Hysterectomy model

Abstract

To provide a surgical simulator for surgical training.SOLUTION: The simulator includes a frame defining an enclosure, and a simulated tissue model located inside the frame. The simulated tissue model is adapted for practicing a large number of surgical procedures including but not limited to transanal excisions and transvaginal hysterectomies. Portions of the frame comprises a material adhesively compatible with a material of portions of the simulated tissue model so as to secure and suspend the simulated tissue model within the frame. The simulated tissue model may also include simulated vasculature configured to loop through apertures in the frame to secure and suspend the simulated tissue model within the frame.SELECTED DRAWING: Figure 12

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 586,059, filed November 14, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application relates generally to surgical training tools and, in particular, to simulated tissue structures and models for teaching and practicing various surgical operations and procedures, including, but not limited to, those associated with laparoscopic, endoscopic, and minimally invasive surgery. [Background technology]

[0003] Medical students and experienced physicians learning new surgical procedures must undergo extensive training before they are qualified to operate on human patients. This training involves learning the correct techniques for cutting, penetrating, clamping, grasping, stapling, cauterizing, and suturing various tissue types using a variety of medical devices. The range of possibilities that trainees may encounter is wide. For example, different organs and patient anatomies and diseases are presented. The thickness and consistency of various tissue layers also vary from body part to body and from patient to patient. Different procedures require different skills. Furthermore, trainees must hone their skills in a variety of anatomical environments influenced by factors such as the size and condition of the patient, the type of target tissue and adjacent anatomical landscape, and whether these tissues are easily accessible or relatively difficult to access.

[0004] Numerous training aids, trainers, simulators, and model organs are available for one or more aspects of surgical training. However, there is a need for models or simulated tissue elements that are likely to be encountered and can be used to practice endoscopic, laparoscopic, minimally invasive, and transluminal surgical procedures. In laparoscopic surgery, a trocar or cannula is inserted to access a body cavity and create a channel for the insertion of a camera, such as a laparoscope. The camera captures images and provides a live video feed, which are displayed to the surgeon on one or more monitors. At least one additional small incision is made through which another trocar / cannula can be inserted to create a pathway through which surgical instruments can be passed to perform the procedure, which is observed on a monitor. Typically, a target tissue site, such as the abdomen, is insufflated by delivering carbon dioxide gas to expand the body cavity, creating a working space large enough to accommodate the surgeon's scope and instruments. Insufflation pressure within the tissue cavity is maintained through the use of specialized trocars. Laparoscopic surgery offers many advantages over open surgery. These advantages include less pain, less bleeding, and a shorter recovery time due to smaller incisions.

[0005] Laparoscopic or endoscopic minimally invasive surgery requires a higher skill level than open surgery because the clinician does not directly observe the target tissue. The target tissue is viewed on a monitor that displays a portion of the surgical site accessed through a small opening. Therefore, clinicians must practice visually judging tissue planes in a two-dimensional viewing plane, three-dimensional depth perception, manual instrument movement, suturing, precise cutting, and tissue and instrument manipulation. Typically, models simulating specific anatomical structures or procedures are placed in a simulated pelvis trainer, which hides the anatomical model from direct visualization by the practitioner. This trainer uses ports for instrument passage so that skills are honed on the anatomical model hidden from direct visualization. The simulated pelvis trainer provides a functional, inexpensive, and practical means for training surgeons and trainees in basic and representative skills used in laparoscopic surgery, such as grasping, manipulating, cutting, tying knots, suturing, stapling, cauterizing, and performing specialized surgical procedures that utilize these basic skills. The simulated pelvic trainer is also an effective sales tool to demonstrate the medical equipment required to perform these laparoscopic procedures. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Publication No. 2013 / 248,449 Summary of the Invention [Problem to be solved by the invention]

[0007] One type of surgery is a hysterectomy, which involves removing the uterus. A hysterectomy can be performed by extracting the uterus transvaginally through the vaginal canal or transabdominally through a small incision in the abdomen. Vaginal hysterectomies are traditionally difficult to train because of their limited field of view. Unlike laparoscopic surgery, there is no camera to project the procedure onto a screen, and unlike open surgery, there is no large incision that multiple people can view. Therefore, the best way to learn vaginal hysterectomies is through a simulation model. Therefore, a model for training hysterectomies is needed. [Means for solving the problem]

[0008] According to various embodiments of the present invention, a surgical simulator is provided. The surgical simulator includes a frame, the frame including a base and a top cover defining a lumen extending along a longitudinal axis of the frame, the lumen having at least one of a proximal opening and a distal opening, the top cover connected to the base, the base covered with a first material. The surgical simulator further includes at least one artificial tissue construct connected to and suspended within the lumen, the at least one artificial tissue construct having a bottom formed of a second material in direct contact with the first material of the base.

