WO2024103120A1

WO2024103120A1 - Surgical training device

Info

Publication number: WO2024103120A1
Application number: PCT/AU2023/051165
Authority: WO
Inventors: James Graham WOOD; Fraser Maurice CALLAGHAN
Original assignee: CFI Surgery Pty Ltd
Priority date: 2022-11-18
Filing date: 2023-11-16
Publication date: 2024-05-23

Abstract

The present disclosure provides a surgical training device that is provided as a kit, which a surgical trainee can convert into an open configuration. Once the surgical training device is in the open configuration, the surgical trainee can perform a simulated surgical procedure. The surgical training device in its open configuration is also configured to position a recording device to record the simulated surgical procedure. The recording of the simulated surgical procedure can then be used to assess the surgical trainee's surgical skill.

Description

SURGICAL TRAINING DEVICE

Technical Field

[0001] The present invention relates generally to a device for simulating anastomosis of human body channels (e.g., blood vessels, intestines, etc.). The present invention also relates to a method of training a trainee surgeon using the device for simulating anastomosis of human body channels.

[0002] This invention has been developed primarily for use as a surgical training device for simulating distal coronary anastomosis and will be described hereinafter by reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use and may be used for simulating anastomosis beyond coronary, such as vascular and micro-vascular etc. and anastomosis of human body channels such as intestines etc.

Background of the invention

[0003] The following discussion of the prior art is intended to present the invention in an appropriate technical context and allow its advantages to be properly appreciated. Unless clearly indicated to the contrary however reference to any prior art in this specification should not be construed as an express or implied admission that such art is widely known or forms part of common general knowledge in the field.

[0004] Conventionally, a trainee surgeon learns to perform an anastomosis (e.g., coronary anastomosis, which is the joining of coronary arteries with grafts for bypass surgery) by observing trained surgeons performing the operation. After a significant period of time, the trainee surgeon starts to perform parts of the anastomosis operation. This is, however, a slow and difficult process to learn and requires intense supervision by highly specialised surgeons, resulting in limited scope for failure or opportunity for feedback.

[0005] The skill for performing such an operation can be learned in a laboratory. However, it is not always possible to attend the laboratory. As seen during the COVID-19 pandemic, where opportunities for travel, elective surgery and associated training were limited by the increasing demand for healthcare workers and hospital beds were created by the pandemic. [0006] Simulated task training has been used to supplement laboratory opportunities, but to be effective, it must be repeated regularly, subjected to feedback and part of a continual learning loop.

[0007] There is a need for the training of a trainee surgeon to be able to occur remotely, in particular at home, and for the trainee surgeon's skills and techniques to be assessed.

[0008] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative. It is an object of the invention in at least one preferred form to provide a surgical training device, particularly for simulating distal coronary anastomosis, that provides repetitive anastomosis training. It is an object of the invention in at least one preferred form to provide a surgical training device, particularly for simulating distal coronary anastomosis, that can be used remotely and then packaged and sent to a designated facility for assessment of the anastomoses.

Summary of the invention

[0009] According to one aspect of the present invention, there is provided a surgical training device configured for simulating a surgical procedure, including: a top section, and a bottom section configured to accommodate the top section, wherein the top section includes a cut-out configured to position a recording device above the bottom section.

[0010] In some embodiments, the surgical training device contains a top section. In some embodiments, the top section includes a top face. In some embodiments, the top face includes a cut-out. In some embodiments, the top face includes a plurality of cut-outs. In some embodiments, the cut-out is sized and shaped such that the user can fit surgical equipment through the cut-out. In some embodiments, the cut-out is sized and shaped such that the user can fit their hands through the cut-out. In some embodiments, the cut-out is sized and shaped to position a recording device above a bottom section of the surgical training device to record the simulated surgical procedure. In some embodiments, the cutout is configured to accommodate a light source. In some other embodiments, the recording device may be positioned above the bottom section of the surgical training device to record the simulated surgical procedure by a different means. [0011] In some embodiments, surgical equipment may be connected to the top section. In some embodiments, surgical equipment may be connected to the top face. In some embodiments, surgical equipment may be removably connected to the top face. In some embodiments, simulation equipment may be connected to the top face. In some embodiments, simulation equipment may be removably connected to the top face.

