WO2017151881A1

WO2017151881A1 - Simulated tissue cartridge

Info

Publication number: WO2017151881A1
Application number: PCT/US2017/020389
Authority: WO
Inventors: Nathan Collins; Gregory K. HOFSTETTER; Joel B. VELASCO; Jigar Shah; Nico SLABBER; Jacob J. Filek
Original assignee: Applied Medical Resources Corporation
Priority date: 2016-03-03
Filing date: 2017-03-02
Publication date: 2017-09-08

Abstract

A tablet is provided for simulating abdominal first entry in laparoscopic surgery. The tablet includes a screen configured to display visual content input from a connected scope located inside a trocar. The tablet includes a removable simulated tissue insert configured to simulate an abdominal wall located adjacent to the screen. The insert is penetrable from the front of the tablet through to the back of the tablet where the depth of penetration of the tip of the trocar beyond the insert can be evaluated. The penetration of the insert is observed in real time on the screen. Trocars are interchangeable and the insert is penetrable many times before being easily interchanged. The tablet is useful for demonstrating surgical trocars and practicing laparoscopic techniques and approaches to minimize entry-related injuries.

Description

SIMULATED TISSUE CARTRIDGE

Cross-Reference to Related Application

[0001] This patent application claims benefit and priority to U.S.

Provisional Patent Application Serial. No. 62/303,292 entitled "Simulated tissue cartridge" filed on March 3, 2016 and incorporated herein by reference in its entirety.

Field of the Invention

[0002] This application relates to surgical training tools, and in particular, to simulated tissue structures and models for teaching, practicing and demonstrating various surgical procedures and instruments related but not limited to laparoscopic, endoscopic and minimally invasive surgery.

Background of the Invention

[0003] Laparoscopic surgery requires several small incisions in the abdomen for the insertion of trocars or small cylindrical tubes approximately 5 to 10 millimeters in diameter through which surgical instruments and a laparoscope are placed into the abdominal cavity. The laparoscope illuminates the surgical field and sends an image from inside the abdominal cavity to a video monitor giving the surgeon a close-up view of the organs and tissues. The surgeon watches the live video feed and performs the operation by manipulating the surgical instruments placed through the trocars.

[0004] The first step in laparoscopic surgery is to make a small incision to access and establish pneumoperitoneum. Pneumoperitoneum is the insufflation of the abdominal cavity with carbon dioxide gas. Insufflation with gas creates an enlarged abdomen which serves as a working space necessary for laparoscopy. Once a proper working space has been created, surgical instruments can be inserted for performing a laparoscopic procedure. This process of penetrating the abdomen and creating pneumoperitoneum prior to insertion of other instruments is called first entry. There are many different ways to achieve pneumoperitoneum. One option is using a Veress needle. A Veress needle is approximately 12-15 centimeters long with a diameter of approximately 2 millimeters. The surgeon inserts the spring-loaded needle into the abdomen of the patient after making a small incision. When the needle breaches the inner abdominal space, the spring-loaded inner stylet springs forward to cover the sharp needle in order protect internal organs. The surgeon relies on the tactile feedback of the needle and spring for proper placement. Once proper entry is confirmed, carbon dioxide is introduced through the Veress needle and into the abdominal cavity of the patient expanding the abdomen to creating a working space.

[0005] Another option is a Hasson technique or cut down technique in which the surgeon makes an initial incision at the umbilicus and the tissue is bluntly dissected. A suture is placed on either side of the incision into the fascia layer to help hold the device in place. The supraperitoneal tissue is dissected away and the peritoneum is incised to enter the abdominal cavity. At this point, a Hasson trocar is inserted into the incision. The Hasson trocar has a blunt tip with suture ties and/or a balloon to hold it in place. After the trocar is placed into the incision, the device is secured with sutures and/or the balloon and carbon dioxide gas is pumped into the patient through the trocar to achieve pneumoperitoneum.

