Vaginal incision model

Abstract

A vaginal incision model is provided to aid in the training and practice of a user performing a vaginal incision procedure. The vaginal incision model has a simulated vaginal opening covering a proximal end of a simulated pelvic frame and a simulated vaginal canal defining an interior space surrounding a simulated cervix. The simulated cervix is ​​suspended via at least one cord to provide a realistic response to a user's interaction with the simulated cervix. A user is instructed to manipulate the simulated cervix and create one or more incisions where the simulated vaginal canal everts near the simulated cervix from these manipulations. The user is then instructed to continue through the vaginal incision model to access the simulated abdominal cavity or other portions of the vaginal incision model according to the simulated surgery being performed.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63 / 271,022, entitled "Colpotomy Model," filed on October 22, 2021, and U.S. Provisional Patent Application Serial No. 63 / 290,586, entitled "Colpotomy Model," filed on December 16, 2021, each of which is incorporated by reference in its entirety.

[0002] This application relates generally to surgical training systems and, in particular, but not exclusively, to simulated tissue structures and models for teaching and practicing various surgical techniques and procedures associated with laparoscopic, endoscopic and minimally invasive surgery. In particular, a surgical training system for teaching and practicing colpotomy via a transvaginal approach is provided. [Background technology]

[0003] Medical students and seasoned professionals (e.g., surgeons) learning new surgical techniques undergo extensive training before being qualified to operate on human patients. Part of this training allows the user to practice the correct techniques employed to perform the operation, which may involve one or more of cutting, penetrating, clamping, grasping, stapling, cauterizing, and suturing various tissue types. To this end, some surgical training systems present useful instructional tools that allow the user to practice and experience a variety of different anatomical structures and scenarios that correspond to different surgical procedures that the user will actually perform. As a result, the user can practice many different surgical techniques in and for different surgical conditions. Furthermore, the surgical conditions may be influenced by patient-specific factors such as the size and condition of the patient, the anatomical landscape related to the surgical operation and neighboring areas, and the type of tissue to be operated on, which may or may not be immediately accessible to the user. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application Serial No. 13 / 248,449 Summary of the Invention [Problem to be solved by the invention]

[0005] Several teaching aids, trainers, simulators, and model organs are available that facilitate the training and practice of one or more aspects of various surgical procedures. However, there is a need for models or simulated tissue elements that are specifically designed to aid in the training and practice of specific surgical procedures.

[0006] For example, there is a need for a surgical training system designed to provide a more accurate and responsive simulation for, among other things, a simulated vaginal incision. Additionally, features associated with a surgical training system that allow a user to practice such surgical procedures with or without electrosurgical energy, or a combination thereof, would also be desirable. [Means for solving the problem]

[0007] According to various embodiments, a surgical model is described herein. The surgical model includes a simulated pelvic frame having a proximal end and a distal end. The simulated pelvic frame has an opening at the proximal end and an internal cavity capable of housing one or more simulated tissue structures. The one or more tissue structures include a simulated vaginal canal and a simulated cervix. The simulated vaginal canal defines an internal space having a first section having a ridge near the proximal end and a smooth second section near the distal end. The simulated cervix is ​​connected to a distal end of the simulated vaginal canal such that a proximal end of the simulated cervix extends into the simulated vaginal canal and a distal end of the simulated cervix extends beyond the distal end of the simulated vaginal canal. The simulated cervix is ​​suspended via at least one cord within the simulated pelvic frame. The cord is connected to the simulated pelvic frame and allows for the simulated cervix to move back and forth in response to user manipulation, thereby also moving the simulated vaginal canal near the simulated cervix. The user can learn to identify where incisions need to be made based on the movement of the simulated vaginal canal.

[0008] According to various embodiments, the surgical model also includes a simulated vesicocervical space as described herein. The simulated vesicocervical space is formed of two or more layers with parts molded together and parts attached to each other with an interface material. Based on the type of attachment between the two layers, different types of incisions are used. In this way, the user can be taught how to identify the location of the incision plane corresponding to where the user should cut this space, which corresponds to where the simulated vesicocervical space allows for blunt dissection rather than sharp dissection.

[0009] According to various embodiments, the surgical model also includes a mock bladder that is configured to be inflated using a fill tube and an attached pump that is used to introduce liquid or air into the balloon to inflate it. The mock bladder also has sections that are reinforced with support structures that help control the direction in which the balloon inflates.

[0010] According to various embodiments, the mock cervix of the surgical model can include an additional support structure (i.e., a connector) attached to the distal end of the mock cervix. The mock cervix and / or support structure can be formed of yarn that is wrapped / braided around a three-dimensional mandrel and cast with a layer of conductive material. The mock cervix and / or support structure can also be formed hollow and then filled with support material.

[0011] 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 description of the drawings]

[0012] [Figure 1A] FIG. 1 shows an example of a vaginal incision model. [Figure 1B] FIG. 1 shows an example of a vaginal incision model. [Figure 2A] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2B] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2C] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2D] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2E] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2F] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2G] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Figure 2H] 1A-1D illustrate example embodiments of internal components of the vaginal incision model. [Diagram 3] 1A-1C show example components of the vaginal incision model unassembled within the simulated pelvic frame. [Figure 4A] 1A-1D illustrate different views of the vaginal incision model. [Figure 4B] 1A-1D illustrate different views of the vaginal incision model. [Figure 4C] 1A-1D illustrate different views of the vaginal incision model. [Figure 4D] 1A-1D illustrate different views of the vaginal incision model. [Diagram 5] FIG. 13 shows the internal components of the vaginal incision model placed within the simulated pelvic frame. [Figure 6A] FIG. 1 is a diagram showing an example of the arrangement of one or more codes. [Figure 6B] FIG. 1 is a diagram showing an example of the arrangement of one or more codes. [Figure 7A] FIG. 1 illustrates the steps of colpotomy performed on a colpotomy model. [Figure 7B] FIG. 1 illustrates the steps of colpotomy performed on a colpotomy model. [Figure 7C] FIG. 1 illustrates the steps of colpotomy performed on a colpotomy model. [Figure 7D] FIG. 1 illustrates the steps of colpotomy performed on a colpotomy model. [Figure 7E] FIG. 1 illustrates the steps of colpotomy performed on a colpotomy model. [Figure 7F] FIG. 1 illustrates the steps of colpotomy performed on a colpotomy model. [Figure 8] 1 is a top perspective view of a surgical training device according to the present invention; [Figure 9A] 1 is an embodiment of a surgical training device housing a vaginal incision model. [Figure 9B] 1 is an embodiment of a surgical training device housing a vaginal incision model. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] According to various embodiments of the present invention, a vaginal dissection model is provided. The vaginal dissection model includes a method for a user (e.g., a medical student, a medical professional) to teach and / or practice how to perform a vaginal dissection. In a vaginal dissection, a user makes an incision in the posterior wall of the vagina near the cervix. For example, a vaginal hysterectomy is completed by approaching the vagina through a circumferential incision around the cervix and removing the cervix and fundus.

[0014] 1A-1B, an example vaginal incision model 100 is shown in accordance with various embodiments. Although the figures show many elements that comprise the example vaginal incision model 100, additional elements (i.e., additional tissue structures) may also be included. Additionally, features shown in the example vaginal incision model 100 may be removed / removable to simplify the overall model.

[0015] The most proximal end of the vaginal incision model (i.e., the left-most portion of the figure) is a simulated vaginal opening 105 that covers the proximal end of the simulated pelvic frame 110 (the base is shown in this view). In various embodiments, the simulated vaginal opening 105 includes simulated tissue that is attached to the top (e.g., cover) of the simulated pelvic frame 110 and extends the entire height of the simulated pelvic frame 110 downward to the base of the simulated pelvic frame 110. In various embodiments, a grounding pad can be associated with any portion of the simulated vaginal opening as long as the opening to the vaginal canal is not obstructed. For example, a grounding pad can be placed on the top of the simulated pelvic frame.

[0016] The opening of the simulated vaginal orifice 105 (e.g., as shown in FIG. 4A ) leads to a simulated vaginal canal 115. The simulated vaginal canal 115 defines an interior space surrounding a portion of the simulated cervix 120. According to various embodiments, as shown, for example, in FIGS. 2A-C , the simulated vaginal canal 115 has two distinct sections. A first section 210 of the simulated vaginal canal has a number of ridges that provide simulated rugae. The first section begins at a proximal end of the simulated vaginal canal 115 and terminates at the beginning of a second section 220. The second section 220 is smooth and is located near a circumferential region of the simulated vaginal canal 115 where the simulated vaginal canal 115 is connected to the simulated cervix 120.

[0017] The distinction or delineation between the two different sections or regions 210, 220 provides the user with a visual landmark or indication where to incise the simulated vaginal canal 115. Another landmark or indication used and provided by the vaginal incision model to identify where to make the incision corresponds to where the simulated vaginal canal everts over the simulated cervix through a motion called "rolling." "Rolling" (as it relates to the simulated vaginal canal) refers to the manipulation (e.g., back and forth) of the simulated cervix. Generally, the point where the incision is made is located within the second section 220 where the simulated vaginal canal everts over the simulated cervix.

