Endoscopic transnasal skull base surgery training device

Abstract

Disclosed herein is a neurosurgical simulator for training various tasks involved in endoscopic transsphenoidal surgery, the simulator comprising a human head model with a front portion including a nose portion and a rear portion removably attached to a tilted base portion, and a number of openings in the nose portion for inserting an endoscope and operating instruments, the tilted base portion being tilted to mimic the position of a patient during an endonasal procedure, the base portion having a protruding platform with slots for forming male-female connections with corresponding protrusions provided under one or more behavioral plates, the behavioral plates being designed to train various tasks including pick-and-place, drilling, dissecting, punching / grasping and precision movements around an anatomical structure. The simulator further comprises sensors including touch sensors, force sensors and accelerometers configured to track a user's performance and provide feedback. The simulator further comprises a pair of articulated arms, each joint of the arms having an encoder connected to the endoscope and instruments for tracking the user's kinematic data.

Description

[Technical field]

[0001] The present invention relates generally to a training device, and more particularly to a training device or trainer or neurosurgical simulator for various tasks involved in an endoscopic transsphenoidal surgical procedure. Tasks identified for EETS surgery include pick and place, drilling, cutting, punching / grasping, and precision movements around the anatomy. [Background technology]

[0002] The endonasal transsphenoidal approach is a minimally traumatic nasal route to the concha and extended skull base, avoiding the need for brain retraction and also providing improved visualization of the surgical field. When compared to transcranial procedures, this approach results in lower morbidity and mortality. However, endoscopic endonasal transsphenoidal surgery (EETS) surgery is a complex procedure that requires careful concentration and technical expertise. Traditional apprenticeship-based training does not provide trainees with hands-on technical skills and is therefore not applicable to training in MIS procedures. Also, the limited duty time of training leads to reduced trainee exposure to surgical cases. These two factors have led to a rapid increase in interest in simulation-based training models for neurosurgery. Neuroendoscopy requires independent visual, bimanual, and psychomotor skills. Narrow monocular vision and video presentation on a two-dimensional (2D) display limit visual feedback. Monocular vision leads to a loss of depth cues, and a narrow field of view makes it difficult to form a three-dimensional (3D) mental image. The endoscope is moved back and forth to acquire depth cues. Light reflections on different surfaces help identify distance. Tactile and haptic feedback are limited due to the use of long instruments, fulcrum action, and reduced degrees of freedom. Long instruments and endoscopes are inserted by creating an opening in the skull or through a natural foramen. The endoscope has four degrees of freedom (DOF) constrained by a fulcrum at the entry site and an additional DOF for the relative rotation of the camera along its axis. Thus, the skills required for neuroendoscopy are challenging and require dedicated training systems and careful practice. Simulation-based training is still in its infancy, and the majority of surgical training rooms lack patient-specific simulators.

[0003] Most of the currently available surgical simulators are related to laparoscopy, and there has been limited development of simulators for neurosurgery. Simulators developed for neurosurgery are not patient-specific, do not cover all tasks, and lack evaluation metrics.

[0004] See US Patent Publication No. 20050181340. This invention discloses an adaptive simulation environment particularly suited for laparoscopic surgical procedures. The computer-based learning environment automatically increases (or decreases) the difficulty of tasks without individual levels based on performance, thereby accommodating different levels of skill without frustration or boredom while keeping the user in an optimal learning "zone." The method includes the steps of specifying a task to be performed in relation to an object, displaying the object in the environment for a predetermined period of time, and modifying the display according to the user's ability to complete the task within the predetermined period of time.

