Surgical training model for laparoscopic procedures

Abstract

To provide a surgical training device that includes a model for training in passing a needle provided with a suture.SOLUTION: The model includes a base with a plurality of openings configured to receive a plurality of suture tabs. The suture tabs are made of elastomeric material. Some suture tabs include pre-formed tab apertures for passing a suture. Some suture tabs include a penetrable area through which a suture needle may penetrate for passing a suture. The suture tabs are movable with respect to the base to orient the suture tabs at different angles with respect to the base. The base itself may include portions that are angled with respect to each other. The suture tabs are movable with respect to the base to pull, expose or open the tab apertures and surfaces. Some of the tab apertures are slits that open upon being pulled relative to the base so that the slits require the user to practice holding the tab while passing the needle through the tab.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE INVENTION This application relates generally to medical training devices, and more particularly to models for practicing suturing.

[0002] Description of Related Applications This application claims priority to and benefits from U.S. Provisional Patent Application No. 62 / 318,902, filed April 6, 2016, entitled "Surgical training model for laparoscopic procedures," and U.S. Provisional Patent Application No. 62 / 167,129, filed May 27, 2015, entitled "Surgical training model for laparoscopic procedures." [Background technology]

[0003] Medical students learning new surgical techniques and experienced surgeons must undergo extensive training before they are qualified to operate on human patients. This training must teach proper technique using a variety of medical instruments to cut, pierce, clamp, grasp, staple, cauterize, and suture various types of tissue. The range of situations trainees may encounter is wide. For example, various organs and patient anatomies and diseases are presented. The thickness and consistency of various tissue layers may also vary from one part of the body to the next and may vary from patient to patient. Different procedures require different skills. Furthermore, trainees must practice their skills in a variety of anatomical environments influenced by factors such as the patient's size and condition, the adjacent anatomical landscape and landscape of the target tissue, and whether the target tissue is easily accessible or relatively inaccessible.

[0004] Many teaching aids, training devices, simulated 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 may be encountered and can be used to practice endoscopic, laparoscopic, and minimally invasive surgical procedures. In laparoscopic surgery, a trocar or cannula is inserted to access the body cavity and create a channel for the insertion of a camera, e.g., a laparoscope. The camera provides a live video feed capturing images, which are then displayed to the surgeon on one or more monitors. At least one additional small incision is made, through which another trocar / cannula is inserted to create a path through which surgical instruments can be inserted to perform the procedure observed on the monitor. The target tissue location, e.g., the abdomen, is typically expanded by delivering carbon dioxide gas to insufflate or insufflate the body cavity to create a working space large enough to accommodate the scope and instruments used by the surgeon. Insufflation pressure within the tissue cavity is maintained using specialized trocars. Laparoscopic surgery offers many advantages over open procedures, including less pain, less bleeding, and shorter recovery times due to smaller incisions.

[0005] Laparoscopic or endoscopic minimally invasive surgery requires a higher skill level than open surgery because the target tissue is not directly observed by the physician. The target tissue is observed via a monitor that displays a portion of the surgical site accessed through a small opening. Therefore, the physician must visually locate tissue planes, practice three-dimensional depth perception on a two-dimensional viewing screen, instrument delivery, suturing, precision cutting, and tissue and instrument manipulation. Typically, models mimicking specific anatomical structures or procedures are placed in a simulated pelvic or lumbar training device, where the anatomical model is hidden from direct visualization by the physician. Ports in the training device are used to practice techniques performed on the hidden anatomical model through instruments. The simulated pelvic trainer provides a functional, inexpensive, and practical means of training surgeons and residents in how to perform the basic skills and typical techniques used in laparoscopic surgery, such as grasping, manipulating, cutting, knotting, suturing, stapling, and cauterizing, as well as specific surgical procedures utilizing these basic skills. The simulated pelvic trainer is also an effective marketing tool for demonstrating the medical equipment required to perform these laparoscopic procedures.

[0006] One of the techniques requiring practice in endoscopic or laparoscopic minimally invasive surgery is suture threading and suturing, which requires the clinician to hone skills, such as three-dimensional depth perception and needle handing with a suture, while observing the target tissue and instruments on a two-dimensional video monitor. Therefore, it is desirable to provide a model suitable for practicing suturing, and in particular, a model that isolates specific steps of the procedure, such as suture threading, for the trainee to practice in a simulated laparoscopic environment. Laparoscopic training models are removably placed in a simulated laparoscopic environment, such as a laparoscopic training device, where the model is at least partially hidden from direct visualization. Cameras and monitors provide visualization to the surgeon. After practicing the technique, it is further desirable for such models to allow repeatable training with ease, speed, and cost savings. In view of the above, it is an object of the present invention to provide a surgical training device that isolates specific stages or steps of a procedure while realistically mimicking anatomical structures and also allowing for repeatable training. The use of a simulated training device has significantly improved the skill level of novice laparoscopic surgeons and has proven to be an excellent tool for training future surgeons in a non-surgical setting. There is a need for such improved, lifelike, and effective surgical training models. Summary of the Invention

[0007] According to one aspect of the present invention, a suture training model is provided. The suture training model has a base with a top surface interconnected with a bottom surface. The base has a plurality of openings in the top surface extending toward the bottom surface. The suture training model further has a plurality of suture tabs removably connected to the base. Each suture tab has a longitudinal axis, is pierceable by a suture needle, and is made of a resilient material that can be drawn from a rest configuration to an elongated configuration along the longitudinal axis. At least one suture tab is disposed in one or more of the plurality of openings, and the at least one suture tab is removably retained within the opening, allowing for two or more fixed orientations of the suture tab about its longitudinal axis relative to the base. Each suture tab has a top portion and a bottom portion. At least a portion of the top portion of the suture tab extends above the top surface of the base when positioned within the opening in the base, and when pulled to the elongated configuration, the bottom portion of the suture tab is held against the base and the length of the suture tab along the longitudinal axis is increased in the elongated configuration relative to the rest configuration.

[0008] According to another aspect of the present invention, a suture training model is provided. The suture training model has a base that is replaceable, extendable, and holds a plurality of suture tabs that are rotatable relative to the base. Each suture tab has a pierceable tab face or each suture tab has at least one pre-formed hole through which a suture is to be threaded. The base has a plurality of openings that receive the plurality of suture tabs. Each opening in the base holds one or more suture tabs. The base has at least one angle such that the openings form at least two flat surfaces with the suture tabs held therein.

[0009] According to another aspect of the present invention, a suturing training model is provided. The surgical training model has a base with a top surface interconnected with a bottom surface. The base has a plurality of openings in the top surface extending toward the bottom surface. The suturing training model has a plurality of suture tabs removably connected to the base. Each suture tab has a longitudinal axis and is pierceable by a suturing needle or each suture tab has at least one pre-formed opening through which a suture is to be threaded. At least one suture tab is disposed in one or more of the plurality of openings. Each suture tab has a top portion and a bottom portion. At least a portion of the top portion of the suture tab extends above the top surface of the base when positioned within the opening in the base. The preformed opening has at least one mating surface, e.g., a sloped surface, about the longitudinal axis, and the suture tab has at least one mating surface sized and shaped to mate with the at least one mating surface of the opening to prevent rotation of the suture tab about the longitudinal axis. In one form, the suture tab and the opening in which it is received are shaped to allow two or more fixed orientations of the suture tab about its longitudinal axis relative to the base. In another form, the suture tab has two or more mating surfaces to allow two or more fixed orientations about the longitudinal axis relative to the base.

