Renal hilar surgery simulation system

Abstract

To provide a renal hilum surgical simulation system.SOLUTION: A renal hilum surgical simulation system includes: multiple penetrable simulated tissue layers; a pocket disposed between the multiple penetrable simulated tissue layers and encased in peripheries of the multiple penetrable simulated tissue layers; multiple fibrous layers disposed between at least one of simulated renal organs and the multiple penetrable simulated tissue layers; and a vasculature disposed between the multiple fibrous layers and enclosed in the pocket. 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 on June 1, 2018, and U.S. Provisional Patent Application No. 62 / 791,450, filed on January 11, 2019, the disclosures of which are hereby incorporated by reference in their entirety.

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

Background Art

[0003] In laparoscopic surgery, it is necessary to form a plurality of small incisions in the abdomen and insert trocars or small cylindrical tubes with a diameter of about 5 - 10 millimeters, through which surgical instruments and a laparoscope are placed into the abdominal cavity. The laparoscope provides an enlarged view of the organs and tissues to the surgeon by illuminating the surgical field and sending an enlarged image from inside the body to a video monitor. The surgeon performs the surgery by observing the live video feed and operating the surgical instruments placed through the trocars.

[0004] Kidney transplantation is the optimal treatment for end-stage renal disease patients, which has increased rapidly in the past decade. Currently, there are 100,000 patients on the kidney transplant list, and many are waiting for kidneys from deceased donors for 5 to 10 years. As a result, living donor nephrectomy has increased, and as a result, minimizing the morbidity and mortality of healthy donors and becoming proficient in removing kidneys in an optimal state for transplantation has become an essential procedure for transplant surgeons. Since then, laparoscopic donor nephrectomy (LDN) has become a preferred surgical approach for reasons including shorter hospital stays, reduced postoperative pain and morbidity, and improved donor satisfaction. However, although laparoscopic surgery has its advantages, the complex surgical tasks associated with it place a heavy burden on the skills of surgeons.

Summary of the Invention

Problems 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 increasing need to train for the LDN procedure, there is a shortage of surgical simulation systems, simulators, or models for simulation training. As a result, trainee doctors are limited to practicing procedures in costly animal and cadaver laboratories or rely on gaining experience through practice on patients in the operating room, which reduces operating room efficiency. To increase the performance of safe surgeries, increase the number of trainee doctors learning LDN, improve the skills of trainee doctors, reduce training costs, and facilitate LDN training, an LDN simulation model that focuses on one or more of the most technically difficult steps in the surgery of renal hilum dissection is desirable and beneficial for shortening the learning curve of transplant trainee doctors and enabling faster proficiency. Also, a model or surgical simulation system focused on LDN enables trainee doctors to practice in a low-risk environment and potentially suppresses the need for animal and cadaver laboratories and related costs.

Means for Solving the Problem

[0006] According to various embodiments of the present invention, a renal hilar surgery simulation system is provided. This surgery simulation system includes a plurality of penetrable simulated tissue layers, a pocket disposed between the plurality of penetrable simulated tissue layers and confined by the peripheral portions 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 vascular system disposed between the plurality of fiber layers and encapsulated 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, the peripheral portion of the upper surface of the second penetrable layer is connected to the peripheral portion 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 defined and confined by the peripheral portions of the first and second penetrable layers connected to each other. 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 vascular system is disposed between the plurality of fiber layers and encapsulated 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, the peripheral portion of the upper surface of the second penetrable layer is connected to the peripheral portion 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 defined and confined by the peripheral portions of the first and second penetrable layers connected to each other. 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 encapsulated 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 peripheral portion of the upper surface of the second penetrable layer is connected to a peripheral portion 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 defined and confined by the peripheral portions of the first and second penetrable layers connected to each other, and in various embodiments, a plurality of fiber layers are disposed between the first and second penetrable layers. In various embodiments, a plurality of simulated renal vascular systems are disposed between the plurality of fiber layers and encapsulated within the pocket, and / or in various embodiments, at least one simulated renal organ is disposed between the plurality of fiber layers and encapsulated within the pocket.