[0012] In some embodiments, the top section includes a supporting portion. In some embodiments, the top section includes a plurality of supporting portions. In some embodiments, the top section includes two supporting portions. Preferably, the top section includes two side supporting portions. In some embodiments, the top section includes a front supporting portion, a back supporting portion and two side supporting portions.

[0013] In some embodiments, the supporting portion includes a cut-out. In some embodiments, the supporting portion includes a plurality of cut-outs. In some embodiments, the cut-outs are located on the front supporting portion. In some embodiments, the cut-outs are located on the front supporting portion and/or the back supporting portion and/or the side supporting portions. In some embodiments, the cut-out is sized and shaped such that the user can fit surgical equipment through the cut-out. In some embodiments, the cut-out is sized and shaped such that the user can fit their hands through the cut-out. In some embodiments, the cut-out is sized and shaped such that the user can perform a simulated operation through the cut-out.

[0014] In some embodiments, the supporting portion has a predetermined height. In some embodiments, the supporting portion may have an adjustable height to better simulate operating conditions.

[0015] In some embodiments, the supporting portion is foldable. In some embodiments, the supporting portion is inwardly foldable. In some embodiments, the supporting portion is outwardly foldable. In some embodiments, the supporting portion is removably attachable to the top section.

[0016] In some embodiments, the top section has an open configuration. In some embodiments, when in an open configuration, the supporting portion is not folded. In some embodiments, when in an open configuration, the supporting portion extends perpendicular to the top face of the top section. In some embodiments, the top section is attachable to a bottom section of the surgical training device. In some embodiments, the top section is removably attached to a bottom section of the surgical training device. In a preferred embodiment, the distal end of the two side supporting portions include flanges configured to attach the top section to the bottom section. Preferably, the flanges are positioned under the bottom section to secure the top section above the bottom section. In some embodiments, other suitable securing means may be used.

[0017] In some embodiments, when in an open configuration, the top section forms a bridge over the bottom section.

[0018] In some embodiments, the top section has a closed configuration. In some embodiments, when in a closed configuration, the supporting portion is folded. In some embodiments, when in a closed configuration, the top section is attachable to a top cover of the bottom section. In some embodiments, when in a closed configuration, the top section is removably attachable to the top cover of the bottom section.

[0019] In some embodiments, the top section includes a securing means. In some embodiments, the top section includes a plurality of securing means. In some embodiments, the securing means is located on the supporting portion. Preferably, the securing means is located on an outer face of the side supporting portion. In some embodiments, the securing means is Velcro. In some embodiments, other suitable securing means may be used.

[0020] In some embodiments, the surgical training device contains a bottom section. In some embodiments, the bottom section includes a wall portion. In some embodiments, the bottom section includes a plurality of wall portions. Preferably, the bottom section includes a front, back and side wall portions. In some embodiments, the bottom section may have a predetermined size and shape. In some embodiments, the bottom section has a substantially rectangular shaped cross-sectional profile. In some embodiments, the bottom section is substantially shaped as a rectangular prism. In some embodiments, the bottom section is sized and shaped such that contents may be placed within the bottom section. Preferably, the bottom section is substantially shaped as a box. In some embodiments, the bottom section is configured to support the top section.

[0021] In some embodiments, the wall portion has a predetermined height. In some embodiments, the wall portion may have an adjustable height to better simulate operating conditions. [0022] In some embodiments, the bottom section has an open top face. In some embodiments, the bottom section has a closed top face. Preferably, the bottom section has an open top face.

[0023] In some embodiments, the bottom section includes a cover. In some embodiments, the bottom section includes a top cover. In some embodiments, the top cover is connected to the bottom section. In some embodiments, the top cover is attachable to the bottom section. In some embodiments, the top cover is removably attachable to the bottom section. In some embodiments, the top cover is integral with the bottom section. In some embodiments, the top cover is connected to a wall portion of the bottom section. In some embodiments, the top cover is connected to the back wall portion of the bottom section. In some embodiments, the top cover is attachable to the back wall portion of the bottom section. In some embodiments, the top cover is removably attachable to the back wall portion of the bottom section. Preferably, the top cover is integral with the back wall portion of the bottom section.

