed along a desired trajectory adjacent to the lesser curvature of the stomach. Opposing walls of the gastric pouch are approximated and held together by the adhesive. To simulate a specific procedure, the stomach can be divided along the adhesive path. That is, the adhesive path guides the trainee to staple or cut along a preferred surgical path. The adhesive simulates the placement of several rows of staples before the cutting element in a surgical stapler is deployed. As a result, the dissected stomach portion appears firmly stapled, while the remaining stomach portion is airtight and rigid. In another variation, the adhesive portion of the stomach is formed of a conductive gel material adjacent to a non-conductive adjacent portion of the stomach. In yet another variation, the predetermined surgical path across the stomach or other organ consists of a conductive gel material adjacent to a non-conductive material in the same organ or adjacent to a non-conductive material in a different organ and anatomical structure.

[0050] In another simulated organ model, a liver made of hydrogel can be placed in the training module 10 where the procedure is believed to involve electrosurgical dissection. In one variation, the base or tray of the training module 10 accepts and holds in place either a silicone liver or a hydrogel liver. The accepting features can include nests, pockets, or receptacles sized and configured to maintain a silicone, hydrogel, or foam rubber liver in a predetermined position based on the needs of the particular training module. If the procedure requires an electrosurgical operation, such as liver resection, the liver is made of conductive gel. The base or tray is configured to accept a liver made of gel, silicone, or foam based on the particular procedure. If the procedure being practiced does not involve electrosurgery, it is much more economical to use a silicone or foam model.

[0051] While certain embodiments have been specifically shown and described with reference to exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope thereof as defined by the claims that follow.

Claims

1. 1. A surgical simulation system, comprising: a simulated uterus having at least one simulated fallopian tube, wherein at least one of the simulated uterus or the at least one simulated fallopian tube comprises an electrically conductive material, and the at least one simulated fallopian tube has a first end and a second end and a bulbous portion near the second end; a simulated lesion disposed within the bulbous portion of the at least one simulated fallopian tube, the simulated lesion configured to be removed using an electric current. Surgical simulation system.

2. The surgical simulation system of claim 1 , wherein the simulated lesion is made of a non-conductive material including silicone rubber and untreated fumed silicon dioxide.

3. 3. The surgical simulation system of claim 1, wherein at least a portion of the at least one simulated fallopian tube comprises a soft, fibrous material configured to maintain the shape of the at least one simulated fallopian tube when collapsed.

4. The surgical simulation system of claim 1 or 2, wherein the at least one simulated fallopian tube further comprises a funnel-shaped configuration near the second end, the funnel-shaped configuration having a plurality of axial cuts.

5. The surgical simulation system of claim 4 , wherein the funnel shape has an opening diameter of 2 centimeters over a length of 3.5 centimeters.

6. 3. The surgical simulation system of claim 1, wherein the at least one simulated fallopian tube has a diameter of 6.5 millimeters and a length of 20 centimeters, the bulbous portion has a diameter of 1.5 millimeters and a length of 3 centimeters, and the wall of the at least one simulated fallopian tube has a thickness of 1 to 1.5 millimeters.

7. 2. The simulation system of claim 1, wherein the simulated uterus has an inner layer adjacent to and in contact with an outer layer, the outer layer being made of a conductive material that is operably cut under the application of an electric current, and the inner layer being made of a non-conductive material that is not operably cut under the application of an electric current.

8. 10. The simulation system of claim 1, wherein the simulated uterus comprises at least one layer of elastomeric hydrogel operably cleavable under application of an electrical current configured to simulate electrosurgery in a training environment.

9. The simulation system of claim 7 , wherein the outer layer of the simulated uterus has a plurality of distinct high-intensity and low-intensity regions.

10. 10. The simulation system of claim 8, wherein the simulated uterus further comprises an integral mesh structural support to prevent tearing of the at least one layer.

11. A simulation system as described in claim 1, wherein the simulated lesion is made of a non-conductive material.

12. 12. The simulation system of claim 1 or 11, wherein the at least one simulated fallopian tube comprises an elastomeric hydrogel.

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