[0006] Another option is direct trocar entry. In this option, the surgeon uses a bladed or non-bladed trocar either optically or non-optically. The trocar is placed through the layers of the abdominal wall after the initial skin incision is made. When used optically, a laparoscope or camera is inserted into the trocar before entry in order to observe placement. After the initial incision is made, the trocar is placed through the layers of the abdomen. Since the laparoscope is present inside the trocar, all of the layers of the abdominal wall can be observed during penetration through the

transparent tip of the trocar. Once the surgeon sees that he or she has broken through the peritoneum, penetration can halt and the obturator tip of the trocar pulled back slightly or removed entirely. Insufflation can commence by pumping carbon dioxide gas in through a cannula in which the trocar was inserted to create pneumoperitoneum.

[0007] Another option involves a specialized first entry trocar such as the FIOS ® first entry trocar made by Applied Medical Resources Corporation in California. Like optical direct trocar entry, a laparoscope is inserted into the FIOS ® trocar and the abdominal wall layers are observed during insertion into the abdominal cavity. The specialized FIOS ® trocar has a small vent hole in the tip such that instead of requiring that the obturator of the trocar be pulled back or removed completely to introduce carbon dioxide through the cannula, carbon dioxide gas is introduced directly through the small vent hole in the tip of the obturator with the laparoscope in place. Because carbon dioxide can be introduced through the tip, the FIOS ® trocar does not have to penetrate as deeply into the abdominal cavity as a traditional trocar, thereby, affording internal organs greater protection before insufflation can commence. Also, because the obturator does not have to be pulled back or removed, observation via the inserted laparoscope can take place at the point of insufflation.

[0008] In addition to the above options for entering the abdominal cavity, generally, there are two common places on the abdomen that a surgeon employs for first entry. The most widely used location for first entry is the umbilicus. The umbilicus is a natural weakening in the abdomen where the umbilical cord was attached in the womb. In this part of the abdomen, there are no rectus muscles, arteries or veins so it is generally easier to reach the abdominal cavity. Additionally, the umbilicus is typically an easy place to hide a scar. When surgeons use the umbilicus as an entry site, particularly for the Hasson technique, clamps are often used to grab the base of the umbilicus and the umbilicus is inverted. At this point, an incision is made and the surgeon cuts down as desired and inserts the trocar or Veress needle. With optical entry, the surgeon is able to see all the layers of the abdominal wall. In this location of penetration, they are able to see the fatty tissue, linea alba, transversalis fascia and, finally, the peritoneum. Additionally, when entering at the umbilicus, the umbilical stalk should also be visible. The stalk is what remains of the umbilical cord and it extends from the skin making up the umbilicus to the peritoneal layer.

[0009] If a patient has had a previous surgery and adhesions are suspected or a hernia is present at the site of the umbilicus, first entry may need to occur at another location. In this case, the surgeon will often enter from the left upper quadrant since there is less chance of damaging a vital organ in this location. The left upper quadrant is different from the umbilicus region in that there are muscle layers. The rectus abdominus muscles run parallel with the patient's abdomen and are found on either side of the patient's midline. [0010] Underneath the rectus abdominus muscles run the inferior epigastric veins and arteries which the surgeon must be careful to avoid. When a surgeon is entering the upper quadrant of the abdominal cavity optically, he or she is able to see the skin, fatty tissue, anterior rectus sheath, rectus abdominus, the epigastric vein, which runs through the posterior rectus sheath, and finally, the peritoneum. If the left upper quadrant is not an ideal position for a port, the surgeon may choose to enter at another location such as sub-xiphoid where subcutaneous fat, rectus sheath and peritoneum are present.

[0011] Since there are many options for first entry, it is important that surgeons have a way to learn and practice the various techniques. There is a need for an anatomical model abdomen that is anatomically correct and includes all the layers of the abdominal wall. There is also a need for the model to provide a realistic aural and tactile sensation. For example, when using a Veress needle, two pops are generally felt as the surgeon pushes the needle through the abdominal wall. For optical entry, the surgeon needs to sequentially view all of the appropriate tissue layers in the abdominal wall. It is also desirable to have an easy way to train practitioners in an easy and repeatable fashion that is also portable, reusable and capable of serving as a

demonstration for sales and learning purposes.