[0024] In some embodiments, the top cover may have a predetermined size and shape. In some embodiments, the top cover is configured to enclose the open top face to secure the contents inside of the bottom section.

[0025] In some embodiments, the top cover includes a securing means. In some embodiments, the top cover includes a plurality of securing means. In some embodiments, the securing means is located on a face of the top cover. Preferably, the securing means is located on the inside face of the top cover when the top cover encloses the bottom section. In some embodiments, the securing means is a hook-and-loop fastener . In some embodiments, other suitable securing means may be used.

[0026] In some embodiments, the bottom section has a layer. In some embodiments, the bottom section has a plurality of layers. In some embodiments, the bottom section has two layers. Preferably, the bottom section has an upper layer and a lower layer. In some embodiments, the upper layer is integral with the bottom section. In some embodiments, the lower layer is integral with the bottom section. In some embodiments, the upper layer and the lower layer are both integral with the bottom section. In some embodiments, the upper layer is removably connected to the bottom section. In some embodiments, the lower layer is removably connected to the bottom section. In some embodiments, the upper layer and the lower layer are both removably connected to the bottom section. [0027] In some embodiments, the upper layer is formed of a lightweight material that can be easily removed from the bottom section. In some embodiments, the upper layer is formed of a protective material to minimise damage of the contents of the upper layer. In some embodiments, the upper layer is formed of foam. In some embodiments, the upper layer may be formed of another suitable material.

[0028] In some embodiments, the upper layer includes a void. In some embodiments, the upper layer includes a plurality of voids. In some embodiments, the void is a compartment. In some embodiments, the compartments are connected to each other to form a group. In some embodiments, the compartments are removably connected to each other. In some embodiments, the compartments are sized and shaped such that, when the compartments are placed in the bottom section, they are close fitting. In some embodiments, the compartments are sized and shaped such that when the compartments are placed in the bottom section, they form a layer.

[0029] In some embodiments, the upper layer is configured for storage. In some embodiments, the upper layer may be configured for other purposes.

[0030] In some embodiments, the compartment includes a cavity. In some embodiments, the compartment includes a plurality of cavities. In some embodiments, the cavity is configured to contain equipment to simulate a medical procedure. In some embodiments, the medical procedure is a surgical procedure. In some embodiments, the cavity is configured to contain medical equipment. In some embodiments, the medical equipment is surgical equipment. In some embodiments, the cavity is configured to contain an anatomical structure. In some embodiments, the cavity is configured to contain a plurality of anatomical structures. In some embodiments, the cavity includes a cut-out to easily remove the anatomical structure. In some embodiments, the cavity includes a plurality of cut-outs to easily remove the anatomical structure. In some embodiments, other suitable means may be used to aid the removal of the anatomical structure from the cavity.

[0031] In some embodiments, the lower layer is formed of a heavy material to minimise the chances of the bottom section moving during use of the surgical training device. In some embodiments, the lower layer is formed of foam. In some embodiments, the lower layer may be formed of another suitable material. In some embodiments, additional weight may be added to the bottom section to minimise the chances of the bottom section moving during use of the surgical training device. In some embodiments, additional weight may be added to the lower layer to minimise the chances of the bottom section moving during use of the surgical training device.

[0032] In some embodiments, the lower layer has a void. In some embodiments, the lower layer includes a plurality of voids. Preferably, the lower layer has at least one void. In some embodiments, the void is configured to receive an anatomical structure. In some embodiments, the void is configured to securely receive an anatomical structure such that the user can operate on the anatomical structure without the anatomical structure moving. In some embodiments, another suitable means may be used to secure an anatomical structure such that the user can operate on the anatomical structure without the anatomical structure moving. In some embodiments, the void includes a cut-out to easily remove the anatomical structure. In some embodiments, the void includes a plurality of cut-outs to easily remove the anatomical structure. In some embodiments, other suitable means may be used to aid the removal of the anatomical structure.

[0033] In some embodiments, the surgical training device is suitable to be used in non- clinical environments. In some embodiments, the surgical training device contains all the necessary equipment to simulate a surgical procedure. In some embodiments, the surgical training device contains all the necessary equipment to simulate a plurality of surgical procedures. In some embodiments, the surgical training device provides the user with an opportunity to practice a surgical procedure. In some embodiments, the surgical training device provides the user with multiple opportunities to practice a surgical procedure. Preferably, the surgical training device provides the user with repeated training of simulated anastomosis.