[0018] Referring to FIG. 2B, an example scenario is shown in which the simulated cervix moves from a first position A to a second position B (e.g., the linea alba). The movement (e.g., "rolling") of the simulated cervix moves a portion of the simulated vaginal canal along with the simulated cervix. Specifically, as the simulated cervix moves from the first position A to the second position B, which corresponds to an area of ​​the simulated vaginal canal where the colpotomy is desired to be incised, the portion of the simulated vaginal canal becomes further tucked / folded in on itself around the simulated cervix.

[0019] The user can access the simulated bladder-cervical space by making an incision at the "rolling" point in the simulated vaginal canal. Among other things, the user can avoid unintentionally cutting, dissecting and / or severing into the simulated cervix or simulated bladder. Figure 2C shows an example of where the incision may be placed in the second section of the simulated vaginal canal.

[0020] Referring again to FIG. 1A, the simulated cervix 120 is designed to move in response to user manipulation (e.g., retracting and withdrawing) to further create a "rolling" on a portion of the simulated vaginal canal 115. This movement is facilitated via at least one cord 125 attached to a connector or support 130 that is connected distally to the simulated cervix 120 beyond the simulated vaginal canal 115. In various embodiments, the connector 130 shown extending from the simulated cervix 120 can correspond to the location of a uterus. In various embodiments, a simulated uterus can also be provided for purposes of simulating a colpotomy. However, various embodiments, including the illustrated embodiment, do not provide a simulated uterus to conserve resources, reduce waste, and facilitate assembly and manufacturability of the model. The connector 130 facilitates the suspension and movement of the simulated cervix 120 and the simulated vaginal canal 115 via the cord 125.

[0021] In various embodiments, a single cord 125 can be used to suspend the simulated cervix 120 via connection to a connector 130 that is distally connected to the simulated cervix 120. For example, the cord 125 can be looped through the connector 130, for example, as shown in FIG. 6A. In other embodiments, two or more cords 125 can be used, for example, as shown in FIG. 6B. For example, two sets of cords 125 can be attached to either side of the connector and used to connect each side of the connector to the simulated pelvic frame 110. In various embodiments, the cords 125 are passed through apertures in the walls of the simulated pelvic frame 110 to connect the connectors 130 to the simulated pelvic frame 110.

[0022] A user can access the simulated bladder-cervical space 135 after incising the simulated vaginal canal 115. FIG. 2D illustrates an embodiment of the simulated bladder-cervical space. Specifically, side and top views of the simulated bladder-cervical space are illustrated showing an exemplary partial cross-sectional cutaway portion of the simulated bladder-cervical space. Referring first to the side view, in various embodiments, the simulated bladder-cervical space is defined by at least two layers 352, 354. Between the two layers 352, 354, an interface layer or material 250 (e.g., silicone grease) is applied at various portions that partially attach the at least two layers 352, 354 to each other. The interface material 250 (e.g., silicone grease) facilitates defining a separation plane where the two layers can be separated from each other using blunt dissection for separation. This separation plane corresponds to a plane that a user (e.g., surgeon) follows during a vaginal dissection to access the peritoneum further behind the simulated bladder-cervical space. Thus, in various embodiments, these interface materials or layers are or function as resist, release or separation materials or layers that enable or facilitate the separation or intended separation of layers or structures between which the interface materials or layers are disposed.

[0023] In the outer area of ​​the separation surface (i.e., the area where the silicone grease is not present), the at least two layers 352, 354 of the simulated bladder-cervical space 135 are fully attached to each other (e.g., molded together). The portion where the two layers 352, 354 of the simulated bladder-cervical space 135 are connected to each other corresponds to at least one simulated vesicovaginal septa 260.

[0024] Referring to the top view (imagine removing the top of 352), the solid filled areas correspond to the location where the layers 352, 354 of the simulated bladder-cervical space 135 are fully attached to one another to form the simulated bladder-vaginal septum 260. The "front" in the top view corresponds to the portion of the simulated bladder-cervical space 135 that the user enters after incising the "rolling" portion of the simulated vaginal canal.

[0025] The fully attached portions of the layers 352, 354 correspond to the simulated vesicovaginal septum 260 and are less likely to separate from one another than other sections or portions of the simulated bladder-cervical space 135 that have interface material 250 disposed between the layers 352, 354. A user will need to use sharp dissection (e.g., a snip) to separate the layers 352, 354 in one of the vesicovaginal septa 260 as opposed to other portions where blunt dissection can be used.

[0026] In various embodiments, the simulated bladder-cervical space 135 is attached, e.g., cast, as two separate layers onto the simulated vaginal canal 115, connector 130, and / or a portion of the simulated cervix 120, i.e., the lower portion of the simulated bladder-cervical space 135 (corresponding to element 354) is cast onto the simulated vaginal canal 115, connector 130, and / or a portion of the simulated cervix 120, and then the upper portion of the simulated bladder-cervical space 135 (corresponding to element 352) is cast. In other embodiments, the lower portion of the simulated bladder-cervical space 135 is cast simultaneously / with the simulated cervix. The upper portion of the simulated bladder-cervical space 135 is cast later, separately from the lower portion of the simulated bladder-cervical space 135. This allows for simplified manufacturing and / or reduced costs by eliminating the casting step (i.e., casting the lower portion of the simulated bladder-cervical space 354 separately from the simulated cervix 120).

[0027] In various embodiments, the simulated bladder-cervical space 135 has a different color than the simulated cervix and the simulated vaginal canal 115. The different color schemes provide a visual cue or indicator that allows the user to visually confirm and identify where to make the incision. In various other embodiments, the color schemes of the simulated vaginal canal 115, the simulated cervix, and / or the simulated bladder-cervical space 135 are similar, prompting the user to identify where to make the incision based on where the movement of the simulated cervix and rolling of the simulated vaginal canal 115 are located.

[0028] Referring again to FIG. 1A, the user is instructed to incise the simulated bladder-cervical space 135 towards the posterior or distal end of the vaginal incision model 100. The user avoids incising into other spaces (e.g., bladder, uterus) by following the separation plane of the simulated bladder-cervical space 135, and instead approaches the simulated peritoneum layer 140. The simulated peritoneum layer 140 is attached to the distal end of the vaginal incision model 100 and is used to separate the proximal interior of the simulated pelvic frame 110 from the distal opening (which may correspond to the simulated peritoneal cavity) of the simulated pelvic frame 110. The simulated peritoneum layer 140 is attached (e.g., via adhesive) to the simulated pelvic frame 110, the simulated bladder 150 and / or the connector 130 at various points. In various embodiments, a conductive adhesive, such as, for example, chitosan adhesive, connects the simulated bladder 150 and / or connector 130 to the simulated peritoneal layer 140. In various embodiments, a non-conductive adhesive, such as, for example, Loctite adhesive, connects the simulated peritoneal layer 140 to the simulated pelvic frame 110.

[0029] After the user has incised the simulated bladder-cervical space 135, the user proceeds to identify the location of the simulated peritoneal reflection 145 of the simulated peritoneal layer 140. Generally, the simulated peritoneal reflection 145 corresponds to the point in the simulated peritoneal layer 140 where the simulated peritoneal layer 140 appears more convex (e.g., folding back on itself in the opposite direction toward the distal end of the vaginal incision model 100, similar to the "rolling" of the simulated vaginal canal 115). The user advances the incision at the simulated peritoneal reflection 145 at the location in the simulated peritoneal layer 140 to access the simulated peritoneal cavity behind the simulated peritoneal layer 140, in various embodiments. The incision at the simulated peritoneal reflection 145 ensures that the user is accessing the simulated peritoneal cavity and not incising further into the simulated cervix / connector, the simulated bladder, and / or the surrounding areas of the simulated bladder.

[0030] The simulated bladder 150 as shown is located above the simulated bladder cervical space 135, the simulated vaginal canal 115, and the connector 130. In various embodiments, the simulated bladder 150 is connected (via a heat shrink seal or a connector / nut) to a fill tube 155 and a pump 160. The simulated bladder 150 can be cast to form a balloon-like object that is used to inflate like a real bladder. The simulated bladder 150 is configured to inflate via the injection of air via the fill tube 155 and the pump 160 when a user utilizes the pump 160. In various embodiments, the fill tube 155 is a type of clear plastic tube. In various embodiments, the pump 160 is a hand pump. Inflation of the bladder 150 using the pump 160 simulates the inflation of the bladder during a colpotomy where a surgeon introduces saline or the like to inflate the bladder. In various embodiments, the simulated bladder 150 comprises a conductive material.

[0031] In various embodiments, the simulated bladder 150 can be formed using a balloon or an airtight or air impermeable inflatable or fillable vessel (e.g., formed from latex, polyolefin, etc.) that is inserted after the simulated bladder 150 is cast. In these embodiments, the balloon located inside the casted exterior surface of the simulated bladder 150 provides an airtight container or vessel that receives and inflates the entire simulated bladder 150, such as by receiving air via a pump and tubing, for example. The use of a balloon allows for less emphasis or concern that the exterior surface or material of the simulated bladder 150 is uniform, impermeable, and / or airtight when the simulated bladder 150 is cast or molded.

