Renal hilum surgical simulation system

Abstract

To provide a renal hilum surgical simulation system.SOLUTION: A renal hilum surgical simulation system is provided. The renal hilum surgical simulation system includes simulated tissue layers and simulated renal organs and / or vasculatures. The renal hilum surgical simulation system is adapted for but not limited to laparoscopic donor nephrectomy surgical procedures.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 679,568, filed June 1, 2018, and U.S. Provisional Patent Application No. 62 / 791,450, filed January 11, 2019, the disclosures of which are incorporated herein by reference in their entireties.

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

[0003] Laparoscopic surgery requires making multiple small incisions in the abdomen and inserting trocars, or small cylindrical tubes approximately 5-10 millimeters in diameter, through which surgical instruments and a laparoscope are placed into the abdominal cavity. The laparoscope provides the surgeon with an enlarged view of organs and tissues by illuminating the surgical field and transmitting a magnified image from inside the body to a video monitor. The surgeon performs the surgery by observing the live video feed and manipulating the surgical instruments placed through the trocars.

[0004] Kidney transplantation is the treatment of choice for patients with end-stage renal failure, a condition that has rapidly increased over the past decade. Currently, there are 100,000 patients on the kidney transplant list, many of whom have been waiting 5–10 years for a kidney from a deceased donor. This has led to an increase in living donor nephrectomies, resulting in the need for transplant surgeons to minimize morbidity and mortality in healthy donors and ensure optimal kidney harvesting for transplantation. Since then, laparoscopic donor nephrectomy (LDN) has become the preferred surgical approach due to its many advantages over open surgery, including reduced hospital stays, reduced postoperative pain and morbidity, and improved donor satisfaction. However, despite the advantages of laparoscopic surgery, the complex surgical tasks involved place significant demands on the surgeon's skills. Summary of the Invention [Problem to be solved by the invention]

[0005] Simulation-based education has greatly enhanced laparoscopic surgical training by providing a safe and effective means for acquiring technical skills. However, despite the growing need to train LDN procedures, there is a lack of surgical simulation systems, mock devices, or models for simulation training. As a result, trainees are limited to practicing procedures in costly animal and cadaveric laboratories or rely on gaining experience through practice on patients in the operating room, which reduces operating room efficiency. To increase safe surgical practices, increase the number of trainees learning LDN, improve trainee skills, reduce training costs, and facilitate LDN training, an LDN simulation model that focuses on and isolates one or more of the most technically challenging steps in the procedure—renal hilum dissection—would be desirable and beneficial for shortening the learning curve and enabling transplant trainees to achieve proficiency more quickly. Furthermore, a model or surgical simulation system focused on LDN would allow trainees to practice in a low-risk environment, potentially reducing the need for and associated costs of animal and cadaveric laboratories. [Means for solving the problem]

[0006] According to various embodiments of the present invention, a renal hilar surgery simulation system is provided, the surgery simulation system including a plurality of penetrable simulated tissue layers, a pocket disposed between and confined by the peripheries of the plurality of penetrable simulated tissue layers, a plurality of fiber layers disposed between the plurality of penetrable simulated tissue layers and at least one of the simulated kidney organs, and a vasculature disposed between and enclosed within the pocket.

[0007] According to various embodiments, a renal hilar surgery simulation system is provided. In various embodiments, the system includes a first penetrable layer having an upper surface and a lower surface and a second penetrable layer having an upper surface and a lower surface. In various embodiments, a periphery of the upper surface of the second penetrable layer is connected to a periphery of the lower surface of the first penetrable layer, and in various embodiments, a pocket is disposed between the first and second penetrable layers. In various embodiments, the pocket is bounded and confined by the peripheries of the connected first and second penetrable layers. In various embodiments, a plurality of fiber layers are disposed between the first and second penetrable layers, and in various embodiments, at least one simulated renal vasculature is disposed between the plurality of fiber layers and enclosed within the pocket.

[0008] According to various embodiments, a renal hilar surgery simulation system includes a first penetrable layer having an upper surface and a lower surface and a second penetrable layer having an upper surface and a lower surface. In various embodiments, a periphery of the upper surface of the second penetrable layer is connected to a periphery of the lower surface of the first penetrable layer, and in various embodiments, a pocket is disposed between the first and second penetrable layers. In various embodiments, the pocket is bounded and confined by the peripheries of the connected first and second penetrable layers. In various embodiments, a plurality of fiber layers are disposed between the first and second penetrable layers, and in various embodiments, at least one simulated kidney organ is disposed between the plurality of fiber layers and enclosed within the pocket.