[0009] According to various embodiments, a surgical simulator includes a frame and at least one artificial tissue construct. The frame includes a base, a top wall, and two side walls. The frame defines a lumen extending along a longitudinal axis of the frame, the lumen having at least one of a proximal opening and a distal opening. At least one of the two side walls has a plurality of apertures. The at least one artificial tissue construct is connected to and suspended within the lumen and includes a plurality of simulated vasculatures. At least one of the plurality of simulated vasculatures has a free end extending outward through a first aperture of the plurality of apertures and a second aperture adjacent to the first aperture.

[0010] According to various embodiments, a surgical simulator for surgical training includes a frame including a base, a top wall, and two side walls. The frame defines a lumen extending along a longitudinal axis of the frame, the lumen having at least one of a proximal opening and a distal opening. The surgical simulator further includes an artificial uterus, an artificial vaginal canal having an opening defined at a proximal end and a distal end connected to the artificial uterus, an artificial rectum having a lumen defining a proximal opening, an artificial urinary bladder, and a silicone sheet having a top surface and a bottom surface. In various embodiments, the artificial uterus and artificial bladder are connected to the bottom surface of the silicone sheet, and the artificial vaginal canal and artificial rectum are connected to the top surface of the silicone sheet.

[0011] These and other features of the present invention will become more apparent from the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings.

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

[0013] [Figure 1] 1 is a top perspective view of a surgical training device according to various embodiments of the present invention. [Figure 2] FIG. 1 is a rear perspective view of a surgical simulator or model according to various embodiments of the present invention. [Figure 3] 1 is a top perspective view of a model according to various embodiments of the present invention. FIG. [Figure 4] 1 is a side perspective view of a model according to various embodiments of the present invention. [Figure 5] 1 is a side perspective view of a frame according to various embodiments of the present invention. FIG. [Figure 6] FIG. 1 is a rear perspective view of a frame according to various embodiments of the present invention. [Figure 7] 1 is a front perspective view of a frame according to various embodiments of the present invention. FIG. [Figure 8] 1 is a side perspective view of a base of a frame according to various embodiments of the present invention. FIG. [Figure 9] 1 is a bottom perspective view of a base of a frame according to various embodiments of the present invention. FIG. [Figure 10] 1 is a top perspective view of a top or upper wall portion of a frame according to various embodiments of the present invention. FIG. [Figure 11] 1 is a side view of the top of a frame according to various embodiments of the present invention. FIG. [Figure 12] FIG. 1 is a schematic side view of a hysterectomy model in accordance with various embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] FIG. 1 illustrates a surgical training device 10 configured to mimic a patient's torso, such as the abdomen. The surgical training device 10 provides a body cavity 12, substantially hidden from a user, for receiving simulated or live tissue, or model organs or training models as described herein. Access to the body cavity 12 is achieved through a tissue simulation region 14, which a user using the device penetrates to hone surgical skills on tissue known to be located within the body cavity 12 or on a practice model. While the body cavity 12 is shown as accessible through the tissue simulation region, the body cavity 12 can alternatively be accessed using a hand-assisted access device or a single-site port device. An exemplary surgical training device is described in U.S. patent application Ser. No. 13 / 248,449, filed Sep. 29, 2011, entitled "Portable Laparoscopic Trainer," which is incorporated herein by reference in its entirety. The surgical training device 10 is particularly suited for practicing laparoscopic or other minimally invasive surgical procedures.

[0015] Continuing to refer to FIG. 1 , the surgical training device 10 includes a top cover 16 connected to and spaced from a base 18 by at least one leg 20. Multiple legs 20 are shown in FIG. 1 . The surgical training device 10 is configured to simulate a patient's torso, such as the abdomen. The top cover 16 represents the front of the patient, and the space 12 between the top cover 16 and the base 18 represents the patient's interior or cavity in which organs reside. The surgical trainer 10 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and associated instruments in a simulated patient undergoing a surgical procedure. Surgical instruments are inserted into the cavity 12 through the tissue simulation area 14 and pre-defined apertures 22 in the top cover 16. Various tools and techniques can be used to penetrate the top cover 16 to perform simulated procedures on a simulated organ or training model positioned between the top cover 16 and the base 18. The base 18 includes a model-receiving area 24 or tray for staging or holding a simulated tissue model or living tissue. The model-receiving area 24 of the base 18 includes a frame-like element for holding a model (not shown) in place. Clips attached to the elastic wires are provided at locations 26 to help hold a simulated tissue model or living organ on the base 18. The elastic wires are stretched and then clipped in place to hold the tissue model in position sufficiently below the tissue-simulation area 14. Other tissue model retention means include patches of hook-and-loop fastener (VELCRO®) attached to the model-receiving area 24 of the base 18 for removably connecting to complementary pieces of hook-and-loop fastener (VELCRO®) attached to the model-receiving area 24 of the base 18.