[0005] Please further refer to Russian Utility Model No. 180078. The invention discloses a simulator for skills development in transnasal endoscopic surgery. The utility model relates to a teaching aid in medical equipment, namely ENT, aimed at developing and improving manual skills of working with medical instruments under the control of an endoscope system, which are necessary for performing basic surgical procedures in transnasal endoscopic surgery. The improvement of the quality of training by expanding the area of ​​operation with medical instruments is achieved by the fact that in a simulator for mastering manual skills in transnasal endoscopic surgery, which is made in the form of a removable cylinder including a tripod on which a model of the nasal cavity is attached and with the possibility of changing its position in space, the interior of the model of the nasal cavity is configured for inserting the endoscope and the instruments for transnasal endoscopic surgery into it and also includes exchangeable elements inside thereof simulating the structure of the nasal cavity, the exchangeable elements being made in the form of inserts which are destroyed as a result of being exposed against it by the transnasal endoscopic surgery instruments, the model of the nasal cavity being made in the form of a truncated cylinder, its beveled end being located on the input side of the endoscope and the instruments for transnasal endoscopic surgery and its longest generatrice being located above its axis.

[0006] Further reference is made to Russian Utility Model No. 190669, which relates to a simulator for the development of manual surgical skills in the brain section of the head in a real topographical anatomical medium. This utility model relates to the field of medicine, i.e., neurosurgery and surgery, and can be used to develop correct manual surgical skills for students in the brain area of ​​the head when performing craniotomy steps, i.e., incision of the skin, installation of cutter holes, cutting of bone grafts, opening of the dura mater solid and layer-by-layer suturing of tissues with bone grafts, as well as objective evaluation of the performed trepanations.

[0007] Please refer to US20180114466. This document discloses a training device for endoscopic transnasal skull base surgery, which is composed of a human head model and a liquid circulation means. The human head model includes an anterior part including a nasal part with nostrils formed therein, and a main part including at least a part of the nasal septum, at least a part of the nasal cavity side wall, at least a part of the posterior wall of the sphenoid sinus, and at least a part of the internal carotid artery, and the liquid circulation means includes a storage tank for storing an opaque colored liquid, a supply flow path disposed between the storage tank and at least a part of the internal carotid artery, a return flow path disposed between at least a part of the internal carotid artery and the storage tank, and a circulation pump for circulating the liquid in the storage tank through the supply flow path, at least a part of the internal carotid artery, and the return flow path. However, it does not provide training for EETS surgical tasks, does not disclose the use of a behavioral plate or platform, and does not disclose the use of sensors or AI technology.

[0008] Yet another reference is made to US Patent No. 10902745, which refers to an electromechanical box trainer for neurosurgery, comprising: (i) a base part with a rubberized working port for inserting an endoscope and an instrument for manipulation, a microcontroller-programmed motorized peg plate arranged at a 45° inclination to define the amount of practice according to neuroendoscopy, a membrane keypad for changing the rotation angle of said peg plate along the vertical axis, a liquid crystal display (LED) array for illuminating the inside of the box, and a removable base plate for housing the circuitry, and (ii) a removable part surrounded by five walls, such as a front wall, two side walls, a rear wall, and a top wall, which comprises a housing for mounting an auxiliary camera for recording all operations for evaluation, and a slider on the back for adjusting the focus of the camera. This document further reveals that the insertion of the endoscope and the instrument through the working port provides access to the action area for performing pick-and-place operations by manipulating rubber rings arranged on the pegs. However, this invention is a box trainer and does not include a head model from a patient's CT database.

[0009] Further reference is made to US Patent No. 10,319,259, which relates to an anatomical simulator manufactured using 3D printing. Disclosed herein is an anatomical simulator manufactured using three-dimensional (3D) printing to manufacture internal components of the simulator. A method for forming void structures in an anatomical mannequin includes 3D printing one or more structures of one or more desired secondary anatomical features using a dissolvable material; The method includes supporting and encapsulating one or more structures within an anatomical mannequin mold; filling a remaining internal volume within the mold between an exterior surface of the one or more structures and an interior surface of the mold with a liquid precursor of a matrix material selected to mimic anatomical tissue, processing the liquid precursor to form a tissue-mimicking matrix material; and dissolving the one or more structures with a fluid selected to dissolve the dissolvable material to form an internal cavity within the tissue-mimicking matrix material.