[0010] In another aspect of the present invention, a method for practicing suture threading is provided. The method includes providing a suture training model having a base with a plurality of openings configured to hold a plurality of suture tabs. Each suture tab has a pierceable tab face or each suture tab has at least one pre-formed hole through which the suture is to be threaded. The base of the suture training model has a plurality of openings that receive the plurality of suture tabs. Each opening holds one or more suture tabs. Each suture tab is retractable from a resting configuration to an elongated configuration along a longitudinal axis. The method further includes providing a suture needle with a suture, retracting the suture tab from the resting configuration to an elongated configuration relative to the base, and threading the suture needle with the suture through the tab face while in the elongated configuration. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a top perspective view of a surgical training instrument of the present invention; FIG. [Figure 2] FIG. 1 is a top perspective view of a model of the present invention. [Figure 3] FIG. 1 is a top perspective view of a model of the present invention. [Figure 4A] FIG. 2 is a front view of the eyelet of the present invention. [Figure 4B] FIG. 2 is a front view of the eyelet of the present invention. [Figure 4C] FIG. 2 is a side view of the eyelet of the present invention. [Figure 4D] FIG. 2 is a side view of the eyelet of the present invention. [Figure 5A] FIG. 1 is a top perspective view of a suture training model with a single suture tab positioned in each hole in accordance with the present invention. [Figure 5B] FIG. 1 is a top perspective view of a suture training model with two eyelets positioned in each hole in accordance with the present invention. [Figure 6] 10A and 10B show a plurality of holes with different shapes in cross section of the base of the suture training model according to the present invention. [Figure 7]FIG. 1 shows a suture training model having two planar sections hinged together in accordance with the present invention. [Figure 8] FIG. 1 illustrates a suture training model having a base with two planar sections hinged together, each planar section having a layer of compressible material and multiple suture tabs connected to the base, in accordance with the present invention. [Figure 9A] FIG. 1 is a top perspective view of a suture tab of the present invention. [Figure 9B] FIG. 1 is a top perspective view of a suture tab of the present invention. [Figure 9C] FIG. 1 is a top perspective view of a suture tab of the present invention. [Figure 9D] FIG. 1 is a top perspective view of a suture tab of the present invention. [Figure 10A] FIG. 1 is a top perspective view of a suture tab of the present invention. [Figure 10B] FIG. 1 is a top perspective view of a suture tab of the present invention. [Figure 11A] FIG. 1 is a top perspective view of a suture training model having a base with three flat sections hinged together in accordance with the present invention. [Figure 11B] FIG. 1 is a top perspective view of a suture training model having a base with three flat sections hinged together in accordance with the present invention. [Figure 12] FIG. 1 is a top perspective view of a suture training model having a base with three flat sections hinged together in accordance with the present invention. [Figure 13A] FIG. 1 is a top perspective view of the suturing training model of the present invention. [Figure 13B] FIG. 1 is a top perspective view of a suture training model in a first orientation according to the present invention. [Figure 13C] FIG. 13C is a top perspective view of the suture training model of FIG. 13B in a second orientation in accordance with the present invention. [Figure 14A] FIG. 1 is an exploded top perspective view of the suturing training model of the present invention. [Figure 14B] FIG. 1 is a top perspective view of the suturing training model of the present invention. [Figure 15A] FIG. 1 is an exploded top perspective view of the suturing training model of the present invention. [Figure 15B] FIG. 1 is a top perspective view of the suturing training model of the present invention. [Figure 16A] FIG. 1 is a top perspective view of the suturing training model of the present invention. [Figure 16B] FIG. 16B is a side view of the suture training model of FIG. 16A of the present invention. [Figure 16C] FIG. 16B is a plan view of the suture training model of FIG. 16A and the suture threaded therethrough of the present invention. [Figure 17A] FIG. 1 is a top perspective view of the base of the present invention. [Figure 17B] FIG. 17B is a plan view of the base of FIG. 17A of the present invention. [Figure 18A] FIG. 1 is a top perspective view of the base of the present invention. [Figure 18B] FIG. 18B is a plan view of the base of FIG. 18A of the present invention. [Figure 19] FIG. 2 is a plan view of the base of the present invention. [Figure 20A] FIG. 2 is a plan view of the base of the present invention. [Figure 20B] FIG. 20B is a side view of the base of FIG. 20A of the present invention. [Figure 21A] 21 is a top perspective view of the base of FIG. 20 coupled to a base in a first orientation in accordance with the present invention. [Figure 21B] 21 is a top perspective view of the base of FIG. 20 coupled to a base in a second orientation in accordance with the present invention. [Figure 21C] 21 is a top perspective view of the base of FIG. 20 coupled to a base in a third orientation in accordance with the present invention. [Figure 22] FIG. 1 is a top perspective view of the base of the present invention. [Figure 23A] FIG. 1 is a top perspective view of a tab of the present invention. [Figure 23B] FIG. 23B is a side view of the tab of FIG. 23A of the present invention. [Figure 23C] FIG. 23B is a front view of the tab of FIG. 23A of the present invention. [Figure 23D] FIG. 23B is a plan view of the tab of FIG. 23A of the present invention. [Figure 24A] FIG. 2 is a front view of a tab in a first configuration in accordance with the present invention. [Figure 24B] FIG. 24B is a front view of the tab of FIG. 24A in a second configuration in accordance with the present invention. [Figure 25] FIG. 2 is a front view of the tab of the present invention. [Figure 26] FIG. 2 is a front view of the tab of the present invention. [Figure 27] FIG. 2 is a front view of the tab of the present invention. [Figure 28] FIG. 1 is a top perspective view of two side-by-side tab halves of the present invention. [Figure 29] FIG. 1 is a top perspective view of two side-by-side tab halves of the present invention. [Figure 30] FIG. 1 is a top perspective view of two side-by-side tab halves of the present invention. [Figure 31A] FIG. 1 is a top perspective view of two side-by-side tab halves of the present invention. [Figure 31B] FIG. 31B is a plan view of the two side-by-side tab halves of FIG. 31A of the present invention. [Figure 31C] FIG. 31B is a front view of the two side-by-side tab halves of FIG. 31A of the present invention. [Figure 32A] FIG. 1 is a top perspective view of two side-by-side tab halves of the present invention. [Figure 32B] FIG. 32B is a front view of the two side-by-side tab halves of FIG. 32A of the present invention. [Figure 32C] FIG. 32B is a side view of the two juxtaposed tab halves of FIG. 32A of the present invention. [Figure 33A] FIG. 1 is a top perspective view of two side-by-side tab halves of the present invention. [Figure 33B] FIG. 33B is a front view of the two side-by-side tab halves of FIG. 33A of the present invention. [Figure 33C] FIG. 33B is a plan view of the two side-by-side tab halves of FIG. 33A of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0012] A surgical training device 10 designed to simulate a patient's torso, e.g., the abdominal region, is shown in FIG. 1 . The surgical training device 10 includes a body cavity 12 that is substantially hidden from the user and receives simulated or live tissue, model organs, training models, or the like, as described herein. The body cavity 12 is accessed through a tissue simulation region 14 that is penetrated by a user using instruments to perform a surgical procedure on the tissue or training model visible within the body cavity 12. While the body cavity 12 is shown as being accessible through the tissue simulation region, the body cavity 12 may alternatively be accessed using a manual access instrument or a single-site port instrument. 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 instrument 10 is particularly well suited for practicing laparoscopic or other minimally invasive surgical procedures.

[0013] Still referring 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. The surgical training device 10 is configured to simulate a patient's torso, e.g., the abdominal region. The top cover 16 represents the anterior surface of the patient, and the space 12 between the top cover 16 and the base 18 represents the patient's interior or body cavity in which organs reside. The surgical training device 10 is a useful tool for teaching, practicing, and demonstrating various surgical procedures and their associated instruments in a simulation of a patient undergoing a surgical procedure. Surgical instruments are inserted into the cavity 12 through the tissue simulation area 14 and pre-drilled holes 22 in the top cover 16. Various tools and techniques can be used to penetrate the top cover 16, thereby performing the simulated procedure on the simulated organ or training model disposed between the top cover 16 and the base 18. The base 18 has 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 has a frame-like element that holds the model (not shown) in place. To help hold the simulated tissue model or living organ on the base 18, a clip attached to a retractable wire is provided at location 26. The retractable wire is extended and then clipped to hold the tissue model in place substantially below the tissue-simulation area 14. Another means for holding the tissue model includes a patch of hook-and-loop fastening material (VELCRO®) attached to the base 18 within the model-receiving area 24, which is removably connectable to a complementary piece of hook-and-loop fastening material (VELCRO®) attached to the model.

[0014] A video display monitor 28 hinged to the top cover 16 is shown in a closed orientation in FIG. 1 . The video monitor 62 can be connected to various visual systems that transmit images to the monitor. For example, a laparoscope inserted through one of the pre-drilled holes 22 or a webcam (webcam) installed in the cavity and used to observe the simulated procedure can be connected to the video monitor 28 and / or a mobile computing device to provide images to the user. Audio recording or transmission means can also be provided and integrated with the training device 10, thereby providing audio and visual capabilities. A portable 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 procedure for demonstration purposes and / or play back pre-recorded footage on the monitor. Of course, connection means can be provided to provide audiovisual output to a screen larger than the monitor. In another variation, the top cover 16 does not include a video display but includes means for connecting a laptop computer, mobile digital device, or tablet, such as an IPAD®, to the training device via wire or wirelessly.

[0015] When assembled, the top cover 16 is positioned directly above the base 18 with the legs 20 disposed substantially circumferentially and interconnected between the top cover 16 and the base 18. The top cover 16 and the base 18 are of 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 have openings to allow ambient light to illuminate the internal cavity as much as possible, while advantageously providing as little weight as possible for portability. The top cover 16 is detachable from the legs 20, which are detachable from the base 18 or foldable, such as by hinges, relative to the base 18. Thus, the unassembled training device 10 has a reduced height that facilitates portability. In essence, the surgical training device 10 includes 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 a hole 22 provided in the top cover 16, allowing a user to access the model through the hole 22 to practice laparoscopic or endoscopic minimally invasive surgical procedures.

[0016] A model 30 for practicing threading sutures during laparoscopic procedures in accordance with the present invention is shown in Figure 2. Model 30 is configured to be placed inside the surgical training instrument 10 described above or other similar surgical training devices to simulate suturing within a body cavity. Model 30 has a base 32 and a plurality of eyelets 34 coupled to a surface of base 32.

