Gallbladder model for teaching and practicing surgical procedures

Abstract

To provide an anatomical model for surgical training.SOLUTION: An anatomical model for surgical training has a first layer that mimics the liver and a second layer that includes a simulated gallbladder. A third layer having an inner surface and an outer surface is provided between the first layer and the second layer. The outer surface of the third layer is attached to the first layer at a location around the simulated gallbladder, and the simulated gallbladder is attached to the inner surface of the third layer. A fourth layer is provided covering both the second layer and the simulated gallbladder. It is connectable to the support with the frame embedded in the first layer. This model provides a substantially upright projection image of the simulated gallbladder and liver in a retracted orientation state that is optimal for practicing laparoscopic cholecystectomy when inserted into the simulated insufflation cavity of a laparoscopic training instrument.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This application relates to surgical training tools, and in particular to simulated tissue structures and models for teaching and practicing surgical procedures involving the gallbladder.

[0002] Description of Related Applications This application claims priority to and benefits from U.S. Provisional Patent Application No. 61 / 836,512, filed June 18, 2013, entitled "Gallbladder model," which is incorporated herein by reference in its entirety. [Background technology]

[0003] A common treatment for gallstones and other gallbladder conditions is cholecystectomy, which is the surgical removal of the gallbladder from the liver bed. Laparoscopic cholecystectomy is the most common laparoscopic procedure and has replaced open cholecystectomy as the treatment of gallstones and the first choice for gallbladder inflammation. Laparoscopic cholecystectomy advantageously requires a smaller incision, resulting in less pain, better cosmetic results, faster healing, and fewer complications, such as inflammation and adhesions.

[0004] Laparoscopic cholecystectomy requires several small incisions in the abdomen to allow for the insertion of trocars, or small cylindrical tubes approximately 5 to 10 millimeters in diameter, through which surgical instruments and a laparoscope are placed into the abdominal cavity. The laparoscope illuminates the surgical field and transmits a magnified image from inside the body to a video monitor, which provides the surgeon with a close-up view of the organs and tissues. The surgeon performs the procedure by monitoring the live video feed and manipulating the surgical instruments placed through the trocars.

[0005] In a laparoscopic cholecystectomy, the patient lies supine on the operating table and is anesthetized. A small incision may be made at the umbilicus using a scalpel. A trocar is used to enter the abdominal cavity and expand it by delivering carbon dioxide gas and insufflating the abdominal cavity, thereby creating a working space within the patient's abdominal region. The trocar may include a laparoscope inserted into the abdominal cavity to observe the penetration, insertion, and insufflation of the intra-abdominal space. An additional trocar is inserted into a location below the ribs. Using the laparoscope, the fundus of the gallbladder, which is covered by the peritoneum, is identified and grasped and retracted with a surgical grasper passed through one of the trocars. A second surgical grasper is used to retract the remainder of the gallbladder laterally, exposing the Calot's triangle. The Calot's triangle is the portion of the gallbladder anatomy bounded by the cystic duct, cystic artery, bile duct, and edge of the liver. The surgeon identifies the cystic duct and cystic artery. In this region, the underlying structures are carefully skeletonized from the peritoneum, separating it from both the cystic duct and the cystic artery. A surgical clip applier is introduced into one of the trocars, and clips are fastened to both the cystic duct and the cystic artery in two locations. The cystic duct and the cystic artery are then divided between the two clip placement locations with surgical scissors, freeing the gallbladder for removal. The gallbladder is then separated from the liver bed and removed through one of the trocars. During laparoscopic cholecystectomy, complications can arise due to gallbladder perforation, which can occur when excessive traction occurs during retraction or dissection of the gallbladder from the liver bed or during removal from the abdomen. The outcome of laparoscopic cholecystectomy is greatly influenced by the training, experience, and skill of the surgeon performing the procedure. Residents and surgeons need lifelike, functional, and anatomically accurate models for use with laparoscopic training instruments to learn and practice these surgical techniques.

[0006] Gallbladder models are not only useful for training residents and surgeons in laparoscopic cholecystectomy, but are also desirable for training residents and surgeons in laparoscopic common bile duct exploration. The common bile duct is a tube that connects the liver, gallbladder, and pancreas to the small intestine and delivers fluids to aid in digestion. Common bile duct exploration is a procedure used to determine whether gallstones or other obstructions are blocking the flow of bile from the gallbladder or liver to the intestine. In a laparoscopic common bile duct exploration, the abdominal cavity is approached as in the cholecystectomy described above. The surgeon identifies the common bile duct and makes a small hemi-circumferential incision in the common bile duct. A cholangiography catheter is inserted through one of the trocars into the insufflated abdominal cavity and then into the incision made in the common bile duct. A contrast agent or radiopaque fluid is introduced into the cystic duct and common bile duct, and x-rays are taken to reveal the location of any gallstones in the common bile duct. If gallstones are present, the obstruction will appear as a discontinuity in the flow of contrast agent. The gallstones are then surgically removed. Summary of the Invention [Problem to be solved by the invention]

[0007] To aid in patient postoperative outcomes and recovery, surgeons need a way to practice laparoscopic cholecystectomy and common bile duct exploration from outside the operating room. The training model needs to be anatomically accurate and include all important landmarks normally visible during surgery to provide the surgeon or resident with the most realistic practice possible. [Means for solving the problem]

[0008] According to one aspect of the present invention, an anatomical model for surgical training is provided. The model includes a first layer having an inner surface and an outer surface. The first layer has a thickness defined between the inner surface and the outer surface. The first layer has a first perimeter and is configured to mimic at least a portion of a first anatomical structure. The model includes a second layer having an inner surface and an outer surface. The second layer defines a thickness between the inner surface and the outer surface. The second layer defines a second perimeter and overlies the first layer such that the outer surface of the second layer faces the inner surface of the first layer. The model includes at least one second simulated anatomical structure, the at least one second simulated anatomical structure defining a third perimeter around the at least one simulated anatomical structure. The at least one simulated anatomical structure is coupled to the inner surface of the second layer. The outer surface of the second layer is coupled to the inner surface of the first layer at least partially around the location of the at least one second simulated anatomical structure.