[0010] See further the paper by Favier et al., "Geometric and mechanical evaluation of 3D-printing materials for skull base anatomical education and endoscopic surgery simulation-A first step to create reliable customized simulators," DOI: 10.1371 / journal.pone.0189486; December 18, 2017. This paper aims to evaluate several consumer-grade materials to create patient-specific 3D-printed skull base models for anatomical learning and surgical training. Four 3D-printed consumer-grade materials were compared to human cadaver bone: calcium sulfate hemihydrate (named Multicolor), polyamide, resin, and polycarbonate. The geometric accuracy, the force required to fracture the thin wall of the material, and the force required during drilling were compared. The authors of this paper state that polycarbonate is a good substitute for human cadaver bone for skull base surgery simulation. Thanks to short lead times and reasonable manufacturing costs, patient-specific 3D printed models can be used in clinical practice for preoperative training, improving patient safety. However, the literature does not contain any suggestions regarding CT-based scalp models and action plates for training pick-and-place, drilling, dissection and fine motor tasks in endoscopic endonasal skull base surgery. Moreover, the paper does not include any mechanism for measuring the kinematics of the surgeon's actions.

[0011] Therefore, there remains a need for a neurosurgical simulator for training the various tasks involved in endoscopic transsphenoidal surgical procedures such as pick-and-place, drilling, dissection, punching / grasping, and precision movements around the anatomical structures. Summary of the Invention [Problem to be solved by the invention]

[0012] The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key / critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description of the invention that is presented later.

[0013] It is an object of the present disclosure to provide a neurosurgical simulator for training the various tasks involved in endoscopic transsphenoidal surgical procedures such as pick and place, drilling, dissection, punching / grasping, and precision movements around the anatomical structures.

[0014] Another object of the present invention is to develop and improve manual skills using neuroendoscopic instruments for endonasal approaches.

[0015] Yet another object of the present invention is to enable the development of basic neuroendoscopic skills in a safe and controlled environment in a surgical training laboratory.

[0016] A further object of the present invention is to develop psychomotor skills and learn to use various neuroendoscopic instruments.

[0017] One aspect of the present invention is to provide a neurosurgical simulator for training various tasks involved in an endoscopic endonasal transsphenoidal surgery (EETS) procedure. It is composed of a human head model with an anterior section including a nose section and a posterior section detachably attached to a tilted base section, and multiple openings in the nose section for inserting endoscopes and operating instruments, the tilted base section being tilted and positioned to mimic the position of a patient during an endonasal procedure, the base section being provided with a protruding platform with slots for forming male-female connections with corresponding multiple protrusions provided under one or more behavioral plates, the behavioral plates being designed to train various tasks including pick-and-place, drilling, dissection, punching / grasping and precision movements around anatomical structures. The EETS simulator is designed using CT scan data of an adult patient to provide an environment similar to the endonasal approach, while most of the prior art is related to box-based simulators. The nose section is made of elastic material and encased in hard plastic using multi-material 3D printing. The behavioral plate is developed by observing surgical footage, CT scan images, and feedback of expert neurosurgeons for tasks including pick-and-place, drilling, dissection, and precision movements. The behavioral plate is made of materials that mimic the biomechanical properties of real tissues. A variety of sensors, including touch sensors, force sensors, and accelerometers, are placed in the simulator or on the instrument to track the surgeon's performance and provide feedback. A pair of articulated arms with encoders at each joint are designed along with the base of the simulator to collect the kinematic data of the surgeon during training. The data collected from all the sensors is analyzed using AI artificial intelligence techniques, including machine learning and deep learning.

[0018] Other aspects, advantages and salient features of the present invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the annexed drawings, discloses illustrative embodiments of the invention. [Brief description of the drawings]