[0016] FIG. 1 shows a video display monitor 28 hinged to the top cover 16 in a closed orientation. The video monitor 28 can be connected to various vision systems to provide images to the monitor. For example, a laparoscope inserted through one of the pre-defined apertures 22, or a webcam positioned within the cavity and used to observe the simulated surgery, can be connected to the video monitor 28 and / or a mobile computing device to provide images to the user. Audio recording or distribution means can also be provided and integrated into the trainer 10 to provide audiovisual capabilities. Means for connecting a portable memory storage device, such as a flash drive, smartphone, digital audio or video player, or other digital mobile device, can also be provided to record the training surgery and / or to play pre-recorded videos on the monitor for demonstration purposes. Naturally, means for providing audiovisual output on a screen larger than the monitor can also be provided. In another variation, the top cover 10 does not include a video display but includes means for connecting to a laptop computer, mobile digital device, or tablet and connecting them to the trainer via wired or wireless connections.

[0017] When assembled, the top cover 16 is positioned directly above the base 18, with the interconnected legs 20 positioned substantially around the periphery between the top cover 16 and the base 18. The top cover 16 and the base 18 are substantially the same shape and size and have substantially the same peripheral contours. The internal cavity is partially or completely hidden from view. In the variation shown in FIG. 1 , the legs include openings that allow as much ambient light as possible to illuminate the internal cavity while advantageously minimizing weight as much as possible for convenient portability. The top cover 16 is detachable from the legs 20, which are also detachable or foldable relative to the base 18 via hinges or the like. Thus, the unassembled trainer 10 has a low height that facilitates easy portability. Essentially, the surgical trainer 10 provides a simulated body cavity 12 that is hidden from the user. The body cavity 12 is configured to receive at least one surgical model accessible through at least one tissue simulation area 14 and / or aperture 22 in the top cover 16, and a user can access the model through the tissue simulation area 14 and / or aperture 22 to practice laparoscopic or endoscopic minimally invasive surgical techniques.

[0018] 2-7, a hysterectomy model 200 is shown. The model 200 includes multiple simulated organ structures 202 connected to and positioned within a frame 204. The frame 204 is configured to simulate a pelvis and function as a box-like encasement to house the multiple simulated organ structures 202. The frame 204 includes two or more semi-rigid plastic pieces. The frame 204 includes a top frame portion 206 connected to side or bottom frame portions 208 by fasteners 210 to form top and bottom planar surfaces interconnected by two upright sidewalls. As shown in FIG. 6, the top and bottom planar surfaces are parallel to one another and form a corner with the sidewalls, from which the sidewalls curve outward. The assembled frame 204, having a base and a top interconnected by two upright sidewalls, defines a central lumen with an open proximal end and an open distal end. The area of ​​the central lumen in a cross section taken perpendicular to the longitudinal axis gradually increases with increasing distance from the proximal end to the distal end. The outer shape of the frame 204 can differ from the shape of the central lumen. The sidewalls slope toward each other, with the sidewalls being closer together at the proximal end and gradually increasing with increasing distance toward the distal end, where the sidewalls are further apart. In various embodiments, the frame is tapered to have a frusto-conical shape, with a wide central lumen without corners. The outer shape of the frame can also match the tapered shape of the central lumen. The frame 204 has a flat base that allows it to be placed on a flat surface and stand upright.

[0019] In various embodiments, the bottom frame portion 208 includes a first height and a raised second floor 209 that raises the height of the model within the frame 204 to align with a transvaginal adapter (not shown), which is used in various embodiments to connect the model to the laparoscopic trainer 10. The frame 204 can include apertures 212 for passing fasteners 210 and / or for connecting tissue structures, such as vasculature 274, by looping them through and around the structure and suspending them within the frame 204. The frame 204 is constructed of folded transparent and / or translucent plastic. Folding the plastic elements of the frame 204 creates corners that represent the pelvis, which are not anatomically accurate but provide benefits necessary for simulating laparoscopic surgery at the expense of the realism of an anatomically accurate pelvis. These benefits include mechanical constriction of organs located at the tapered proximal end, which has the smallest luminal cross-sectional area. The physical contraction of organs at the proximal end results in a more rigid response of the organs when manipulated with surgical instruments, compared to the distal end, where the organs located therein contract less, move more freely, and respond more fluidly to manipulation with surgical instruments. The frame 204, according to various embodiments, intentionally simplifies the pelvis by combining variable resistance of the organs along the length of the central lumen's longitudinal axis. The smaller opening to the central lumen at the proximal end of the frame is where the opening to the vaginal canal will be located when an organ is placed inside the frame. The proximal end of the frame also faces a transvaginal or transanal adapter for connection. The distal end of the frame 204 is the location of the artificial uterus 216. The central lumen of the frame expands and angles outward toward the distal end. The tapered portion of this box-like frame allows for greater relaxation of the organs located therein, while the narrow proximal end constricts and tightly confines and supports the organs, resulting in a relatively limited range of motion.