[0009] According to another aspect of the present invention, an anatomical model for surgical training is provided. The model includes an anatomical portion and a support removably connectable to the anatomical portion. The anatomical portion includes at least a first layer with inner and outer surfaces interconnected by a top side, a bottom side, a left side, and a right side. The first layer has a thickness determined between the inner and outer surfaces. The first layer is configured to mimic at least a portion of a liver. The top side of the first layer includes a ridge. The model includes a simulated gallbladder positioned above the ridge location. The model includes a frame connected to at least the first layer. The frame has a first end connected to a second end by a central portion. The first and second ends of the frame are removably connectable to the support to hold the anatomical portion in a substantially upright position. The frame does not extend into the ridge location so that the first layer located at the ridge location can flex relative to the frame.

[0010] According to another aspect of the present invention, an anatomical model for surgical training is provided. The model includes an anatomical portion having a first layer. The first layer has inner and outer surfaces interconnected by a top side, a bottom side, a left side, and a right side. The first layer has a thickness between the inner and outer surfaces. The first layer is configured to mimic at least one anatomical structure. The anatomical portion has a second layer including at least one anatomical structure overlying the first layer. The anatomical portion has a frame with a first end interconnected to the second end by a central portion. At least a portion of the frame is embedded within the first layer with the first and second ends of the frame extending from the first layer. The model includes a support, the first and second ends of the frame being removably connectable to the support to hold the anatomical portion in a substantially upright position relative to a support surface.

[0011] According to another aspect of the present invention, a surgical simulation system is provided. The system includes an anatomical model. The model has an anatomical portion. The anatomical portion has a first layer with inner and outer surfaces interconnected by a top side, a bottom side, a left side, and a right side. The first layer has a thickness defined between the inner and outer surfaces. The first layer is configured to mimic at least one anatomical structure and defines a substantially flattened configuration. The model has a second layer coupled to the inner surface of the first layer and including a plurality of anatomical structures covering the inner surface. A support is connectable to the anatomical portion and configured to hold the anatomical portion in a substantially perpendicular orientation relative to the support surface. The system further includes a surgical training instrument. The surgical training instrument has a base and a top cover, the top cover coupled to and spaced from the base to define a simulated insufflated internal cavity between the top cover and the base. The internal cavity is at least partially obscured from direct observation by a user. The top cover of the surgical training instrument has a hole or a penetrable simulated tissue area. The top cover of the surgical training instrument is tilted at an acute angle relative to a horizontal plane as measured from within the cavity. The anatomical model is positioned within the internal cavity at a distance opposite the acute angle so that the inner surface of the first layer faces the acute angle and the hole or penetrable simulated tissue area.

[0012] According to another aspect of the present invention, an anatomical model for surgical training is provided. The model includes an anatomical portion. The anatomical portion includes a first layer having an inner surface and an outer surface interconnected by a top side, a bottom side, a left side, and a right side. The inner surface is substantially flat, and the first layer has a thickness defined between the inner surface and the outer surface. The first layer is configured to mimic at least a portion of a liver. The top side of the first layer has a ridge. The anatomical portion includes a second layer having an inner surface and an outer surface interconnected by a top side, a bottom side, a left side, and a right side. The second layer overlies the first layer such that the outer surface of the second layer faces the inner surface of the first layer. The outer surface of the second layer is connected to the inner surface of the first layer along at least a portion of the first perimeter. The second layer defines a thickness between the inner surface and the outer surface, the thickness of the second layer being less than the thickness of the first layer. The anatomical portion has a third layer including at least one simulated anatomical structure. The at least one simulated anatomical structure is connected to the inner surface of the second layer. The anatomical portion further has a fourth layer having inner and outer surfaces interconnected by a top side, a bottom side, a left side, and a right side. The fourth layer covers the second and third layers such that the outer surface of the fourth layer faces the inner surface of the second layer and the at least one simulated anatomical structure. The outer surface of the fourth layer is connected to the inner surface of the second layer along at least a portion of the second periphery. The fourth layer defines a thickness between the inner and outer surfaces, the thickness of the fourth layer being less than the thickness of the first layer. The anatomical portion has a frame at least partially embedded within the first layer. The model has a support connectable to the frame to hold the anatomical portion in a substantially upright position.