[0017] The base 32 of the model 30 is a platform that serves as a bottom support for the rest of the model 30, and is sized and shaped to prevent the model 30 from tipping over. The platform may be made of any material, such as metal or plastic. The base 32 is heavy enough to maintain the stability of the model 30 in an upright position while being manipulated by a user. The model 30 is sized and shaped to be placed within the body cavity 12 of the surgical training device 10 at the model receiving area 24. The underside of the base 32 includes means for mounting the model 30 inside the surgical training device 10. Such means for attaching model 30 to the interior of training device 10 include, but are not limited to, adhesives, suction cups, magnets, snap fits, and hook-and-loop fasteners (hook-and-loop fasteners) attached to the bottom surface of base 32 and configured to mate with complementary hook-and-loop fasteners or adhesives attached to base 18 of surgical training device 10.

[0018] The base 32 of the model 30 has an outer surface 36 that may be flat or contoured in various ways. For example, the outer surface may be convex, as shown in FIG. 2 . The outer surface 36 may be concave, curved, sloped, undulating, or have any form or topographical feature, including upward hills, downward hills, and small surface additions, such as ridges or depressions, that complement larger features. The topographical features of the outer surface 36 create a gradated or multi-surface surface that allows a user to practice depth perception in laparoscopic surgery. In one variation, the base 32 is not rigid and solid, but is soft, resilient, and flexible, and can bend when manipulated with surgical instruments used in laparoscopic surgery. Therefore, the base 32 is made of a flexible, resilient material, such as rubber or silicone. Another example of the topographical features of the outer surface 36 of the base 32 is shown in FIG. 3 . 2 and 3 is shown positioned with the outer working surface 36 facing upward. However, the model 30 may be positioned on its side within the training device 10 to provide another variation and display of the internal body structure for practicing laparoscopic procedures. In this alternative orientation, the side of the model 30 includes the eyelet 34.

[0019] The model 30 has a plurality of eyelets or holes 34 connected to the base 32. The eyelets 34 are configured to be positioned above the exterior surface 36 or side of the model 30, as shown in FIGS. 2 and 3. An exemplary eyelet 34 is shown in FIG. 4A. Generally speaking, the eyelet 34 is configured to provide an opening through which a physician can practice threading a needle and suture (hereinafter also referred to as a "suture needle"). The eyelet 34 has a neck portion 38 and a head portion 40. The head portion 40 has at least one hole 42, which defines a hole plane in which the hole 42 is located. While the holes 42 are shown as having a circular shape, the invention is not limited thereto, and the holes 42 may be any shape, such as a circle, a polygon, or a closed curve. While FIG. 4A shows a closed hole 42, an open, hook-like hole 44, as shown in FIG. 4B, is within the scope of the invention. The open or hook-shaped hole 44 is a hole that is open and only partially surrounded by the surrounding material of the head portion 40, leaving an opening or entrance to the hole 42 located anywhere from about 1 / 8 to 1 / 4 of the hole's circumference in size. In one variation, the hole 42 in the eyelet 34 is covered with a layer of silicone or other pierceable material, which may include a mesh or woven reinforcement, so that threading the needle with suture through the hole 42 requires the needle with suture to pierce the covering of the hole 42. The covering mimics real tissue, thus contributing to the realism of the training.

[0020] In one variation, the eyelet 34 is rigid. In another variation, the neck portion 38 of the eyelet 34 is flexible and the head portion 40 is rigid. In another variation, both the neck portion 38 and the head portion 40 are flexible or bendable. A bendable or flexible eyelet 34 increases the difficulty of threading a suture. In another variation, the eyelet 34 is pre-bent or angled. The plane defined by the hole intersects the longitudinal axis of the neck portion 38, as shown in FIGS. 4C and 4D. Generally speaking, the eyelet 34 provides a hole 42 through which the surgeon can practice threading the needle and suture. The neck 38 of the eyelet 34 is configured to separate the hole 42 from the outer surface 36 of the base 32. Other means for separating the hole 42 from the outer surface 36 of the base 32 are within the scope of the present invention. The neck 38 is also configured to couple to the base 32, and thus the neck 38 may have threads, adhesive, or other means for coupling to the base. The eyelet 34 may also be attached to the base 32 such that the entire eyelet 34 rotates or is rotatable relative to the base 32, or in another variation, the eyelet 34 is configured such that the head 40 of the eyelet 34 rotates relative to the neck portion 38 in a free-spinning eyelet configuration. This resulting ability to rotate the hole 42 relative to the base 32 increases the difficulty when threading the suture.

[0021] A plurality of eyelets 34 are coupled to the outer surface 36 of the base 32, as shown in Figures 2 and 3. In another variation, one or more of the eyelets 34 are retractable relative to the outer surface 36, such that the retractable eyelets 34 have a first position in which the aperture 42 in the eyelet 34 is located a first distance relative to the outer surface 36 and a second position in which the aperture 42 is located a second distance relative to the outer surface 36, the second distance being greater than the first distance above the outer surface 36. In one variation, the eyelets 34 are biased toward the first position such that the eyelets 34 have a tendency to spring back toward the first position. Furthermore, at least one eyelet 34 is coupled to the base 32 such that at least a portion of the eyelet 34, e.g., at least a portion of the hole 42 in the eyelet 36, is located below the upper surface 36, so that the eyelet 34 is visible to the user, but to thread a suture through the eyelet 34, the eyelet 34 located partially below the upper surface can be raised or pulled out by the user and one instrument held in the pulled position so that a suture needle and suture can be threaded through the hole 42 in the eyelet 34 with another instrument held in the opposite hand. The retractable eyelet 34 is embedded in a resilient base different from the upper surface 36 or is spring-loaded against the upper surface 36. The retractable eyelet 34 is also biased in the retracted position such that a force is required to pull the eyelet above the surface and hold it in place above the upper surface 36 for suture threading. When the eyelet 34 is released, it is pulled back below the surface. In another variation, the retractable eyelet 34 is not biased inwardly but moves between a first position and a second position above the surface, the first position being at least partially below the surface. The eyelet 34 is slotted for axial movement within the slot relative to the upper surface 36.Each eyelet 34 may be identical, or the plurality of eyelets 34 may be a mixture of eyelets 34 with various characteristics as described above, such as eyelets with different sized and shaped holes 42, flexible eyelets, rotatable eyelets, covered eyelets, open eyelets, bendable eyelets, plastically deformable eyelets that remain bent when bent, and bendable eyelets that resume their previous position after bending. The plurality of eyelets 34 may include eyelets of different colors, including colors that blend with the background or color of the exterior surface 36 of the base 32, to increase the difficulty of visualizing the eyelet holes 42 on a camera observation monitor. At least one of the eyelets 34 attached to the base 32 may also be colored to visually stand out or contrast when viewed laparoscopically against the background or exterior surface 36 of the base. Additionally, the plurality of eyelets 34 may be of the same color, thus including one or more groups of color-coded eyelets such that the predetermined path along which the suture must be threaded is defined by the color of the eyelets 34. For example, a set of green-colored eyelets 34 may define a predetermined path specific to a surgical procedure, or a relatively easy skill level, defined, for example, by eyelets 34 with relatively large bores 42. Alternatively, the predetermined path may be marked not by coloring the eyelets 34, but by indicia 46 applied to the exterior surface 36 of the base 32, as shown in FIG. 2. Such indicia 46 on the exterior surface 36 may include anatomical landmarks from which a user can derive the precise path to follow to thread the suture. Alternatively, the indicia 46 may be lines drawn on the exterior surface between the eyelets 34 interconnecting the indicia to define the predetermined path. The lines 46 may be colored in a contrasting color to the base 32 and color-coded to indicate a particular predetermined path, as shown in Figure 2. Additionally, within a plurality of eyelets 34 attached to the base 32, groups of eyelets 34 may be interconnected by indicia 46, such as lines drawn on the base 32 that connect the eyelets 34 within a particular group.A particular group of eyelets may define a predetermined path to be followed to test a user's skill in ensuring that all of a particular group of eyelets 34 located along a particular path have been threaded. Therefore, the placement and selection of eyelets 34 from a subset of the plurality of eyelets attached to the base may be used to improve the skill of threading the needle with suture through the hole, and therefore the paths and the eyelets selected in each path may vary in difficulty from relatively easy eyelets, e.g., eyelets with large holes, upright eyelets, and eyelets that are rigid and located in a relatively flat area of ​​the exterior surface and that contrast starkly with the background, to more difficult eyelets, e.g., eyelets with small holes, flexible eyelets, bendable eyelets, and eyelets that are colored to blend in with the background. The base 32 may be commercially available as part of a kit including a plurality of different types of eyelets 34 as described above, and the user assembles the eyelets by selecting from the plurality of different eyelets and then placing the eyelets within the base 32 as desired to form a channel tailored for the exercise. The eyelets 34 and base 32 are configured such that the eyelets 34 can be pulled through an exterior surface 36 of the base 32 to securely attach the eyelets 34. The kit may further include organs or other anatomical features that can also be connected to the base to form an anatomical configuration suitable for a particular exercise.

[0022] The predetermined path for threading the suture can be predetermined based on the surgical procedure to be practiced. For example, practicing vaginal vault closure may require a generally circular path at a particular angle with small-hole eyelets. Therefore, such a path can be defined and marked with colored eyelets or base markings for the surgeon to follow. Another surgical procedure, such as bowel anastomosis, may require a generally circular, large-diameter path with closely spaced pairs of eyelets. Therefore, the surgical procedure to be practiced can dictate the type of eyelets to be used, as well as their placement and markings to direct the user to the particular path.