[0020] The frame 204 is generally comprised of two or more structures. These structures may include some variation of a top, right side wall, left side wall, and bottom platform, all formed from one or more components. The base structure can be assembled using a variety of fasteners and / or adhesives. The top and side walls provide a small working area, which is beneficial to the end user, but can also be difficult to manufacture. Utilizing a top that is independent of the side walls facilitates assembly during the manufacturing process. Organ models can be placed and assembled on the bottom frame portion 208, or on the elevated second floor 209, if employed, and the top can be fastened once assembly is complete. Furthermore, manufacturers and / or end users may reuse any frame elements that are not permanently bonded to any other material. Thus, a frame comprised of two or more structures facilitates the recovery and reuse of frame elements that are not damaged during manufacturing and / or use. The frame elements are easily disassembled, allowing an end user to remove frame elements as needed to adjust organ structures connected to the frame elements, or to remove one or more organ structures for evaluation after a user has completed simulated surgical training on the organ structures. In various embodiments, the frame 204 is formed from five components or structures, including a top or apex 211, two side walls, and two bottom elements 208, 209, that interlock to form the frame 204. The top 211 and side walls form a workspace that variably contracts along the longitudinal axis for use of the model.

[0021] In particular, Figures 8-9 show the base in more detail. The base or bottom 208 includes one or more levels, such as a second deck positioned above the first deck 207. A silicone sheet 205 is fastened using fasteners 210. The fasteners 210 penetrate the sheet 205 and fit into apertures 212 in the base 208 of the frame 204. The silicone sheet 205 is used to aid in the assembly of the model. Specifically, the silicone sheet 205 serves as an easy point for silicone-to-silicone attachment and a more difficult point for silicone-to-plastic attachment. Silicone adheres easily to silicone, and the silicone sheet 205 simplifies removal of the silicone organ structure from the frame 204, allowing for removal and replacement of the model. The silicone sheet 205 is not an anatomically accurate element of the human anatomy. Therefore, the model is not an accurate representation of the human anatomy. Nevertheless, the appearance of the model maintains anatomical integrity for users undergoing surgical training using laparoscopic surgical techniques. The silicone sheet 205 forms a background for the user. This background does not detract from important realism for the user, such as the simulated organs positioned and attached to the background of the silicone sheet 205. FIG. 8 shows a simulated colon 220 attached to the silicone sheet 205. In various embodiments, the simulated colon is formed from silicone, a material compatible with adhesion to silicone, or a similar material different from plastic. In various embodiments, the simulated colon 220 is formed from a second material, such as silicone, or at least its bottom and sheet 205 are formed from a first material. In various embodiments, the first and second materials are the same and / or are formed from silicone. FIG. 9 shows the underside of the bottom 208, which has two pieces of fastener material, such as hook-and-loop fasteners, for connecting the model to the base of the surgical trainer 10. In various embodiments, the first deck 207 and / or the second deck 209 are formed from a third material, such as plastic, different from the first material, such as silicone.

[0022] Referring to Figures 10-12 of the patent, according to various embodiments, the top wall or top 211 is removable from the side walls, allowing the silicone model to be placed on the bases 208, 209 before attaching the top 211. Apertures in the top 211 are used for attachment to the side walls with fasteners 210. Other apertures 212 are used for interconnecting the silicone organ with the frame 204 and / or top wall 211. The top wall is formed of a sixth material, such as a rigid plastic, and in various embodiments, overlaps or is covered with a layer formed of a fourth material, such as silicone, that is different from the sixth material. In various embodiments, the top surface of the top wall is covered with a layer formed of a fourth material, such as silicone, and the bottom surface is covered with a layer formed of a fifth material that is the same as the fourth material but different from the sixth material. Specifically, silicone layers 302, 304 cover the rigid plastic of the top wall such that the two layers of silicone 302, 304 are directly connected to each other at a single point, such as through apertures in the top wall, sandwiching the top wall between the layers. In various embodiments, top 211 is formed by curing a first layer of silicone 302, placing a top 211 with a plurality of apertures 212 formed therein on the cured first layer 302, and then casting a second layer 304 on the opposite side of top 211 such that uncured silicone, such as the second layer, penetrates the apertures 212 and contacts the first layer of silicone 302, such that after second layer 304 has cured, the first and second layers 302, 304 are bonded together with top 211 tightly sandwiched between the two layers 302, 304. For example, in FIG. 11 , fingers 306 of silicone can be seen penetrating the apertures 212 in top 211. The second layer 304 is applied while uncured to interlock with the adjacent first layer 302 and embed the apex 211. The apex 211 provides structural rigidity to the resulting frame 204. The two layers 302, 304 can be attached at selected areas where apertures 212 are formed, by applying adjacent uncured silicone layers 302 through holes in the apex 211 so that they attach to the adjacent layer 304 at selected areas defined by the location of the apertures 212.

[0023] 12 and again with reference to FIGS. 2-4, the plurality of simulated organ structures 202 and their connection to the frame 204 will be described. The plurality of simulated organ structures 202 include one or more of a simulated bladder 214, a simulated uterus 216, a simulated vaginal canal 218, a simulated rectum / colon 220, a first sheet 222, a second sheet 224, and a third sheet 226. The plurality of organ structures 202 are interconnected as shown in FIG. 12 and also connected to the frame 204. The model may also include tubular vasculature, ducts, and arteries 274, etc., in anatomically accurate or anatomically similar locations in the same or different anatomical regions of the body, in addition to other simulated organ structures not mentioned herein.