[0034] In some embodiments, the surgical training device provides the user with other simulated experiences. In some embodiments, the surgical training device provides the user with simulated surgical procedures. In some embodiments, the surgical training device provides the user with simulated surgical procedures of human body channels, for example, blood vessels and intestines. In some embodiments, the surgical training device provides the user with simulated surgical procedures of the circulatory system. In some embodiments, the surgical training device provides the user with simulated surgical procedures of the vascular system. In some embodiments, the surgical training device provides the user with simulated surgical procedures of coronary arteries. In some embodiments, the surgical training device provides the user with simulated surgical procedures of the micro-vascular system. In some embodiments, the surgical training device provides the user with simulated surgical procedures of intestines.

[0035] In some embodiments, the surgical training device is in the form of a kit. In some embodiments, the surgical training device is in the form of a compact kit. In some embodiments, the compact kit is easily transportable, packed and unpacked. In some embodiments, the surgical training device may be transported to a clinic or lab for assessment of the surgical procedure(s) performed. In some embodiments, the surgical training device may be transported to another suitable facility for assessment of the surgical procedure(s) performed.

[0036] In some embodiments, the surgical training device is configured to be posted. In some embodiments, the surgical training device is configured to be posted as a whole kit. In some embodiments, the surgical training device is configured to be posted in parts. In some embodiments, the surgical training device is configured such that minimal damage to the contents of the device will occur during postage. In some embodiments, the surgical training device is configured to be posted to the user. In some embodiments, the surgical training device is configured to be posted for processing and analysis.

[0037] In some embodiments, the user of the surgical training device is a clinician. In some embodiments, the user of the surgical training device is a surgical trainee.

Brief description of the drawings

[0038] An embodiment of the disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:

[0039] Figure 1 is a top perspective view of a surgical training device for simulating anastomosis of a human body channel;

[0040] Figures 2 to 6 show a user using the surgical training device;

[0041] Figure 7 is a top view of the surgical training device with the surgical components removed and the top cover open;

[0042] Figure 8 is a front perspective view of the surgical training device with the upper layer removed and the top section secured within the bottom section; [0043] Figure 9 is a perspective view of the surgical training device packed away with the top cover open; and

[0044] Figure 10 is a perspective view of the surgical training device packed away with the top cover closed.

Detailed description of the preferred embodiment of the invention

[0045] The present invention will now be described with reference to the following example which should be considered in all respects as illustrative and non-restrictive. In the Figures, corresponding features within the same embodiment have been given the same reference numerals.

[0046] In overview and referring initially to Figure 1 , the surgical training device 1 is configured to simulate anastomosis of a human body channel, in particular anastomosis of a distal coronary artery. As best shown in Figures 9 and 10, the surgical training device 1 is advantageously in the form of a compact kit that contains all the necessary equipment to complete and record multiple anastomosis procedures without the need to obtain further equipment. The compact nature of the surgical training device 1 advantageously allows the device to be quickly and easily packed up and sent off for assessment either as a whole kit or in stages across the training program.

[0047] Referring to Figure 8, the surgical training device 1 includes a top section 2, and a bottom section 3. The top section 2 has a first and a second side support 6, 7 (see Figure 1). In an open configuration, the first and the second side supports 6, 7 are perpendicular to the top section 2 to form a bridge over the bottom section 3. The first and the second side supports 6, 7 each include a flange or a tab (not shown) that extends from the distal end of the side support 6, 7 and runs parallel to the top section 2 to secure the top section under the bottom section 3 by placing the flanges or the tabs under the lower layer 10 of the bottom section 3.

[0048] The top section 2 includes a cut-out 8 which advantageously allows the user to position a recording device 15 above the bottom section 3 to record the anastomosis. By recording the anastomosis, the user can review their surgical technique themselves and/or send the recording to a clinician for review and feedback. This is particularly advantageous for surgical trainees who currently only learn how to perform coronary anastomosis in the operating theatre. Anastomosis is also a difficult skill to learn on the job as the high- pressure environment in the operating theatre means there is limited scope for failure or opportunity for feedback.