[0023] The eyelets 34 are embedded within the base in various patterns and configurations that create patterns and pathways. The purpose of some pathways is to allow the clinician to visualize all of the eyelets or ensure that the suture is successfully threaded through all of a set without missing any difficult-to-thread eyelets. Naturally, the eyelets are positioned at various heights and angles, with the goal being for the surgeon to complete each pathway by threading a real or simulated suture needle through each eyelet and in a specific order. There are multiple pathways with different sized eyelets for various skill levels, allowing for skill development within the same platform. The training model 30 is placed within the laparoscopic training device 10, and a laparoscope is inserted into the cavity 12 to view the model 30. The procedure of placing the suture needle and suture through one of the holes 22 or through the tissue simulation area 14 and into the cavity 12, and threading the suture through the eyelets 34, is observed on a video display monitor 28, which provides the physician with a two-dimensional video representation of a three-dimensional model 30 located inside and hidden from direct visualization of the laparoscopic training device 10. The combination of the model 30 and training device 10 advantageously allows the user to identify a desired surgical path for the suture and practice moving the needle and threading the suture through multiple eyelets 34 laparoscopically.

[0024] The model 30 may include interchangeable eyelets 34, allowing the user to select a particular eyelet or a predetermined set of eyelets corresponding to a particular skill, level of difficulty, or surgical path for practicing the procedure. The model 30 is advantageously challenging and adjustable for all skill levels and is effective in requiring the user to use both hands equally to complete the path. The needle must also be manipulated to orient it properly for each insertion in order to successfully pass it through the hole. Therefore, the model is particularly useful for laparoscopic suture insertion, tissue plane determination and visualization practice, eyelet depth perception and visualization practice, instrument and needle handing, suturing, and tissue manipulation. This model allows clinicians to maintain their skills in excellent condition or "warm up" beforehand to ensure successful results during an actual surgery.

[0025] 5A and 5B, another embodiment of the suture training model 100 of the present invention is shown. The model 100 includes a base 102 and a plurality of suture tabs 104 connected to the base 102. The base 102 has a top surface 106 and a bottom surface 108 interconnected by a sidewall 109. Typically, the top surface 106 is parallel to the bottom surface 108 to form a plate or flat structure having a thickness. A plurality of openings 110 are formed in the base 102 and extend between the top surface 106 and the bottom surface 108. The openings 110 are shaped to receive the plurality of suture tabs 104. The base 106 is made of plastic, polymer, or any suitable material. The base 106 is generally rigid or semi-rigid and may be constructed of a single layer of material or may include one or more layers of material with different properties and characteristics. For example, a top base layer may be provided to give the model a realistic, textured appearance in terms of color and / or texture and / or to increase the difficulty of accessing the target suture tab 104, as described in more detail below. The base 102 has at least one aperture-equipped portion 112 that includes an opening 110. For example, in FIG. 7, the suture training model 100 has two portions 112a, 112b hinged to one another. Each portion 112 may consist of a single planar portion or may include multiple interconnected planar portions or surfaces. In FIG. 7, each aperture-equipped portion 112a, 112b constitutes a separate planar portion. The separate planar portions may be integrally formed / molded with one another such that the planar portions and their relative angles are fixed, for example, as shown in FIGS. 12-15. In another form, one or more aperture-containing portions 112, whether flattened or not, can move relative to one another so that the angle between the one or more aperture-containing portions 112 can be adjusted as desired. This angle can be adjusted or readjusted as needed to create different suture threading landscapes that may or may not represent the anatomical situation.Adjusting the angle also creates a custom and variable level of difficulty for training sutures through the model, thereby creating a progressive learning experience. The angle between two or more distinct and separate aperture-equipped portions 112 may be fixed by thumbscrews, a friction fit, or other structure configured to lock the relative position by tightening hinges 114 connecting two or more flat portions 112 to one another. In another configuration, the separate aperture-equipped portions 112 or surfaces of the aperture-equipped portions 112 are moved relative to one another by bending the base 102, whether flat or not. In such a configuration, the base 102 is made of a suitable compliant material, such as aluminum, and has a thickness that allows the base to rotate.

[0026] Referring back to FIGS. 5A and 5B and further to FIGS. 6 and 7, the openings 110 in the base 102 will now be described in detail. Each opening 110 defines a longitudinal axis substantially perpendicular to the opening 110 at the top surface. Each opening 110 is sized and shaped to removably receive at least one suture tab 104. Some possible shapes of the openings 110 in the base 102 as viewed along the longitudinal axis are shown in FIG. 6. In FIG. 6, one opening 110a has the shape of a slot. The slot is rectangular and elongated. The opening 110a has a shape complementary to the rectangular shape of at least a portion of the suture tab 104 to be received therein. The slot is sized slightly oversized or slightly undersized to create a friction-fit engagement with the suture tab to retain the tab within the base opening. Still referring to FIG. 6, another exemplary opening 110b has a cross or X-shaped shape. The cross-shaped opening 110b is formed by two rectangular openings similar to the rectangular slot-like opening 110a intersecting each other at 90°. The cross-shaped shape of the opening 110b allows at least a portion of a suture tab 104 having a complementary rectangular shape to be inserted into one of the two legs of the opening 110b. The tab 104 is inserted in a first direction or orientation, and the tab is removable to be inserted into the other leg of the opening 110b in a second direction that is transverse, perpendicular, or angled relative to the first direction. By being able to receive the suture tabs 104 in more than one orientation within a single opening 110, the suture path can be defined as desired, making it easier or more difficult to thread the suture through the suture tab 104 depending on the orientation or orientation of the suture within the multidirectional opening 110 relative to the orientation of the adjacent suture tabs 110. Still referring to FIG. 6, in another form, opening 110c has an octagonal shape that allows alignment of suture tab 104 within the opening along four different directions.Opposite facets of a multi-faceted opening, e.g., an octagon, allow alignment and friction-fit engagement for suture tab 104 within opening 110c. At least a portion of suture tab 104 conforms closely to the facets and is sized to abut the edge of opening 110c. Similar to octagonal opening 110c, FIG. 7 illustrates a star-shaped opening 110 formed by four intersecting rectangular openings that allow suture tab 104 to be oriented at four different angles and orientations within one of the four intersecting rectangular openings. Circular opening 110 also serves to retain suture tab 104 within opening 110, but does not serve to orient the tab in any predetermined direction.

[0027] Referring to FIG. 7, a suture training model 100 of the present invention is shown. The suture training model 100 has two aperture-providing portions 112a, 112b movably connected to one another at a hinge 114. The first aperture-providing portion 112a is articulatable relative to the second aperture-providing portion 112b. Each of the first and second aperture-providing portions 112a, 112b is substantially flat, and each aperture-providing portion has a plurality of star-shaped apertures 110, all of which are shown to have the same shape. In another embodiment, the apertures 110 may have different shapes. The base 102 with apertures 110 having different shapes helps inform the user of a predetermined path, and the user inserts the suture tabs 104 into the apertures 110 according to these predetermined angulations relative to adjacent apertures.

[0028] Referring now to FIG. 8, another suture training model 100 of the present invention is shown. The suture training model 100 includes a base 102 having two or more layers. Specifically, the base 102 includes a first layer 116 and a second layer 118. The second layer 118 is disposed above the first layer 116. In the configuration of the suture training model 100 shown in FIG. 8, the base 102 includes a first aperture-equipped portion 112a angularly connected to a second aperture-equipped portion 112b via a hinge 114, which allows the first aperture-equipped portion 112a to be adjustable and movable relative to the second aperture-equipped portion 112b. In one configuration, each portion 112a, 112b has a separate second layer 118a, 118b, respectively. In another configuration, a single second layer 118 spans both sections 112a, 112b, thereby bridging the gap between them. The second layer 118 has a top surface 120 and a bottom surface 122 that define a thickness. The bottom surface 122 of the second base layer 118 abuts and rests on the top surface of the first base layer 116, and the bottom surface may be attached with an adhesive. The second base layer 118 also has a plurality of holes 124 extending between the top surface 120 and the bottom surface 122. The holes 124 in the second base layer 118 align with the openings 110 in the first base layer 116 to allow the suture tabs 104 to pass through both layers 116, 118. In one configuration, at least a portion of the suture tabs 104 extend above the top surface 120. In another configuration, the suture tabs 104 do not extend above the top surface 120. The configuration of the suture training model 100 in FIG. 8 is shown as having two aperture-equipped sections 112a, 112b connected to each other by a hinge 114, with each aperture-equipped section having a first base layer 116a, 116b, a second base layer 118a, 118b, and holes 124a, 124b, respectively. The second layer 118 is made of a soft, compressible material, such as foam, which provides a realistic tissue surface to the base 102 while helping to hide and embed the suture tabs 104. The addition of the soft foam second layer 118 enhances training and provides another material that must be manipulated by the user to complete the exercise.For example, the user may press down or compress the second layer of foam 118 to access or view the holes 126 of the suture tabs 104 .