[0009] According to various embodiments, a renal hilar surgery simulation system includes a first penetrable layer having an upper surface and a lower surface and a second penetrable layer having an upper surface and a lower surface. In various embodiments, a periphery of the upper surface of the second penetrable layer is connected to a periphery of the lower surface of the first penetrable layer, and in various embodiments, a pocket is disposed between the first and second penetrable layers. In various embodiments, the pocket is bounded and confined by the peripheries of the connected first and second penetrable layers, and in various embodiments, multiple fiber layers are disposed between the first and second penetrable layers. In various embodiments, multiple simulated renal vasculatures are disposed between the multiple fiber layers and enclosed within the pocket, and / or in various embodiments, at least one simulated kidney organ is disposed between the multiple fiber layers and enclosed within the pocket.

[0010] According to various embodiments, a renal hilar surgery simulation system is provided that includes a simulated renal vasculature and / or a simulated kidney organ. In various embodiments, a renal hilar surgery simulation system is provided that includes at least one fiber layer, such as batting. In various embodiments, a renal hilar surgery simulation system or a renal hilar laparoscopic donor nephrectomy simulation system is provided. In various embodiments, a surgical simulation system is provided that includes a simulated vasculature, a simulated organ, a simulated renal vasculature, a simulated kidney organ, and / or any combination and / or individual thereof. In various embodiments, the system includes a first penetrable layer having an upper surface and a lower surface and a second penetrable layer having an upper surface and a lower surface. In various embodiments, the periphery of the upper surface of the second penetrable layer is connected to the periphery of the lower surface of the first penetrable layer, and in various embodiments, the first and second penetrable layers are formed of silicone. In various embodiments, a pocket is disposed between the first and second penetrable layers, and in various embodiments, the pocket is bounded and confined by the peripheries of the first and second penetrable layers connected to each other. In various embodiments, the upper fiber layer has an upper surface and a lower surface, and in various embodiments, the upper fiber layer is disposed below the first penetrable layer, with the lower surface of the first penetrable layer adjacent to and in contact with the upper surface of the upper fiber layer. In various embodiments, the lower fiber layer has an upper surface and a lower surface, and in various embodiments, the lower fiber layer is disposed above the second penetrable layer, with the upper surface of the second penetrable layer adjacent to and in contact with the lower surface of the lower fiber layer. In various embodiments, the middle fiber layer has an upper surface and a lower surface, and in various embodiments, is disposed between the upper and lower fiber layers. In various embodiments, a first simulated renal vasculature is connected to the upper surface of the lower fiber layer and the lower surface of the middle fiber layer, and in various embodiments, a second simulated renal vasculature is connected to the lower surface of the upper fiber layer and the upper surface of the middle fiber layer. In various embodiments, the upper, lower, and middle fiber layers, and the first and second simulated renal vasculature are enclosed within a pocket.

[0011] Many of the attendant features of this invention will be readily appreciated as the same becomes better understood by reference to the foregoing and following description and by consideration in connection with the accompanying drawings in which like reference characters refer to like parts throughout.

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

[0013] [Figure 1] FIG. 1 is an exploded view of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 2] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 3] 1A-1C are cross-sectional views of a renal vein and a renal artery according to various embodiments of the present invention. [Figure 4A] FIG. 1 is a side view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 4B] FIG. 1 is a top view of an assembled portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 5A] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 5B] FIG. 1 is a top view of an assembled portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 6] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 7] FIG. 1 is a top view of an assembled portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 8] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 9]FIG. 1 is a top view of an assembled portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 10] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 11] FIG. 1 is a top view of an assembled portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 12] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 13] FIG. 1 is an exploded perspective view of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 14] FIG. 1 is an exploded side view of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 15] FIG. 1 is a top view of a portion of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 16] FIG. 1 is a top view of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 17] FIG. 1 is a perspective view of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 18] FIG. 1 is a perspective view of a renal hilar surgery simulation system according to various embodiments of the present invention. [Figure 19] FIG. 1 is a side view of a renal hilar surgery simulation system according to various embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] In the LDN procedure, renal hilar dissection is one of the most challenging and high-risk steps due to the need to mobilize multiple critical structures. Currently, there is an unmet need for a simulation model or surgical simulation system that allows trainees to practice proficiency in this surgical step. A simulation model or surgical simulation system of the renal hilum shortens the learning curve by allowing surgical trainees to repeatedly practice the necessary dissections in a low-risk environment. To be effective, a surgical simulation system should enable complete dissection of specific structures within the renal hilum from a laparoscopic approach and include one or more simulated anatomical structures and landmarks, such as the kidney, adrenal gland, renal vein, renal artery, ureter, gonadal vein, adrenal vein, and aorta, that should be present and identifiable within the model or surgical simulation system. These structures should be anatomically accurate and / or made of materials that mimic tissue reactions similar to those encountered in the LDN procedure. Additionally, these structures can be surrounded by simulated dissectible areolar tissue of appropriate density to provide realistic tactile feedback. Practice with this surgical simulation system can facilitate identification of appropriate anatomical structures and the acquisition of appropriate tissue handling and dissection skills required for the procedure.