[0012] In the case of a demonstration model, surgical simulators are sometimes used to demonstrate medical devices to doctors to compare functionality between competing devices in order to sell a product. For example, a first-entry device is inserted into a simulated abdominal wall, under direct visualization via a laparoscope inserted into the device lumen if the device is so configured. The user observes the image from the laparoscope on a small video display such as a computer screen or tablet in real time in order to monitor the execution of the procedure and observe the various abdominal wall layers as the device penetrates with the user knowing from observation when penetration of the abdomen must cease. Then, the underside of the simulated abdominal wall observed to check the penetration depth into what would be considered the abdominal cavity and compare the penetration depth achieved with previous attempts and with different first entry devices. Multiple first-entry devices can be used side-by-side for the purpose of comparing the quality and depth of penetration. In general, surgical simulators are large, difficult and time consuming to set up which makes their use as a tool to communicate efficiently with doctors undesirable as they have busy schedules and often do not have the time required to wait for such a device to either be set up or taken to a separate location where said device is set up and waiting. A simple device is needed to demonstrate and practice first-entry penetration on-the-go including a device that is easily carried, and quickly assembled, is hand-held, inexpensive, reusable/recyclable and can be assembled for demonstration while standing or walking.

Summary of the Invention

[0013] According to one aspect of the invention, a

[0014] According to another aspect of the invention,

[0015] According to another aspect of the invention, a simulated abdominal wall model that is ideal for practicing laparoscopic first entry surgical techniques is provided. The model includes a simulated abdominal wall portion captured between two frame elements of a support. The support is connectable to a surgical trainer. When connected to the trainer, the model provides a penetrable abdominal tissue portion for accessing an internal cavity of the trainer. The simulated abdominal wall includes a plurality of layers including a skin layer, a fabric posterior rectus sheath layer, a simulated fat layer of low-resilience polyurethane foam and at least two layers that provide distinctive haptic feedback upon penetration of the simulated transversalis fascia and muscle layers. The simulated abdominal wall insert is disposable and replaceable and interchangeable for continued practice of different practice procedures employing different simulated tissue structures/organs.

Brief Description of the Drawings

[0016] FIG. 1 is a top perspective view of a simulated tissue cartridge according to the present invention.

[0017] FIG. 2 is a top perspective view of a simulated tissue cartridge according to the present invention. [0018] FIG. 3 is an exploded view of a simulated tissue structure of a simulated tissue cartridge according to the present invention.

[0019] FIG. 4 is a top perspective view of a demonstration tablet according to the present invention.

[0020] FIG. 5 is a top perspective view of a demonstration tablet with a simulated tissue cartridge removed according to the present invention.

[0021] FIG. 6 is a top perspective view of a demonstration tablet and a first entry device positioned to penetrate a simulated tissue cartridge according to the present invention.

[0022] FIG. 7 is a top perspective view of a demonstration table and a first entry device penetrating a simulated tissue cartridge according to the present invention.

[0023] FIG. 8 is a back sectional perspective view of a demonstration tablet and first entry device penetrating a simulated tissue cartridge according to the present invention.

Detailed Description of the Drawings

[0024] Turning to FIGs. 1 -2, there is shown a cartridge 10 comprising a simulated tissue structure insert 12 and a frame 14. The simulated tissue structure insert 12 is captured within the frame 14.