[0029] 9A-9D, several variations of the suture tab 104 of the present invention are shown. The suture tab 104 has a first side 128 and a second side 130, defining a thickness therebetween. The first and second sides 128, 130 are substantially vertical, and the sides are interconnected by a top 132 and a bottom 134. The suture tab 104 has at least one pre-formed hole 126 extending between the first side 128 and the second side 130. The hole 126 can be of any shape and size. In one form, the hole 126 has an elongated, slot-like shape. The elongated hole 126 can have curved sides and can be oval in shape to reduce stress concentrations when the hole 126 is pulled. The suture tab 104 is made of a resilient material, such as silicone, elastomer, rubber, or a polymer. The suture tab 104 may also be made of a hard plastic. The bottom 134 of the suture tab 104 has a wide footprint and is wider than the top 132. A shelf 136 is formed around at least a portion of the suture tab 104 at the intersection of the wide bottom 134 and the narrow top 132. The top 132 of the suture tab 104 can have any type of shape. For example, in FIG. 9A , the top 132 of the suture tab 104 has a flattened shape to form a square or rectangular top around the hole 126. In FIG. 9B , the top 132 has a tapered or pointed end to form a triangle-like shape around the hole 126. In FIG. 9C , the top 132 is rounded or curved. In Figure 9D, the top 132 is also rounded and curved, and is longer and narrower than the top 132 of the suture tab 104 shown in Figure 9C. The hole 126 in Figure 9D is also shorter than the hole 126 in Figure 9C. The suture tab 104 is sized and shaped to be inserted into the opening 110 in the base 102. Prior to insertion, the suture tab 104 is aligned with the opening 110 in the base 102. Specifically, if the opening 110 in the base 102, such as opening 110a in Figure 6, is shaped to receive the suture tab 104 in one direction, the suture tab 104 is aligned with the opening 110.If opening 110, e.g., openings 110b and 110c in FIG. 6, are shaped to allow multiple orientations of suture tab 104, an orientation of suture tab 104 is selected and inserted so that the outer surface of suture tab 104 is aligned with the facet of opening 110 to be retained therein. To insert suture tab 104 into base 102, base 102 is approached from the bottom surface 108, and the small, narrow top 132 of suture tab 104 guides insertion into aligned opening 110. When fully inserted, shelf 136 of suture tab 104 abuts bottom surface 108 of base 102, retaining suture tab 104 within opening 110. Suture tab 104 is retained within opening 110 by a slight interference fit between the soft silicone tab 104 and the hard plastic base 102.

[0030] Additionally, the plurality of suture tabs 104 may include one or more groups of tabs 104 of the same color, and thus may be color-coded such that the color of the tabs 104 defines a predetermined path along which the suture must be threaded. For example, a set of green tabs 104 may either define a predetermined path specific to a surgical procedure or define a relatively easy skill level defined by the tabs 104. Suture threading practice requires the user to thread the suture through the green tabs while avoiding the red tabs. In another form, the red tabs may be replaced with tabs that do not include holes 126.

[0031] Once inserted, the suture tabs 104 remain in a coupled relationship with the base 102, as shown in FIG. 5A. In FIG. 5A, the holes 126 of the suture tabs 104 are located substantially above the top surface 106 of the base 102. In another embodiment, the holes 126 are located substantially below the top surface 106 of the base 102 so as to conceal or at least partially obscure the holes 126 or tabs 104. In another embodiment, the openings 110 of the base 102 are sized and shaped to receive two or more suture tabs 104 in a juxtaposed relationship, as shown in FIG. 5B. In FIG. 5B, two juxtaposed suture tabs 104 are shown inserted into each opening 110. The two suture tabs 104 may have apices 132 that are identical in shape or may have apices 132 that are different in shape. Additionally, adjacent suture tabs may be color-coded differently or may have the same color. The suture tab 104 extends above the top surface 106 of the base 102 so that the top 132 of the suture tab 104 can be grasped by the surgeon and pulled vertically. Pulling the elastic suture tab 104 results in the suture tab 104 stretching vertically. Such stretching causes the suture tab hole 126 to elongate vertically, thereby enlarging the hole 126. All the while, pulling on the suture tab 104 is biased by the ledge 136 contacting the base 102, which prevents the suture tab 104 from being completely withdrawn from the base 102 when it is pulled upward. The suture tab is removable from the base 102 when moved downward. With two or more suture tabs positioned within the openings in a suture tab appositional arrangement, the user takes care to pull the appropriate tab or pull both tabs as needed to complete the exercise. The suture tab 104 has a first, resting configuration in which the suture tab hole 126 has a first size and a second, elongated or pulled configuration in which the suture tab hole 126 has a second size larger than the first size. The suture tab 104 can be moved between the first and second configurations by pulling the proximal end or top of the suture tab 104 upwardly relative to the base top surface 106.The second configuration allows the aperture 126 to have an elongated vertical size when pulled, facilitating the passage of suture. The elongated slot-like aperture 126 in Figures 9A-9D has a longitudinal axis that is substantially perpendicular to the vertical pull direction, and therefore the vertical size of the aperture 126 increases when pulled. In one configuration, the aperture 126 is merely a slit or cut in the tab that is barely visible but opens when pulled and stretched against the base.

[0032] Another configuration of the suture tab 104 is shown in FIG. 8. The suture tab 104 of FIG. 8 has a circular hole 126 and an extension apex 132 that provides an area or extension that can be easily grasped by a user. This extension may have a different shape that is more difficult to grasp and hold. In this configuration, when the suture tab 104 is pulled upward, the circular hole assumes an elongated and narrow configuration, which makes it difficult to thread the suture through the hole 126, thereby teaching the surgeon, with regard to their tissue skill level, to handle the simulated tissue represented by the suture tab 104 carefully when suturing. Thus, the suture tab 104 has a first, resting configuration in which the suture tab hole 126 has a first size, including a first dimension, and a second, withdrawn or pulled configuration in which the suture tab hole 126 has a second size, where the first dimension is smaller than when viewed in the first configuration, and the first dimension is the same measured dimension in the first and second configurations. The suture tab 104 can be moved between the first and second configurations by pulling the proximal end or top of the suture tab 104 upwardly relative to the top surface 106 of the base. The second configuration makes it difficult to thread a suture by narrowing the width of the hole 126. The hole 126 has a lateral dimension having a component perpendicular to the vertical or pull direction, and it is this lateral dimension that reduces the size of the second configuration relative to the first configuration.

[0033] 10A and 10B, a configuration of the suture tab 104 is shown that does not include the hole 126. These suture tabs 104 are similar to the suture tabs of FIGS. 9A-9D, but do not include the hole 126. The suture tab 104 of FIG. 10A has a flat top 132 that is rectangular or square in shape. The top 132 of the suture tab 104 includes a pierceable portion 138 located between the first side 128 and the second side 130. In this configuration, a non-default hole 126 is provided for practicing threading a needle with a suture. Instead, the physician pierces the hole with a needle to thread the suture through the top 132 of the suture tab 104. The silicone material of the suture tab 104 provides a tissue-like feel when penetrated by a needle. Additionally, the top 132 of the tab 104 can be pulled upward, causing the suture tab 104 to respond like real tissue and stretch in a manner similar to the way a needle with a suture can be threaded through it. These non-perforated suture tabs 104 may be placed side-by-side with two or more other non-perforated suture tabs 104 within the same opening 110, or with two or more suture tabs 104 with holes 126. In one form, the suture tab 104 does not include a shelf 136 on one side of the tab 104, so that this side is flush from the top 132 to the bottom 134. This flush side of one suture tab 104 rests against another flush side of another suture tab 104 in the juxtaposed position of the two suture tabs 104 within an opening 110, leaving no space between the two tabs 104, which makes it difficult to grasp and pull a single suture tab 104. In another form, both opposing sides of the suture tab may be free of ledges, such that the ledges are only located on two of the four opposing sides of the tab or along at least a portion of the tab sufficient to hold the tab against a base.

[0034] 11A and 11B, another form of model 100 is shown that includes a base 102 having two or more interconnecting surfaces 112. In particular, FIGS. 11A and 11B show three aperture-equipped sections 112a, 112b, 112c interconnected by hinges 114. Each aperture-equipped section 112 includes an aperture 110, and each aperture-equipped section defines a movable surface or plane that can be angled, if desired, relative to another aperture-equipped section 112 to increase the difficulty of the exercise or to mimic anatomical features.

[0035] Referring now to FIG. 12, another configuration of the model 100 is shown, which includes a base 102 having two or more interconnected surface portions 112. In particular, FIG. 12 shows three aperture-equipped portions 112a, 112b, and 112c interconnected by hinges 114. Each aperture-equipped portion 112 includes an aperture 110, and each aperture-equipped portion constitutes a movable surface or plane that can be angled, if desired, relative to another aperture-equipped portion 112 to increase the difficulty of the exercise or to mimic anatomical features. The configuration of FIG. 12 has complementary surface portions within each portion 112 to form a foldable version, such that one aperture-equipped portion 112 can fold over and be placed side-by-side with another aperture-equipped portion 112.