[0024] The simulated bladder 214 forms a closed receptacle with an outer membrane made of pink silicone. The interior of the simulated bladder 214 can be filled with polyfill or other material to maintain its shape. The simulated bladder 214 has a proximal end 240 and a distal end 242. The simulated uterus 216 is also made of silicone. The simulated uterus 216 includes a proximal end 260 and a distal end 262. The simulated vaginal canal 218 is a tubular structure made of silicone and may optionally include an embedded mesh layer. The simulated vaginal canal 218 has a proximal end 256 and a distal end 258. The simulated rectum 220 is a tubular structure made of silicone with molded transverse folds. The simulated rectum 220 has a proximal end 244 and a distal end 246. The first sheet 222 and the second sheet 224 each include a wide, flat, planar layer of silicone material. Both sheets 222, 224 represent peritoneum. First sheet 222 has first and second surfaces 232, 234 and proximal and distal ends 248, 250. Second sheet 224 has first and second surfaces 236, 238 and proximal and distal ends 252, 254.

[0025] 12 , the assembly, configuration, and connection of the multiple simulated organ structures 202 will now be described. The distal end 242 of the bladder is attached to a first surface 232 of a first sheet 222 by adhesive such that the first sheet 222 wraps around the distal end 242 of the simulated bladder 214 from the bottom of the simulated bladder to the top of the simulated bladder 214. The second surface 234 is attached to the first silicone layer 302 near the distal end 248 of the first sheet 222 by adhesive. The first sheet 222 is folded into a general U-shape such that the distal end 250 of the first sheet 222, specifically the second surface 234 of the first sheet 222, is attached to the simulated uterus 216 and simulated vaginal canal 218 via a dissecting layer 226 using adhesive. The first sheet 222 forms a pouch around the edge 242 of the bladder 214. The first sheet 222 is attached to itself and wrapped around the top end of the top portion 211 and is adhered to the first silicone layer 302 by an adhesive.

[0026] The release layer 226 is a structure including a silicone layer, which may include a fiber layer. In this variation, the fiber layer is embedded into the silicone release layer 226 while it is still uncured to form the release layer 226. The release layer 226 is attached to the simulated vaginal canal 218. Although the release layers 226 are designated by the same reference numeral, two release layers 226 may be provided on opposite sides of the simulated vaginal canal 218, as shown. The release layer 226 may also be referred to as a third sheet. Both sheets 222 and 224 represent the peritoneum, and the third sheet 226 represents a bladder flap or peritoneal reflection. The release layer 226 is also attached to the distal end 258 of the simulated vaginal canal 218. The release layer 226 is a critical connection for hysterectomy procedures. In one variation, the first sheet 222 is adhered all the way to the simulated uterus 216, and in another variation, the second sheet 224 is adhered until it fills the bladder 214.

[0027] The second sheet 224 is attached between the simulated uterus 216 and the simulated rectum 220, as shown in FIG. 12 . Specifically, a first surface 236 at a distal end 252 of the second sheet 224 is attached near the distal end 262 of the simulated uterus 216. The second sheet 224 is attached along the length of the simulated uterus 216 toward the proximal end 260 using an adhesive. The second sheet 224 is attached to the release layer 226. Specifically, a first surface 236 of the second sheet 224 is attached to the silicone layer 228 of the release layer 226 using an adhesive. The second sheet 224 includes a slit to allow the simulated uterus 216 to pass through, extending upward as shown by the dotted line. At this time, the second sheet 224 extends proximally and then turns distally so that the surface 236 adheres to the simulated rectum 220. The simulated rectum 220 is then adhered to the silicone sheet 205. In various embodiments, the tissue construct is connected to the base via adhesion to the support structure. In various embodiments, apertures 212 on the frame 204 are used to form a mechanical connection between the tissue construct and the base, utilizing the tissue sheet and silicone as a mechanical link through the aperture. The tissue sheet involved in this connection is not anatomically accurate and is used only for structural and / or aesthetic purposes.

[0028] The simulated organ structures 202 are connected to the frame 204 in a suspended manner. The interconnected simulated organ structures 202 advantageously vibrate and move together in a realistic manner while suspended from the top frame 204, with contact with instruments, etc., moving most simulated organs farther from the instrument contact to a lesser extent. The bottom side of the simulated rectum 220 is adhesively attached to a silicone sheet 205 wrapped around the bottom 208 of the frame 204. Thus, the simulated organ structures, along with the first sheet 222, the second sheet 222, and the third sheet 226, form an interconnected webbing across the central opening / lumen of the frame 202. The proximal end 260 of the simulated uterus 216 is inserted into and adhesively bonded to the distal end 258 of the simulated vaginal canal 218. A silicone simulated cervix is ​​provided and positioned at the proximal end 260 within the simulated uterus 216.