[0032] In various embodiments, additional material can be placed on various portions of the upper section of the simulated bladder 150 as it is being cast in the mold. Such material can include batting similar to the embodiment having batting included at the simulated vaginal opening 105 for additional support. The material added to the simulated bladder 150 provides additional structural support to the simulated bladder 150 as well as control and / or direction of expansion of the simulated bladder 150. In various embodiments, the lower portion of the simulated bladder 150 contacts the connector 130, the simulated vaginal canal 115, and / or the simulated bladder cervical space 135. The simulated bladder 150 may expand toward the top of the vaginal incision model if expanded without the addition of reinforcing material. However, upward expansion of the simulated bladder 150 may be undesirable. Adding material (e.g., padding) to the top of the simulated bladder 150 or thickening the silicone or the like at the top of the simulated bladder 150 can provide simulated resistance to upward expansion of the simulated bladder and thus, as the simulated bladder 150 expands, can provide downward expansion towards the connector 130, the simulated vaginal canal 115 and / or the simulated bladder-cervical space 135, e.g., similar to a surgical procedure and / or training therefor.

[0033] In various embodiments, the simulated bladder 150 is secured within the vaginal incision model 100 using an adhesive. In various embodiments, the simulated bladder 150 is secured to the simulated pelvic frame 110 using a non-conductive adhesive, such as Loctite adhesive. In various embodiments, the simulated bladder 150 is secured to the simulated peritoneal layer using a conductive adhesive, such as chitosan adhesive.

[0034] FIG. 1B shows another view of the vaginal incision model. Specifically, FIG. 1B shows further details regarding additional materials or features that can be incorporated into the vaginal incision model to provide additional support. In various embodiments, support structures can be incorporated / embedded into one or more of the elements of the vaginal incision model. For example, the simulated vaginal opening can have batting embedded in various locations within it. A reinforcing matrix or sleeve can also be incorporated into the simulated cervix and the connector distally connected to the simulated cervix. In various embodiments, a heat shrink tube can be heat shrunk around the connection point between the fill tube and the simulated bladder to strengthen the connection between them.

[0035] Example components of the vaginal incision model that are not connected to the simulated pelvic frame are shown in Figure 3. Specifically, this figure shows an inflatable bladder 150 connected to a fill tube 155 (and pump, not shown), a simulated vaginal opening 105, a simulated vaginal canal 115, a simulated bladder-cervical space 135, a connector 130 connected to a portion of a simulated cervix, and one or more cords 125 connected to the connector 130. A portion of a simulated cervix, not shown, is connected to the connector 130 and is contained or enclosed within an interior space defined by the simulated vaginal canal 115.

[0036] As described above, the simulated bladder 150 is connected to a fill tube 155 that extends outside the simulated pelvic frame of the vaginal incision model. In various embodiments, the fill tube 155 passes through a fill tube dedicated hole 335 in the simulated vaginal opening 105. The dedicated hole 335 is located above the main opening of the simulated vaginal opening 105 that provides access to the simulated vaginal canal 115. The fill tube 155 is connected to a pump (e.g., a hand pump) (not shown).

[0037] In various embodiments, the simulated vaginal opening 105, the simulated vaginal canal 115, the simulated cervix, the connector 130, and the simulated bladder-cervical space 135 are formed together as a single structural or monolithic piece. In various embodiments, this is done by continuous casting using several different molds. Specifically, one mold can be used to cast the simulated vaginal canal 115 along with the simulated cervix and the connector as a single monolithic structure. Once this mold is complete, the combined structure is introduced into another mold, casting the simulated bladder-cervical space 135 over the simulated vaginal canal 115 and the simulated cervix. Another cast is then performed to cast the simulated vaginal opening 105 over the previous combination. These continuous castings result in a group of components (e.g., the simulated vaginal opening 105, the simulated cervix, the simulated bladder-cervical space 135, the connector 130, and the simulated vaginal canal 115) that are all connected to each other or formed as a single monolithic structure without the need for adhesives or other types of bonding features to hold the components together. In various embodiments, the group of components (e.g., the simulated vaginal opening 105, the simulated cervix, the simulated bladder-cervical space 135, the connector 130, and the simulated vaginal canal 115) can be cast in separate molding steps and assembled together, for example, using an adhesive. In various embodiments, the connector and the simulated cervix are formed as a single monolithic structure.

[0038] In various embodiments, the simulated vaginal opening is sized and / or shaped to provide an enlarged portion of the simulated vaginal opening that folds over the top of the simulated pelvic frame. In some embodiments, the simulated pelvic frame can have a cover spaced apart from and parallel to a base of the simulated pelvic frame. In various embodiments, a cover is attached to a proximal end of the simulated pelvic frame (e.g., as shown in Figures 4D and 5). An enlarged portion of the simulated vaginal opening is attached to the cover. The enlarged or folded portion of the simulated vaginal opening is configured to provide a thickened area of ​​simulated conductive tissue and is thus positioned and adapted to make physical and electrical contact with a ground pad removably connected to an electrosurgical generator.

[0039] Continuing to refer to FIG. 3, in various embodiments, a simulated cervix is ​​connected to the simulated vaginal canal 115. Specifically, the simulated cervix is ​​so connected that the proximal end of the simulated cervix extends toward the main opening of the simulated vaginal introitus 105. Meanwhile, the simulated cervix is ​​connected and / or extends to provide a connector 130 that extends distally toward the distal end of the vaginal incision model. In various embodiments, the user is instructed to manipulate and steer the proximal end of the simulated cervix. Thus, the simulated cervix and the simulated vaginal canal can move relative to each other. In various embodiments, the connector 130, distally connected and / or integral to the simulated cervix, is connected to one or more cords 125.

[0040] In various embodiments, the connector 130 comprises an elongated tube, which in various embodiments is formed of a conductive material and / or a reinforcing sleeve (e.g., mesh). The number and arrangement of the cords 125 provide suspension, movement and / or tension of the simulated cervix and simulated vaginal canal 115 that is not particularly anatomically correct (e.g., because the vaginal canal and / or cervix are held by any number of different tissues and / or organs, such as the uterus and ligaments). In various embodiments, one or more cords 125 and / or connectors 130 allow the entire vaginal incision model to not implement various organs and / or tissues that would increase the complexity of the model. The simplification of the vaginal incision model provides advantages in assembly, cost and waste reduction, as well as focusing the user's attention on the relevant parts of the model that are uniquely suited to learning, training and practicing vaginal incision techniques.

[0041] 2E shows another view of the simulated vaginal canal 115, the simulated cervix 120, the simulated bladder-cervical space 135, and the connector 130. For example, the connector 130 is shown with an embedded reinforcing matrix (e.g., reinforcing sleeve material) 350. Also shown is further detail regarding the simulated bladder-cervical space 135. Specifically, the simulated bladder-cervical space 135 has a first layer 352, a second layer 354, and an interface material (e.g., silicone grease) 250 disposed in various portions between the first layer 352 and the second layer 354.

[0042] 2F illustrates another embodiment of the simulated bladder-cervical space 135. Specifically, the placement of the simulated bladder-vaginal septum 260 is reduced such that the simulated bladder-vaginal septum 260 does not extend along the entire length of the simulated bladder-cervical space 135. Instead, an additional interface material 250 is provided between the two layers 352, 354 of the simulated bladder-cervical space 135 beyond the simulated bladder-vaginal septum 260. The additional interface material 250 added to the simulated bladder-cervical space 135 provides additional space within the layers 352, 354 of the simulated bladder-cervical space 135 that can be separated using blunt dissection, thereby expanding the separation surface over which a user (e.g., surgeon) can work during the simulated vaginal dissection procedure.

[0043] 4A-4D, which illustrate different views (e.g., front, back, side, and top) of an embodiment of a vaginal incision model. The vaginal incision model provides a particular simulation model for teaching, training, and / or practicing a vaginal incision. In various embodiments, the components and component arrangements associated with the vaginal incision model are not designed to be exact replicas of human anatomy. Rather, in various embodiments, the vaginal incision model includes components useful for a user to learn and practice a vaginal incision, for example, with irrelevant tissues and / or organs (e.g., uterus) omitted. Some of the components of the model and / or portions thereof are provided to allow a user to recognize and become familiar with the interaction with the various tissues and / or organs associated with a vaginal incision. For example, the simulated vaginal canal has associated folds that are provided as useful anatomical markings or indicators that can direct the user as to where the user should look for the incision point within the simulated vaginal canal.

[0044] FIG. 4A shows the anterior or proximal end of the vaginal incision model. From the front of the vaginal incision model, one can see the simulated vaginal opening attached to the simulated pelvic frame, the filling tube and the connected pump. The filling tube and pump are provided to allow for simulating the inflation of the bladder during the vaginal incision. The user uses the pump to introduce air into the simulated bladder (through the filling tube) so that the simulated bladder is inflated during the simulated vaginal incision. This action can correspond to the surgical practice of, for example, introducing saline to inflate the bladder while the surgeon is performing the vaginal incision. In various alternative embodiments, it is also contemplated to replace the pump to provide other liquid or gas sources to simulate this step of the vaginal incision. The filling tube is inserted into the vaginal incision model through the opening of the simulated vaginal opening.