[0036] 13A-13C, an additional configuration of the suture threader model 100 is shown that does not include a movable aperture-equipped portion 112. The model 100 of FIG. 13A includes two aperture-equipped portions 112a, 112b that are integrally connected to one another as part of the base 102 of the model 100 at a predetermined angle between the two portions 112a, 112b. The two aperture-equipped portions 112a, 112b each have a plurality of apertures 110 disposed therein. In one configuration, the angle between the two portions 112a, 112b is greater than 90°. The base 102 may be connected to the base 18 of the surgical training instrument 10 via hook-and-loop fasteners 140 or other attachment means that are partially attached to the model 100 at one or more locations on the model 100 so that the model 100 can be removably secured to the base 18 of the training instrument 10 or other surface at different orientations / angulations relative thereto. Figures 13B and 13C show the model 100 having three aperture-equipped portions 112a, 112b, 112c that are integrally interconnected as part of the base 104 of the model 100 at predetermined angles relative to portions 112a, 112b, 112c. Model 100 can be coupled to the table top or base 18 of the surgical training instrument 10 in a first orientation, such as shown in Figure 13B, by optional fasteners 140, such as hook-and-loop fasteners 140, and oriented upside down in a second orientation, such as shown in Figure 13C, to provide multiple options and angled configurations for practicing suture threading with the same model 100. Model 100 can also be biased about one or more of its sides, thereby providing another configuration of relatively fixed angles for practice.

[0037] 14A and 14B, another embodiment of a suture threader model 100 of the present invention is shown. The model 100 includes an aperture 102 having a plurality of apertures 110. The base 102 can further include one or more interlocking aperture-providing portions 112 that are angled relative to one another. In FIGS. 14A and 14B, the base 102 includes two aperture-providing portions 112a, 112b that are angled relative to one another. The model 100 also includes pegs along the periphery of the base 102 that are sized and shaped to be inserted into holes 144 formed in a stand 146. The stand 146 is configured to hold the base 102 in an upright and stable orientation relative to a tabletop or other surface, such as the base surface 18, of the surgical training instrument 10. The base 102 is movable relative to the stand 146 so that the base 102 can be oriented in a different direction by inserting a different set of pegs 142 on another side of the base 102 into holes 144 in the stand 146. FIG. 14A shows the base 102 detached from the stand 146, while FIG. 14B shows the base 102 connected to the stand 146. The holes 144 in the stand 146 are shaped to receive the pegs 144 and hold the base 102 stable in any of its orientations relative to the base, thereby enabling suturing training. The base 102 in FIGS. 14A and 14B is an integral angled (chevron-shaped) base 102 with two or more suture planes 112a, 112b. In another form, the base 102 may have two or more sewing planes 112a, 112b connected to one another via a hinge.

[0038] 15A and 15B, another embodiment of a suture training model 100 is shown. The model 100 has a base 102 with a plurality of apertures 110 disposed on one or more aperture-providing portions 112. The embodiment of FIGS. 15A and 15B has two aperture-providing portions 112A, 112B integrally formed at an angle to one another. The aperture-providing portions may be configured such that two or more aperture-providing portions 112 can move relative to one another to adjust the angle between the aperture-providing portions 112. The model 100 has a stand 146 with a plurality of holes 144 configured to mate with pegs 142 of a holder 148. The holder 148 is configured to snap into the stand 146 to hold the base 102. The holder 148 has at least one upright opening 150 that provides a gap that can receive a notch 152 formed in the base 102 to hold the base 102 in an upright orientation relative to the stand 146, which is configured to support the base 102 on a flat tabletop surface or other surface of the surgical training instrument 10, such as the base 18. The base 102 has multiple notches 152 formed around its periphery, allowing the base 102 to be oriented in multiple directions. For example, in FIG. 15A , the notch 152 on one side of the base 102 engages with the opening 150 of the holder 148 to orient the base 102 in a horizontal position. In FIG. 15B , the notch 152 on another side of the base 102 mates with the opening in the opening 150 of the holder 148 to orient the base 102 in a vertical position. With multiple orientations, a single model 100 can provide a variety of training regimes for threading sutures through flat surfaces at various angles and in various orientations.

[0039] The suturing training model 100 provides a versatile training platform that allows users of all skill levels to practice suturing and suture threading techniques. The model 100 employs a flexible suture tab 104 and an adjustable base 102 that can be configured and reconfigured depending on the user's skill and desired type of training. The model 100 consists of a base 102 with multiple openings through which the suture tabs 104 can be placed and pulled. The base 102 can be a single item with no moving parts or an item with multiple adjustable surfaces or flats. The suture tab 104 has a wide stop base 134 that prevents the suture tab 104 from being pulled through the opening 110. The opening 110 in the base 102 can be a variety of shapes, including slots, X-shapes, hexagons, octagons, etc. Similarly, the suture tab 104 can be of various shapes and sizes. Additionally, the suture tabs 104 may have one or more holes or slots 126 through which the suture can be threaded. Other tabs do not have slotted holes 126 but provide a penetrable area, and such tabs can be used alone or in conjunction with slotted tabs to provide increased difficulty and a more realistic simulated or imitation condition. In one practice mode, the user targets the slotted tabs 104 and avoids the non-hole tabs 104; in another practice mode, the user threads the suture through the non-hole tabs and avoids the slotted tabs 104. In yet another practice mode, the user can thread the suture through both tabs, whether one or more of the tabs have holes 126 or not. This practice requires the user to pull both adjacent tabs and carefully thread the target and suture. The shape of the opening 110 in the base 102 determines the orientation of the tabs 104 relative to the base 102. The shape of the openings 110, and thus the orientation of the suture tabs, is predetermined relative to the other openings 110 in one form of the base 102, and therefore such orientation can be customized to define the suture paths encountered in actual surgery.In another form, the single opening 110 has the potential for multiple orientations for the suture tab 104, allowing the user to orient the tab as desired or in response to various levels of difficulty, exam or anatomical situations, and manual design to design various possible paths for practicing the procedure. Because the suture tab 104 is made of an elastomeric material, when manipulating the tab 104 with a laparoscopic grasper or dissector, the user can advantageously stretch the hole 126 to a more open position where the suture can be threaded. Because the hole 126 is not at rest in the open position and the tab 104 has a tendency to spring back to its unbiased, unstretched position, the user is forced to use both hands in coordination to complete the exercise. One hand is used to hold the tab stretched in the hole-open configuration while the other hand is used to thread the needle through the hole 126 while the tab is in the open configuration. The suture threading exercises provided by the model 100 are open to the user's interpretation. By providing multiple openings 110 through which tabs 104 can be placed and by providing an adjustable base 102, the instrument 100 can be used to challenge users of a range of skill levels. Furthermore, the exercises can be reconfigured to mimic specific anatomical structures of interest to the physician. The size and shape of the tabs and their respective slots also increase the difficulty of the exercises. The suturing training model 100 requires the user to manipulate the tabs to sufficiently open the holes 126 and thread the suture through the holes 126. This added dimension increases the difficulty and realism of the exercises. Providing tabs 104 of various shapes and sizes, as well as the configuration of the tab placement on the base 102, provides varying degrees of difficulty for the exercises. Large tabs 104 with pre-formed holes are the easiest. The user can level up to tabs 104 with slots that require the use of two hands to deflect the slot into the hole and thread the suture. The small slots can be linear cuts in the tabs 104. The smaller the holes 126, the greater the level of precision required to successfully complete the exercise.The addition of tabs 104 without holes 126 further increases the level of skill required to avoid surrounding tissue while approximating the target anatomical structure with the suture. Additionally, the apposition of tabs with or without holes 126 also increases the level of difficulty of practice. Tabs 104 without holes 126 are used to provide a high level of fidelity where the user must practice passing the needle through the tissue itself rather than through a pre-formed hole 126.

[0040] Referring now to FIGS. 16A-16C, another embodiment of a suturing training model 200 is shown. The model 200 includes a stand 202, a base 204, and one or more tabs 206. The stand 202 supports the base 204. The base 204 may be supported in various orientations when attached to the stand 202, as shown in FIGS. 21A-21C. One or more tabs 206 are coupled to the base 204 in various orientations. The one or more tabs 206 are shaped to allow a needle with a suture to pass through one or more of the tabs 206. A suture 211 is shown passing through several of the tabs 206 in FIG. 16C. The suturing training model 200 is configured to be easily placed in and removed from the cavity 12 of the surgical training instrument 10. Alternatively, model 200 may be used outside of trainer 10 to practice threading a suture. Stand 202 supports base 204 and tab 206 and is configured to withstand forces exerted by a user during threading of a suture-loaded needle without tipping or reacting in an unrealistic manner during operation. Model 200 is configured to be sufficiently rigid to withstand such forces applied during suturing, including knot tying and pulling and pushing actions. Base 204 is easily coupled to and detached from stand 202 to change the orientation of base 204 relative to stand 202 and / or for configuration purposes. Tab 206 is removably coupled to base 204 so that a used tab 206 can be replaced with a new tab 206 after use, if necessary. Tabs 206 are configured to receive sutures 211 threaded with needles and / or other instruments and to withstand forces applied during suturing, knot tying, accidental or intentional pushing, pulling, or rotating in multiple directions. Base 204 has multiple tab receiving locations, e.g., holes 220, which provide multiple options for suture routing and orientation, providing varying levels of difficulty for simulating the task.