[0010] According to various embodiments, a hilar surgery simulation system including a simulated renal vasculature and / or a simulated kidney organ is provided. In various embodiments, a hilar surgery simulation system including at least one fiber layer, such as batting for example, is provided. In various embodiments, a hilar surgery simulation system or a hilar laparoscopic donor nephrectomy simulation system is provided. In various embodiments, a surgery simulation system including a simulated vasculature, a simulated organ, a simulated renal vasculature, a simulated kidney organ, and / or any combination and / or individual thereof 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 peripheral portion of the upper surface of the second penetrable layer is connected to a peripheral portion 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 defined and confined by a peripheral portion of the first and second penetrable layers connected to each other. In various embodiments, an 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, a 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, an intermediate fiber layer has an upper surface and a lower surface, and in various embodiments, is disposed between the upper fiber layer and the lower fiber layer. 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 intermediate 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 intermediate fiber layer. In various embodiments, the upper fiber layer, the lower fiber layer, and the intermediate fiber layer, and the first and second simulated renal vasculatures are enclosed within the pocket.

[0011] Many of the accompanying features of the present invention will become readily apparent as the present invention becomes better understood by reference to the accompanying drawings, in which like reference numerals refer to like parts throughout the above and following description.

[0012] The present invention can be understood by reference to the following description which is made in connection with the accompanying drawings that specify parts with the same reference numbers throughout.

Brief Description of the Drawings

[0013]

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Embodiments for Carrying Out the Invention

[0014] In the LDN procedure, hilar dissection is one of the high-risk steps with high difficulty due to the need to mobilize multiple important structures. Currently, the needs for a simulation model or surgical simulation system where trainee surgeons can practice improving in this surgical step are not met. A hilar simulation model or surgical simulation system shortens the learning curve by enabling trainee surgeons to repeatedly practice the required dissection in a low-risk environment. For a surgical simulation system to be effective, it should enable complete dissection of specific structures within the hilum from a laparoscopic approach, and include one or more of the simulated biological 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 distinguishable within the model or surgical simulation system. These structures should be anatomically accurate and / or formed of materials with similar simulated tissue reactions encountered in the LDN procedure. Also, these structures can be surrounded by appropriately dense simulated dissectible areolar tissue to provide realistic tactile feedback. Practice in this surgical simulation system can facilitate the identification of appropriate biological structures and the acquisition of appropriate tissue handling and dissection skills required for the procedure.

[0015] In a hilar surgery simulation system according to various embodiments, a trainee doctor can focus on the skills necessary to practice the most difficult steps within the LDN procedure. To provide a realistic procedure training environment, in various embodiments, the surgical simulation system is appropriately arranged. The surgical simulation system uses a simulation material for representing various anatomical landmarks and a material for simulating an area of incisable tissue that provides important visual and tactile feedback useful for training in the LDN procedure to further enhance the training environment. According to various embodiments, a specific combination of materials, structures, and designs is selected for various components seen within the surgical simulation system to simulate the tactile sensation of anatomical structures encountered during the LDN procedure.

[0016] FIG. 1 is an exploded perspective view of a hilar surgery simulation model or system 10 according to various embodiments of the present invention. The inner contents (anatomical structures and fibers) of the surgical simulation system 10 are enclosed between an upper penetrable layer 12 and a lower penetrable layer 14, which are two silicone layers adhered to each other to form a closed pocket. Within the pocket, there is an upper fiber layer 16, which is the outermost upper layer and is composed of a plurality of layers of sheet-like polyester fibers, such as batting, adhered using a small amount of silicone or adhesive that the surgeon cuts or severs to remove and reach the anatomical structures encountered in the LDN procedure. The incision area composed of a plurality of polyester fiber layers, such as a half-fibrous layer 18 where fibers such as this batting are adhered to each other and to the anatomical simulation structures, is formed to exhibit various densities of biological structures seen within the body. According to various embodiments, one or more of these layers are planar and / or overlap with respect to each other.

[0017] According to various embodiments, a layer of simulated anatomical landmarks is provided. In various embodiments, these simulated anatomical landmarks include the simulated kidney 20, adrenal gland 22, ureter 24, and / or aorta 26. None of these components are to be incised or transected during the simulation procedure, and these landmarks are included in the surgical simulation system 10 to assist the trainee's orientation and / or education. For example, the simulated ureter 24 is to be identified but not touched and is used as a tool to proceed to the location of the gonadal vein 28. The trainee should not contact or manipulate these simulated landmarks, but one or more of these simulated anatomical structures may include one or more visual features such as size, shape, color, and / or any combination thereof to simulate a biological structure and / or to provide an indication to enable 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, resilience, elasticity, and / or any combination thereof to further enhance the identification of the simulated landmarks and / or as an evaluation and / or educational indicator. For example, in various embodiments, one or more of the simulated landmarks retain their shape until incised or overly manipulated, thus reflecting this treatment if inadvertently incised or otherwise overly manipulated, thereby providing an evaluation to the evaluator and / or an educational indicator to the trainee.