[0015] In various embodiments, a renal hilar surgery simulation system allows trainees to focus on the skills necessary to practice the most challenging steps within the LDN procedure. In various embodiments, the surgical simulation system is appropriately positioned to provide a realistic procedural training environment. To further enhance the training environment, the surgical simulation system uses simulated materials to represent various anatomical landmarks and materials to simulate areas of dissectable tissue, providing important visual and tactile feedback to aid in training in the LDN procedure. To simulate the tactile feel of the anatomical structures encountered during the LDN procedure, various embodiments select specific combinations of materials, structures, and designs for the various components found within the surgical simulation system.

[0016] FIG. 1 is an exploded perspective view of a renal hilar surgery simulation model or system 10 according to various embodiments of the present invention. The inner contents (anatomical structures and tissues) of the surgical simulation system 10 are encapsulated between upper and lower penetrable layers 12, 14, which are two silicone layers bonded together to form a closed pocket. Within the pocket, the upper outermost layer is an upper fibrous layer 16, which is comprised of a simulated dissectable tissue area formed from multiple layers of sheet-like polyester fiber, such as batting, bonded together using a small amount of silicone or adhesive, which the surgeon dissects or cuts to remove and access the anatomical structures encountered in LDN procedures. The dissection area, comprised of multiple polyester fiber layers, such as a half-fibrous layer 18, bonded together with the batting and with the anatomical structures, is shaped to represent the various densities of biological structures found in the body. According to various embodiments, one or more of these layers are planar and / or stacked against each other.

[0017] According to various embodiments, a layer of simulated anatomical landmarks is provided. In various embodiments, these simulated anatomical landmarks include simulated kidneys 20, adrenal glands 22, ureters 24, and / or aorta 26. None of these components should be dissected or cut during the simulated procedure, and these landmarks are included in the surgical simulation system 10 to aid in the orientation and / or education of the trainee. For example, the simulated ureters 24 should be identified, but not touched, and are used as a tool to navigate to the location of the gonadal veins 28. While the trainee should not touch or manipulate these simulated landmarks, one or more of these simulated anatomical structures include one or more visual features, such as size, shape, color, and / or any combination thereof, to simulate biological structures and / or to provide cues that allow orientation within the simulated environment. In various embodiments, one or more of these simulated anatomical structures also include one or more tactile features, such as texture, springiness, elasticity, and / or any combination thereof, to further enhance identification of the simulated landmarks and / or as evaluation and / or educational indicators. For example, in various embodiments, one or more of the simulated landmarks retain their shape until cut or overly manipulated, thereby reflecting this treatment if unintentionally cut or otherwise overly manipulated, thereby providing an evaluation to the evaluator and / or an educational indicator to the trainee.

[0018] During the simulated procedure, simulated gonadal veins 28, adrenal veins 30, and lumbar veins 32 are located and circumferentially dissected, or skeletonized. During this skeletonization, the surgeon can pull on the veins to cut or dissect the fibers or batting. This step is one of the most difficult steps in the procedure because the veins are very fragile and will break or tear if cut or too much force is applied. To become familiar with or proficient in these procedural steps, surgeons must understand the force required to manipulate the veins without injuring them during dissection, thus simulating the fragility of the veins.

[0019] According to various embodiments, the simulated gonadal veins 28, adrenal veins 30, and / or lumbar veins 32 are formed from silicone or silicone foam molded into a thin, flat structure to simulate the fragility of various veins. Note that the gonadal veins, adrenal veins, and lumbar veins found in the human body are hollow, cylindrical structures through which blood flows, measuring 3 mm, 4 mm, and 2 mm in diameter, respectively. Thus, according to various embodiments, the simulated gonadal veins 28, adrenal veins 30, and / or lumbar veins 32 are not exact replicas of biological structures, e.g., in terms of size and / or shape, but rather, these simulated veins are provided to aid in the manufacturing process and to recreate the tactile feel of the corresponding structures, e.g., in terms of size and / or shape, and the selection of materials, e.g., silicone.

[0020] In various embodiments, as shown in FIG. 2 , the simulated gonadal, adrenal, and lumbar veins 28, 30, 32 include one or more cuts or notches 50 at predetermined locations along their length. These predetermined notches 50 create weak or fracture points at specific locations, allowing the simulated vessels to simulate the fragility of such vessels. Also, in various embodiments, if excessive force or manipulation is applied to the simulated vein, the simulated vein will separate at one or more of the notches 50. The separated or fractured vessels can provide an evaluation and / or educational indicator of or regarding the trainee's specific performance during or during the simulated procedure. Furthermore, the location of the fracture, as indicated by the specific cuts or weak points, can also serve to provide a more detailed evaluation and / or educational indicator of the force or manipulation applied to the fractured simulated vessel. However, simulated vessels with predetermined notches can hinder evaluation of the simulated vessels after the procedure, for example, it can be difficult to distinguish between new notches and old or pre-installed notches; therefore, predetermining the location and / or size of the notches or weak points can help reduce or eliminate this inhibition.