[0013] According to another aspect of the present invention, a gallbladder model is provided that allows a user to practice open and laparoscopic cholecystectomy and common bile duct exploration. The gallbladder model includes anatomical parts connected to a support. The anatomical parts include a liver layer, a fascia layer, a gallbladder layer, a peritoneum layer, and a frame, which are connected to each other and held in an upright orientation by the support. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a top perspective view of the anatomical model of the present invention. [Figure 2] FIG. 1 is an exploded top perspective view of the anatomical model of the present invention. [Figure 3] FIG. 1 is a side view of the liver layer of the anatomical portion of the anatomical model of the present invention. [Figure 4] FIG. 10 is a partial side view of a prong of a frame of an anatomical portion of the anatomical model of the present invention. [Figure 5] FIG. 1 is a cross-sectional side view of a support for an anatomical portion of the anatomical model of the present invention. [Figure 6] FIG. 1 is a top perspective view of a laparoscopic training instrument for use with the anatomical model of the present invention. [Figure 7] FIG. 1 is a top perspective view of the frame and support of the anatomical model of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0015] Referring now to FIG. 1 , a gallbladder model 10 of the present invention is shown. Gallbladder model 10 has an anatomical portion 12 removably connected to a support 14. The substantially flat anatomical portion 12 is maintained in an upright configuration by the support 14. During a cholecystectomy procedure, as described above in the Background section of this specification, the fundus of the gallbladder is visualized and retracted. In doing so, the remainder of the gallbladder, located anteriorly and below the liver of the patient, is exposed and made visible within the cavity during gas exposure, along with Calot's triangle. This retraction elevates a portion of the underside or inferior portion of the right lobe of the liver. With the liver and gallbladder substantially in the patient's X-Z or anterior plane, and with the liver and gallbladder elevated upon retraction substantially in the patient's Y or lateral plane, the gallbladder model 10 of the present invention is a substantial or partial projection of at least a portion of the retracted liver and gallbladder onto the patient's X-Y or lateral plane. Therefore, the gallbladder model 10 represents a substantially planar projection of the retracted liver and gallbladder within the simulated insufflation lumen. Thus, the configuration of the gallbladder model 10 advantageously provides a surgical approach to the simulated gallbladder, which is already in a retracted, vertical orientation when viewed by a user approaching the gallbladder from the location of the umbilicus. The configuration of the gallbladder model 10 also allows for user practice without the need for another user to hold portions of the model in a retracted position with a grasper, and thus the model 10 is advantageously designed for use by one person at a time. Furthermore, only a portion of the liver, specifically the right lobe of the liver, is simulated in the model 10. The entire biliary structure, including the gallbladder, along with the right lobe, is included in the model.

[0016] 2, an exploded view of a gallbladder model 10 is shown having an anatomical portion 12 connected to a support 14. The anatomical portion 12 includes a liver layer 16, a fascia layer 18, a gallbladder layer 20, a peritoneal layer 22, and a frame 24, which are connected to one another. Each layer will now be described in detail.

[0017] Still referring to FIG. 2, the liver layer or first layer 16 is molded from red-dyed silicone or thermoplastic elastomer and is configured to mimic a retracted portion of a liver. Specifically, the liver layer 16 is shaped to represent a portion of the right lobe of a human liver retracted to expose the gallbladder and Calot's triangle. Referring to FIG. 3, the liver layer 16 has a flat, planar inner surface 26 and a convexly curved outer surface 28. The inner and outer surfaces 26, 28 are interconnected along four sides: a curved top side, a straight bottom side, and left and right sides, which interconnect the top and bottom sides. The curved top side has a ridge 30 near or at the left side of the model. The top side curves downward from the ridge 30 to a lower portion interconnected to the right side. This ridged shape resembles a substantially planar projection of a retracted right lobe of a human liver. The ridges 30 have a longer length relative to the rest of the liver layer 16. The thickest portion of the liver layer 16 is approximately 0.5 inches (12.7 mm) and is located approximately midway. In one form, as shown in FIG. 3, the frame 24 is molded directly into the liver layer 16 such that at least a portion of the frame 24 is located inside the liver layer 16 and a portion of the frame 24 is located outside the liver layer 16. The frame 24 is described in more detail below.

[0018] Still referring to FIG. 2 , the fascia layer or second layer 18 is a thin, approximately 0.01-0.03 inch (0.254-0.762 mm) thick layer made of a thermoplastic elastomer or silicone that is partially translucent, transparent, or tinted a slight yellow. The fascia layer 18 has the same convex shape as the liver layer 16 and is sized and shaped to cover the liver layer 16. The fascia layer 18 has an inner and outer surface, and the outer surface covers a portion of the inner surface 26 of the liver 16. The fascia layer 18 is attached to the liver layer 16 with an adhesive that is disposed at least along the periphery, such that the middle portion of the fascia layer 18 or the majority of the portion of the fascia layer 18 that is inwardly of the periphery is not attached to the liver layer 16 but instead is free to move and separate from the liver layer 16. This fascial layer 18 does not exist in reality, i.e., there is no tissue layer between the gallbladder and the liver, and the gallbladder model 10 of the present invention advantageously includes a fascial layer 18 that mimics the dissection and removal of the gallbladder from the liver, the advantages of which are described in more detail below.

[0019] Still referring to FIG. 2 , the gallbladder layer or third layer 20 has at least one body component. In FIG. 2 , the at least one body component is a plurality of anatomical structures. For example, the gallbladder layer 20 includes a body wall 32 connected to a cystic duct 34, a common hepatic duct 36 connected to a common bile duct 38, a cystic artery 40, and a common hepatic artery 42 connected to and branching into a right hepatic artery 44 and a left hepatic artery 46. All of these anatomical structures are configured to mimic actual human anatomy and are positioned in an anatomically accurate manner within the gallbladder layer 20. The gallbladder 32 is a hollow, spherical structure molded from silicone or other thermoplastic material dyed a light green or yellow color to simulate bile. In another embodiment, the gallbladder 32 is a solid, solid structure. The cystic duct 34, common hepatic duct 36, and common bile duct 38 are also made from silicone or thermoplastic material dyed a light green color. The cystic duct 34 is tubular in shape, has a tapered end, and has a diameter of approximately 0.15 to 0.25 inches (3.81 to 6.35 mm). In one embodiment, the gallbladder 34 has a lumen with a minimum inner diameter of 0.15 inches (3.81 mm) and a maximum outer diameter of 0.25 inches (6.35 mm), making the lumen small enough to clip it but large enough to allow insertion of a catheter. In yet another embodiment, the cystic duct 34 has a lumen with an inner surface that is lubricated with a lubricant. In yet another embodiment, the cystic duct 34 has an outer diameter larger than the actual size of the cystic duct 34 to facilitate training and insertion of a catheter into the lumen. The common hepatic duct 36 and the common bile duct 38 are also tubular in shape and have a diameter of approximately 0.15 inches (3.81 mm). In one embodiment, the cystic duct 34, common hepatic duct 36, and common bile duct 38 are hollow; in another embodiment, they are solid. The cystic artery 40, common hepatic artery 42, right hepatic artery 44, and left hepatic artery 46 are made of silicone or thermoplastic material that is stained red and molded into a tubular shape having a diameter of approximately 0.15 inches (3.81 mm). In one embodiment, the cystic artery 40, common hepatic artery 42, right hepatic artery 44, and left hepatic artery 46 are hollow; in another embodiment, they are solid structures. The gallbladder layer 20 is connected to the fascia layer 18 by a selectively placed adhesive.The gallbladder layer 20 may be formed of multiple pieces joined together or may be formed as a unit without discontinuities. To form the one-piece gallbladder layer 20, the manufacturing process involves dipping a wax former into molten plastic and melting it out once the plastic has hardened.