[0049] In the open configuration, the cut-out 8 in conjunction with the first and second side supports 6,7 and the bottom layer 3 define a void 8A through which surgical trainees can perform the anastomosis. The void 8A simulates an opening through a body cavity. As discussed below, the void 8A is defined by the cut-out 8, first and second side supports 6, 7, and wall portion 4 of the bottom layer 3 (when the wall portion 4 is used).

[0050] In a closed configuration, the first and the second side supports 6, 7 are folded inwardly to collapse the top section 2. The outer faces of the first and the second side supports 6, 7 include an adhesive strip 16A (e.g., Velcro) to removably attach the collapsed top section 2 to an adhesive strip 16B of a top cover 5 of the bottom section 3, as best shown in Figure 9. The top section 2 is designed to fit conveniently on the top cover 5 of the bottom section 3. It will be appreciated that storing the top section 2 on the bottom section 3 creates a compact surgical training device 1.

[0051] In the illustrated embodiment, the first and the second side supports 6, 7 are a predetermined set height for the recording device 15 to clearly view the simulated surgical procedure. In other embodiments, the height of the first and the second side supports 6, 7 may be adjustable to more accurately simulate operating conditions, for example, to simulate operating within a deeper body cavity. Height adjustments of the first and second side supports 6, 7 also adjust the height of the void 8A, which in turn adjust the simulated operation conditions.

[0052] Referring to Figures 8 and 9, the bottom section 3 includes a front, back and side wall portions 4 and a top cover 5. The bottom section 3 is in the form of a box with a lid. The top cover 5 contains adhesive strips 16B, in this case Velcro, which are complementary to the adhesive strip 16A (disposed on the first and the second side supports 6, 7). The adhesive strips 16A and 16B enable the top section 2 (in its closed configuration) to removably attach to the top cover 5 of the bottom section 3.

[0053] The front, back and side wall portions 4 are of a predetermined set height. However, in other embodiments, the height of the front, back and side wall portions 4 may be adjustable to more accurately simulate operating conditions, for example, to simulate operating within a deeper body cavity. In one arrangement, a section having a predetermined height is provided with the training device 1. This section can then be attached to the front side wall portion 4 to increase the height of the wall portion on the side of the cut-out 8.

[0054] The bottom section 3 further includes an upper layer 9 and a lower layer 10, as best shown in Figures 8 and 9. The upper layer 9 includes multiple compartments 13 containing numerous anatomical structures 12 of human body channels. It will be appreciated that the inclusion of numerous anatomical structures 12 of human body channels provides the user repeated opportunities to perform an anastomosis in a cost-effective manner which is particularly advantageous as in order for simulated task training to be effective, it must be repeated regularly.

[0055] Referring to Figure 8, several compartments 13 of the upper layer 9 are grouped together to easily and quickly remove the compartments 13 from the bottom section 3. The compartments 13 also fit together like pieces of a puzzle, as best shown in Figures 7 and 9. The upper layer 9 is made of foam to protect the anatomical structures 12 during transportation.

[0056] The lower layer 10 is positioned under the upper layer 9. The lower layer 10 includes a void 14 which is configured to secure an anatomical structure 12. The lower layer has two cut-outs on either side of the void 14 to easily remove the anatomical structure 12. The void 14 is positioned under the cut-out 8 of the top section 2 so the procedure conducted on the anatomical structure 12 may be recorded for assessment purposes.

[0057] The following description describes the use of the surgical training device 1.

[0058] First, the user receives a complete surgical training device 1 , as shown in Figure 10. The user then opens the top cover 5 of the bottom section 3 to expose the top section 2 and the upper layer 9 of the bottom section 3 which contains the anatomical structures 12 of human body channels and the surgical equipment 11 necessary to perform the anastomosis. The user then removes the upper layer 9 to uncover the lower layer 10. An anatomical structure 12 is then removed from the upper layer 9 and secured within the void 14 of the lower layer 10. The top section 2 is then removed from the top cover 5 of the bottom section 3. The first and the second side supports 6, 7 of the top section 2 are then unfolded, bringing the top section 2 into an open configuration. The user then positions the flanges or tables of the first and the second side supports 6, 7 under the lower layer 10 of the bottom section 3 to secure the top section 2 in place. The top section 2 forms a bridge over the lower layer 10 and is positioned such that the cut-out 8 sits above the void 14 of the lower layer 10 to enable the surgical procedure to be recorded, as best shown in Figures 3 and 4.