[0021] In various embodiments, the simulated lumbar vein in the surgical simulation system is in tension. In various embodiments, the simulated lumbar vein is pulled taut and attached to the back of the model or surgical simulation system and placed in tension. Placing the simulated lumbar vein in tension allows the simulated lumbar vein, or a portion thereof, to snap if injured or pulled too tightly during circumferential dissection. This snapping simulates or represents the fragility of the simulated lumbar vein because the amount of force used to snap the simulated vessel is similar to the amount of force that would similarly affect a non-simulated lumbar vein.

[0022] In various embodiments, the surgical simulation system 10 includes a simulated renal vein 34 and a simulated renal artery 36. The simulated renal vein 34 and the renal artery 36 are separated from the surrounding fabric or batting (i.e., skeletonized) during the simulated procedure. The simulated renal vein 34 and the renal artery 36 have diameters (approximately 1.2 cm and 6 mm, respectively) that are much larger than the diameters of the simulated gonadal, adrenal, and lumbar veins 28, 30, 32, giving them greater integrity and / or strength so that their tactile differences can be simulated.

[0023] Referring to FIG. 3 , according to various embodiments, the illustrated simulated renal artery 36 has a smaller overall diameter but a thicker wall than the simulated renal vein 34, which has a larger diameter and a thinner wall. In various embodiments, the simulated renal artery and vein are formed from silicone, and in various embodiments, the simulated renal artery includes a thicker silicone layer, which results in a thicker wall thickness for the simulated vessel. In various embodiments, the silicone layer is thickened by applying multiple thin wet or dry silicone layers or films. The thicker wall results in a more difficult vessel to penetrate, i.e., the simulated renal artery is more difficult to penetrate than the simulated renal vein. In various embodiments, the simulated renal vein has a thinner silicone layer, which results in a thinner wall thickness. This makes the vessel, such as the simulated renal vein, easier to puncture or score.

[0024] Providing contrast in the structural integrity of the renal vein and renal artery further provides or enhances simulation and / or training and / or assessment metrics, as the tactile forces that can be used to dissect circumferentially around each structure during a simulated procedure without puncturing or otherwise unduly disturbing the structure vary from vessel to vessel. In various embodiments, the thinner renal vein 34 has a weaker wall and / or is formed of a thinner layer of material. In contrast, in various embodiments, the simulated renal artery 36 is formed of one or more thicker layers of material. Both vessels are formed or molded from materials including silicone and / or similar weak conductive materials that retain their shape.

[0025] In various embodiments, the simulated renal vein 34 and / or renal artery 36 are filled with fluid or the like to further mimic anatomy and / or for evaluation or training indication. For example, if any of the vasculature is punctured, fluid may leak or leak out of the simulated vessel, providing a visual indication of the punctured vasculature and potentially indicating further training or poor proficiency of the trainee.

[0026] In FIGS. 4A-4B , the simulated adrenal vein 30, gonadal vein 28, and lumbar vein 32 are adhered or otherwise attached to the simulated renal vein 34 at the renal vein attachment area 52, and in various embodiments, through silicone-to-silicone bonding. The renal vein attachment area 52 is illustrated by a rectangular box in FIG. 4B . While the attachment area is shown as a rectangle, it can be any shape. Throughout, the attachment area 52 is shown or referenced as a guide and exemplary method for indicating where components are glued or otherwise attached, or where adhesives or the like are applied. In various embodiments, the simulated gonadal vein 28, adrenal vein 30, and lumbar vein 32 are individually shaped and minimally and / or weakly adhered to the renal vein 34 to increase the fragility of the simulated veins when the simulated vessel is placed in tension and dissected around them, e.g., for evaluation and / or training. In various embodiments, weak adhesion is achieved by using a weak adhesive such as soft durometer silicone or similar attachment device, and / or by removing connector 33 and attaching simulated veins 28, 30, 32 directly to simulated renal vein 34.

[0027] 5A-5B illustrate a second vasculature subassembly according to various embodiments. As shown, the simulated renal arteries 36 are glued or otherwise attached to the simulated aorta 26 by silicone-to-silicone bonding, and in various embodiments, using a consistent durometer silicone. In various embodiments, wet silicone is used as the adhesive and is allowed to cure to harden the connection. The aortic adhesive region 52 is illustrated by a rectangular box in FIG. 5B. In various embodiments, the simulated aorta 26 has a semi-cylindrical shape, as shown, for example, in FIG. 14.

[0028] Next, referring to FIG. 6, the back fibrous layer 38 is shown. In various embodiments, the back fibrous layer 38 is formed of or includes batting. In various embodiments, the back fibrous layer is a substantially planar, rectangular layer of polyfill or other fibrous material. The back fibrous layer 38 includes holes or openings 54 through which the lumbar veins 32 pass. The openings 54 are specific to the surgical simulation system 10 and are not anatomically accurate. As shown in FIG. 7, a second vascular system subassembly including the renal arteries 36 and the aorta 26 is adhered to the back or first fibrous layer 38 using an adhesive. An adhesive region 52 is shown to be substantially below the entire second subassembly.