[0018] During the simulation procedure, the positions of the simulated gonadal vein 28, adrenal vein 30, and lumbar vein 32 are identified and incised circumferentially or skeletonized. During this skeletonization, the surgeon can lift the vein to cut or incise the fibers or soft tissue. Since the vein is very fragile and will break or rupture if incised or if too much force is applied, this step is one of the most difficult steps in the procedure. Surgeons must understand the need to simulate the force required to manipulate the vein without damaging it during the incision and thus the fragility of the vein in order to become accustomed or proficient in these procedural steps.

[0019] According to various embodiments, the simulated gonadal vein 28, adrenal vein 30, and / or lumbar vein 32 are formed of silicone or silicone foam shaped into a thin flat structure to simulate the various vein fragilities. Note that the gonadal vein, adrenal vein, and lumbar vein found in the human body are hollow cylindrical structures through which blood flows internally and have diameters of 3 mm, 4 mm, and 2 mm, respectively. Thus, according to various embodiments, the simulated gonadal vein 28, adrenal vein 30, and / or lumbar vein 32 are not replicas of the exact biological structures, for example, in terms of size and / or shape, and these simulated veins are provided to assist in the manufacturing process and reproduce the tactile sensation of the corresponding structures, for example, in the selection of materials such as size and / or shape and silicone.

[0020] In various embodiments, as shown in FIG. 2, the simulated gonadal vein, adrenal vein, and lumbar veins 28, 30, 32 include one or more incisions or notches 50 at predetermined positions along their lengths. These predetermined notches 50 form weak or break points at specific locations, enabling the simulated blood vessels to simulate the vulnerability of such blood vessels. Also, in various embodiments, when excessive force or manipulation is applied to the simulated vein, the simulated vein separates at one or more notches 50. The separated or severed blood vessel can provide an evaluation and / or educational metric for a particular execution of the simulated procedure or for the training physician during such an execution. Further, the location where a break occurs, as indicated at a particular notch or weak point, also serves to provide a more detailed evaluation and / or educational metric regarding the force or manipulation applied to the severed simulated blood vessel. However, simulated blood vessels with predetermined notches may also impede the evaluation of the simulated blood vessel after the execution of the procedure, for example, when it becomes difficult to distinguish new notches from old or pre - incorporated notches. Thus, pre - determining the location and / or size of the notch or weak point can help reduce or eliminate this inhibition.

[0021] In various embodiments, the simulated lumbar vein within the surgical simulation system is in a tensioned state. In various embodiments, the simulated lumbar vein is pulled taut and attached to the back side of the model or surgical simulation system to be in a tensioned state. By arranging the simulated lumbar vein in a tensioned state, it can be made to break when the simulated vein or a part thereof is damaged or overly strongly pulled during a circumferential incision. Since the amount of force used for the simulated blood vessel to break is similar to the amount of force that similarly affects the non - simulated lumbar vein, this snapping simulates or represents the vulnerability of the 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 renal artery 36 are separated (i.e., skeletonized) from surrounding fibers or packing during the simulation procedure. The simulated renal vein 34 and renal artery 36 have diameters (about 1.2 cm and 6 mm respectively) that are much larger than the diameters of the simulated gonadal vein, adrenal vein, and lumbar vein 28, 30, 32 to provide them with a higher integrity and / or strength so as to simulate their tactile differences.

[0023] Referring to FIG. 3, according to various embodiments, the illustrated simulated renal artery 36 has a smaller overall diameter but a thicker wall compared to 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 of silicone, and in various embodiments, the simulated renal artery includes a thick silicone layer that results in a thick wall of the simulated blood vessel. In various embodiments, the silicone layer is thickened by applying a plurality of thin wet or dry silicone layers or membranes. As a result of the thickened wall, it becomes difficult to penetrate the blood vessel, 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 thin silicone layer that results in a thin wall thickness. As a result, it is easier to puncture or create incisions in blood vessels such as the simulated renal vein, for example.