[0045] In addition to the filling tube and pump, FIG. 4A also shows a simulated vaginal opening assembled on the simulated pelvic frame. The simulated vaginal opening provides access via a main opening to a simulated vaginal canal (not shown) that defines an interior space in which the simulated cervix (not shown) can be grasped and manipulated (e.g., pulled). In various embodiments, the simulated vaginal opening is attached to the simulated pelvic frame, for example using an adhesive, so that the simulated vaginal opening does not become dislodged from the simulated pelvic frame during use. In various embodiments, the simulated vaginal opening is removable from the simulated pelvic frame. This allows for removal and replacement of the simulated vaginal opening (and any of the associated ancillary components, such as the simulated cervix, simulated vaginal canal, simulated bladder-cervical space, etc.). In various embodiments, the simulated vaginal opening and associated components are designed to be single-use and / or disposable.

[0046] In various embodiments, particularly when the vaginal incision model is used in connection with simulating electrosurgery, a grounding pad may be attached and / or incorporated into the simulated vaginal opening for the purpose of managing the electricity used during the simulation. The grounding pad may be removably attached and / or contacted to at least a portion of the surface of the simulated vaginal opening, for example, via a portion of the top of the vaginal incision model. Other embodiments are contemplated that incorporate grounding pads on more or less of the surface of the simulated vaginal opening and at different locations along the simulated vaginal opening while not obscuring the main opening that provides access to the simulated vaginal canal.

[0047] In various embodiments, the vaginal incision model or portions thereof are formed of a conductive material (e.g., including a conductive hydrogel). In various embodiments, only the simulated cervix, simulated peritoneal layer, simulated bladder-cervical space, simulated vaginal canal, and / or simulated vaginal opening are formed of or include a conductive material. In various embodiments, the simulated pelvic frame, one or more cords, filling tubes, and / or pumps are not conductive, insulated, and / or formed of a conductive material to prevent or reduce potential damage and / or heat spread and / or effects on other portions of the vaginal incision model, the surgical training device, and / or surrounding areas.

[0048] FIG. 4B shows the rear or distal end of the vaginal incision model. Specifically, a layer is used to simulate the peritoneal layer located at the rear of the pelvic frame. In various embodiments, the layer used to simulate the simulated peritoneal layer comprises a conductive material. The simulated peritoneal layer is a part of the simulated vaginal incision that the user must incise to reach the simulated peritoneal cavity that corresponds to the open space at the distal end of the vaginal incision model behind the simulated peritoneal layer. Reaching the simulated peritoneal layer requires that the user has already made an incision in the simulated vaginal canal and dissected the simulated bladder-cervical space.

[0049] In various embodiments, the simulated peritoneal layer covers the entire posterior / distal end of the vaginal incision model (e.g., from the top where the simulated vaginal opening is located with the simulated pelvic frame to the base of the simulated pelvic frame), and the edges of the simulated peritoneal layer are attached (e.g., via adhesive) to the sides and / or base of the simulated pelvic frame such that access to the simulated bladder and simulated cervix is ​​completely blocked by the simulated peritoneal layer from the posterior or distal end of the vaginal incision model.

[0050] In various embodiments, a portion of the simulated peritoneal layer is also attached (e.g., via conductive adhesive) to the simulated bladder and connector. As shown in FIG. 1A, attaching the simulated peritoneal layer to the simulated bladder allows the simulated peritoneal layer to move based on changes associated with the expansion of the simulated bladder and / or the movement of the connector / simulated cervix. Similarly, a portion of the simulated peritoneal layer is attached (e.g., via conductive adhesive) to the connector and / or simulated cervix. Thus, the user (while performing the simulated vaginal incision) will look for a point in the simulated peritoneal layer where the simulated peritoneal layer will invert based on the current state of the simulated peritoneal layer. The simulated peritoneal inversion corresponds to a portion where the simulated peritoneal layer appears to be partially folded back on itself. In other words, when viewed from the side of the simulated vaginal canal of the vaginal incision model, the simulated peritoneal layer has a portion that appears more convex as opposed to concave. The simulated peritoneal inversion is a desired location for the user to incise the simulated peritoneal layer to access the peritoneal cavity behind the simulated peritoneal layer while avoiding incising or accessing undesirable areas such as the simulated cervix, connector, simulated bladder and / or areas surrounding the simulated bladder.

[0051] FIG. 4C shows a side view of the vaginal incision model. This view of the vaginal incision model shows various apertures associated with the simulated pelvic frame, apart from the simulated vaginal opening, filling tube and pump visible above in FIG. 4A. Specifically, the simulated pelvic frame has a first series of apertures located near the central outer surface. In various embodiments, the first series of apertures are used to suspend (in conjunction with cords attached to connectors) the internal components of the vaginal incision model housed within the simulated pelvic frame. In various embodiments, the internal components of the vaginal incision model can be suspended using one (e.g., as shown in FIG. 6A) or two or more cords (e.g., as shown in FIG. 6B).

[0052] In an example embodiment, a cord is used to suspend the internal components of the vaginal incision model within the simulated pelvic frame. As shown in FIG. 6A, a first end of the cord is tied to itself at an aperture (1) in one wall of the simulated pelvic frame. The opposite end of the same cord passes through one end of a connector (2) to interconnect with an aperture (3) in the other wall of the simulated pelvic frame. The cord then exits the simulated pelvic frame through one aperture and re-enters the simulated pelvic frame through a nearby aperture (4). Thus, when viewed from outside the vaginal incision model (as shown in FIG. 4C), the user only sees a portion of the cord (B) that obscures a portion of the aperture associated with the simulated pelvic frame. After re-entering the simulated pelvic frame, the cord passes through an opposite end (5) of the connector and can be tied to itself at a nearby aperture (6) in the same wall as the first end of the cord.

[0053] In various embodiments, the connector, simulated cervix, and / or portions thereof are reinforced and / or tear resistant to withstand movement and / or support one or more cords that pass through and / or are otherwise attached to the connector. In various embodiments, the connector comprises conductive tissue having embedded therein a reinforcing matrix or sleeve (e.g., a knitted Kevlar tube or mesh) including a conductive hydrogel or the like, through which the cords are threaded and / or attached.

[0054] In various embodiments, a fiber-based support structure can be used to reinforce the connector, and in various embodiments, the connector is a braided, woven, and / or wound yarn support structure. Example embodiments of yarn support structures are shown in Figure 2G. Specifically, Figure 2G shows the yarn support structure in a mold prior to being assembled into a connector.

[0055] The yarns can limit the stretching of the simulated cervix and / or connector when the user performs a simulated colpotomy. Additionally, embodiments using yarn support structures can be customized by adjusting the type of yarn used and the amount of yarn used. For example, more yarns can be used when constructing the yarn support structure such that a higher percentage of fiber is present when the volume associated with the connector 130 and / or simulated cervix 120 is the same. The change in the percentage of fiber can be used to adjust the feel and stretch of the connector and / or simulated cervix to better simulate a colpotomy.

[0056] Also, by using yarns or the like, the embodiments can be color coded by selecting yarns of any color. For example, in various embodiments, the yarn color can be selected to correspond to the color associated with the simulated cervix 120. This can eliminate a casting step in forming the vaginal incision model, since a separate step is no longer required to differentiate colors between the interior of the simulated cervix 120 and structures associated with the simulated bladder-cervical space 135. Thus, the yarn support structure can simplify or reduce manufacturing costs. In various embodiments, the yarn color can be selected to be different / different from the color associated with the simulated cervix 120. This color difference allows for a viewing direction that the user can use to indicate where to proceed in the simulated vaginal incision. In various embodiments, the yarn color difference can be used in place of any texture landmarks or other anatomical color schemes to instruct the user how to proceed in the simulated vaginal incision. In various embodiments, the yarn color difference can be used in conjunction with texture landmarks or anatomical color schemes to guide the user during the simulated vaginal incision.

[0057] Figure 2H illustrates various steps associated with forming a yarn support structure prior to placement of the yarn support structure molded with connector 130 as shown in Figure 2G, although variations on the steps (other than those shown) are contemplated, some of which are highlighted below where appropriate.

[0058] A three-dimensional mandrel is formed to provide a particular shape of the yarn support structure that corresponds to the shape of the connector mold. A three-dimensional mandrel, such as mandrel 292, is designed to hold strands of yarn in place as the yarn support structure is assembled (e.g., knitted, woven, bundled, and / or wound). The three-dimensional mandrel can be formed via two or more separate two-dimensional components 290, where the two-dimensional components are connected to form the three-dimensional shape of mandrel 292 that corresponds to the shape of the yarn support structure.

[0059] In the embodiment shown in FIG. 2H(1), the two-dimensional components 290 have corresponding slits that run partially through the center of each component. This allows the two corresponding components to hold together and maintain their shape without the use of adhesives. Other embodiments can utilize a different number of separate components (two-dimensional or three-dimensional) that are connected in different ways to form a three-dimensional mandrel, such as mandrel 292 as shown in FIG. 2H(2). For example, two-dimensional components can be glued together to form a three-dimensional mandrel. In different embodiments, multiple three-dimensional sections can be stacked together to form the three-dimensional mandrel. Additionally, in various embodiments, the mandrel can be a three-dimensional monolithic structure.