[0029] Referring now to FIG. 8 , according to various embodiments, a second fabric layer 40 is adhered to the simulated renal arteries 36 and aorta 26 of the second vasculature subassembly. The second fabric layer 40 is formed of or includes batting. In various embodiments, the second fabric layer is a rectangular, substantially planar layer of polyfill or other fibrous material. The second fabric layer 40 is also adhered to the back or first fabric layer 38 using adhesive areas 52, represented by the large rectangles. The second fabric layer 40 also includes a hole or aperture 56 that penetrates from the top to the bottom of the second fabric layer 40. The simulated lumbar vein 32 passes through this hole 56 and through a hole 54 in the back fabric layer 38, such that the holes 54, 56 align when the layers are stacked such that the peripheries of the layers substantially coincide to fit within the pocket. 9, a first vasculature assembly including simulated gonadal veins 28, adrenal veins 30, lumbar veins 32, and renal veins 34 is adhered to the second fiber layer 40 using adhesion areas 52 underlying the renal veins 34, adrenal veins 30, and gonadal veins 28, as shown in FIG. 9, where adhesion areas 52 are indicated by three rectangles. The simulated lumbar vein 32 passes through holes 56 and 54 in the fiber layers 40, 38.

[0030] 10 , the simulated kidney 20, ureter 24, and adrenal gland 22 are connected to the simulated renal vein 34 and adrenal vein 30 and the second layer of fiber 40. The simulated ureter 24 is glued or otherwise attached to the back side of the simulated kidney 20. The kidney 20 is glued to the upper end of the simulated renal vein 34 and to the second layer of fiber 40. The simulated ureter 24 is glued to the second layer of fiber 40. The simulated adrenal gland 22 is glued to the simulated adrenal vein 30 and the second layer of fiber 40. The simulated adrenal gland 22 is not glued to the simulated kidney 20. The rectangular shape in FIG. 10 indicates the glued area 52, and the oval in FIG. 10 indicates the non-glued area 58 between the adrenal gland 22 and the kidney.

[0031] Referring now to FIG. 11 , a semi-fiber layer 18 is adhered to the simulated kidney 20, simulated adrenal gland 22, adrenal vein 30, renal vein 34, and second fiber layer 40. The adhesion area 52 is indicated by a rectangle substantially completely below the semi-fiber layer 18. The semi-fiber layer 18 is provided to simulate the dense, dissectable, loose connective tissue found in a patient. In various embodiments, the semi-fiber layer 18 is formed by cutting a large piece of fibrous material, such as batting, in half lengthwise and pulling away layers of the batting to form thin sections that add to the density of the dissectable tissue. According to various embodiments, these fibers or fibrous material encapsulate and surround one, more than one, or all of the simulated anatomical structures. Multiple layers of fibrous material, such as batting, provide varying densities of dissectable material that the surgeon must cut through. As mentioned above, the simulated lumbar vein 32 passes through holes 54, 56 in the fiber layers 38, 40. As shown in FIG. 12, when the surgical simulation system 10 is turned over so that the rear side faces up, the simulated lumbar vein 32 penetrates through the holes 54 and 56 and is exposed on the rear side.

[0032] 12-13 , the surgeon must dissect circumferentially around the renal vein 34. According to various embodiments, the contents of the surgical simulation system 10 are encapsulated between the upper silicone layer 12 and the lower silicone layer 14. In various embodiments, the lower silicone layer 14 of the surgical simulation system 10 is comprised of uncured silicone that, when cured along with the upper fabric layer 16, adheres to the upper fabric layer 16 around its outer perimeter to form a pocket that holds and positions all components within. During assembly, the lower silicone layer 14 is uncured, so the backing fabric layer 38 also adheres to the wet silicone. If the backing fabric layer 38 becomes too saturated with uncured silicone, it may begin to adhere the simulated renal artery 36 and aorta 26 to the lower silicone layer 14, thereby interfering with the surgical trainee's ability to dissect circumferentially around the renal artery in a simulated LDN procedure. To prevent or reduce this unwanted adhesion, an adhesion blocker 42 is used to ensure that an incision can be made circumferentially around the simulated renal artery 36, as shown in FIG. 13 , which defines the boundary of the incision area 60 with an oval. In various embodiments, the adhesion blocker 42 is formed from a silicone sheet, molded to approximately the thickness of the lower silicone layer 14, and cut to the size of the renal artery 36 to prevent any unwanted adhesion. In various embodiments, the adhesion blocker 42 is positioned or used so as not to interfere with the lumbar veins 32, as these will ultimately be adhered to the lower silicone layer 14 on the back side of the surgical simulation system 10. In various embodiments, the adhesion blocker 42 is adhered to the backing fabric layer 38, as indicated by the rectangular adhesive area, without applying excessive force to prevent adhesion of the simulated renal artery 36 or aorta 26 by impregnating a fibrous material, such as batting.