[0020] In one embodiment, the gallbladder model 10 is configured for practicing bile duct exploration. In this embodiment, the bile duct structures of the gallbladder layer 20 are hollow and filled with a fluid that simulates bile. An exemplary fluid is green-colored dishwashing liquid. The hollow bile duct structures have an inner diameter of approximately 0.09 inches (2.286 mm) and an outer diameter of approximately 0.15 inches (3.81 mm). The gallbladder model 10 configured for bile duct exploration includes a hollow gallbladder 32 filled with a fluid that simulates bile. To prevent loss of simulated bile fluid, the free ends of the cystic duct 34, common hepatic duct 36, and common bile duct 38 are closed or capped with standard tube caps, solid connectors, or barbed connectors that retain the fluid within these ducts. If not molded as a single unit, bile duct structures made of multiple tubular structures are connected to each other by connectors. For example, the junction of the common hepatic duct 36 and the common bile duct 38 is connected to a connector, such as a Y-split, that allows fluid to flow between them. In one embodiment, the cystic duct 34 and the common bile duct 38 are connected by a connector or molded as a single unit, allowing fluid to flow between the cystic duct 34 and the common bile duct 38. The use of a connector is advantageous in that after a training procedure in which the cystic duct and the common bile duct are severed, for example during a cholecystectomy, the severed ducts can be replaced with new ducts reconnected in the same location using the same connector, thereby allowing for repeated training procedures. In a gallbladder model 10 configured for bile duct test dissection, any one or more of the gallbladder 32, bile duct 34, common hepatic duct 36, and common bile duct 38 may include one or more simulated gallstones (not shown). The simulated gallstones are small, bead-like structures made of plastic or other materials. The simulated gallstones are placed within the hollow space of the gallbladder 32 and / or within the lumen of one or more of the cystic duct 34, the common hepatic duct 36, and the common bile duct 38.These simulated gallstones are shaped and configured so that, although they are invisible to the user when the model is received, a syringe and / or catheter can be used to inject simulated contrast fluid, such as colored water, into one or more of these ducts, and the continuous flow of contrast fluid is visually obstructed or blocked by the gallstones as the simulated contrast fluid fills the biliary structures. In another embodiment, a kit is provided that includes a syringe and / or simulated gallstones as a means for injecting fluid into the gallbladder 32. In another embodiment, the gallbladder 32 is not filled with liquid but is filled with air, which can be injected into the open cavity of the gallbladder 32 using a syringe or other similar device. The cavity of the gallbladder 32 can be pressurized to a pressure greater than ambient pressure, causing the gallbladder 32 to visibly deflate, thus providing a visual indication to the trainee, should the gallbladder 32 be inadvertently penetrated by improper surgical technique. In such a configuration, the gallbladder 32 has a wall thickness configured to allow for observation of deflation of the gallbladder 32.

[0021] Still referring to FIG. 2 , the peritoneal or fourth layer 22 is a thin layer approximately 0.01 to 0.03 inches (0.254 to 0.762 mm) thick made of a thermoplastic elastomer or silicone that is transparent or partially translucent and / or tinted a pale yellow. The peritoneal layer 22 is substantially identical to the fascia layer 18 and has the same convex shape as the underlying fascia layer 18 and liver layer 16. The peritoneal layer 22 has an inner and outer surface and covers the gallbladder layer 20 and at least a portion of the inner surface of the second layer 18. In one form, both the fascia layer 18 and the peritoneal layer 22 are each formed by molding liquid silicone onto a layer of foam, such as a layer of packaging foam or other spongy structure, which is then peeled away from the foam after it has hardened, thereby imparting at least one patterned surface to the fascia layer 18 and the peritoneal layer 22. The peritoneal layer 22 is sized and shaped to cover the gallbladder layer 20. The peritoneal layer 22 is attached to the fascia layer 18 with an adhesive, which is positioned where it can directly contact the fascia layer 18 without interference from the intervening gallbladder layer 20. Thus, only some portions of the peritoneal layer 22 are attached to the fascia layer 18; in one form, the peritoneal layer 22 is attached only to the fascia layer 18 and not to the gallbladder layer 20. In another form, some portions of the peritoneal layer 22 are attached to the gallbladder layer 20 as well as some portions of the fascia layer 18. In yet another form, some portions of the peritoneal layer 22 are attached only to some portions of the gallbladder layer 20. These layers are attached to one another by an adhesive or by the inherent adhesiveness of the materials comprising these layers. Essentially, the peritoneal layer 22 is selectively attached to one or more of the underlying gallbladder layer 20 and fascia layer 18 by an adhesive.