[0024] Contrasting the structural consistency of the renal vein and renal artery, the tactile forces that can circumferentially incise around these structures without puncturing or otherwise unduly disturbing each structure during the simulation procedure are different for each blood vessel, so simulation and / or training and / or evaluation metrics are further provided or enhanced. In various embodiments, the wall of the thinner renal vein 34 is fragile and / or is formed of a layer of thinner material. In contrast, in various embodiments, the simulated renal artery 36 is formed of one or more layers of thicker material. Both blood vessels are formed or molded of a material that includes silicone and / or a similar fragile conductive material that retains its shape.

[0025] In various embodiments, to further mimic a biological structure and / or for evaluation or training metrics, the simulated renal vein 34 and / or the renal artery 36 are filled with a fluid such as water. For example, if any of the vasculature is punctured, fluid flowing out or leaking from the simulated vessel can serve as a visual metric of the punctured vasculature and potentially indicate further training or low proficiency of the trainee physician.

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

[0027] FIGS. 5A-5B show a second vascular subassembly according to various embodiments. As shown, the simulated renal artery 36 is attached or otherwise affixed to the simulated aorta 26 by silicone-to-silicone adhesion and, in various embodiments, using a silicone of a consistent hardness durometer. In various embodiments, wet silicone is used as an adhesive and can cure to solidify the connection. The aorta adhesion region 52 is indicated by the 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, FIG. 6 shows the back fibrous layer 38. In various embodiments, the back fibrous layer 38 is formed of or includes batting. In various embodiments, the back fibrous layer is a layer of substantially planar rectangular polyfill or other fibrous material. The back fibrous layer 38 includes a hole or opening 54 through which the lumbar vein 32 passes. The opening 54 is specific to the surgical simulation system 10 and is not anatomically accurate. As shown in FIG. 7, a second vascular sub-assembly including the renal artery 36 and the aorta 26 is adhered to the back or first fibrous layer 38 using an adhesive. The adhesion region 52 is shown to be substantially below the entire second sub-assembly.

[0029] Referring now to FIG. 8, according to various embodiments, a second fibrous layer 40 is adhered to the simulated renal artery 36 and aorta 26 of the second vascular sub-assembly. The second fibrous layer 40 is formed of or includes batting. In various embodiments, the second fibrous layer is a layer of rectangular substantially planar polyfill or other fibrous material. The second fibrous layer 40 is also adhered to the back or first fibrous layer 38 using an adhesion region 52 indicated by a large rectangle. The second fibrous layer 40 also includes a hole or aperture 56 that passes from the top surface to the bottom surface of the second fibrous layer 40. The simulated lumbar vein 32 passes through this hole 56 and the hole 54 in the back fibrous layer 38, and thus the holes 54, 56 are aligned when the layers are stacked such that the peripheries of these layers substantially coincide and fit within the pocket. Referring now to FIG. 9, as shown in FIG. 9 where the adhesion region 52 is indicated by three rectangles, a first vascular assembly including the simulated gonadal vein 28, adrenal vein 30, lumbar vein 32, and renal vein 34 is adhered to the second fibrous layer 40 using an adhesion region 52 that is below the renal vein 34, adrenal vein 30, and gonadal vein 28. The simulated lumbar vein 32 passes through the holes 56 and 54 in the fibrous layers 40, 38.

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

[0031] Next, referring to FIG. 11, the semi - fiber layer 18 is adhered to the simulated kidney 20, the simulated adrenal gland 22, the adrenal vein 30, the renal vein 34, and the second fiber layer 40. The adhesion region 52 is indicated by a substantially completely lower rectangle of the semi - fiber layer 18. The semi - fiber layer 18 is provided to simulate a high - density cut - able hydrophobic connective tissue as seen within a patient. In various embodiments, the semi - fiber layer 18 is formed by, for example, cutting a large piece of fibrous material such as cotton batting longitudinally in half, pulling apart the layers of cotton batting to form thin slices, and adding them to the density of the cut - able tissue. According to various embodiments, these fibers or fibrous materials enclose and surround one or two or more, or all, of the simulated anatomical structures. For example, multiple layers of fibrous materials such as cotton batting provide cut - able materials of various densities through which a surgeon needs to cut through. As described above, the simulated lumbar vein 32 passes through the holes 54, 56 of the fiber layers 38, 40. As shown in FIG. 12, when the back surface of the surgical simulation system 10 is turned upwards, the simulated lumbar vein 32 penetrates through the holes 54, 56 and is exposed on the back surface.