[0060] In various embodiments, the cross section of the three-dimensional mandrel is a "plus sign" formed by two two-dimensional components 290 connected together. In other embodiments, multiple two-dimensional components can be prepared that when connected result in different cross sections of the three-dimensional mandrel, such as a lattice. Based on this shape (and the corresponding cross section of the three-dimensional mandrel), the placement of the yarns and / or the amount of yarn present in the yarn support structure can be controlled. By varying the placement and volume percentage of the yarns or fibers, etc. contained in the yarn or fiber support structure, the stretchability and stiffness of the connector 130 with the yarn or fiber support structure embedded therein can be adjusted.

[0061] In various embodiments, once the three-dimensional mandrel is formed, a strand of yarn is placed onto the three-dimensional mandrel. In one embodiment, the strand is wrapped longitudinally around one of the associated sides (e.g., an extension of the plus sign) of the three-dimensional mandrel, as shown, for example, in FIG. 2H(3). In various embodiments, this wrapping continues until each side of the three-dimensional mandrel is completely covered with yarn, as shown, for example, in FIG. 2H(4).

[0062] In various embodiments, after each side of the three-dimensional mandrel is wrapped longitudinally, yarns are wrapped along the cross-section of the three-dimensional mandrel along the entire length of the three-dimensional mandrel, for example as shown in FIG. 2H(5). The yarn support structure is completed such that the inner arrangement of yarns is surrounded by an outer layer of yarn. In various other embodiments, other arrangements (e.g., reversing or alternating horizontal and longitudinal arrangements of yarns) may be possible.

[0063] Once the yarn support structure is formed on the three-dimensional mandrel, the yarn support structure and the three-dimensional mandrel are placed in a mold (as shown in FIG. 2G) to cast into the connector 130. In various embodiments, the material used to cast the connector 130 can be a conductive material. After casting the connector 130 (and the lower portion of the simulated bladder-cervical space 135), various exposed fibers associated with the yarn support structure may be present along with the three-dimensional mandrel. If left in this state, the connector 130 is considered usable but not ideal, as the excess yarn and / or three-dimensional mandrel material may confuse the user and interfere with the simulated vaginal incision. Once the material of the connector 130 has hardened (thereby encapsulating most of the yarn support structure inside), the excess yarn can be removed to accommodate the outer surface of the connector.

[0064] In addition to removing excess yarns, the three-dimensional mandrel may also be removed from within the connector 130. In some embodiments, if the three-dimensional mandrel is formed of multiple two-dimensional or three-dimensional components, these separate components may be disassembled and removed individually. In other embodiments, yarns may be placed around the three-dimensional mandrel such that the three-dimensional mandrel will slide out from within the connector 130 once the material forming the outer surface or portion of the connector 130 has hardened. In some embodiments, the three-dimensional mandrel may be freed for removal by cutting a portion of the yarn from within the yarn support structure that holds the three-dimensional mandrel in place.

[0065] In various embodiments, once the three-dimensional mandrel is removed, the interior of the yarn support structure can be filled with additional yarn or other material to provide additional support / structure to the connector 130. In various embodiments, the interior of the yarn support structure can also be left empty.

[0066] In various embodiments, two or more cords are used to suspend the connector, the simulated vaginal canal, and / or the simulated cervix. For example, as shown in FIG. 6B, each cord is connected (one end) to a different point on the connector that is distally connected to the simulated cervix (X). The other end (Y) of each cord is looped at a different aperture and tied to itself to secure the cord to the simulated pelvic frame. In various embodiments, one end of a cord, such as a proximal cord and / or a distal cord, is attached or connected to a first wall of the simulated pelvic frame, and the cord extends through or through the connector to a second or opposing wall of the simulated pelvic frame, where the other end of the cord is attached. In various embodiments, the cord is attached to the wall of the pelvic frame by passing the cord through an adjacent opening or aperture and tying a knot.

[0067] In various embodiments, the cord extends perpendicular to the direction of the connector and remains generally parallel to the base of the simulated pelvic frame. In various embodiments, the free end(s) of the cord are then "looped" through an aperture in the pelvic frame, such that the free end of the cord exits the interior of the pelvic frame through one aperture and re-enters the pelvic frame through an adjacent aperture. In various embodiments, the cords are generally positioned equidistant from each other along the overall length of the connector, such that the position of the cord on one side of the connector accurately mirrors the other side of the connector. Inside, the cord can be attached to itself or the connector, for example, using an adhesive. In various embodiments, a portion of the cord can be threaded and / or embedded in the connector. In various embodiments, the cord can be knotted or tied near the aperture to secure the cord to the simulated pelvic frame. In various embodiments, the tension / elasticity of the cord can be adjusted to similarly affect the suspension and movement of the simulated cervix within the simulated pelvic frame.

[0068] In various embodiments, the cord is formed of a continuous length of fiber or filament. In various embodiments, the cord is formed of monofilament fiber. In various embodiments, the cord comprises yarn and / or nylon. In various embodiments, the cord is flexible, allowing it to bend, curve and / or move on its own. In various embodiments, the cord is tear resistant. In various embodiments, the cord has greater tensile strength, longitudinal strength and / or lateral strength than the connector, the simulated cervix and / or the simulated vaginal canal. In various embodiments, the simulated pelvic frame or a portion thereof is stiffer and / or has a higher tensile strength than the cord. In various embodiments, the cord can be incorporated into, attached to and / or extend from the yarn support structure and / or be a monolithic extension or continuation of the yarn or fiber of the yarn support structure.

[0069] In various embodiments, the simulated pelvic frame can include multiple other apertures in other locations (e.g., on the sides of the exterior surface B of the simulated pelvic frame wall as shown in FIG. 4C). These apertures can also be used to suspend other additional organs or tissues not described in this disclosure, but can also be added later to allow the present vaginal incision model to be used for other simulated surgical procedures. These apertures can also be used to secure the pelvic frame to a surgical training device. In various embodiments, one or more of these other apertures can be used to suspend the simulated cervix and other components (e.g., a simulated vaginal canal), and therefore some of the apertures shown can be removed / not included.

[0070] 4D shows the top of the vaginal incision model. In various embodiments, this view of the vaginal incision model shows a portion of the simulated vaginal opening disposed across the top of the simulated pelvic frame above the simulated vaginal canal and simulated cervix, and in various embodiments participating in and / or forming an enclosed space. In various embodiments, a grounding pad may be attached or otherwise attached to this portion of the simulated vaginal opening.

[0071] The top view of the vaginal incision model also provides a view of the overall shape of the simulated pelvic frame. Specifically, the simulated pelvic frame has a conical or frusto-conical shape that generally corresponds to a distal end being wider than a proximal end. Additionally, the simulated pelvic frame has two side walls perpendicular to the base. The interior of the simulated pelvic frame (between the two side walls) is generally open between the distal and proximal ends.

[0072] In various embodiments, the top of the simulated pelvic frame can include a top cover that is parallel to the base and at least partially covers the interior of the simulated pelvic frame, which can be used to secure a simulated vaginal opening and / or a grounding pad in position above the internal components of the vaginal incision model.

[0073] 5 shows the internal components of the vaginal incision model placed within the simulated pelvic frame. Specifically, this figure shows an embodiment of the vaginal incision model viewed from the distal end where the simulated peritoneal layer does not obscure the internal components of the vaginal incision model. In various embodiments, the simulated peritoneal layer is removable and replaceable.

[0074] In various embodiments, the cord is arranged in a predetermined manner to allow the simulated cervix to move back and forth in response to a user grasping and moving the simulated cervix within the simulated vaginal canal. As shown, the cord is attached to the connector with generally equal spacing on either side of the connector. The cord is also arranged substantially parallel to the base of the simulated pelvic frame. Additionally, the cord has a predetermined height above the base of the simulated pelvic frame and / or a predetermined tension and / or elasticity such that the connector maintains movement within the frame and / or relative to other portions of the vaginal incision model.

[0075] In various embodiments, the vaginal incision model may also include a ground cable removably attached to the vaginal incision model, for example at the end of a connector distally connected to the simulated cervix, and another end of the cable removably attached to the electrosurgical generator, as shown in Figure 5. If the vaginal incision model is to be used via cold-cutting devices only (i.e., not electrosurgery), the ground cable may be removed and / or a ground pad may not be attached to or in contact with the model.

[0076] In various embodiments, the cables and / or ports can be associated with a portion of the vaginal incision model that is adapted to receive other cables and / or ports used to manage electrosurgical energy. Features of the cables and / or ports can be cast as part of the vaginal incision model.

[0077] In various embodiments, it may not be desirable to attach a ground cable to the connector, as the ground cable itself may interfere with the movement of the simulated cervix and even affect the user's ability to discern where "rolling" of the simulated vaginal canal occurs. Additionally, the use of a ground cable inside the patient is not representative of traditional management of electrosurgical energy during the performance of an electrosurgery procedure.

[0078] Alternative embodiments are envisioned in which a removable ground pad is attached directly to the connector instead of using a ground cable, however similar to the use of a ground cable as described above, this may affect the suspension and associated movement of the simulated cervix.

[0079] In various embodiments, a selection of a portion of the simulated vaginal opening (e.g., the top cover) provides sufficient area for electrical connection, and therefore, it may be desirable to implement the grounding pad in such a location so as not to interfere with user manipulation of other portions of the vaginal incision model (e.g., movement of the simulated cervix / vaginal canal and / or movement that distracts the user).