[0022] Still referring to FIG. 2 , anatomical portion 12 includes a frame 24 configured to be supported in a substantially upright orientation against a tabletop or other substantially flat surface, including an organ-receiving tray or other surface located within a laparoscopic training simulator. Frame 24 includes a left leg 48 and a right leg 50 interconnected by a central portion 52. Central portion 52 is curved to mimic the overall shape of a chevron with the other layers 16, 18, and 22. Frame 24 is sized smaller than liver layer 16, fascia layer 18, and peritoneum layer 22. Frame 24 is made of a rigid metal, plastic, or other polymer or material capable of and strong enough to support the silicone and plastic layers comprising anatomical portion 12 of model 10 in an upright orientation. The left leg 48 is located at or adjacent to the crest and is approximately 3.5 to 4.0 inches (8.89 to 10.16 cm) long, while the shorter right leg 50 is approximately 2.5 to 3.0 inches (6.35 to 7.62 cm) long. The curved central section 52 is approximately 4.0 to 4.5 inches (10.16 to 11.43 cm) long and follows the curvature of the layers 16, 18, and 22. The overall height of the gallbladder model 10 is approximately 5 to 6 inches (12.7 to 15.24 cm), and the length of the model 10 is approximately 5 to 6 inches (12.7 to 15.24 cm). The left leg 48 has a left prong 54 at its free end, and the right leg 50 has a right prong 56 at its free end. The left prong 54 and the right prong 56 extend beyond the anatomical portion 12 so that they can be inserted into the support 14. The frame 24 is substantially circular in cross section, measuring approximately 0.15 inches (3.81 mm) in diameter, with the prongs 54, 56 having a slightly larger diameter. Each prong 54, 56 has a curved, ball-shaped, spherical, or angle-shaped detent 58, as shown in FIG. 4, which is a cross-sectional view of the left leg 48. The prongs 54, 56 have angle-shaped distal tips. The frame 24 is connected to the anatomical portion 12 so that the prongs 54, 56 protrude from the layers described above so that they can be connected to the support 14.As mentioned above, in one form, the frame 24 is molded directly into the liver layer 16, and the frame is clear or transparent in color or has substantially the same color as the liver layer 16 in which it is embedded so that the frame is not readily visible to the user.

[0023] In another configuration, the frame 24 does not include ridges and is substantially U-shaped. As shown in FIG. 7, the central portion 52 of the frame 24 is straight and does not follow the ridge shape of the other layers 16, 18, and 22. This configuration provides less support to the other layers 16, 18, and 22 at the location of the ridges 30, and advantageously, all of these layers are highly flexible and can be easily pushed distally or proximally relative to the area adjacent to the frame 24, thereby allowing practice of retraction of the liver 16 from the gallbladder 32, while still providing support for the entire model 10 at the support 14. In this configuration, both the right leg 50 and the left leg 48 are the same length, approximately 2.5 to 3.0 inches (6.35 to 7.62 cm), rather than the left leg 48 being longer at the location of the ridges 30. The ridges 30 formed in layers 16, 18, and 22 represent only a portion of the liver, specifically the right lobe of the liver; all of the anatomical structures of the gallbladder layer 20 are shown in model 10.

[0024] 5 , the support 14 is configured to couple to the anatomical portion 12 and hold the anatomical portion 12 in a substantially upright orientation relative to a tabletop or other surface. The support 14 includes a base 60 interconnected with an upright portion 62. The upright portion 62 includes at least two receptacles 64 sized and shaped to receive the prongs 54, 56 of the frame 24. The upright portion 62 also includes a spring-loaded plunger 66 in communication with each receptacle 64. To couple the anatomical portion 12 to the support 14, the prongs 54, 56 are inserted into the receptacles 64 of the support 14. The angled distal tips of the prongs 54, 56 cam against the plunger 66 until they snap into detents 58 on each prong 54, 56, thereby securely locking the anatomical portion 12 to the support 14. The anatomical part 12 can be removed from the support 14 by releasing the plunger 66 from each detent 58 or by pulling with enough force that the detents 58 cam against the plunger 66, moving it out of the way. The anatomical part 12 can be snap-fit ​​into the support 14 or into a receptacle formed as a removable part of a larger anatomical model, organ tray, or laparoscopic training instrument. Any type of interlocking fitting means for connecting the anatomical part 12 to the support 14 is within the scope of the present invention, including left and right prongs 54, 56 that are split and fan outward, as shown in FIG. 7. The prongs 54, 56 are biased further outward and tilted, thereby snapping over and behind the detents in their deflected state, thereby securing the anatomical part 12 to the support 14. To remove the anatomical portion 12, the user squeezes or pinches the split ends of the prongs 54, 56 together under the support 14, thereby allowing the prongs 54, 56 to slide past the detents. The frame 24 and anatomical portion 12 are separated from the support 14.

[0025] The gallbladder model 10 can be used to practice open procedures involving the gallbladder anatomy. The gallbladder model 10 is particularly well-suited for practicing laparoscopic gallbladder procedures. To practice laparoscopic gallbladder procedures, the model 10 is placed within a laparoscopic training device 68, such as the training device 68 shown in FIG. 6 and described in co-pending U.S. patent application Ser. No. 13 / 248,449 (titled "Portable Laparoscopic Trainer"), filed Sep. 29, 2011, by Pravong et al., and assigned to Applied Medical Resources Corporation, and published as U.S. Patent Application Publication No. 2012 / 0082970, which is incorporated herein by reference in its entirety.