[0032] Referring to FIGS. 12-13, the surgeon must incise circumferentially around the renal vein 34. According to various embodiments, the contents of the surgical simulation system 10 are encapsulated between an upper silicone layer 12 and a lower silicone layer 14. In various embodiments, the lower silicone layer 14 of the surgical simulation system 10 is composed of uncured silicone and, when cured together with the upper fiber layer 16, the outer boundary is adhered to the upper fiber layer 16 to form a pocket, and all components are held and arranged within the pocket. During the manufacture of the assembly, since the lower silicone layer 14 of the silicone is uncured, the back fiber layer 38 is also adhered to the wet silicone. If the back fiber layer 38 is saturated with uncured silicone, there is a risk of preventing the surgical trainee from incising circumferentially around the renal artery during the simulated LDN procedure by starting to adhere the simulated renal artery 36 and the aorta 26 to the lower silicone layer 14. To prevent or suppress this undesirable adhesion, as shown in FIG. 13 where the boundary of the incision area 60 is defined by an ellipse, an adhesion blocker 42 is used to ensure that the area around the simulated renal artery 36 can be incised circumferentially. In various embodiments, the adhesion blocker 42 is formed of a silicone sheet, shaped approximately to the thickness of the lower silicone layer 14, and cut to the size of the renal artery 36 to prevent any undesirable adhesion. In various embodiments, since the lumbar vein 32 is ultimately adhered to the back lower silicone layer 14 of the surgical simulation system 10, the adhesion blocker 42 is arranged or used so as not to interfere with the lumbar vein 32. In various embodiments, the adhesion blocker 42 is adhered to the back fiber layer 38, which is shown by, for example, a rectangular adhesion area, without applying excessive force to prevent adhesion of the simulated renal artery 36 or the aorta 26 by impregnating a fibrous material, such as batting.

[0033] Referring to FIG. 14, in various embodiments, the simulated lumbar vein 32 is adhered to the simulated renal vein 34 and then adhered to the lower silicone layer 14 through the second fiber layer 40 and the back fiber layer 38. According to various embodiments, the lumbar vein 32 is adhered to the lower silicone layer 14 while the model or surgical simulation system is disposed on the uncured lower silicone layer 14. When the lower silicone layer 14 cures, the contact between the lumbar vein 32 and the uncured lower silicone layer 14 forms the necessary adhesion. In various other embodiments, the lumbar vein 32 is adhered to the second fiber layer 40 and the back fiber layer 38 at the respective holes 56, 54.

[0034] In various embodiments, these layers are adhered to each other by twisting the surrounding fiber layers within the surgical simulation system, holding the simulated structure in place regardless of the use of silicone or a silicone adhesive.

[0035] In various embodiments, the fibers of the fiber layer such as batting mesh with each other to form a knit matrix, and / or a slight adhesion between the batting and the silicone is formed when separating the silicone components. Thus, the tissue (e.g., batting) is sufficiently adhered to the organ (e.g., silicone) that the surgeon incises through during the simulation procedure. Such a knit matrix can also avoid or reduce the use of a silicone adhesive layer that can produce residues that are difficult or undesirable to control throughout the surgical simulation system.

[0036] Referring to FIGS. 15 and 16, in various embodiments, the simulated ureter 24 and gonadal vein 28 are visible through the boundary / periphery 62 of the surgical simulation system 10 to ensure discrimination between the simulated ureter 24 and gonadal vein 28. According to various embodiments, the boundary / periphery 62 is formed by the upper silicone layer 12 adhering to the lower silicone layer 14 to form a pocket 64. The simulated ureter 24 and gonadal vein 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 regarding the location where the surgeon should initiate the incision of the surgical simulation system 10. To enable these landmarks to be visible through the boundary 62, the simulated ureter 24 and gonadal vein 28 extend outwardly into the boundary past the fiber layer, which is emphasized by the circle 63 in FIGS. 15-16. In various other embodiments, to enable the visibility of the landmarks through the upper silicone layer 12, the color and / or opacity of the upper silicone layer 12 is made prominent with respect to the simulated ureter 24 and gonadal vein 28.