[0019] The above and other aspects, features, and advantages of the embodiments of the present disclosure will become more apparent in the following description taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 shows the complete setup of the EETS simulator with the involved equipment and articulated arms for recording of kinematic data. [Diagram 2] FIG. 1 is a block diagram depicting the EETS simulator and skills assessment workflow. [Diagram 3] FIG. 1 is a schematic diagram depicting an exploded view of the EETS simulator. [Figure 4] FIG. 2 is a schematic diagram depicting the front and rear of the simulator, excluding the nose. [Diagram 5] FIG. 1 is a schematic diagram showing the flexible nose of the EETS simulator. [Figure 6] FIG. 1 is a schematic diagram of the base of the EETS simulator that allows the fixing of the rear of the human head model and the behavioral plate. [Figure 7] FIG. 1 is a schematic diagram illustrating a pick and place action plate. [Figure 8] FIG. 1 is a schematic diagram depicting the internal fine motor action plate. [Figure 9] FIG. 1 is a schematic diagram depicting the external fine motor action plate. [Figure 10] FIG. 1 is a schematic diagram depicting a dissection behavior plate. [Figure 11] FIG. 1 is a schematic diagram depicting a perforated behavior plate.

[0020] Those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may not be drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of various exemplary embodiments of the present disclosure. Note that like reference numbers are used throughout the figures to denote the same or similar elements, features, and structures. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The following description, with reference to the accompanying drawings, is provided to aid in a comprehensive understanding of exemplary embodiments of the present invention. To aid in the understanding, various specific details are included, but these should be considered as merely examples.

[0022] Features described and / or illustrated with respect to one embodiment may be used in the same or similar manner in one or more other embodiments and / or may be used in combination with or instead of features of the other embodiments.

[0023] Various embodiments of the present invention describe an endoscopic transnasal skull base surgical trainer / simulator. Various embodiments herein may include one or more of the components to provide an endoscopic transnasal transsphenoidal surgery (EETS) simulator. In the following description, for purposes of explanation, specific details are set forth to provide an understanding of the present disclosure.

[0024] The present invention relates to a neurosurgical simulator for training various tasks involved in endoscopic transsphenoidal surgery, the simulator comprising a human head model having a front part including a nose part and a rear part removably attached to a tilted base part, and a number of openings in the nose part for inserting an endoscope and operating instruments, the tilted base part being tilted and positioned to mimic the position of a patient during an endonasal surgery, the base part having a protruding platform with slots for forming male-female connections with a number of corresponding protrusions provided under one or more behavioral plates, the behavioral plates being designed to train various tasks including pick and place, drilling, dissection, punching / grasping and precision movements around anatomical structures.

[0025] According to one embodiment of the invention, the base portion is inclined at an angle of 45°.

[0026] In one of the embodiments, the invention relates to an EETS simulator whose outer body is developed by using CT scan data of the head, the surface model of the outer body being developed by segmentation of a region of interest related to endoscopic transsphenoidal surgery.

[0027] In another embodiment, a 3D solid model of the outer body is developed by reverse engineering of a surface model developed by segmentation of CT images and a physical model using 3D printing technology.

[0028] In another embodiment, the nose is developed from a soft polymeric material and the remainder of the simulator body is developed from a hard plastic material.

[0029] In a preferred embodiment, the soft polymeric material is selected from Agilus and silicone materials and combinations thereof. In a preferred embodiment, the hard polymeric material is acrylonitrile butadiene styrene (ABS) plastic.

[0030] In another embodiment, the behavioral plate is made of materials such as bone matrix, Agilus, and silicone that mimic the biomechanical properties of real tissue.

[0031] In another embodiment, a variety of action plates have been developed that are related to pick and place, punch, cut, punch / grasp and fine motor tasks.

[0032] In another embodiment, a base is developed for the fixation of the simulator body and for the insertion of the various action plates. The angle of the base is maintained according to the patient's position as during the intranasal surgery. In a preferred embodiment, said base is inclined at an angle of 45°.

[0033] In yet another embodiment, various sensors are placed inside the simulator and on the equipment to track the surgeon's actions and provide feedback if he makes an erroneous movement. These sensors may include touch sensors, force sensors, and accelerometers depending on the surgical task.

[0034] In yet another embodiment, the simulator is fitted with a pair of articulated arms that connect to the endoscope and instruments to track the kinematic data of the surgeon in training.

[0035] In yet another embodiment, artificial intelligence techniques, including machine learning and deep learning techniques, are used to analyze and score surgeon skills according to proficiency.