[0026] Still referring to FIG. 6 , the laparoscopic training instrument 68 includes a top cover 70 connected to a base 72 by a pair of legs 74 that separate the top cover 70 from the base 72. The laparoscopic training instrument 68 is configured to simulate a patient's torso, e.g., the abdominal region. The top cover 70 represents the anterior aspect of the patient, and the space defined between the top cover 70 and the base 72 represents the patient's interior or body cavity in which the organs are located. The laparoscopic training instrument 68 is a useful tool for teaching, practicing, and / or demonstrating various surgical procedures and their associated instruments in a simulated patient environment. Surgical instruments are inserted into cavities through pre-drilled holes 76 in the top cover 48. These pre-drilled holes 76 may include seals that simulate trocars or may include simulated tissue areas that simulate the patient's skin and abdominal wall. Various tools and methods can be used to penetrate the top cover 70, thereby allowing a life-size procedure to be performed on a model organ, such as the gallbladder model 10, positioned between the top cover 70 and the base 72. When placed within the cavity of the training instrument 68, the gallbladder model 10 is generally obscured from the user's view, and the user can then laparoscopically practice performing a surgical procedure by indirectly observing the surgical site via a video feed displayed on a video monitor 78. The video display monitor 78 is hinged to the top cover 70 and is shown in an open orientation in FIG. 6. The video monitor 78 can be coupled to various vision systems for transmitting images to the monitor 78. For example, a laparoscope inserted through one of the pre-formed holes 76 or a webcam located within the cavity and used to complete the mock procedure can be coupled to the video monitor 78 and / or a mobile computing device to provide images to the user.

[0027] When assembled, the top cover 70 is placed directly over the base 72 with the legs 76 positioned substantially around the periphery and interconnected between the top cover 70 and the base 72. The top cover 70 and the base 72 are of substantially the same shape and size and have substantially the same peripheral contours. The laparoscopic training instrument 68 has the top cover 70 angled relative to the base 72. The legs 52 are configured to allow adjustment of the angle of the top cover 70 relative to the base 72. FIG. 6 shows the training instrument 68 adjusted to an angle of approximately 30-45° relative to the base 72. The selected angle of inclination of the top cover 70 is locked by tightening the thumbscrews on the legs 74. This angle of inclination of the top cover 70 of the training instrument 68 relative to the base 72 is particularly advantageous for receiving the gallbladder model 10 of the present invention.

[0028] With the top cover 70 tilted as shown in FIG. 6 , the gallbladder model 10 is inserted into the cavity of the training device 68 and positioned between the top cover 70 and the base 72. With the gallbladder model 10 inserted into the training device 68, the peritoneal layer 20 faces the front of the training device 68. Specifically, the inner surface of the gallbladder model 10 faces substantially toward the holes or simulated tissue areas 76. The top cover 70 is tilted so that the top cover 70 is positioned between the user and the gallbladder model 10. The user has access through the holes or simulated tissue areas 76 in the top cover 70. The user can insert the top cover 70 into these areas 76 to access the gallbladder model 10 and practice a surgical procedure. Alternatively, a scope can be inserted through one of the holes 76 into the training device cavity between the top cover 70 and the base 72 to capture video images of the hidden gallbladder model 10 and display them to the user on the video monitor 78.

[0029] A user practicing laparoscopic cholecystectomy accesses the gallbladder model 10 within the laparoscopic training instrument 68 by passing other instruments, in addition to a scope, through the cavity of the training instrument 68. Because the model 10 advantageously depicts or mimics a gallbladder in a retracted state, the user does not need to retract the simulated liver using surgical graspers, nor does the user need to have an assistant hold one or more of the graspers to maintain the retracted position. Alternatively, the gallbladder model 10 is designed to be used by a single person.