[0080] With reference to Figures 7A-7E, the various steps of the vaginal incision procedure (described above) are described in relation to the use of a vaginal incision model. In Figure 7A, a user can grasp / manipulate the simulated cervix (located within the simulated vaginal canal) back and forth while simultaneously retracting the main opening of the simulated vaginal canal to identify where in the simulated vaginal canal the incision should be placed. The location of the incision is useful to avoid accidentally cutting into undesirable tissue and / or organs (such as the cervix, uterus, bladder, etc.). Generally, the point of interest is located beyond the folds of the simulated vaginal canal in areas where the simulated vaginal canal is smooth. The folds, as shown in Figure 7B, correspond to successive ridges in the simulated vaginal canal. As the cervix is ​​moved, a portion of the tissue of the vaginal canal rolls corresponding to where the tissue near the simulated cervix becomes concave. The point where the tissue of the vaginal canal rolls is where the incision will be made. Figure 7C shows an example scenario where a user incises the tissue of the simulated vaginal canal near the simulated cervix. Such a stationary or not easily movable or manipulable simulated cervix is ​​not ideal for identifying target areas within the vaginal canal because identifying target areas for dissection may be difficult, if not possible at all.

[0081] The user incises the vaginal mucosa of the simulated vaginal canal after identifying the incision point. The user enters the simulated bladder-cervical space beyond the incision in the simulated vaginal canal, as shown in FIG. 7D. The user then begins to incise the simulated bladder-cervical space.

[0082] As shown in FIG. 2D, the simulated bladder-cervical space has a separation surface that the user follows that leads to the distal portion of the vaginal incision model toward the simulated peritoneum. This separation surface of the simulated bladder-cervical space has layers that can be separated using blunt dissection. FIG. 7F shows the user dissecting the separation surface. In areas where the interface material (e.g., silicone grease) is placed, the two layers are only partially, temporarily and / or removably attached and can be peeled away using blunt dissection. In areas where the interface material is not present, the two layers come together to form a cohesive strip (corresponding to a septum) that can only be separated by sharp dissection (e.g., snipping). The peeling action in separating the two partially attached layers corresponds to the feeling of separating tissues in the corresponding areas of the human anatomy.

[0083] After exiting the simulated bladder-cervical space, the user seeks to identify the location of the simulated peritoneal inversion (see FIG. 1A ) located on the simulated peritoneal layer. The simulated peritoneal inversion generally corresponds to a convex (e.g., partially folded over itself) point in the simulated peritoneal layer. Once identified, the user is instructed to make an incision in the simulated peritoneal inversion to access the simulated peritoneal cavity beyond the simulated peritoneal layer. For example, FIG. 7E shows the completion of this incision.

[0084] In various embodiments, the surgical training device 10 is configured to receive one or more simulated tissues, organs, or models for the purpose of simulating a laparoscopic surgical procedure performed in a patient. In the context of the present application, and with reference to FIG. 8, the surgical training device 10 is configured to receive the vaginal incision model described above. FIG. 8 is a top perspective view of an exemplary surgical training device. The surgical training device 10 is particularly suited for practicing laparoscopic or other minimally invasive surgical procedures because the surgical training device 10 is configured to simulate conditions associated with laparoscopic procedures, such as the torso / abdominal area of ​​a patient. One feature that facilitates the simulation of conditions associated with laparoscopic procedures is that the surgical training device 10 can be configured to obscure a user's direct view of the simulated tissues, model organs, and / or training models contained within the surgical training device 10 to be practiced.

[0085] Continuing to refer to FIG. 8, the surgical training device 10 provides a body cavity 12, substantially hidden from a user, configured to receive simulated tissue, model organs, and / or training models as described herein. In some embodiments, the body cavity 12 can be accessed through a tissue simulation region 14 that is penetrated by a user using surgical instruments (e.g., laparoscopic instruments) to practice surgical techniques on simulated tissue, model organs, and / or training models known to be disposed within the body cavity 12. In various embodiments, the body cavity 12 can also be accessed through a hand-assisted access device or a single-site port device that is alternatively employed to access the body cavity 12. In various embodiments, the body cavity 12 can be accessible through both the tissue simulation region 14 and the hand-assisted access device or single-site port device. An exemplary surgical training device is described in U.S. patent application Ser. No. 13 / 248,449, entitled "Portable Laparoscopic Trainer," filed Sep. 29, 2011, which is incorporated by reference in its entirety into this specification.

[0086] The surgical training device 10 is designed to have a top cover 16 connected to and spaced apart from a base 20 by at least one leg 20 to hide the body cavity 12 from a user. In various embodiments, the surgical training device 10 can have one or more legs 20. Using the top cover 16, the base 20, and the at least one leg 20, the surgical training device 10 is configured to simulate laparoscopic conditions in which the body cavity 12 is hidden from a direct view of the user. Such laparoscopic conditions can correspond to procedures associated with a user (e.g., a surgeon) operating on tissues or organs present inside a patient (e.g., a body cavity), such as the abdominal region. Thus, the surgical training device 10 is a useful tool for teaching, practicing, and demonstrating surgical procedures with associated surgical instruments by simulating a patient undergoing a surgical procedure.

[0087] As described above, surgical instruments are inserted into the body cavity 12 through one or more tissue simulation areas 14 and predefined apertures 22 via a hand-assisted access device or single site port device located in the top cover 16 of the surgical training device 10. The top cover 16 may have pre-formed openings, or may allow for further simulation of a surgical procedure by penetrating the top cover 16 using various surgical instruments and techniques to access the body cavity 12. Once inside the body cavity 12, a user may perform a simulated surgical procedure using simulated tissues, organs or models located within the body cavity 12 between the top cover 16 and the base 18. FIG. 9A illustrates an example embodiment of the surgical training device 10 used to house a vaginal incision model (as described above in this application) designed for teaching, practicing and demonstrating vaginal incision techniques.

[0088] Referring again to FIG. 8 , in various embodiments, the simulated tissue, organ, or model is secured beneath one or more of the tissue simulation areas 14 or apertures 22 disposed within the top cover to ensure that the simulated tissue, organ, or model does not move during use of the surgical training device 10. To secure one or more simulated tissues, organs, or models disposed within the body cavity 12, the base 18 can be designed with a model receiving area 24 or tray configured to place or secure the simulated tissue, organ, or model in place within the surgical training device 10. In various embodiments, the model receiving area 24 of the base 18 can include a frame-like element for holding the simulated tissue, organ, or model in place. The frame-like element can interface with at least a portion (e.g., a bottom portion) of the simulated tissue, organ, or model to prevent the simulated tissue, organ, or model from moving or being displaced during use of the surgical training device 10. In various embodiments, the frame-like element is configured to receive a number of different types of simulated tissues, organs or models such that the simulated tissues, organs or models are removable and replaceable with other simulated tissues, organs or models.

[0089] Continuing to refer to FIG. 8, in other embodiments, the simulated tissue, organ, or model may also be secured via a clip attached to the retractable wire. Specifically, the retractable wire and clip may be provided at various locations (e.g., 26) within the body cavity 12 associated with the model receiving area 24. The retractable wire may be extendable from various locations (e.g., 26) to allow the clip to be attached to the simulated tissue, organ, or model. As a result, the retractable wire may be tensioned to secure the simulated tissue, organ, or model. Similarly, in various embodiments, the retractable wire and clip may also allow for a removable connection between the base 18 and the simulated tissue, organ, or model. The retractable wire and clip are adapted to secure a variety of different simulated tissues, organs, or models within the body cavity 12, where each simulated tissue, organ, or model may have a different size and shape.

[0090] Other means for securing the simulated tissue, organ or model within the body cavity 12 are also envisioned. For example, the simulated tissue, organ or model may be secured to the base 18 using a patch of hook-and-loop type fastening material, such as VELCRO®, that allows the simulated tissue, organ or model to be removably connected to the base 18. In other embodiments, other attachment methods may be utilized that do not provide a removable connection between the base 18 and the simulated tissue, organ or model. For example, an adhesive may be used to provide an additional connection between the base 18 and the simulated tissue, organ or model that is not easily removable.

[0091] In various embodiments, a video display monitor 28 is provided with the surgical training device 10. For example, the video display monitor 28 can be hinged to the top cover 16 and have at least two different orientations: a closed orientation in which the video display monitor 28 is hidden, and an open orientation in which the video display monitor 28 is viewable by a user. In various embodiments, the video display monitor 28 can be separate from the top cover 16 while still being communicatively connected to the surgical training device 10.

[0092] In various embodiments, the video display monitor 28 is communicatively connected to various vision systems that deliver images to the video display monitor 28. For example, a laparoscope inserted through one of the predefined apertures 22, or an image capture device (e.g., a webcam) positioned within the body cavity 12, can be configured to capture images of the simulated surgery performed by the user and transmit the captured images to the video display monitor 28 and / or other computing devices (e.g., desktop, mobile devices) so that the user can view areas within the surgical training device 10. In various embodiments, other devices (e.g., microphones, sensors) can also be used in conjunction with the surgical training device 10 to capture other types of data, such as audio data that can be displayed on the video display monitor 28 in combination with the visual data.