[0036] According to one embodiment of the present invention, FIG. 1 includes a complete setup of an EETS simulator, showing an EETS simulator assembly 1, a simulator head model 2, a tilted base plate assembly 3, an articulated arm 4 for recording kinematic data, a mounting 5 for the base plate assembly and articulated arm, as well as an endoscope 6, a biopsy instrument 7, and an encoder 8.

[0037] FIG. 2 includes a block diagram illustrating the workflow of the EETS simulator training method and artificial intelligence based skills assessment using kinematic or sensor data.

[0038] FIG. 3 shows a schematic diagram illustrating an exploded view of the EETS simulator, showing the elastic nose section 9, the simulator head model 2, the behavior plate mounting base 10, the upper base plate 11 and the lower base plate 12.

[0039] FIG. 4 shows a schematic diagram depicting the noseless front 14 and rear 13 parts of the simulator.

[0040] FIG. 5 shows a schematic diagram illustrating the flexible nose portion 9 of the EETS simulator with the endoscope and instrument entry point 16, and the provision for its attachment to the head model 16.

[0041] FIG. 6 shows a schematic diagram of the base of the EETS simulator with the rear of the human head model 18 and provisions for the fixation of the behavior plate 17.

[0042] FIG. 7 shows a schematic diagram illustrating a pick and place action plate 19 and an object 20 for the pick and place action.

[0043] FIG. 8 shows a schematic diagram illustrating the internal fine motor activity plate 21 and the internal fine motor activity area 22.

[0044] FIG. 9 shows a schematic diagram depicting an external fine motor behavior plate 23, an external fine motor behavior path 24, and an object 25 for moving along the path.

[0045] FIG. 10 shows a schematic diagram illustrating a cutting action plate 26 having a cutting area 27 based on a soft elastic material.

[0046] FIG. 11 shows a schematic diagram depicting a perforated behavior plate 28 having perforated behavior areas.

[0047] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope and spirit of the invention, and the present invention is intended to include all such modifications and variations disclosed herein.

Claims

1. 1. A neurosurgical simulator for training various tasks involved in endoscopic transsphenoidal surgery, comprising a human head model having an anterior portion including a nose portion and a posterior portion removably attached to an inclined base portion, and a number of openings in the nose portion for insertion of an endoscope and operating instruments, the inclined base portion being inclined to mimic a patient's position during intranasal surgery, the base portion comprising a protruding platform having slots for forming male-female connections with a number of corresponding protrusions provided underneath one or more behavioral plates, the behavioral plates being designed to train various tasks including pick and place, drilling, dissection, punching / grasping and precision movements around anatomical structures.

2. The neurosurgical simulator of claim 1 , wherein the base is inclined at a 45° angle.

3. The neurosurgical simulator of claim 1 , wherein the human head model is developed using CT scan data of an adult patient to provide a path similar to an endonasal approach.

4. The neurosurgical simulator of claim 1 , wherein the nose portion is made of a soft polymer material and the anterior and posterior portions are made of a hard polymer material using multi-material 3D printing.

5. The neurosurgical simulator of claim 3 , wherein the soft polymeric material is selected from Agilus and silicone materials and combinations thereof.

6. The neurosurgical simulator of claim 3 , wherein the hard polymeric material is acrylonitrile butadiene styrene (ABS) plastic.

7. The neurosurgical simulator of claim 1, wherein the behavior plate is fabricated using 3D printing technology with materials selected from bone matrix, Agilus and silicone that mimic the biomechanical properties of real tissue.

8. The neurosurgical simulator of claim 1 , further comprising sensors including touch sensors, force sensors, and accelerometers configured to track a user's performance and provide feedback.

9. 10. The neurosurgical simulator of claim 1, further comprising a pair of articulated arms, each joint of the arms having an encoder connected to the endoscope and the instrument for tracking kinematic data of the user.

10. The neurosurgical simulator of claim 6, wherein the data collected from the sensors is analyzed using AI artificial intelligence techniques including machine learning and deep learning.

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