[0025] With reference now to FIG. 3, the simulated tissue structure 12 will now be described in greater detail. The simulated tissue structure 12 is configured to simulate a single organ or part of an organ, tissue or other anatomical structure. The simulated tissue structure 12 serves as a penetrable target for surgical training and attention. In one variation, the simulated tissue structure 12 is a region of a human abdominal wall and as such serves as a target for practicing first entry with a first entry device. It should be noted that the invention is not limited to serving as a target of training but may comprise an element of one or more steps of several steps of a surgical procedure. In the case of the simulated tissue structure 12 being configured to simulate a human abdominal wall as shown in FIG. 3, the simulated tissue structure 12 includes a plurality of layers. In FIG. 3, the plurality of layers is configured to simulate the plurality of layers encountered in the penetration of a real abdominal wall. The plurality of layers includes one or more of the following simulated abdominal layers: a topmost skin layer 16, a fat layer 18, an anterior rectus sheath layer 20, a first rectus muscle layer 22, a second rectus muscle layer 24, a third rectus muscle layer 26, a posterior rectus sheath layer 28, a transversalis fascia layer 30, and a peritonmeum layer 32. The layers are selected from materials and colors that provide a realistic visual representation of real anatomy via a camera and video monitor. Also, the layers are selected to provide a tactile response and feel that is realistic to a surgeon. The invention is not limited to this particular arrangement of layers and may include fewer or more layers and/or other anatomical structures such as an umbilicus and vasculature. Other examples of simulated tissue structures for practicing first entry through a simulated abdominal wall region are described in U.S. Patent Application Publication Nos. 2015-0031008, 2015-0187229, 2014-0242564, 2013-0101973 incorporated herein by reference in their entireties.

[0026] With reference back to FIGs. 1 -2, the frame 14 will now be described. The frame 14 includes a planar first side 36 and a planar second side 38 that are nearly identical and are configured to mate together in order to capture the simulated tissue structure insert 12 between the first side 36 and the second side 38. The first side 36 includes a frame window 34a and the second side 38 includes a frame window 34b. The size and shape of the frame windows 34a, 34b are the same in the variation shown and the size and shape of the frame windows 34a, 34b are aligned and configured to receive the insert 12 in the windows 34a, 34b such that the sides 36, 38 can be joined to capture the insert 14 between the sides 36, 38. One or more of the sides 36, 38 include projections 40 or teeth to assist in gripping the insert 12 in place. Opposite from the projections 40, corresponding recesses 42 are formed in the other one or more of the sides 36, 38 and sized and configured to receive the projections 40. The projections 40 may be in the shape of spikes and the recesses may have a corresponding shape to receive the spikes. When the assembled cartridge 10 is inserted into its destination location, the insertion of the cartridge 10 into a cartridge pocket or receiving area results in the frame sides 36, 38 compressing and grabbing firmly onto the insert 12. Ridges, or other physical geometry using matching male and female counterparts, that pinch, grab, or physically increase the hold of the frame 14 on the insert 12 can also be used. When the insert 12 is placed inside the frame 14, the resulting cartridge 10 is then inserted into a pocket-like slide where it is held in place by friction created from the pressure of the compressed cartridge 10. Springs, ball detents, latches, compression-fit, friction-fit, snap-fit, or other mechanical apparatuses/fasteners can also be used to hold the frame sides 36, 38 closed onto the insert 12 as well as to hold the cartridge 10 in place at its destination location. When the insert 12 needs to be replaced the cartridge 10 can be pulled or pushed out of its destination location, opened and the insert 12 quickly disposed and another insert 12 inserted into the same reusable frame 14. The frame sides 36, 38 can be hinged together or attached by other mechanical attachment that prevents the two sides from falling apart once the cartridge is removed from its destination location.

[0027] The frame 14 may optionally include a second opening 44a in the first side 36 and a second opening 44b in the second side 38. The second openings 44a, 44b line up when the sides 36, 38 are joined to create a window that serves as a finger pull for the ease of inserting and removing or otherwise handling the cartridge 10. A finger pull without an opening is also an alternative variation. Although one frame window 34 is shown in the figures, the frame 34 may have one or more frame windows 34 configured to accommodate and receive inserts 12 of different shapes and sizes simulating same or different organs and tissue structures. The frame 14 is substantially planar such that the two sides come together to sandwich the insert 12 such that the frame 14 remains substantially flat and unitary.