[0030] To practice laparoscopic cholecystectomy, a user practices identifying Calot's triangle by using the inserted scope and observing images on the monitor 78. After identifying Calot's triangle, the peritoneal layer 22 is incised to access the cystic duct 34 and the cystic artery 40. Advantageously, only selected portions of the peritoneal layer 22 are attached to the underlying layer 18 or layers 18, 20, thereby easily skeletonizing or separating the cystic duct 34 and the cystic artery 40 from the peritoneal layer 22. Also, because portions of the cystic duct 34 and the cystic artery 40, as well as other elements of the gallbladder layer 20, are selectively attached to the underlying layer, they advantageously maintain their anatomical layout and remain relatively mobile, as they would be in vivo. Mobility of elements including the gallbladder layer 20 relative to the liver layer 16 or one or more adjacent fascial or peritoneal layers 18, 22 is advantageously enhanced not only by the mere presence of such layers 18, 22 within the model 10 and the selective attachment of such gallbladder layer elements to one or more of the fascial layer 18 and peritoneal layer 22, but also by the mobility of the underlying fascial layer 18, which is itself selectively attached to the underlying liver layer 16. Selective attachment of one layer to an adjacent layer is achieved due to the application of adhesive to preselected areas and the absence of adhesive in strategic areas of the anatomical structure requiring significant mobility and / or removal relative to the adjacent layer. With respect to the gallbladder 32, the gallbladder 32 is attached to the fascial layer 18 disposed above the liver layer 16. This allows the gallbladder 32 to be removed from the model 10 without damage to the liver layer 16 or minimal damage to the liver layer 16, both of which are realistic consequences of the procedure. The liver is a highly vascular and sensitive structure, and removing the gallbladder without significant liver disturbance is important to the success of the cholecystectomy, and model 10 advantageously allows for such an outcome in practice. Although fascia layer 18 does not exist in reality, it aids in the simulation because, without fascia layer 18, the adhesive would not be able to be dissected in the same manner as real connective tissue between the gallbladder and liver. In one form, the outer surface of peritoneal layer 22 is attached to gallbladder layer 20 with adhesive.In the same configuration, the peritoneal layer 22 is also adhesively attached to the inner surface of the second layer 18 only along at least a portion of its periphery. Also, in the same configuration, the outer surface of the second layer 18 is adhesively attached to the inner surface of the liver layer 16 only along at least a portion of its periphery. As a result of this configuration, pulling on the peritoneal layer 22 results in the gallbladder layer 20 being pulled along with it, resulting in a tenting of the combination of the peritoneal layer 22 and the gallbladder layer 20 relative to the second layer 18 and the liver layer 16, because the peritoneal layer 22 is attached only around its periphery to the second layer 18 and the second layer 18 is attached only around at least a portion of its periphery to the liver layer 16, thereby achieving an effective tenting effect. In a variation of this configuration, the gallbladder 32 is attached to the inner surface of the second layer 30. Pulling the gallbladder layer 20 and / or the peritoneal layer 22 and / or the gallbladder 32 in a direction substantially perpendicular to layers 16, 18, and 22 or away from the liver layer 16 results in further tenting of the second layer 18 relative to the liver layer 16 at the location of the gallbladder 32. Because layers 18 and 22 are extensible and selectively attached as described above, tenting of layers 18, 20, and 22 readily occurs. Therefore, as the peritoneal layer 22 is pulled away from the liver layer 16, a predetermined number of selective attachments result in tenting of the peritoneal layer 22, thereby forming a first gap or pocket between the peritoneal layer 22 and the fascia layer 18. Additionally, a second gap or pocket is formed between the fascia layer 18 and the liver layer 16 because the fascia layer 18 tent-like against the liver layer 16 as the fascia layer 18 is pulled due to the predetermined and selective attachment of the gallbladder 32 to the second layer 18. In this case, the second gap or pocket is smaller than the first gap or pocket when the peritoneal layer 22 is pulled away from the liver layer 16. Additionally, the second layer 18 may be made slightly thicker than the peritoneal layer 22. The peritoneal layer 22 and the second layer 18 are thicker than the liver layer 16.

[0031] Prior to removing the gallbladder 32, the user introduces a surgical clip applier through one of the holes 76 in the training instrument 68 and practices fastening clips to both the cystic duct 34 and the cystic artery 40 at two locations. The vascular and biliary structures are made of a material that allows the simulated tissue structures to function similarly to human anatomical structures, yet is flexible, dissectable, and able to withstand actual clip application from a surgical clip, so that the clip will not cut through these structures when closed against the structures of the gallbladder layer 20. The user then inserts laparoscopic scissors through one of the holes 76 and cuts the cystic duct 34 and the cystic artery 40 between the two clip locations. The gallbladder 32 is then separated from the liver bed and removed through one of the trocars inserted through one of the holes 76. The gallbladder 32 is advantageously attached to the fascia layer 18 and not directly attached to the liver layer 16. The presence of the fascial layer 18 facilitates removal of the gallbladder 32 as described above, thereby providing a location for the incision.

[0032] The gallbladder model 10 is also useful for training residents and surgeons in laparoscopic common bile duct exploration, a procedure used to determine whether gallstones or other obstructions are blocking the flow of bile from the gallbladder or liver to the intestine. To practice this procedure, the gallbladder model 10 is placed in the cavity of a laparoscopic training instrument 68, and the abdominal cavity is approached in a manner similar to that described above for a cholecystectomy, with a scope inserted into one of the holes 76 in the laparoscopic training instrument 68 and the resulting live image displayed on the video monitor 78. The user identifies the common bile duct 38 on the monitor 78. A bladed instrument is introduced into the cavity of the training instrument 68 and a small semicircular incision is made in the common bile duct 38. A cholangiography catheter (not shown), an AEROSTAT® manufactured by Applied Medical Resources Corporation of California, is inserted into the cavity of the laparoscopic training instrument 68 through one of the holes 76 and into the incision made in the common bile duct 38. Instead of a contrast agent or radiopaque fluid, colored water is injected into the distal end of the catheter with a syringe, and the colored water is allowed to flow into the cystic duct 34 and the common bile duct 38. The colored water fills one or more bile duct structures, thereby allowing simulated gallstones to be visualized. Therefore, when training for bile duct exploration, fluoroscopy is not required to identify the presence of gallstones in training procedures using the gallbladder model 10 of the present invention. If a gallstone is present, the obstruction is visible as a discontinuity in the flow of colored water. The user can then practice locating the simulated gallstone at the location of the fluid flow obstruction or color discontinuity. Once the simulated gallstones are located, the user practices removing the gallstones from the hollow bile duct structure.

[0033] The present invention also includes a kit for practicing common bile duct exploration. The kit for common bile duct exploration includes a gallbladder model 10 and a syringe of colored water. The kit may further include a catheter and / or a plurality of simulated gallstones that can be inserted into the bile duct structure of the gallbladder layer 20. The kit may further include replacement portions for any one or more of the tubes 34, 36, 38 and arteries 40, 42, 44, 46 and / or connectors. The replacement tubes have hollow lumens for practicing common bile duct exploration. Other replacement tubes and / or arteries included in the kit are solid diameter structures for replacing tubes and / or arteries previously severed during practice of the previous procedure.

[0034] Although the gallbladder model 10 of the present invention is particularly suited for laparoscopic procedures, the invention is not so limited and the gallbladder model of the present invention can be used equally effectively in open surgical procedures.