[0059] The user then connects surgical equipment 11 to the top section 2 to hold a human body channel in place above the anatomical structure so that anastomosis may be performed on the human body channel on the anatomical structure 12. Before commencing the simulated surgical procedure, a recording device 15 is placed on the edge of the cut-out 8 of the top section 2 to record the surgical procedure.

[0060] Once the simulated surgical procedure is complete, the user stops the recording and removes the anatomical structure 12 from the lower layer 10 and places the anatomical structure 12 back in its respective compartment 13 of the upper layer 9. The user may continue practising their anastomosis by placing another anatomical structure 12 within the void 14 of the lower layer or they may pack up the device.

[0061] To pack up the device, the recording device 15 is removed from the top section 2. The top section 2 is then removed from the bottom section 3, and the first and the second side supports 6, 7 of the top section 2 are collapsed to bring the top section 2 into a closed configuration. The upper layer 9 is then reassembled, and the surgical equipment 11 is placed back in its respective compartment 13. The top section 2 is then attached to the top cover 5 via the adhesive strips 16A and 16B, and the top cover 5 is closed over the bottom section 3.

[0062] After each anastomosis, the user may send the structure 12 (with the joined human body channels), within the protection of a compartment of the upper layer 13, back to a laboratory for assessment. It will be appreciated that multiple structures 12 may reside in a single compartment of the upper layer 13. This advantageously allows the user to safely send one or more structures 12 back to a laboratory for assessment when completed which ensures the user receives continual and frequent feedback on their surgical technique.

[0063] Examples of the assessment include fluid dynamics analysis and stitching analysis of the joined human body channels. In one arrangement, the fluid dynamics analysis uses micro-CT scanning, whereby a three-dimensional model of the internal parts of the human body channels are generated and computational fluid dynamics (e.g., pressure, velocity of flow and radius) are simulated. In another arrangement, the stitching analysis uses a scanner (e.g., a laser scanner, a photogrammetry scanner, etc.) to generate a three- dimensional model of the outer parts of the joined human body channels. The three- dimensional model of the outer parts is then used to analyse the suture placement. This data is then made available to the user for regular self, peer, and institutional review.

[0064] The surgical device described herein is particularly useful for simulated anastomosis training of human body channels and represents a practical and commercially significant improvement over the prior art.

[0065] It will be appreciated that the surgical training device is a convenient and cost- effective way for a user to not only repeatedly practice anastomosis of human body channels outside of the human body in the operating theatre but also to receive objective and quantifiable feedback on their surgical techniques.

[0066] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Reference table

Claims

1. A surgical training device configured for simulating a surgical procedure, including: a top section, and a bottom section configured to accommodate the top section, wherein the top section includes a cut-out configured to position a recording device above the bottom section.

2. A surgical training device according to claim 1, wherein the top section is connected to a first support and a second support.

3. A surgical training device according to claim 1 or claim 2, wherein the height of the first support and the second support are adjustable.

4. A surgical training device according to any one of the preceding claims, wherein the top section is configurable into an open configuration and a closed configuration.

5. A surgical training device according to claim 4, wherein when in an open configuration, the first support and the second support are configured to removably secure the top section to the bottom section.

6. A surgical training device according to claim 4, wherein when in a closed configuration, the first support and the second support are folded.

7. A surgical training device according to any one of the preceding claims, wherein the bottom section includes an upper layer and a lower layer.

8. A surgical training device according to claim 7, wherein the upper layer includes a plurality of compartments.

9. A surgical training device according to claim 8, wherein the plurality of compartments are configured to contain surgical equipment and one or more anatomical structures.

10. A surgical training device according to claim 9, wherein at least one compartment is configured to contain two or more anatomical structures. A surgical training device according to any one of claims 7 to 10, wherein the lower layer includes a void. A surgical training device according to claim 11, wherein the void is configured for accommodating at least one anatomical structure. A surgical training device according to any one of the preceding claims, wherein the bottom section further includes a front, back and side wall portions. A surgical training device according to claim 13, wherein the height of the front, back and side wall portions are adjustable.