[0028] With reference to FIGs. 1 -3, the two outer layers, the skin layer 16 and the peritoneum layer 32, are larger and their outer rims are adhered together with adhesive to contain the inner layers and create one overall abdominal insert unit. The inner layers are first assembled and are cut slightly smaller than the outer layers and smaller than the window 34 of the frame 14 to ease assembly. After all of the layers are cut to size, they can be mechanically fixed together using tags, fasteners or adhesive to help keep their shape and ease assembly; however, this is not necessary to achieve final functionality. The two outer layers are each placed into a mold having the same shape and same inner geometry as the frame window 34. The two outer layers are stretched slightly to accommodate the inner layers. The outer layers may be heat formed to create recessed areas 46 for receiving the inner layers. The recessed area 46 of one of the two outer layers 16, 32 forms a pocket for approximately half of the inner layers and the recessed area 46 of the other one of the two outer layers 16, 32 forms a pocket for approximately half of the other inner layers. The outer surface of the recessed areas 46 are dome shaped or may also be shaped to have curvature suggestive or corresponding to certain anatomy. The outer rims/lips 48 extend laterally outwardly from and around the entire perimeter of the outer layers. Rubber cement or other adhesive is applied to the inner surface perimeter of the one or more rims 48 where the top and bottom layers meet each other. The inner layers are placed inside the recessed areas 42 or between the two outer layers if recesses 42 are not formed and the unit is held in place by clamping the frame mold together until it dries. Once dried, the insert 12 no longer needs a frame mold to hold its shape, can be removed from the frame mold and placed inside the frame 14 to complete the cartridge 10. The rims 48 extend laterally outwardly along a distance that is sufficient to be captured between the frame sides 34, 36 and gripped in place by the projections 40. The cartridge 10 can then be inserted, using the finger pull 44, into a larger surgical trainer or larger simulated tissue structure, for example, or other device such as a

demonstration tool. Examples of surgical trainers are described in US Patent

Application Publication Nos. 2012-0082970 and 201 1 -053859 incorporated herein by reference in their entireties.

[0029] To hold the top and bottom layers together, and contain the inside layers, any adhesive may be used especially adhesive that remains flexible once dried. Glues that dry rigid may also be used but cracking or shattering of the adhesive may be detrimental during the demonstration or practice session. Glues that dry rigid would also increase the difficulty of the insert 12 being held by the frame 12. The top and bottom layers can also be attached mechanically such as with staples or other low profile mechanical methods but using a mechanical method may necessitate changes in the cartridge frame, known to one having ordinary skill in the art, to allow for the increased thickness of the physical components. These physical components may allow for a greater hold if there are recesses provided in the inner surfaces of the frame sides 36, 38 for them. If the top and bottom layers are made of heat sealable material, they can be fused together eliminating the need for glue or mechanical attachment methods. In one variation, the EVA foam from which the top and bottom layers^'! 6, 32 are made of is not heat sealable, but if a heat sealable replacement material is used for these layers, heat sealing would a preferred attachment method.