[0029] The simulated organ constructs are connected to the aforementioned frame for suspension and support in an orientation that most closely replicates the human anatomy. Traditionally, organ constructs have been directly attached to the frame with adhesives or fasteners. However, fasteners and adhesives may not provide a strong enough bond to prevent disassembly during use of the model. The placement of adhesives and fasteners within the model can also confuse the user during use due to the presence of elements that do not represent the associated biological structure. To maintain anatomical integrity, the organ constructs are connected to the base via a support structure made of a material that is identical or similar in appearance and functionality to the organ construct, such as silicone. Silicone readily adheres to silicone, thus allowing organ constructs made of silicone or similar compatible adhesives to be directly attached to a support structure made of silicone or a similar compatible adhesive, while providing an interface between the functional and structural materials that provides a strong bond capable of withstanding the forces applied to the organ construct during simulated surgical training. To implement this silicone-to-silicone bonding, support structures such as the first silicone layer 302, the second silicone layer 304, and the silicone sheet 205 can be attached to the frame 204 using adhesives or fasteners that can be positioned below the organ structures or other frame elements when incorporated into the support structures and frame elements so as not to cause visual confusion or distraction to the user during surgical training. Thus, the support structures 302, 304, and 205 not only serve as an important visual backdrop but also as a powerful method for connecting the simulated organ to the rigid plastic frame in a silicone-to-silicone attachment manner, whether or not an adhesive is used. In this case, the simulated organ structure is bonded to the support structure using silicone, silicone glue, or adhesive. In another variation, the support structure can incorporate the rigid or plastic frame elements using silicone as an adhesive through apertures on the base that provide a mechanical link between the silicone layers after the silicone hardens. The support structure is designed and positioned in an orientation that is likely to maintain the anatomical integrity of the simulated organ structure. This prevents the support structure from causing visual confusion or distraction to the user during simulated surgical training.However, the support structures do not represent any anatomical structures necessary for realistic visualization during surgical training. Therefore, these support structures uniquely function to integrate the non-realistic structural support layers 302, 304, 205 into a realistic simulated organ environment. The simulated organ constructs are then adhered to the support structures using silicone, silicone glue, or adhesive. Until now, plastic frame elements have been known to confuse and / or distract users during surgical training due to their color, texture, and hardness, which can lead users to believe they are observing bone or cartilage, for example. Therefore, additional support structures are also used to conceal the base elements. The addition of support structures provides both visual and functional improvements that minimize the number of visual elements that do not maintain the anatomical integrity of the model during use and increase the attachment strength of the organ constructs to the frame elements. While at least three support structures 302, 304, and 205 are described above, any number of support structures can be used around the frame, as well as in various locations, such as on the side walls.

[0030] The model may also include tubular-shaped vasculature, ducts, arteries, and the like 274, in addition to other simulated organ structures not mentioned herein, in anatomically accurate or anatomically similar locations in the same or different anatomical regions of the body. The tubular / cylindrical simulated vasculature 274, ducts, fallopian tubes, ureters, or other anatomical or non-anatomical structures, typically made of silicone, are threaded through appropriately sized apertures 212 during attachment, as shown in Figures 7-8, to further support and maintain the connected simulated tissue structures in the correct orientation / position. These tubular structures have a free end and the other end attached to another simulated tissue structure. The free end passes through apertures 212 in the frame sidewall and is fixed at an adjustable length to adjust the tension applied to the connected simulated tissue structure. For example, loose tension can be achieved by fixing the tubular structure with a large amount of slack between the frame and the other simulated tissue structure. Alternatively, tension on the simulated tissue can be increased by pulling the tubular structure against the frame, creating a relatively stable simulated tissue construct within the frame. The tubular rope-like structure can also be tied along its length to form knots to adjust tension. To secure larger tissue constructs to the frame, the diameter of the knot is made larger than the aperture 212 in the frame. The knot 275 can be untied to remove the simulated tissue construct or retied to create different tension levels.

[0031] In various embodiments, the tubular, rope-like structure is threaded through one or more apertures on the base and connected to itself, forming a ring to provide additional strength. In various embodiments, a tubular silicone simulated vasculature 274, duct, fallopian tube, ureter, or other anatomical or non-anatomical structure having a tubular / cylindrical shape is provided with rivets at its distal end. These rivets include a distal end that connects to the frame and a proximal portion that is embedded or swaged into the end of the silicone tubular structure to provide a mechanical connection. The rivet-like fasteners 210 serve as interconnects between the soft, pliable silicone of the simulated tissue construct and the rigid plastic frame. Simulated tissue constructs are often fragile and can easily tear without reinforcement. This makes connecting such artificial tissue constructs to a frame challenging.