[0033] 14 , in various embodiments, the simulated lumbar vein 32 is bonded to the simulated renal vein 34, then through the second fabric layer 40 and back fabric layer 38 and bonded to the lower silicone layer 14. According to various embodiments, the lumbar vein 32 is bonded to the lower silicone layer 14 while a model or surgical simulation system is placed on the uncured lower silicone layer 14. Once the lower silicone layer 14 cures, contact between the lumbar vein 32 and the uncured lower silicone layer 14 forms the necessary bond. In various other embodiments, the lumbar vein 32 is bonded to the second fabric layer 40 and back fabric layer 38 at the respective holes 56, 54.

[0034] In various embodiments, these layers are adhered to one another by twisting the surrounding fabric layers together within the surgical simulation system, with or without the use of silicone or silicone adhesive to hold the simulated structure in place.

[0035] In various embodiments, fibers in a fibrous layer, such as a batting, interlock to form a knit matrix and / or form a light bond between the batting and the silicone as the silicone component is pushed through. This allows for sufficient adhesion of the tissue (e.g., the batting) to the organ (e.g., the silicone) that the surgeon will incision during the simulated procedure. Such a knit matrix may also avoid or reduce the use of silicone adhesive layers, which can be difficult to control consistently throughout the surgical simulation system or can leave undesirable residue.

[0036] 15 and 16 , in various embodiments, the simulated ureters 24 and gonadal veins 28 are visible through a boundary / periphery 62 of the surgical simulation system 10 to ensure identification of the simulated ureters 24 and gonadal veins 28. According to various embodiments, the boundary / periphery 62 is formed by bonding the upper silicone layer 12 to the lower silicone layer 14 to form a pocket 64. The simulated ureters 24 and gonadal veins 28 are visible through the upper silicone layer 12 at the boundary / periphery 62 of the surgical simulation system 10. These landmarks serve as indicators as to where the surgeon should begin dissecting the surgical simulation system 10. To enable these landmarks to be visible through the boundary 62, the simulated ureters 24 and gonadal veins 28 extend outward past the fibrous layer into the boundary, which is highlighted by circles 63 in FIGS. 15-16 . In various other embodiments, the color and / or opacity of the top silicone layer 12 contrasts with the simulated ureter 24 and gonadal veins 28 to allow visibility of the landmarks through the top silicone layer 12 .

[0037] 17-19 , according to various embodiments, the renal hilar resection surgical simulation model 10 can include two or more holes along the perimeter 62 for attachment to a stand 66 having a base 68 and at least two upright posts 70 extending upward from the base 68. The posts 70 pass through the holes in the perimeter 62. The stand 66 containing the surgical simulation system model 10 can then be placed within a cavity of a laparoscopic trainer 72 to begin practicing the procedure. The trainer defines a cavity between a top cover and a base. The cavity is hidden from direct view by the trainee, and a scope is inserted through the top cover to capture a live video feed of the cavity, which is displayed to the trainee on a monitor. The trainee or doctor inserts various instruments through the top cover and performs a simulated procedure on the surgical simulation system 10 within the cavity. The stand 66 serves to support the surgical simulation model or system 10 within the trainer 72. In various embodiments, the surgical simulation system 10 contains one or more holes or apertures in each of the two upper corners of the boundary 62. These holes interconnect with posts 70. In various embodiments, the stand 66 includes four posts 70. In various embodiments, the boundary 62 is formed of a resilient silicone material that stretches and returns to its original shape, and the holes in the boundary stretch to conform to the posts 70 and then tighten back to secure the surgical simulation system 10 in place on the posts 70 of the base 68. The placement of the holes on the posts 70, combined with the angled orientation of the flap 44, allows the surgical simulation system 10 to be positioned at various angles relative to the base 68 that may be required to complete the simulated procedure. In various embodiments, to stabilize the upper corners of the surgical simulation system 10, clips 74 in the trainer 72 are used to pull the surgical simulation system upright and / or hold it in place. According to various embodiments, a stand or stable structure and / or similar mount for the surgical simulation system and / or trainer can hold the surgical simulation system stable in an inclined position for the simulated surgical procedure.

[0038] In various embodiments, to replicate or simulate a tilted patient position, the surgical simulation system includes a frame that supports, suspends, and / or tilts the surgical simulation system, and is integrated into or embedded in such a frame. The surgical simulation system is removably attached to the frame, which in various embodiments is removably attached to a surgical trainer. In such embodiments, apertures within the boundary and / or boundary-provided add-ons can be removed along with the flaps, associated add-ons, and / or add-ons provided by the surgical simulation system that provides the boundary.