[0030] Turning now to FIGs 4-8, an exemplary destination location for the cartridge 10 is shown. The exemplary destination location is a first entry demonstration tablet 50. The tablet 50 is configured to serve as a practice or demo tool for practicing or demonstrating moving a first entry device 52 such as a trocar 52 into the insert 12 of the cartridge 10. The tablet 50 includes a first entry device 52 which can be any of the aforementioned first-entry devices or other first entry devices including, but not limited to, the FIOS® trocar manufactured by Applied Medical Resources Corporation in California. The trocar 52 includes a tapered, transparent distal tip configured to penetrate tissue and a central lumen configured to receive a laparoscope. The trocar 52 may be provided with a cannula 66 that has a seal assembly 68 at the proximal end. The trocar 52 is removably insertable into the lumen of the cannula 66. A scope 54 is provided with the tablet 52 and inserted into lumen of the trocar 52. The scope 54 is configured to receive an image captured at its distal end through the transparent tip 70 of the trocar 52. The scope 54 is connected to a visual display output such as a monitor or screen 56 on a pad-like computing device via a wire (not shown). The tablet 50 further includes a microprocessor comprising at least an image processor configured to display an image on the screen captured by the scope. The cartridge 10, according to the present invention, is removably connected to the tablet 50. The tablet 50 is flat and substantially planar and has the size of a large notebook. In operation, the tablet 50 is powered on, the trocar 52, with a removable yet fixedly contained scope 54 in its lumen, is removed from a holding location and inserted into the insert 12 portion of the cartridge 10 as shown in FIGs. 6-7. The trocar 52 is tethered via a wire connecting the tablet 52 to the scope 54. The scope 54 provides visualization of the various layers of the insert 12 simultaneous with its insertion providing a live video feed to the user. The user carefully observes the layers as insertion progresses, noting the layers, colors, vessels, anatomy, adhesions and the like provided visually by the insert as well as feeling the tactility of each layer teaching the user to regulate applied force according to the sequential presentment of each layer. The advancement of the trocar 52 into the insert 12 is slowed and carefully stopped once the last layer 32 is pierced by the tip 70 as shown in FIG. 8 in the practice or demonstration of laparoscopic first entry surgical procedures and instruments. The user will then turn the tablet 50 is then turned over to observe the degree of penetration as shown in FIG. 8. Trocar insertion requires application of considerable axial push-force to the trocar and care is taken in practice to minimize accidental entry-related injuries to the patient's underlying organs. In case of a demonstration of competing trocars, a number of different trocars may be inserted into the same insert, side-by-side, and their depth and quality of penetration compared. The invention specifically makes use of a replaceable abdominal wall insert system in which the insert does not require a frame to hold its shape while not in use. A used insert 12 may be removed and a new insert 12 is placed into a reusable frame 14 to secure the insert 12 and then inserted into the device to continue practice/demonstration with first entry devices.

[0031] The screen 56 and computer processor are part of a typical padlike tablet computing device. The computing device is sandwiched between two bezels 58 defining a thickness therebetween with one of the bezels 58 defining an opening 60 surrounding the touch screen 56 and any control portions. The bezels 58 hold the computing device/screen 56 in place and provide a uniform body that leaves at least one side exposed so that buttons and electronic ports can be accessed. The bezels 58 advantageously allow the tablet 50 to be gripped from any side without interfering with the operation of the tablet as well as permitting the tablet 50 to be positioned as desired for first entry demonstration. In one variation, the thickness between the two bezels is not greater than approximately three inches. In another variation, the thickness between the two bezels is not greater than approximately two inches. In another variation, the thickness between the two bezels is not greater than approximately 1 .5 inches. In another variation, the thickness between the two bezels is not greater than one inch. Below the opening 60 is a cut out storage area 62 for the trocar 52 from which it can be easily removed from a mounted tip protector found inside the cut out storage area 62 hidden between the bezels 58. The tip protector includes a cylindrical shaped object made of plastic having an inner diameter that is sized and configured to receive the trocar 52 and/or cannula 66 in a friction-fit, snap-fit engagement with the outer diameter of the trocar 52and/or cannula 66 or other fastener configured to retain the trocar and/or cannula inside the housing. The scope 54 is located inside the trocar 52 and attached to a USB cable (not shown) that travels to an image processing board mounted and hidden inside the tablet 50. Another USB cable travels from the processing board to the tablet 50 where the image is output on the screen. Below the trocar storage area 62 is a slotted opening 64 extending through both bezels 58 and sized and configured to slidably receive the cartridge 10. The slotted opening 64 serves as a window that exposes a length of insert 12 so that the trocar 52 can be inserted completely through all of the layers from the first outer layer at the front of the tablet to the second outer layer at the back of the tablet. The layers are penetrated and at the same time visualized on the screen 56. The tablet 50 can then be flipped over to observe the penetration depth of the selected trocar 52. Upon completion of the practice/demonstration session, the cartridge 10 can be pulled out through the side of the slotted opening 64 and replaced by separating the two frame sides 36, 38 and replacing the insert 12. As previously mentioned, one frame has spikes while the other frame has recesses for the spikes that allow the removable frame to secure the insert firmly in place while the first entry simulation is being performed. The slotted opening 64 is also sized and configured to provide a friction fit engagement to help keep the cartridge in position during the procedure. As previously mentions, the two outer layers are held together by rubber cement that allows flexibility without damaging the adhesive or causing separation of the abdominal layers.