[0041] 17A and 17B, a stand 202 of the present invention is shown. The stand 202 has a flat bottom surface that can be placed on a flat surface, such as the base 18 of the surgical training instrument 10 or a tabletop. The bottom surface is interconnected with a top surface that includes at least one upstanding clip 208. FIGS. 17A and 17B show the stand 202 with two clips 208 aligned and spaced apart from one another. Each clip 208 has two finger-like protrusions 210 that are spaced apart and facing each other to provide a gap for receiving a portion of the base 204. The opposing surfaces of the protrusions 210 have features that guide and receive the base 204, such as a channel 212, and features that can be coupled to the base 204, such as a snap fit, friction fit, or other engagement. These features may include, but are not limited to, a channel 212, clips, or any other structure that interacts with the base 204 to facilitate coupling thereto. In one form, the base 204 includes a complementary clip adapter that interacts with the clip 208 to secure the base 204 to the model 200. One or more finger-like protrusions 210 may be provided for each clip 208. In one form, one or more finger-like protrusions 210 include one or more reinforcing ribs 214 disposed on the outer surface of the protrusion 210 as shown in FIGS. 18A and 18B or on the inner surface of the protrusion 210 as shown in FIG. 19. The reinforcing ribs 214 in FIGS. 18A and 18B are substantially perpendicular to the outer surface of the protrusion. The reinforcing ribs 214 may also be oriented perpendicularly on the outer or inner surface as shown in FIG. 19. The reinforcing ribs 214 are configured to increase the stiffness of the protrusion 210 to prevent excessive deflection of the base 204 during operation. The reinforcing ribs 214 are coupled to, attached to, or integrally formed with the protrusion 210.

[0042] The stand 202 is made of a rigid material. In one form, the stand 202 is configured to be securely attached to the base 18 of the surgical training instrument 10 by hook-and-loop fastening material. In such a form, the bottom surface of the stand 202 includes one side of the hook-and-loop fastening material facing outward. A complementary piece of hook-and-loop fastening material is coupled to the surface of the base 18 of the surgical training instrument 10. Other means of removably attaching the model 200 to the surface of the training instrument 10 to secure the model 200 during use are within the scope of the present invention.

[0043] The base 204 will now be described with reference to Figures 20-22. The base 204 is made of a rigid material and has two planar operating sections 216, 218 that are angled relative to one another. In one embodiment, the planar operating sections 216, 218 are connected to one another at a common intersection. In another embodiment, the angle between the planar operating sections 216, 218 is approximately 120°. Any number of planar operating sections 216, 218 may be provided, with each planar operating section serving as a simulated planar section to allow suture threading to be practiced across an inclined plane. The base 204 has a top surface and a bottom surface, with a thickness defined between the top and bottom surfaces. A plurality of holes 220 are formed in the base 204 through the top and bottom surfaces. The holes 220 may have any shape suitable for receiving the tabs 206 in various directions, orientations, and angulations to provide various suture paths, as described in more detail below. In the illustrated embodiment, the holes 220 are polygonal in shape, and more particularly, the holes are octagonal. The base 204 further includes a plurality of mating surfaces 222 configured to couple with clips 208 on the stand 202. In one embodiment, the mating surfaces 222 are mating extensions that can directly engage with a pair of clips 208 on the stand 202. The mating surfaces 222 may include clips that slidably fit within channels 212 on the clips 208 and / or snap-fit ​​holes in ribs. The plurality of mating surfaces 222 are provided along the edges of the base 204, such that the base 204 can be coupled to the stand 202 in any number of orientations. The mating surfaces 222 may also be provided as extensions from the top or bottom of the base 204 to further increase the number of possible orientations. Various orientations of the base 204 relative to the stand 202 are shown in FIGS. 21A-21C. Three orientations of the base 204 are shown in Figures 21A-21C. In one configuration, pairs of mating surfaces 222 are provided along at least three locations on the base 204. Due to the angled configuration of the base 204, the mating surfaces 222 located along the straight edges of the base 204 snap into the clip 208 as shown in Figure 21A.Due to the corner configuration of base 204, mating surfaces 222 located along the beveled edges of base 204 snap into clip 208, as shown in Figure 21C. Due to the turtle-back configuration of base 204 relative to stand 202, mating surfaces 222 located on the bottom surface of base 204 fit into clip 208.

[0044] Referring to FIG. 22 , another configuration of the base 204 is shown. In this configuration of the base 204, a hinge 224 is provided between the two planar portions 216, 218 to connect the planar portions 216, 218 to one another in such a way that the angle between the planar portions 216, 218 is adjustable. The angle between the planar portions 216, 218 is fixed by a ratchet 226 provided on one or more sides of the base 204 and disposed between the two planar portions 216, 218 and a mating surface 222. The mating surface 222 is connected to the ratchet 226 so that the mating surface can be adjusted to accommodate changes in the angle between the planar portions 216, 218. The mating surface 222 is an elongated, flat tab configured to mate with a clip 208 on the stand 202. The hinged configuration of the base 204 of FIG. 22 allows for various planar angles for suturing practice.

[0045] 23A-27, the tabs 206 will be described in detail. Each tab 206 has a tab base 230 interconnected to a tab face 234 by a tab neck 232. The tab base 230, when viewed in cross section perpendicular to the longitudinal axis of the tab 206, has a shape that substantially matches the shape, or half of the shape, of the hole 220 in the base 204 through which the tab is to be received. The tab base 230 is sized slightly larger than the hole 220 and configured to allow the tab base 230 to be inserted into and removed from the hole 220. When inserted into the hole 220, the tab base 230 lies outside the hole 220 and adjacent the bottom surface of the base 204. In one form, the tabs 206 are made of a soft, compliant material, such as silicone, that mimics the consistency of real tissue. The silicone tab 206 is easily deformed and pulled like real tissue, making it suitable for practicing suturing and simultaneously easily insertable into the hole 220. The tab neck 232 has a shape, when viewed in cross section perpendicular to the longitudinal axis of the tab 206, that substantially matches the shape or half of the hole 220 into which the tab is to be received. The polygonal cross-sectional shape of the base neck 232 disposed within the matching half or full shape of the polygonal hole 220 will prevent rotation within the hole 220, unlike a circular tab neck 232 within a circular hole 220. When disposed within the hole 220, the tab neck 232 is positioned substantially within the hole 220 between the top and bottom surfaces of the base 204. The tab face 234 is located above the top surface of the base 204. The tab face 234 has at least one tab opening 236. The tab opening 236 may be of any shape and size. In one form, tab opening 236 is a slit that is not readily apparent to a user. However, grasping and pulling tab face 234 causes tab face 234 to elongate, as shown in FIG. 24B , thereby enlarging tab opening 236 so that a suture can be threaded through tab opening 236. Thus, tab 206 has a first form that is a relaxed form in which tab opening 236 has a small, first size, and a stretched or elongated second form in which tab opening 236 has a relatively larger, second size.The elastic properties of the tab material allow the tab to be moved from the first configuration to the second configuration. When the tab 236 is released from the second configuration, the tab 236 springs back to its first, relaxed configuration. The tab opening 236 advantageously serves as a place to thread a suture, in which case, removing the tab opening 236 can serve as a measure of a user's skill. The tab opening 236 also helps prevent the suture from tearing through the soft silicone of the tab face 234. In one configuration, the tab face 234 is reinforced with a mesh material to help retain the suture, particularly in a configuration in which the tab face 234 does not include the tab opening 236. In such a configuration, the tab face 234 is open to be penetrated by the user anywhere on the tab face 234. The transition between tab base 230 and tab neck 232 defines a ledge 238 that surrounds tab 206 and prevents tab 206 from being pulled proximally out of aperture 220. Additionally, the transition between tab neck 232 and tab face 234 defines an undercut 240 that prevents tab 206 from being pushed distally out of aperture 220. Both ledge 238 and undercut 240, along with faceted tab neck 232, help keep tab 206 securely, yet removably, attached to base 204 and able to withstand the pulling and traction associated with the suturing procedure, thereby preventing rotation of tab 206 relative to the base.

[0046] Multiple tabs 206 are typically inserted into various holes 220 selected randomly throughout the base 204 or in a predetermined manner and configuration to create a predetermined suture path that may be associated with a particular level of difficulty to improve skill or mimic a particular suture path that may be encountered in an actual surgical procedure. Thus, any number of tabs 206 can be inserted into the base 204. Some holes 220 may be left without tabs, if desired. Approximately 10 tabs 206 are inserted into the base 204, thereby providing an extended practice session. Color-coded tabs 206 may be employed to allow the user to identify the predetermined suture path, where only red tabs 206 would be threaded in, for example, a suturing exercise.