[0039] During an LDN procedure, the patient lies on their side with a slight posterior tilt. Various embodiments of the renal hilar incision surgical simulation system 10 incorporate a flap 44 designed to be used as a support platform to replicate or simulate the patient's reclined position. The loop side of a hook-and-loop fastener 46, such as a VELCRO®, is adhered to the flap 44 and configured to mate with the opposite or hook side of a hook-and-loop fastener 46 placed on the bottom floor of the trainer 72. The flap 44 extends from the bottom side of the surgical simulation system 10 and, in various embodiments, is constructed of a soft, flexible, yet durable silicone that allows for bending while maintaining its structural integrity. In various embodiments, the flexibility of the flap 44 allows the two elements of the hook-and-loop fastener 46 to interlock, forming a curved stand to hold the surgical simulation system at a desired angle and orientation within the laparoscopic trainer 72. The flap 44 can be used in conjunction with a stand 66 or alone. The attachment of the flap 44 to the trainer floor can vary, and in various embodiments, the hook-and-loop fasteners can be replaced with or further include, for example, one or more snaps, magnets, posts, or clips, and / or can penetrate or be attached or glued to an intermediate component, such as an extension of the base 68, between the mount / surgical simulation system and the trainer floor. The mount of the surgical simulation system can make the surgical simulation system removable, thereby facilitating replaceability, relocation, or reorientation of the surgical simulation system. This attachment or placement of various parts of the surgical simulation system relative to the trainer ensures that the orientation or tilt of the surgical simulation system can replicate the patient's orientation or position, and in various embodiments, ensures that haptic feedback, flexibility, or other features provided by the surgical simulation system are not sacrificed and / or the simulated LDN procedure is not compromised.

[0040] In various embodiments, other variations of the surgical simulation system 10 can include variations in the anatomy within the pocket to include abnormalities, diseases, or different anatomical structures. Such anatomical structures can include the right renal hilum, or additional lumbar veins and / or tumor inclusions. In other embodiments, the surgical simulation system 10 is immersed or impregnated with water or other liquid to better represent the patient's environment. For example, a fibrous or batting layer tends to become denser and more adhesive when saturated with liquid. In various embodiments, this allows for a more accurate representation of the difficulties of an LDN procedure. The pocket 64 can also be filled with a gel-like substance instead of a liquid such as water.

[0041] In various embodiments, the arrangement and / or composition of various parts and components are provided to vary the difficulty of the surgical simulation system, thereby varying the simulated surgical procedure to enhance surgical training and assessment of surgical skills. Examples of such variations are described throughout this specification and claimed, and while they may appear optional, they may nonetheless be included or excluded to vary and adjust the difficulty of the surgical simulation system to enhance surgical training and assessment of skills. Some of these variations include varying fiber layer density, exaggerating or underrepresenting the simulated renal vasculature and / or organ shape, size, and / or tactile response, saturating the fiber layers with fluid, forming simulated vasculature pathways, such as simulated renal vasculature threaded or penetrated through at least one opening in one or more different fiber layers, and / or varying the color and / or composition of the simulated renal vasculature, organ, and / or surrounding structures.

[0042] In various embodiments, both sides or layers of the surgical simulation system are penetrable to ensure or further assess surgical skill such that if mishandling or manipulation of the simulated tissue, e.g., excessive force, is used, a noticeable puncture wound or hole will be visible on the other side of the surgical simulation system. Similarly, the thickness or distance between the layers is minimal, e.g., no more than the length or width of the surgical simulation system or a pocket contained therein, to further test or enhance assessment of surgical skill or effective manipulation of the simulated surgical procedure.

[0043] In various embodiments, the surgical simulation system is constrained in this manner to limit the workspace available for simulating a surgical procedure. Similarly, the difficulty of the simulated surgical procedure can be increased, for example, by modifying the size of the pocket to further limit the surgical space. The number and / or size of components, and combinations thereof, can also be further limited to increase the portability of the surgical simulation system, enhance operation within a trainer, such as a portable laparoscopic trainer, and / or further focus the surgical trainer on the particular simulated procedure. Similarly, features can be omitted or reduced in size or shape to enhance the surgical simulation system, for example, to increase the difficulty or focus the surgical trainer on the particular simulated surgical procedure, even if they may not be anatomically accurate. In various embodiments, the surgical simulation system includes at least one simulated renal vasculature, such as a renal vein, renal artery, and / or the like and / or other vasculature / vessels shown herein, and / or at least one simulated renal organ, such as an adrenal gland, kidney, and / or the like and / or other organs / glands shown herein.

[0044] The above description is provided to enable any person skilled in the art to make and use one or more surgical simulation systems and practice the methods described herein, and describes the best mode contemplated by the inventors for carrying out the invention. However, various modifications will still be apparent to those skilled in the art. These modifications are intended to be within the scope of the present disclosure. Different embodiments or aspects of such embodiments may be shown in the various figures and described throughout the specification. However, each embodiment and aspect thereof shown or described alone may also be combined with one or more of the other embodiments and aspects thereof, unless expressly stated otherwise. The omission of each combination is solely for the purpose of facilitating the readability of the specification.