[0032] Instead of sliding the cartridge 10 in from the side as shown in the figures, the cartridge 10 can be slid in from the bottom. Instead of using sliding as the method of insertion, a small door may be provided in the tablet 50 that hinges open allowing the insert 12 to be placed in, and then hinged closed and latched in place. In one variation, the hinged door variation would also eliminate the need for the frame sides 36, 38, as the hinged door mechanism would have the necessary physical holding methods (e.g. spikes or ridges) and windowed opening for the insert 12 to be

penetrated from one end to the other end including an opening at the back side bezel for inspection of the first entry depth of penetration. The door would also be latched or locked closed. The sliding mechanism eliminates the need for the extra hardware (hinges and latches) required for the door mechanism. Conversely, the door

mechanism eliminates the need for detachable frame elements.

[0033] The frameless insert or the cartridge with frame sides can be employed with other devices such as a surgical lap trainer of the like incorporated herein by reference above. For example, a top cover of the lap trainer can be provided with a slotted opening for the insertion of a cartridge 10 or provided with a compartment for inserting the cartridge 10 without the frame sides. Any such destination device may include a plurality of slotted openings or receiving locations for receiving one or more inserts and/or cartridges 10 containing the same or different simulated tissue structures for a particular anatomy in an interchangeable system. For example, the lap trainer may be provided with two or more slotted openings for slidably receiving a simulated abdominal wall insert in one opening and an simulated organ insert in another opening such that practice of surgical procedures can be expanded to include more than one type of procedure. For example, first entry procedures may be practiced on a first insert configured to simulate an abdominal wall and gall bladder or hysterectomy procedure can be performed on a second insert configured to simulate a gall bladder or uterus, respectively.

[0034] The tablet 50 in combination with the cartridge 10 of the present invention advantageously provides sales representatives with a hand-held tool that is small and lightweight enough to hold in one hand while inserting the trocar with the other hand. The tablet 50 can be used while standing up or walking down a hallway with a doctor. Time limitations also necessitate low setup time. In order to demonstrate a trocar device 52, the tablet is powered-up and the trocar removed from the storage area. Only the simulated abdominal wall insert is needed by the user which is a consumable that can be easily replaced or carried in a pocket. Sales representatives carry a lot of product already and are limited on space in their travel cases so the device is advantageously as self-contained as possible and prevents missing or losing parts from getting lost in their bag. The tablet 50 and accompanying inserts are easily insertable and removable from their travel cases. The tablet 50 can be used alone without special set-up or space accommodations. The tablet 50 can be held by a sales representative while the surgeon performs the first entry insertion. Furthermore, the exposed abdominal wall underside is configured to be easily accessible and visible for quick inspection of the procedure. The tablet 50 is also self-contained, battery- powered, and rechargeable and prevents components from being lost during storage and transport. The set-up time is quick and performed by one person.

[0035] It is understood that various modifications may be made to the embodiments and variations disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

Claims

Claims We claim:

1 . A tablet for simulating a surgical procedure, comprising:

a screen configured to display visual content;

a housing having a planar front wall with a first front opening having a size and shape in accordance with the screen; the housing further including a planar back wall interconnected with the front wall to define a thickness and cavity therebetween; the display being securely connected within the cavity in the location of the first front opening; the front wall having a second front opening aligned with a first back opening formed in the back wall; the cavity in the location between the second front opening and the first back opening being configured to removably receive and retain a simulated tissue structure such that the simulated tissue structure is penetrable from the second front opening to the first back opening;

a trocar having an elongate shaft with a central lumen and tapered transparent tip; and

a scope removably connected to the trocar and configured to capture a video image through the transparent tip; the scope being connected to the screen and configured to display the video image in real-time on the screen as the trocar is employed to penetrate the simulated tissue structure.