[0047] 25-27, the tab face 234, when viewed in cross section perpendicular to the longitudinal axis, has a polygonal shape, e.g., a square, a rectangle, as shown in FIG. 25, or a triangle, as shown in FIG. 26. Any shape, e.g., circular, curved, or oval, is also within the scope of the present invention. The tab 206 is designed in a variety of shapes and dimensions to provide various features for grasping, pulling, and manipulation, as well as various tab opening 236 sizes and shapes. The tab opening 236 in FIGS. 25 and 26 is an elongated slit with a long axis and a short axis, the long axis being substantially perpendicular to the longitudinal axis of the tab. In another form, the slit is elongated and angled or substantially parallel to the longitudinal axis. The tab openings 236 may have long axes that are, for example, about 0.25 inches (6.35 mm) long, 0.125 inches (3.175 mm) long, 0.0625 inches (1.5875 mm) long, and 0.03125 inches (0.79375 mm) long. FIG. 27 also illustrates a face 234 configuration with two or more tab openings 236. In particular, two openings in the shape of slits are positioned side by side and substantially along a line perpendicular to the longitudinal axis. Each of the two side by side slits is about 0.03125 inches (0.79375 mm) long.

[0048] In one configuration of the tab 206, shown in FIGS. 23A-23D, the tab base 230 and tab neck 232 are approximately half the size and shape of the base hole 220. This configuration allows two tab halves 206a, 206b to be positioned side-by-side and back-to-back within the same base opening 220, as shown in FIGS. 28-33. The tab 206 is sized and shaped to facilitate secure attachment to the base 204 through friction and geometric constraint. The tab 206 is prevented from inadvertently rotating within the hole 220 of the base 204 by the shape of the tab neck 232, where the trapezoidal and / or polygonal corners of the tab neck 232 prevent it from rotating out of the corners of the polygonal / octagonal hole 220 of the opening 220 of the base 204 when the corners of the tab neck 232 are positioned within the corresponding corners of the polygonal hole 220. Additionally, the octagonal shape of aperture 220 and the corresponding shape of tab neck 232 allows for four rotational orientations of tab 206 with base opening 220, thereby advantageously allowing for multiple suture paths and approach orientations for various exercises; i.e., tab 206 can be inserted in a first orientation defined along the 12 and 6 o'clock positions, removed and reinserted in a second orientation defined along the 9 and 3 o'clock positions, and reinserted in a third orientation defined approximately along the 2 and 8 o'clock positions and a fourth orientation defined approximately along the 10 and 4 o'clock positions.

[0049] 28-33, in a configuration in which the tab 206 is comprised of a first tab half 206a and a second tab half 206b, the first tab half 206a has a tab base 230a and a tab neck 232a having a first shape, and the second tab half 206b has a tab base 230b and a tab neck 232b having a second shape. Both the first and second shapes complement each other at their mating surfaces and define the overall peripheral shape of the base hole 220. Because two tab halves 206a, 206b are inserted into a single hole 220, the skill level is advantageously increased or made more challenging by the placement of different tabs 206 in juxtaposition. For example, one tab half 206a may not include a tab opening 236, thereby obscuring the tab opening 236 of the adjacent tab half 206b. In another embodiment, the tab halves 206a, 206b may be different colors, so that if the training instruction is to suture through tabs of the same color, the user needs to grasp the tab 206 of the correct color. Furthermore, grasping tab halves 206a, 206b that are positioned side-by-side within a base hole 220 is more difficult than grasping a single tab 206 within the base hole 220. Also, the two tab halves 206a, 206b positioned side-by-side within a single base hole 220 may have tab faces 234a, 234b that are identical to those shown in FIGS. 28, 29, and 30, where the tab faces 234a, 234b are polygonal, curved, and triangular, respectively. In another form, the two tab halves 206a, 206b disposed side-by-side within a single base hole 220 may have different tab faces 234a, 234b. For example, in Figures 31, 32, and 33, tab face 234a is polygonal and tab face 234b is curved, tab face 234a is polygonal and tab face 234b is triangular, and tab face 234a is triangular and tab face 234b is curved, respectively.When tab faces 234a, 234b are identical, the skill level for distinguishing the two tab faces from one another is increased, as is the difficulty in grasping one of the tab faces, as opposed to an arrangement in which only one tab face 234 is provided within a single base hole 220. Whether grasping the surface of tab face 234a or 234b is indistinguishable from the overlapping portions of adjacent tab faces with different shapes, as can be seen in Figures 31C, 32B, and 33B. Of course, in another arrangement, a single tab 206 may include two upstanding tab faces 234 having different tab opening 236 configurations and / or tab face 234 shapes, while sharing a common tab base 230 and tab neck 232.

[0050] While certain embodiments have been specifically shown and described, it will be understood by those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention as set forth in the claims.

Claims

1. 1. A method for practicing suture threading, comprising: providing a suture training model, the suture training model having a base configured to hold a plurality of suture tabs, each of the plurality of suture tabs having a first side and a second side defining a thickness therebetween, the first and second sides being interconnected by a top and a bottom such that a shelf is defined at an intersection between the top and bottom or a tab neck connects the top and bottom, the base including a plurality of openings extending therethrough to receive the plurality of suture tabs, the plurality of suture tabs having a resting configuration and an elongated configuration along a longitudinal axis, and when a suture tab disposed within one of the plurality of openings is pulled into the elongated configuration, a length of the suture tab along the longitudinal axis increases relative to the resting configuration and a bottom of the suture tab is held against the base; providing a suture and a needle; pulling one of the plurality of suture tabs disposed within one of the plurality of openings relative to the base from the rest configuration to the elongated configuration; and threading the suture and needle over the top of the tensioned suture tab while in the elongated configuration. A method characterized by:

2. providing the suture training model includes providing the suture training model with tops of some of the plurality of suture tabs having at least one pre-formed opening; the step of threading the suture and needle includes threading the suture through the at least one pre-formed opening. The method of claim 1.

3. at least one of the pre-formed openings extends through the top between the first and second sides; At least one of the pre-formed openings comprises an elongated slit having a major axis and a minor axis. The method of claim 2.

4. The major axis of the slit is elongated substantially perpendicular to the longitudinal axis, at an angle to the longitudinal axis, or substantially parallel to the longitudinal axis of the suture tab. The method of claim 3.

5. The pulling step includes the step of stretching one of the suture tabs to enlarge the at least one pre-formed opening.

5. The method according to any one of claims 2 to 4.

6. providing the suture training model includes providing, on the suture training model, a top portion of some of the plurality of suture tabs defining a penetrable region without a pre-formed opening; The step of passing the suture and the suture needle includes the step of causing the suture needle to pierce the penetrable region to form an opening, and passing the suture through the pierced opening. The method of claim 1.

7. The pulling step includes the step of stretching one of the suture tabs to enlarge the perforated opening. The method of claim 6.

8. The method further comprises creating predetermined suture paths for practicing the intended surgical procedure or different skill levels.

8. The method according to any one of claims 1 to 7.

9. The step of creating the predetermined suture path further comprises: inserting some of the plurality of suture tabs into the plurality of openings in a random or predetermined manner; and aligning each of the suture tabs with the plurality of openings, the aligning step occurring prior to insertion of each of the suture tabs. The method of claim 8.

10. the aligning step further comprises the step of selecting an orientation of the suture tab if the single opening allows multiple orientations of the suture tab.

10. The method of claim 9.

11. the inserting step includes approximating a bottom surface of the base while aligning one of the suture tabs with an opening of the plurality of openings; and inserting the suture tab into the one opening such that the aligned apex of the suture tab guides insertion into the one opening.

11. The method according to claim 9 or 10.

12. when the suture tab is fully inserted into one of the openings, a shelf formed between the top and bottom of the suture tab abuts the bottom surface of the base to retain the suture tab within the one of the openings, and at least a portion of the top of the suture tab resides above the top surface of the base. The method of claim 11.

13. when the suture tab is fully inserted into the one opening, a tab neck of the suture tab resides within the one opening between the top and bottom surfaces of the base; The method of claim 11.

14. At least a portion of the top of the suture tab is above the top surface of the base, while the bottom is adjacent the bottom surface of the base outside the opening. The method of claim 13.

15. the bottom of each of the plurality of suture tabs has a projection in a plane perpendicular to the longitudinal axis that is greater than the projection of the top of the suture tab in the same plane; 15. The method of any one of claims 1 to 14.

16. a bottom portion of each of the plurality of suture tabs being wider than a top portion of each of the plurality of suture tabs to prevent the bottom portion from being pulled through any one of the plurality of openings; 16. The method of any one of claims 1 to 15.

17. providing the suture training model includes providing a base to the suture training model having a top surface interconnected with a bottom surface; the top surface is parallel to the bottom surface to form a substantially planar structure having a thickness; a plurality of openings formed in the base extending between the top and bottom surfaces; 17. The method of any one of claims 1 to 16.

18. the step of preparing the suturing training model further comprises providing a suturing training model having a stand with an interlocking mechanism for holding the base in various orientations relative to the stand; 18. The method of any one of claims 1 to 17.

19. the step of providing the suture training model includes providing a base on the suture training model having at least one bend that forms at least two planes with openings that hold the plurality of suture tabs; 19. The method of any one of claims 1 to 18.

20. further comprising forming the at least two planar surfaces integrally or interconnecting the at least two planar surfaces using a hinge; 20. The method of claim 19.

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