[0035] It will be appreciated that various modifications can be made to the embodiments of gallbladder model 10 disclosed herein. Accordingly, the foregoing description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments. Those skilled in the art will recognize other modifications that fall within the scope and spirit of the invention.

Claims

1. An anatomical model (10) for surgical training, comprising: An anatomical portion (12) comprising: a first layer (16) having an inner surface (26) and an outer surface (28) interconnected by a top side, a bottom side, a left side, and a right side, the first layer (16) having a thickness defined between the inner surface (26) and the outer surface (28), the first layer (16) being configured to mimic at least one anatomical structure; a second layer (18) having an inner surface and an outer surface, the second layer (18) covering the first layer (16) such that the outer surface of the second layer (18) faces the inner surface (26) of the first layer (16), the outer surface of the second layer (18) being connected to a selected portion of the periphery of the first layer (16); a third layer (20) including at least one simulated anatomical structure, said third layer (20) being connected to a selected portion of said inner surface of said second layer (18) within the periphery of said first layer (16); The connection of the outer surface of the second layer (18) to a selected portion of the periphery of the first layer (16) and the connection of the third layer (20) to a selected portion of the inner surface of the second layer (18) inside the periphery of the first layer (16) allows each of the first layer (16), the second layer (18), and the third layer (20) to be tented relative to one another.

2. An anatomical model (10) for surgical training, comprising: An anatomical portion (12) comprising: a first layer (16) having an inner surface (26) and an outer surface (28) interconnected by a top side, a bottom side, a left side, and a right side, the first layer (16) having a thickness defined between the inner surface (26) and the outer surface (28), the first layer (16) being configured to mimic at least one anatomical structure; a second layer (18) having an inner surface and an outer surface, the second layer (18) covering the first layer (16) such that the outer surface of the second layer (18) faces the inner surface (26) of the first layer (16), the outer surface of the second layer (18) being connected to a selected portion of the periphery of the first layer (16); a third layer (20) including at least one simulated anatomical structure, said third layer (20) being connected to a selected portion of said inner surface of said second layer (18) within the periphery of said first layer (16); The connection of the outer surface of the second layer to a selected portion of the periphery of the first layer and the connection of the third layer to a selected portion of the inner surface of the second layer inside the periphery of the first layer are arranged such that pulling the second layer and / or the third layer away from the first layer results in the formation of a gap or pocket between the second layer and the first layer.

3. 3. The anatomical model (10) of claim 1 or 2, wherein the first layer (16) mimics at least a portion of a liver and the third layer (20) includes a simulated gallbladder (32).

4. 4. The anatomical model (10) of claim 1, wherein the first layer (16) has a flat, planar inner surface and a convex, curved outer surface, and the first layer (16) is thicker than the second layer (18).

5. 5. The anatomical model (10) of claim 1, further comprising a fourth layer (22) having an inner surface and an outer surface, the fourth layer (22) covering the second layer (18) and the third layer (20) such that the outer surface of the fourth layer (22) faces the second layer (18) and the third layer (20), and the fourth layer (22) is selectively coupled to the second layer (18).

6. 6. The anatomical model (10) of claim 5, wherein the second layer (18) and the fourth layer (22) are planar layers, each having a perimeter that coincides with the perimeter of the first layer (16).

7. 7. The anatomical model (10) of claim 5 or 6, wherein the second layer (18) and the fourth layer (22) mimic a fascial layer and a peritoneal layer, respectively.

8. 8. The anatomical model (10) of any one of claims 1 to 7, further comprising a frame (24) with a first end interconnected to a second end by a central portion.

9. 9. The anatomical model (10) of claim 8, wherein at least a portion of the frame is embedded within the first layer (16), and the first end and the second end of the frame extend from the first layer (16).

10. 10. The anatomical model (10) of claim 8 or 9, wherein the frame has a first leg connected to the first end and a second leg connected to the second end, the first leg and the second leg being parallel.

11. 11. The anatomical model (10) of claim 10, wherein the central portion is disposed between the first leg and the second leg, the central portion being perpendicular to the first leg and the second leg so as to define a U-shaped configuration for the frame.

12. 12. The anatomical model (10) of any one of claims 8 to 11, wherein the first end and the second end extend from the bottom side of the first layer (16).

13. 13. The anatomical model (10) of any one of claims 8 to 12, further comprising a support for holding the anatomical part (12) in an upright position relative to a support surface.

14. 14. The anatomical model (10) of claim 13, wherein the first end and the second end of the frame are removably connectable to the support.

15. 15. The anatomical model (10) of claim 13 or 14, wherein the support comprises a support base interconnected with upright portions, the upright portions having at least two receptacles sized and shaped to receive the first end and the second end.

16. 16. The anatomical model (10) of claim 15, wherein the upstanding portion further comprises a spring-loaded plunger in communication with each of the at least two receptacles.

17. 17. The anatomical model (10) of any one of claims 13 to 16, wherein each of the first end and the second end has a chevron-shaped distal tip and a curved, spherical, or chevron-shaped detent for securely locking the anatomical portion (12) to the support.

18. 18. The anatomical model (10) of any one of claims 1 to 17, wherein the anatomical model (10) is configured to be placed within an internal cavity of a surgical training instrument, the internal cavity being formed between a base and a top cover of the surgical training instrument.

19. 20. The anatomical model (10) of claim 18, wherein the top cover is configured to have holes or penetrable simulated tissue regions, and the top cover is inclined at an acute angle relative to a horizontal plane or the base.

20. 20. The anatomical model (10) of claim 19, wherein the anatomical model (10) is positioned at a distance opposite the acute angle so that the inner surface of the first layer (16) faces the acute angle and the hole or penetrable simulated tissue region.

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