[0037] Referring to FIGS. 17-19, according to various embodiments, the renal hilar incision surgical simulation model 10 can include two or more holes along the boundary 62 for attachment to a stand 66 having a base 68 and at least two upright posts 70 extending upwardly from the base 68. The posts 70 pass through the holes in the boundary 62. Thereafter, the stand 66 including the surgical simulation system model 10 can be placed within the cavity of the laparoscopic trainer 72 to initiate practice of the procedure. The trainer defines a cavity between a top cover and a base. This cavity is hidden from the direct view of the trainee, and a scope is inserted through the top cover to capture a live video feed of the cavity, which is displayed on a monitor for the trainee. The trainee or trainer inserts various instruments through the top cover and performs simulated procedures 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 accommodates one or more holes or apertures at each of the two upper corners of the boundary 62. These holes interconnect with the posts 70. In various embodiments, the stand 66 includes four posts 70. In various embodiments, the boundary 62 is formed of an elastic silicone material that stretches and returns to its original shape, and the holes in the boundary conform to the posts 70 after stretching and then return to a tightened state 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, in combination with the tilted posture of the flap 44, allows the surgical simulation system 10 to be positioned at various angles relative to the base 68, which may be necessary to complete the simulated procedure. In various embodiments, clips 74 within the trainer 72 are used to pull and / or hold the surgical simulation system in an upright position to stabilize the upper corners of the surgical simulation system 10. According to various embodiments, a stand or stabilizing structure and / or similar fixtures for the surgical simulation system and / or trainer can keep the surgical simulation system stably maintained in a tilted posture for the simulated surgical procedure.

[0038] In various embodiments, to reproduce or simulate the posture of a tilted patient, a surgical simulation system includes a frame that supports, suspends, and / or tilts the surgical simulation system, and such a frame is integrated or embedded therein. The surgical simulation system is removably attached to the frame, and in various embodiments, the frame is removably attached to a surgical training machine. In such embodiments, the aperture within the boundary and / or the additional portion provided by the boundary can be removed together with the flap, the fixture, and / or the flap provided by the surgical simulation system that provides the boundary, the associated fixture, and / or the additional portion.

[0039] During the LDN procedure, the patient is lying on their side, slightly tilted backward. The nephrectomy simulation system 10 according to various embodiments incorporates a flap 44 designed to be used as a support base to reproduce or simulate the patient's tilted posture. The loop side of a hook-and-loop fastener 46, such as VELCRO®, is adhered to the flap 44 and configured to engage with the opposite or hook side of the hook-and-loop fastener 46 disposed on the bottom surface of the training machine 72. The flap 44 extends from the bottom side of the surgical simulation system 10 and is constructed of a soft, flexible, and durable silicone that allows for bending while maintaining its structural integrity in various embodiments. In various embodiments, the flexibility of the flap 44 enables the two elements of the hook-and-loop fastener 46 to engage while forming a bent stand that holds the surgical simulation system at a desired angle and posture within the laparoscopic training machine 72. The flap 44 is used with the stand 66 or alone. The attachment of the flap 44 to the floor of the training machine can be varied, and in various embodiments, the hook-and-loop fastener can be replaced by, for example, one or more snaps, magnets, struts, or clips, or can further include these, and / or penetrate an intermediate component such as an extension of the base 68 between the fixture / surgical simulation system and the floor of the training machine, or can be attached or adhered to such an intermediate component. The fixture of the surgical simulation system can enable the surgical simulation system to be removable, thus facilitating the replacement, repositioning, or reorientation of the surgical simulation system. The attachment or placement of various parts of the surgical simulation system to such a training machine ensures that the orientation or tilted posture of the surgical simulation system can accurately reproduce the patient's orientation or position, and in various embodiments, ensures that the tactile feedback, flexibility, or other features provided by the surgical simulation system are not sacrificed and / or the simulated LDN procedure is not impaired.

[0040] In various embodiments, other variations of the surgical simulation system 10 can include changes to the anatomical structures within the pocket to include abnormalities, diseases, or various biological structures. Such biological structures can include the right renal hilum, or can include additional lumbar veins and / or tumor inclusions. In other embodiments, the surgical simulation system 10 is immersed or impregnated in water or other liquid so as to better represent the patient's environment. For example, a fiber layer or batting layer tends to increase in density and adhesiveness when saturated with liquid. In various embodiments, this can accurately represent the difficulty of the LDN procedure with high applicability. 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 the various parts and components are provided to vary the difficulty of the surgical simulation system, thereby varying the simulated surgical procedure to enhance the evaluation of surgical training and surgical skills. Such examples are described throughout this specification and set forth in the claims, which may seem arbitrary but are nonetheless included or excluded to vary and adjust the difficulty of the surgical simulation system and enhance the evaluation of surgical training and skills. Some of these examples can include changes in fiber layer density, exaggeration or underrepresentation of the simulated renal vasculature and / or organ shape, dimensions, and / or tactile response, saturation of the fiber layer with liquid, formation of a simulated vascular system pathway such as a simulated renal vasculature passed or penetrated through at least one opening of one or two or more different fiber layers, and / or changes in the coloring and / or composition of the simulated renal vasculature, organs, and / or surrounding structures.