[0093] The surgical training device 10 may be configured to receive a portable memory storage device, such as a flash drive, a smart phone, a digital audio or video player, or other digital mobile device, which further facilitates recording of the simulated surgical procedure for demonstration purposes and / or playback on a monitor of data acquired from the surgical training device 10. In various embodiments, additional or different (e.g., larger) audiovisual devices may be connected to the surgical training device 10 that may be used to display audiovisual data acquired from the surgical training device 10. In various embodiments, the surgical training device 10 may be communicatively connected (e.g., wired or wireless) to a different computing device (e.g., desktop, laptop, mobile device) configured to receive data acquired from the surgical training device 10 and display the data for viewing by other persons. Such embodiments may be useful in variations of the surgical training device 10 that do not include a video display monitor 28.

[0094] As shown in FIG. 8, the top cover 16 is generally disposed directly over the base 18 using one or more legs 20 disposed substantially along the periphery of the base 18. The legs 20 interconnect between the top cover 16 and the base 18. In embodiments where there are one or more legs 20, the legs are spaced equidistant from one another and can function as structural support to hold the top cover 16 in place over the base 18. In various embodiments, the top cover 16 and the base 18 are substantially the same shape and size, and have substantially the same peripheral contours. In various embodiments, the shape can correspond to the shape of a human anatomy, such as a patient's torso / abdominal region.

[0095] In various embodiments, the body cavity 12 can be partially or completely hidden from a user's view depending on the arrangement of the top cover 16, the base 18, and the one or more legs 20. In some variations, the legs 20 can include openings to allow the body cavity 12 to be illuminated by ambient light while providing an overall lighter weight for the surgical training device 10. The apertures associated with the legs 20 can also allow a user to view and / or access within the body cavity 12 of the surgical training device 10.

[0096] In various embodiments, the top cover 16 is removable from one or more legs 20. Also, in various embodiments, each leg is removable or foldable relative to the base 18. These features allow a user to convert the surgical training device 10 into a low-profile, portable configuration.

[0097] As mentioned above, the surgical training device 10 is configured to receive a vaginal incision model for the purpose of simulating laparoscopic conditions useful for simulating surgical procedures performed in a patient. As shown in FIG. 9A, an embodiment of the surgical training device 10 is used to accommodate the vaginal incision model. As mentioned above, the vaginal incision model is designed to allow a user, such as a surgeon, to learn how to perform a vaginal incision based on what is shown by identifying relevant anatomical landmarks. Furthermore, the vaginal incision model is designed to provide feedback and / or responses to a user's interaction with the vaginal incision model similar to responses that would occur when performing an actual vaginal incision.

[0098] In various embodiments, the vaginal incision model is designed to be compatible with cold cutting devices, such as electrosurgical devices as well as non-electrosurgical devices, and thus the vaginal incision model can be used to simulate electrosurgical procedures, non-electrosurgical procedures, or a combination thereof.

[0099] FIG. 9B illustrates an embodiment of the surgical training device 10 housing a vaginal incision model while being utilized to simulate a vaginal incision. Specifically, a user utilizes different surgical instruments (e.g., laparoscope, grasper, dissector) to perform different surgical tasks using the vaginal incision model within the surgical training device 10 to perform a vaginal incision. For example, one or more surgical instruments can be used to provide a visual of the vaginal incision model disposed within the surgical training device 10. Additionally, one or more instruments can be used to manipulate various features of the vaginal incision model, including, but not limited to, moving parts of the vaginal incision model to identify where the required incision should be made and making the incision at the desired location.

[0100] According to various embodiments, described herein is a model designed to teach a user how to perform and allow them to practice a colpotomy. The present disclosure describes various embodiments of a colpotomy model.

[0101] According to various embodiments, the vaginal incision model includes a simulated vaginal opening, a simulated pelvic frame, a simulated vaginal canal, a simulated cervix, a simulated bladder-cervical space, a simulated peritoneal layer, a connector, and / or a simulated bladder. In further embodiments, a fill tube and a pump can be connected to the simulated bladder to allow the user to inflate the simulated bladder.

[0102] In various embodiments, the vaginal incision model can be adapted for electrosurgical simulation. Thus, the vaginal incision model can have one or more features including conductive materials such as a simulated vaginal opening, a simulated vaginal canal, a simulated cervix, a simulated bladder-cervical space, a simulated peritoneal layer, a connector, and / or a simulated bladder. Additionally, the one or more features can include non-conductive materials such as a simulated pelvic frame. Additionally, the vaginal incision model can further include a grounding element useful for managing electrosurgical energy used in the electrosurgical simulation. In various embodiments, the grounding element can be a grounding pad attached to a portion of the simulated vaginal opening. In various embodiments, the grounding element can be a grounding cable attached to another portion of the vaginal incision model, such as a connector.

[0103] In various embodiments, the simulated pelvic frame accommodates the internal features of the vaginal incision model. In various embodiments, the simulated pelvic frame has a conical or frustoconical shape such that the proximal end of the simulated pelvic frame is narrower than the distal end of the simulated pelvic frame. In various embodiments, the simulated pelvic frame has at least two side walls with a plurality of apertures (or openings). The at least two side walls are perpendicular to the base of the simulated pelvic frame. In various embodiments, the interior of the simulated pelvic frame is generally open between the at least two side walls. In some embodiments, the simulated pelvic frame can have a cover spaced from the base at opposite ends of the side walls. The cover can generally enclose a portion of the interior space of the simulated pelvic frame. In various embodiments, the cover can be used to attach and hold the simulated vaginal opening and / or the grounding pad.

[0104] In various embodiments, the vaginal incision model includes a simulated vaginal opening surrounding a proximal end of the simulated pelvic frame. The simulated vaginal opening has at least one opening that provides access to the simulated vaginal canal. In various embodiments, the simulated vaginal opening includes a portion adapted to receive a grounding pad to configure the vaginal incision model to be compatible with an electrosurgical instrument. In various embodiments, batting is embedded within the simulated vaginal opening for support.

[0105] In various embodiments, the simulated vaginal canal includes two distinct sections. The first section of the simulated vaginal canal has a number of folds represented via ridges. The first section starts at the proximal end of the simulated vaginal canal and terminates at the beginning of the second section. The second section of the simulated vaginal canal is smooth (i.e., does not have ridges). The second section is located near the simulated cervix that extends from the distal end of the simulated vaginal canal into the interior space defined by the simulated vaginal canal. In various embodiments, the simulated vaginal canal is tubular or cylindrical with an open proximal end and a distal end to which the simulated cervix is ​​attached and / or penetrates. In various embodiments, the simulated vaginal canal includes a number of circumferential ridges resulting in peaks and valleys disposed throughout the length of the simulated vaginal canal.

[0106] In various embodiments, the proximal end of the simulated cervix extends into the interior space of the simulated vaginal canal. In various embodiments, the proximal end of the simulated cervix is ​​dome-shaped or hemispherical, and the distal side extends in a tubular or cylindrical shape. The distal end of the simulated cervix is ​​connected to or formed into a connector configured to receive one or more cords. The connector and one or more cords are provided to suspend the simulated cervix and allow for back and forth movement (e.g., a "rolling" motion) of the simulated cervix. In various embodiments, as the simulated cervix "rolls," a portion of the simulated vaginal canal everts (e.g., folds over) on itself. The eversion of tissue associated with the simulated vaginal canal near the simulated cervix corresponds to the area where the user will make an incision to access other portions of the model, as described below.

[0107] In various embodiments, the distal side of the connector or support is connected to or integral with the simulated cervix. The connector extends from the simulated cervix toward the distal end of the vaginal incision model. In various embodiments, the connector is configured to be connected to one or more cords that are provided to suspend the simulated cervix to facilitate movement, such as elastic and / or tensioning, thereof. In various embodiments, the cords can be threaded through the connector. The cords run parallel to the base of the simulated pelvic frame. The cords are configured to interface with the sidewalls of the simulated pelvic frame to provide suspension and / or movement of the simulated cervix. In various embodiments, the cords "loop" through apertures associated with the sidewalls of the simulated pelvic frame. In various embodiments, the connector is embedded with a reinforcing matrix that provides useful support when threading the one or more cords through the connector. In various embodiments, the connector is configured to receive a ground cable.

[0108] In various embodiments, a reinforcing matrix or sleeve formed of Kevlar or mesh is embedded in the connector. In other embodiments, the connector can be constructed of a yarn or fiber support structure. The yarn support structure is formed by wrapping strands of yarn around a three-dimensional mandrel. The yarn support structure is embedded by casting alongside / within the connector once positioned around the three-dimensional mandrel. The excess yarn and three-dimensional mandrel can be removed after the material has cured. The embedded reinforcing matrix, sleeve, yarn or fiber support structure provide the connector with various degrees of tensile resistance / stretchability and hardness.

[0109] In various embodiments, the simulated bladder-cervical space includes at least two layers. Various locations between the layers are provided with an interface material, such as silicone grease, that partially adheres the layers to each other at these locations. These locations also correspond to dissection planes that can be peeled apart using blunt dissection. In locations where an interface material, such as silicone grease, is not provided, the layers adhere to each other to form a cohesive zone or portion (corresponding to one or more vesicovaginal septa). The user dissects the simulated bladder-cervical space along the dissection planes to reach the simulated peritoneal layer. In various embodiments, the vesicovaginal septa can extend from one end of the simulated bladder-cervical space near the simulated vaginal canal to the other end of the simulated bladder-cervical space near the simulated peritoneal layer.