[0045] While the present invention has been described in certain specific aspects, many further modifications and variations will be apparent to those skilled in the art. It is therefore to be understood that the present invention may be practiced other than as specifically described, including various changes in size, shape, and materials, without departing from the scope and spirit of the invention. The present embodiments, therefore, are to be considered in all respects as illustrative and not restrictive. [Explanation of symbols]

[0046] 10. Surgical Simulation System 12 Upper penetrable layer 14 Lower penetrable layer 16 Upper fiber layer 18 semi-fiber layer 20 Simulated kidney 22 Simulated Adrenal Gland 24 Simulated ureter 26 Mock aorta 28 Simulated gonadal veins 30 Simulated adrenal veins 32 Simulated lumbar vein 34 Simulated renal vein 36 Simulated renal artery 38 Back fiber layer 40 Second fiber layer 42 Adhesion Blocker 44 Flap 54 holes 56 holes

Claims

1. 1. A renal hilar surgery simulation system, comprising: a first penetrable layer having an upper surface and a lower surface; a second penetrable layer having an upper surface and a lower surface; a plurality of simulated renal vasculature systems disposed between the first penetrable layer and the second penetrable layer, the plurality of simulated renal vasculature systems including a first simulated renal vasculature system and a second simulated renal vasculature system; a connector disposed between the first simulated renal vasculature and the second simulated renal vasculature, the connector configured to dissimilarly resemble an anatomical structure; A system comprising:

2. The system of claim 1 , wherein the connector is formed from the same material as the first simulated renal vasculature and the second simulated renal vasculature.

3. The system of claim 2 , wherein the first simulated renal vasculature and the second simulated renal vasculature are connected to a third simulated renal vasculature.

4. The system of claim 3 , wherein the connectors are disposed between the first simulated renal vasculature, the second simulated renal vasculature, and the third simulated renal vasculature.

5. 1. A renal hilar surgery simulation system, comprising: a first penetrable layer having an upper surface and a lower surface; a second penetrable layer having an upper surface and a lower surface; a plurality of simulated renal vasculature structures disposed between the first and second penetrable layers; an anti-adhesion member disposed between the first penetrable layer and the second penetrable layer and configured to prevent at least one of the plurality of simulated renal vasculature systems from adhering to the second penetrable layer; A system comprising:

6. The system of claim 1 or 5, wherein the plurality of simulated renal vasculatures includes a simulated adrenal vein and a simulated renal vein.

7. The system of claim 1 or 5, wherein the plurality of simulated renal vasculatures includes a plurality of weakened portions.

8. The system of claim 1 or 5, wherein a periphery of the upper surface of the second penetrable layer is connected to a periphery of the lower surface of the first penetrable layer.

9. 10. The system of claim 1 or 5, further comprising at least one simulated kidney organ positioned adjacent to at least one simulated renal vasculature of the plurality of simulated renal vasculatures.

10. The system of claim 1 or 5, wherein the plurality of simulated renal vasculature systems are adhered to each other at predetermined adhesion regions.

11. The system of claim 10 , wherein the bonding between the plurality of simulated renal vasculature systems is by silicone-to-silicone bonding.

12. The system of claim 1 or 5, wherein at least one of the plurality of simulated renal vasculatures is filled with fluid.

13. The system of claim 1 or 5, wherein at least one of the plurality of simulated renal vasculatures includes at least one notch.

14. The system of claim 1 or 5, wherein at least one of the plurality of simulated renal vasculatures includes a plurality of spaced apart notches.

15. 10. The system of claim 1 or 5, wherein at least one of the plurality of simulated renal vasculature systems includes at least one notch disposed in an upper portion of the at least one simulated renal vasculature system and at least one notch disposed in a lower portion of the at least one simulated renal vasculature system.

16. 6. The system of claim 5, wherein the plurality of simulated renal vasculature systems includes a first simulated renal vasculature system, a second simulated renal vasculature system, and a connector disposed between the first simulated renal vasculature system and the second simulated renal vasculature system and configured to not resemble an anatomical structure.

17. 6. The system of claim 5, wherein the plurality of simulated renal vasculature systems includes a first simulated renal vasculature system and a second simulated renal vasculature system, the first simulated renal vasculature system being tubular and having a thicker wall than the second simulated renal vasculature system.

18. 6. The system of claim 5, wherein the plurality of simulated renal vasculature systems includes a first simulated renal vasculature system and a second simulated renal vasculature system, the first simulated renal vasculature system being minimally adhered to the second simulated renal vasculature system, and the second simulated renal vasculature system being adhered to a fiber layer disposed between the first penetrable layer and the second penetrable layer.

19. 2. The system of claim 1, wherein the first simulated vasculature includes a first tube and the second simulated vasculature includes a second tube, the first tube being smaller and thinner than the second tube.

20. 17. The system of claim 16, further comprising a stand, wherein upper portions of the first and second penetrable layers are attached to the stand, lower portions of the first and second penetrable layers are not attached to the stand and are spaced apart from the stand, and the first and second penetrable layers are inclined relative to the stand.

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