[0042] In various embodiments, both sides or layers of the surgical simulation system are penetrable so that, for example, in the event of incorrect handling or manipulation of the simulated tissue, such as excessive force, a significant stab wound or hole can be seen on the opposite side of the surgical simulation system, thus enabling the assurance or further evaluation of surgical skills. Similarly, the thickness or distance between the layers is minimal, for example, just the length or width of a pocket contained within the surgical simulation system or its interior, so as to further test or enhance the evaluation of surgical skills or the effective operation of the simulated surgical procedure.

[0043] In various embodiments, the surgical simulation system is thus constrained to limit the workspace available for the simulation of the 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. Also, to enhance the portability of the surgical simulation system, to strengthen the operations within a trainer such as a portable laparoscope trainer, and / or to further align the focus of the surgical trainee to a specific simulated procedure, the number and / or size of the components, and combinations thereof, are further restricted. Similarly, to enhance the surgical simulation system, features may be omitted, or the size or shape reduced, even if they may not be anatomically accurate, for example, to increase the difficulty or focus on a specific simulated surgical procedure. In various embodiments, the surgical simulation system includes at least one simulated renal vascular system, such as, for example, the 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, for example, the adrenal gland, kidney, and / or the like and / or other organs / glands shown herein.

[0044] The foregoing description has been presented to enable one of ordinary skill in the art to make and use one or more surgical simulation systems and to perform the methods described herein, and to describe the best mode contemplated by the inventors of carrying out the invention. However, various modifications will still be apparent to those of ordinary skill in the art. These modifications are intended to be included within the scope of this disclosure. The various figures may show different embodiments or aspects of such embodiments and may be described throughout this specification. However, each embodiment and aspect shown or described separately may be combined with one or more of the other embodiments and aspects, unless otherwise explicitly stated. The failure to explicitly state each combination is for the sole purpose of facilitating the readability of this specification.

[0045] Although the invention has been described in some specific aspects, many further modifications and variations will be apparent to those of ordinary skill in the art. Accordingly, it is to be understood that the invention can be practiced in other forms than those specifically described, including various changes in size, shape, and materials, without departing from the scope and spirit of the invention. Accordingly, the embodiments of the invention are to be regarded as illustrative in all aspects and not restrictive.

Explanation of Reference Numerals

[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 Simulated aorta 28 Simulated gonadal vein 30 Simulated adrenal vein 32 Simulated lumbar vein 34 Simulated renal vein 36 Simulated renal artery 38 Back fiber layer 40 Second fiber layer 42 Adhesion blocker 44 flaps 54 holes 56 holes

Claims

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 vascular systems disposed between the first penetrable layer and the second penetrable layer, wherein the tissue around the plurality of simulated renal vascular systems is configured to be incised and removed in the circumferential direction; and at least one of the plurality of simulated renal vascular systems is configured to have a certain degree of vulnerability by cutting when a part of the at least one simulated renal vascular system is damaged or overly stretched during circumferential incision. The system.

2. The system according to claim 1, wherein the degree of vulnerability of the at least one simulated renal vascular system is provided by disposing the at least one simulated renal vascular system in a tension state.

3. The system according to claim 2, wherein the tension is provided by pulling the at least one simulated renal vascular system and attaching at least a part of the at least one simulated renal vascular system to a part of the system.

4. The system according to claim 1, further comprising a plurality of fiber layers disposed between the first penetrable layer and the second penetrable layer.

5. The system according to claim 4, wherein the plurality of simulated renal vascular systems are disposed between the plurality of fiber layers and are configured to be separated from the plurality of fiber layers.

6. The system according to claim 2, wherein the amount of force associated with cutting the at least one simulated renal vascular system disposed in the tension state simulates the amount of corresponding force for cutting a corresponding non-simulated renal vascular system.