[0110] In various embodiments, the simulated bladder-cervical space can be cast as two separate steps, including a first step of casting a lower portion of the simulated bladder-cervical space onto the connector, and a second step of casting an upper portion of the simulated bladder-cervical space onto the lower portion of the simulated bladder-cervical space. In other embodiments, the lower portion of the simulated bladder-cervical space can be cast with the connector, and in a subsequent step, the upper portion can be cast onto the lower portion, with the latter embodiment eliminating or avoiding a separate casting step.

[0111] In various embodiments, the simulated vaginal opening, the simulated vaginal canal, the simulated cervix and connector, and the simulated bladder-cervical space are cast as a single monolithic structure, In various embodiments, the same elements can be cast as separate components and assembled together, for example, using an adhesive.

[0112] In various embodiments, a simulated peritoneal layer is disposed at the distal end of the vaginal incision model connected to at least the simulated pelvic frame, the simulated bladder, and a connector distally connected to the simulated cervix. A portion of the simulated peritoneal layer can be inverted based on movement of the simulated bladder and / or the connector corresponding to the point in the simulated peritoneal layer where the user will make the incision. In various embodiments, the simulated peritoneal layer comprises a conductive material.

[0113] In various embodiments, a mock bladder is provided that is configured to inflate during a mock colpotomy to replicate inflation of a bladder with saline during a real colpotomy. The mock bladder is inflated using a fill tube and a pump connected to the mock bladder. A user can use the pump to inflate the mock bladder by filling it with air.

[0114] In various embodiments, the mock bladder can be cast as an inflatable structure or envelope configured to receive air or the like used to simulate bladder expansion during colpotomy. In various embodiments, the mock bladder can include a balloon or fillable or inflatable container inserted within the inflatable structure. The balloon provides an airtight or air impermeable container for air or the like used to simulate bladder expansion. In various embodiments, the mock bladder can include additional material on top of the mock bladder. The additional material (embedded within or otherwise attached) provides a resistance associated with the expansion of the mock bladder, thereby orienting the mock bladder in a direction opposite to the placement of the additional material.

[0115] In various embodiments, the vaginal incision model is configured to be received and housed within the surgical training device. The surgical training device allows a user to simulate a vaginal incision under a laparoscope by simulating laparoscopic conditions. In various embodiments, the surgical training device includes a base, a cover, and one or more legs that are used to define an interior space that is generally hidden from the user's view. In various embodiments, a laparoscopic tool, sensor, or image capture device is used to capture audiovisual data within the surgical training device. A display screen or other connected computing device is also provided that allows the captured audiovisual data from within the surgical training device to be visible to the user.

[0116] While the present invention has been described in some specific aspects, many further modifications and variations will be apparent to those skilled in the art. It should therefore be understood that the present invention may be embodied in forms other than those specifically described, including various changes in size, shape and materials, without departing from the scope and spirit of the present invention. For example, those skilled in the art should be able to use these examples to derive a variety of different implementations that retain the primary functionality of the surgical training system described throughout this disclosure. Although some of the embodiments utilize descriptions that focus on structural and / or method-related steps, it should be understood that such subject matter is not necessarily limited to the details (e.g., the functionality of features may be distributed in different ways across multiple components or may be performed by different combinations of components than those specifically identified above). The embodiments of the present invention should therefore be considered in all respects as illustrative and not restrictive.

[0117] The above description is provided to enable one skilled in the art to make and use the apparatus or system and to perform the methods described herein, and also describes 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 lack of explicit description of each combination is merely for ease of reading this specification. [Explanation of symbols]

[0118] 100 Vaginal incision model 105 Simulated Vaginal Opening 110 Simulated pelvic frame 115 Simulated vaginal canal 120 Simulated cervix 125 Code 130 Connector 135 Simulated bladder cervical space 140 Simulated peritoneal layer 150 Simulated bladder 155 Filling Tube 160 Pump

Claims

1. A surgical model comprising: a simulated pelvic frame having a proximal end and a distal end, the simulated pelvic frame having a top cover, a base, and two side walls, the simulated pelvic frame having an opening at the proximal end defining an internal cavity adapted to receive one or more simulated tissue structures; a simulated vaginal opening configured to provide access into the simulated pelvic frame, the simulated vaginal opening including simulated tissue attached to the top cover of the simulated pelvic frame and extending downwardly at the proximal end of the simulated pelvic frame to the base of the simulated pelvic frame; a simulated vaginal canal defining an interior space within the simulated pelvic frame accessible through the simulated vaginal opening, the simulated vaginal canal having a proximal end and a distal end; a simulated cervix connected at its distal end to the simulated vaginal canal, having a proximal end extending into the simulated vaginal canal and a distal end extending beyond the simulated vaginal canal, the simulated cervix suspended within the simulated pelvic frame via at least one cord adapted to allow the simulated cervix to move back and forth in response to user interaction; A surgical model comprising:

2. the simulated vaginal opening includes a simulated conductive material and a removably connected grounding pad attached to a portion of the simulated vaginal opening; The surgical model of claim 1 .

3. The simulated vaginal canal includes a first section and a second section, the first section having a plurality of ridges and the second section being smooth. The surgical model according to claim 1 or 2.

4. the simulated cervix further includes a structure connected to the distal end of the simulated cervix, the structure having an elongated tubular shape. The surgical model according to claim 3 .

5. The at least one cord is threaded through the structure and looped. The surgical model according to claim 4.

6. the at least one cord comprises nylon or yarn; The surgical model according to claim 5.

7. a simulated bladder-cervical space disposed above the simulated cervix beyond the distal end of the simulated vaginal canal, the simulated bladder-cervical space including at least two layers and having a proximal end near the distal end of the simulated vaginal canal and a distal end; The surgical model according to claim 5.

8. the at least two layers of the simulated bladder-cervical space are attached to one another via a material that allows the at least two layers to be separated via blunt dissection at a first predetermined series of locations, the first predetermined series of locations corresponding to a separation plane; The surgical model of claim 7.

9. the material at the first predetermined series of locations is silicone grease; The surgical model of claim 8.

10. the at least two layers of the simulated bladder-cervical space are molded together at a second predetermined series of positions, and sharp dissection is required to separate the at least two layers. The surgical model of claim 8.

11. and a simulated peritoneal layer located at the distal end of the simulated pelvic frame near the distal end of the simulated bladder-cervical space, the simulated peritoneal layer being attached at various locations relative to the simulated pelvic frame. The surgical model of claim 10.

12. and a simulated bladder positioned above the simulated bladder-cervical space, the simulated bladder connected to a fill tube and a pump configured to inflate the simulated bladder. The surgical model of claim 11.

13. an upper portion of the simulated bladder configured to provide downward expansion of the simulated bladder toward the simulated bladder-cervical space; The surgical model of claim 12.

14. the simulated cervix further comprises a reinforcing matrix or sleeve configured as a support structure for the simulated cervix; The surgical model of claim 13.

15. the simulated cervix further includes a grounding pad disposed at the distal end beyond the simulated vaginal canal. The surgical model of claim 14.

16. the simulated cervix further includes a detachable ground cable attached to the distal end beyond the simulated vaginal canal; The surgical model of claim 14.

17. the simulated peritoneum layer comprises a conductive material; The surgical model of claim 16.

18. The at least one cord includes one end connected to the simulated pelvic frame through a first aperture on a first of the two side walls, the one cord penetrating the simulated cervix to a second of the two side walls, exiting the simulated pelvic frame through a first aperture of the plurality of apertures in the second side wall, re-entering the simulated pelvic frame through a second aperture of the plurality of apertures in the second side wall, penetrating to the first side wall at a different position on the simulated cervix, and connecting to a second aperture in the first side wall. The surgical model of claim 1 .

19. The at least one cord includes two cords used to suspend the simulated cervix, each of the two cords having one end connected to the simulated pelvic frame through different apertures on a first of the two side walls, penetrating the simulated cervix to a second of the two side walls at different positions, and having an opposite end connected to the simulated pelvic frame through different apertures on the second of the two side walls. The surgical model of claim 1 .

20. the reinforcing matrix or sleeve comprises a Kevlar knit tube or mesh; The surgical model of claim 14.

21. At least a portion of the simulated cervix includes a yarn support structure covered with an outer conductive material. The surgical model of claim 1 .

22. The surgical model is contained within a surgical training device configured to substantially hide a view of the surgical model from a user, the surgical training device comprising: The top cover and a base connected to and spaced from the top cover by at least one leg; a simulated body cavity configured to receive the surgical model; at least one area providing user access from outside the surgical training device into the simulated body cavity while using surgical instruments; 22. The surgical model of claim 1, 2, 18, 19 or 21, comprising:

23. the simulated vaginal opening further includes a dedicated hole through which the filling tube can be inserted so that one end of the filling tube is connected to the pump outside the simulated pelvic frame and the other end of the filling tube is connected to the simulated bladder inside the simulated pelvic frame; The surgical model of claim 13.

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