2. The simulation tablet of any one of the previous claims wherein the thickness between the front wall and the back wall is not greater than approximately two inches.

3. The simulation tablet of any one of the previous claims wherein the simulated tissue structure includes multiple layers sandwiched between a first outer layer exposed at the first front opening and a second outer layer exposed at the first back opening.

4. The simulation tablet of any one of the previous claims wherein the simulated tissue structured is configured to simulate an abdominal wall.

5. The simulation tablet of any one of the previous claims wherein the simulated tissue structure includes the following simulated layers of an abdominal wall: a topmost skin layer, a fat layer, an anterior rectus sheath layer, a first rectus muscle layer, a second rectus muscle layer, a third rectus sheath layer, a first rectus muscle layer, a second rectus muscle layer, a third rectus muscle layer, a posterior rectus sheath layer, a transversalis fascia layer, and a peritoneum layer.

6. The simulation tablet of any one of the previous claims wherein the simulated tissue structure is removably enclosed in a frame to form a cartridge.

7. The simulation tablet of any one of the previous claims wherein a first side of the simulated tissue structure is exposed in the second front opening and a second side of the simulated tissue structure is exposed in the first back opening.

8. The simulation tablet of any one of the previous claims wherein the housing includes a side wall around the perimeter of the tablet.

9. The simulation tablet of any one of the previous claims further including a storage area for the trocar located in a sidewall and configured to receive at least part of the trocar between the front wall and the back wall.

10. The simulation tablet of any one of the previous claims wherein the second front opening is below the first front opening.

1 1 . The simulation tablet of any one of the previous claims wherein the housing includes a storage area for the trocar defined in the cavity between the front wall and the back wall with an opening in side of the housing through which the trocar can be inserted into and removed.

12. The simulation tablet of any one of the previous claims wherein the storage area includes a fastener configured to retain the trocar inside the housing.

13. The simulation tablet of any one of the previous claims wherein a storage area for the trocar is located between the simulated tissue structure and the display

14. The simulation tablet of any one of the previous claims wherein penetration of the simulated tissue structure is directly observable at the back wall of the housing.

15. The simulation tablet of any one of the previous claims further including a cannula having a lumen and a seal assembly; the lumen sized and configured to receive the trocar.

16. The simulation tablet of any one of the previous claims wherein the scope is removably connected to a microprocessor in the housing with a wire via an input jack on the housing; the trocar is removably connected to the scope; the scope is tethered via the wire to the housing.

17. A tissue simulation cartridge, comprising:

a frame including a planar first side defining a first frame window and a planar second side defining second frame window; wherein the first side and the second side are configured to mate such that the first frame window and second frame window are aligned; and

a simulated tissue insert including a first outer layer and a second outer layer located opposite from the first outer layer; the first outer layer having a first recessed area and a first rim extending laterally from and around the first recessed area; the second outer layer having a second recessed area and a second rim extending laterally from and around the second recessed area; the simulated tissue insert further including a plurality of planar layers located inside the first and second recessed areas wherein the first rim and the second rim are joined with adhesive and captured between the first side and second side of the frame.

18. The simulation cartridge of any one of the previous claims further including a finger pull located on the frame.

19. The simulation cartridge of any one of the previous claims further including a fastener configured to hold the first side and the second side of the frame together.

20. The simulation cartridge of any one of the previous claims wherein the first outer surface is a simulated skin layer and the second outer surface is a simulated

peritoneum layer.

21 . The simulation cartridge of any one of the previous claims wherein the plurality of planar layers are configured to simulate abdominal tissue.

22. The simulation cartridge of any one of the previous claims being sized configured for insertion into a slotted opening of a simulation tablet.