7. The system according to claim 1, further comprising one or more notches disposed in the at least one simulated renal vascular system, wherein the one or more notches are configured to provide a predetermined position along the at least one simulated renal vascular system where separation occurs when the at least one simulated renal vascular system is overly stretched.

8. The system according to claim 1, 2 or 3, wherein the degree of vulnerability of the at least one simulated renal vascular system is provided by a predetermined wall thickness of the at least one simulated renal vascular system.

9. The system according to claim 1, wherein the plurality of simulated renal vascular systems include a simulated renal vein configured to be more easily penetrated than a simulated renal artery.

10. 10. The system of claim 9, wherein the simulated renal artery has an overall diameter and a wall thickness, and the simulated renal vein has an overall diameter greater than the overall diameter of the simulated renal artery and a wall thickness less than the wall thickness of the simulated renal artery.

11. The system of claim 9 , wherein the simulated renal artery comprises more layers of silicone than the simulated renal vein.

12. The system of claim 9 , wherein the simulated renal artery and the simulated renal vein have a diameter greater than a diameter of any of the plurality of simulated renal vasculatures.

13. The system of claim 12 , wherein the simulated renal artery and the simulated renal vein comprise a conductive material.

14. 2. The system of claim 1, wherein the plurality of simulated renal vasculature systems includes two or more subsets of renal vessels each having a different vulnerability compared to each other, and the two or more subsets of renal vessels correspond to different types of non-simulated renal vasculature.

15. The system of claim 1 , wherein the plurality of simulated renal vasculatures are formed and molded from silicone.

16. Further comprising a plurality of fiber layers disposed between the first and second penetrable layers; the plurality of simulated renal vasculature systems are disposed between the plurality of fiber layers; The plurality of fiber layers are a first fibrous layer coupled to a lower surface of the first penetrable layer; a second fibrous layer connected to the first fibrous layer and not connected to the first penetrable layer; the first fibrous layer is disposed between the first penetrable layer and the second fibrous layer and spaces the second fibrous layer from the first penetrable layer; The system of claim 1 .

17. 20. The system of claim 1 or 16, wherein a periphery of an upper surface of the second penetrable layer is connected to a periphery of a lower surface of the first penetrable layer.

18. 20. The system of claim 1 or 16, further comprising at least one simulated kidney organ positioned adjacent to at least one simulated renal vasculature of the plurality of simulated renal vasculatures.

19. 17. The system of any one of claims 4, 5 and 16, wherein one or more of the plurality of fiber layers includes an opening configured to allow at least a portion of the plurality of simulated renal vasculature systems to pass therethrough.

20. 20. The system of claim 1 or 16, wherein the plurality of simulated renal vasculatures are adhered to one another at predetermined adhesion areas.

21. The system according to claim 20, wherein the adhesion between the plurality of simulated renal vascular systems is performed through the adhesion of silicone to silicone.

22. The system according to claim 1 or 16, wherein one or more of the simulated renal vascular systems are filled with a fluid, and the fluid is configured to flow out or leak when one or more of the plurality of simulated renal vascular systems are punctured.

23. An adhesion blocker disposed on the second penetrable layer, the adhesion blocker being configured to prevent adhesion between the plurality of simulated renal vascular systems and the second penetrable layer, further comprising an adhesion blocker. The system according to claim 1 or claim 16.

24. The system according to claim 23, further comprising at least one simulated kidney organ disposed adjacent to at least one simulated renal vascular system of the plurality of simulated renal vascular systems.

25. The system according to claim 24, wherein the adhesion blocker is configured to prevent adhesion between the at least one simulated kidney organ and the second penetrable layer.

26. A connector disposed between a first simulated renal vascular system and a second simulated renal vascular system among the plurality of simulated renal vascular systems, the connector not being similar to an anatomical structure, further comprising a connector. The system according to any one of claims 1, 16 and 23.

27. The system according to claim 26, wherein the connector is removable, and the first simulated renal vascular system and the second simulated renal vascular system are connected to a third simulated renal vascular system.

28. The system according to claim 26, wherein the plurality of simulated renal vascular systems include a simulated adrenal vein and a simulated renal vein.

29. The system according to claim 26, wherein at least one of the plurality of simulated renal vascular systems is weakened to include a plurality of weak points.

30. The system according to claim 26, wherein a peripheral portion of an upper surface of the second penetrable layer is connected to a peripheral portion of a lower surface of the first penetrable layer.

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