[0032] As can be seen in FIG. 3 , the simulated vasculature 274 on the left side passes through an aperture 212 and is fastened with a knot 275 tied on the outside of the frame 204 as described above. As will be described below, the simulated vasculature 274 on the right side passes through two apertures 212. The different attachment methods shown in FIG. 3 are for illustrative purposes. Two apertures 212 are used to secure the vasculature 274 because it was discovered that silicone vessels could be severed during shipping and / or during friction between the hard, sharp plastic frame and the soft silicone. Two side-by-side apertures 212 are formed in the frame 274. The simulated silicone vasculature 274 is threaded through both holes and glued to itself to form a loop. Silicone, silicone glue, and superglue can be used to attach the vasculature 274. The use of silicone is useful because the excess silicone provides a cushion that helps prevent vasculature 274 from being severed. This loop is clearly visible in Figure 4, where side-by-side apertures 212 are positioned one above the other. The string of vasculature 274 passes through one aperture 212, forming a U-shaped loop, and returns to the lumen of the frame 204 through the adjacent aperture 212. Uncured silicone can be applied as an adhesive and allowed to cure. The excess silicone further secures the vasculature 274 to the frame 204.

[0033] The simulated blood vessels 274 are threaded through the holes in the frame 204 to suspend the silicone elements in an orientation that most closely replicates human anatomy. The simulated blood vessels are then tied in place to prevent movement of the suspended simulated tissue. This method of fastening through stiff, pointed frame elements could cause the simulated blood vessels 274 to sever during use and transport of the model, compromising the accurate suspension of the simulated organ structures and thus hindering the user's realistic surgical training. To prevent vessel severance or movement during transport while maintaining anatomical integrity, the blood vessels 274 are threaded through two apertures 12 and / or reinforced with silicone to form rings or loops at each vessel / sidewall junction. This loop fixation method prevents unnecessary friction at the vessel / sidewall junction during use and transport, preventing vessel severance and enabling accurate suspension of the model. Furthermore, this reinforcement allows the user to apply significant forces to the simulated anatomical structures during surgical training without compromising the structural integrity of the model.

[0034] During use, the model 200 is placed inside the laparoscopic trainer 10 and connected to the trainer 10 via a transvaginal adapter or the like. The transvaginal adapter is formed as a leg configured to support the top cover 16 of the trainer 10. The transvaginal adapter is configured to simulate transvaginal surgery, including transvaginal hysterectomy. The transvaginal adapter includes a flat plate having an inner surface facing the interior of the trainer and an outer surface facing outward toward the user. The flat plate has a rectangular shape and includes an aperture penetrating the plate from the inner surface to the outer surface. In various embodiments, the aperture is circular in shape. In various other embodiments, the aperture is elongated oval, oval, or oriented perpendicular to the longitudinal axis of the adapter. In various other embodiments, the aperture is elongated oval, oval, or oriented perpendicular to the longitudinal axis of the adapter. The transvaginal adapter is positioned between the top cover 16 and the base 18 and provides a side access aperture to the side of the trainer 10, or substantially perpendicular to the top cover 16 and the base 18. The access aperture is particularly large to simulate a pre-retracted vaginal canal as described above. The proximal end 256 of the simulated vaginal canal 218 extends across the access aperture to connect the simulated vaginal canal 218 to an adapter. The adapter in various embodiments secures the model to the trainer 10.

[0035] A user of the model can perform a transvaginal hysterectomy by using surgical instruments and retractors to approach the simulated uterus 216 through the transvaginal adapter. Alternatively, the simulated uterus 216 can be approached through the simulated abdominal wall of the top cover 16 of the trainer 10. The user can use trocars and a scope to observe the anatomy and perform a surgical hysterectomy simulation to practice laparoscopic surgical skills. The procedure involves making a main incision to separate the uterus, which is then removed. Specifically, the model 200 provides first sheet 222, second sheet 224, and third sheet 226 and / or silicone webbing to realistically separate and dissect the simulated uterus 216. Additionally, the simulated cervix, reinforced with KEVLAR® synthetic fiber mesh, prevents the silicone from tearing when pulled. The user can further practice suturing the simulated vaginal canal 218 after removing the simulated uterus 216. To this end, the simulated vaginal canal 218 includes an embedded mesh that allows the silicone to hold the sutures without easily tearing. After use, the model 200 is removed from the trainer 10, and the plurality of simulated organ structures 202 are removed from the model 200. New plurality of simulated organ structures 202 are then connected to the frame 204 and inserted into the trainer 10 for continued practice.

[0036] Various portions of various embodiments of the model may be formed from one or more organic-based polymers, including, but not limited to, hydrogels, single-polymer hydrogels, multi-polymer hydrogels, rubber, latex, nitrile, proteins, gelatin, collagen, soy, thermoplastic elastomers, and other inorganic-based polymers, such as KRATON®, silicone, foams, silicone-based foams, urethane-based foams, and ethylene vinyl acetate foams. Within any base polymer, one or more fillers may be used, such as woven or nonwoven fibers, polyester, nylon, cotton, and silk, graphite, platinum, silver, gold, copper, miscellaneous additives, gels, oils, cornstarch, glass, dolomite, carbonate minerals, alcohols, deadeners, silicone oils, pigments, foams, conductive fillers such as poloxamers, collagen, and gelatin. Adhesives used may include, but are not limited to, cyanoacrylates, silicones, epoxies, spray adhesives, and rubber adhesives.

[0037] The above description is provided to enable any person skilled in the art to make and use the invention and practice the methods described herein, and sets forth the best mode contemplated by the inventors for carrying out the invention. However, various modifications will remain apparent to those skilled in the art. These modifications are intended to be within the scope of the present disclosure. Throughout this specification, different embodiments or aspects of such embodiments may be shown and described in various figures. However, each embodiment and aspect thereof shown or described alone may also be combined with one or more of the other embodiments and aspects thereof, unless expressly stated otherwise. The omission of each combination is solely for the purpose of facilitating the readability of this specification.

[0038] While the present invention has been described in certain specific aspects, many further modifications and variations will be apparent to those skilled in the art. It is therefore to be understood that the present invention may be practiced other than as specifically described, including various changes in size, shape, and materials, without departing from the scope and spirit of the invention. The present embodiments, therefore, are to be considered in all respects as illustrative and not restrictive.

Claims

1. 1. A surgical simulator for surgical training, comprising: a frame having a proximal end and a distal end; at least one artificial tissue construct removably coupled to and suspended within the frame; At least a portion of the frame has a plurality of support structures connected to the frame and positioned inside the frame, the support structures providing a silicone-silicone interface for the at least one artificial tissue construct. Surgery simulator.

2. The surgical simulator of claim 1 , wherein the cross-sectional area of ​​the frame lumen increases from the proximal end to the distal end.

3. The surgical simulator of claim 1 , wherein one or more of the plurality of support structures is detachable from the frame.

4. 2. The surgical simulator of claim 1, wherein the frame has a plurality of openings, and one or more of a plurality of support structures are disposed on opposite sides of the portion of the frame and comprise at least two layers of silicone connected together through at least one of a plurality of openings associated with the frame.

5. The surgical simulator of claim 4 , wherein the at least two layers of silicone are cured on opposite sides of the frame.

6. The surgical simulator of claim 1 , wherein the plurality of support structures are configured to maintain anatomical integrity of the frame, the frame simulating a pelvis.

7. The surgical simulator of claim 6, wherein the plurality of support structures are made of the same material as the at least one artificial tissue construct, and the at least one artificial tissue construct comprises a simulated uterus and a simulated bladder.

8. The frame is a first wall defining a top plane; a second wall parallel to the first wall and defining a bottom plane; a third wall and a fourth wall configured to interconnect the first wall and the second wall; the first wall, the second wall, the third wall, and the fourth wall define an inner cavity of the frame; The surgical simulator of claim 1 .

9. The surgical simulator of claim 8 , wherein one of the plurality of support structures is associated with the second wall.

10. The surgical simulator of claim 8 , wherein the first wall is detachable from the remainder of the frame to facilitate introduction of the at least one artificial tissue construct into the frame.

11. 9. The surgical simulator of claim 8, wherein the frame further comprises an elevated level above the second wall, and wherein the at least one artificial tissue construct can be positioned on the second wall, the elevated level, or both the second wall and the elevated level.

12. 1. A surgical simulator for surgical training, comprising: a frame having a first wall and a second wall disposed below the first wall; at least one artificial tissue construct removably coupled to and suspended within the frame; at least a portion of the frame comprises a plurality of support structures; The plurality of support structures include: a first support structure coupled at one end to an outer surface of the first wall and at an opposite end to a first portion of the at least one artificial tissue construct via a silicone-silicone interface; a second support structure coupled to an inner surface of the second wall and disposed between the second wall and a second portion of the at least one artificial tissue construct via a silicone-silicone interface. Surgery simulator.

13. 13. The surgical simulator of claim 1 or 12, wherein the at least one artificial tissue construct is removably coupled to the frame via the plurality of support structures without the use of adhesives and is suspended within the frame.

14. the plurality of support structures: a first support structure coupled to an outer surface of the first wall at one end thereof and coupled to a first portion of the at least one artificial tissue construct at an opposite end thereof via a first silicone-silicone interface; a second support structure connected to an inner surface of the second wall, disposed between the second wall and at least one artificial tissue structure, and connected to a second portion of the at least one artificial tissue structure via a second silicone-silicone interface at an opposite end of the second support structure. The surgical simulator of claim 8.

15. 15. The surgical simulator of claim 12 or 14, wherein the first support structure comprises a first silicone layer, the first portion of the artificial tissue structure comprises a simulated uterus or a simulated bladder, the second support structure comprises a silicone sheet, and the second portion of the artificial tissue structure comprises a simulated colon or a simulated rectum.

16. 15. The surgical simulator of claim 12 or 14, wherein the first wall and the second wall are made of a different, more rigid material than the first support structure and the second support structure, and the surgical simulator further comprises a third support structure connected to an inner surface of the first wall.

17. 13. The surgical simulator of claim 1 or 12, further comprising a laparoscopic trainer including a top trainer cover and a trainer base, defining a cavity between said top trainer cover and said trainer base, said cavity being arranged to receive said frame.

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