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Proximal Tibia Intraosseous Access Simulator And Method Thereof

Abstract: The present invention relates to a portable intraosseous access simulator (1) designed to mimic the anatomical features of the proximal tibia region of a human leg for training purposes. The simulator includes a skin-like material (1a), a cavity (1b) housing a multilayered bone module (3) with a subcutaneous tissue layer (3b), a bone layer (3c), and a marrow cavity (3g). The bone module (3) is adjustable via a knob (3h) and provides haptic feedback during needle insertion. A fluid simulation system comprising tubing (5), a multi-valve (14), and a syringe (6) enables realistic marrow aspiration and infusion. Integrated systems include a camera (10), display (11), speaker (12), and artificial intelligence module for analyzing needle placement and trainee performance. Additional features include Hall effect sensors (13) and strain gauge sensors (14a, 14b) for force and position analysis. The simulator supports multiple punctures, data storage, and remote feedback, ensuring effective and ethical training. FIGURE 1

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
30 April 2024
Publication Number
44/2025
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

RCUPE LIFESCIENCES PRIVATE LIMITED
Unit No. 1301, Block-A, Third Floor, Ardent Office One, Hoodi Circle, Mahadevpura Post, Bangalore-560048, Karnataka, India

Inventors

1. KARVE, Jayant Sitaram
A302, SVS Palms-1, Chinnapanahalli, Bangalore-560037, Karnataka, India
2. PASALA, Krupakar
Unit No. 1301, Block-A Third Floor, Ardent Office One, Hoodi Circle, Mahadevpura Post, Bangalore-560048, Karnataka, India

Specification

DESC:
Field of Invention
The present invention relates to a simulator for medical training systems. Particularly, the present invention relates to a proximal tibia simulator that can be used to train the intraosseous insertion, aspiration and infusion procedure through the simulator.

Background and prior art
Training of the care providers and first responders in medical emergencies is an essential requirement. Every beginner is trained through simulated models of human anatomy and physiology. The practice can be done by the trainee through these training simulators. This offsets the requirement of cadavers and help the training to be done in cost effective way. Also, simulators help in simulating the particular disease state, procedure.

The Intraosseous(IO) access is gained in patients where there is a difficult or failure to gain intravenous access(IV). The intraosseous access is gained through long bones in places such as proximal tibia, distal tibia and humeral head.

EP 2852941B1 relates to a Tactical Combat Casualty Care Training System. The document discloses a training device for human casualties consisting of: a human skeleton-like structure comprising a torso, neck, and skull, wherein the torso consists of ribs, a sternum, a left proximal humeral head, a right proximal humeral head, a lumbar spine, a thoracic spine, and a cervical spine, and where the human skeleton-like structure is cast from rigid polyurethane and filled with a low density rigid urethane foam void filler and the cervical spine is embedded with a flexible wire to provide flexure; removable pucks for needles and catheters, a removable puck being located at the top of the sternum, and a removable puck being located at least one of the left proximal humeral head and right proximal humeral head, and where the removable pucks are comprised of polycarbonate resin thermoplastic and a layer of polystyrene which simulates an intraosseous infusion site by approximating human bone density, fastened to the skeleton with silicone elastomer; a human skin-like material that covers the skeleton; and a removable trachea module, where the skull comprises a mouth with movable jaw and tongue, nasal passage, and eye sockets, where the neck section comprises an opening configured to receive the removable trachea module.

CN201638446 relates to an infant bone marrow puncture model, which is mainly composed of a simulation infant lower body, leg skins, simulation tibias and simulation bone marrows and is characterized by simulating the lower body of a 6-month-old infant and being made of a hard PVC material, wherein the insides of double legs are provided with cylindrical cavities; front inside surfaces of the legs are provided with rectangular openings; the leg skins are made of silicone materials and have high simulation and high elasticity; the shape of the leg skins corresponds to that of the legs of the model; the leg skins can be sleeved outside the legs of the model; the simulation tibias are made of specific thin plastics and are of long cylinder shape; the insides of the simulation tibias are hollow; one ends of the simulation tibias are open and can be filled with the simulation marrows; and the simulation tibias can be inserted into the cylindrical cavities inside the double legs. The utility model has the advantages that both the infant double-leg tibias can be subjected to bone marrow puncture operation; the needling sensation is vivid; the falling sensation can be generated after a needle is inserted; and when the puncture is correctly operated, the simulation marrows can flow out correspondingly.

GB2552451 discloses an intraosseous infusion training system. The system comprises an artificial body portion 102 comprising a housing portion 104 and an artificial bone section 106 moveable between a plurality of orientations relative to the housing portion 104 to provide a plurality of access points in which the artificial bone section 106 can be accessed. This means that the artificial bone section 106 can be moved and is thus capable of repeated use for a practitioner undergoing training. There may be a covering 105 for at least partially covering the bone section 106, the covering 105 configured to represent the skin of a patient. The bone section 106 may comprise a hollow inner core which may comprise a plurality of discrete chambers (116a-d figure 4). There may be a port 120 to fill the chamber(s) which may comprise a one way valve or a two way valve.

US 2021/0272476 discloses a trainer for practicing an intraosseous infusion is presented. The trainer includes a mannequin and an injection-site simulant. The mannequin is in the form of a body, human or animal, in part or whole. The injection-site simulant further includes a pocket, an insert, and an outer cover. The pocket extends into the mannequin. The insert simulates a hard exterior of a bone. The insert is disposed within the pocket. The outer cover with a plug simulates a skin, human or animal. The outer cover conceals the insert, the pocket, and the plug. The pocket and the insert cooperate to form a cavity. The cavity is disposed where marrow resides within the bone. The cavity is capable of receiving a fluid injected through a hole formed during use through the outer cover, the plug, and the insert. The plug sealingly contacts and cooperates with at least one of the insert or the wall within the pocket to confine the fluid within the cavity.

WO 2022197393 relates to a trainer (1) for practicing an intraosseous infusion. The trainer (1) includes a mannequin (2) and an injection-site simulant (3). The mannequin (2) is in the form of a body, human or animal, in part or whole. The injection-site simulant (3) further includes a pocket (6), an insert (8), and an outer cover (4). The pocket (6) extends into the mannequin (2). The insert (8) simulates a hard exterior (20) of a bone. The insert (8) is disposed within the pocket (6). The outer cover (4) with a plug (14) simulates a skin, human or animal. The outer cover (4) conceals the insert (8), the pocket (6), and the plug (14). The pocket (6) and the insert (8) cooperate to form a cavity (16). The cavity (16) is disposed where marrow resides within the bone. The cavity (16) is capable of receiving a fluid injected through a hole (23) formed during use through the outer cover (4), the plug (14), and the insert (8). The plug (14) sealingly contacts and cooperates with at least one of the insert (8) or the wall (17) within the pocket (6) to confine the fluid within the cavity (16).

Though there are simulators available, there is a need of portable simulator which can simulate the anatomical features of the access, simulate the realistic bone, tissue, marrow characteristics, provide ability to learn the insertion procedure with haptic feedback. There is a need for a simulator with the ability to aspire the marrow, the ability to train multiple trainees without loss of key characteristics of insertion including realistic insertion, haptic feedback, aspiration, infusion and biopsy and the ability to capture the insertion force by the care-provider during insertion procedure. There is a need for a portable solution with ability to practice even in the field. There is need for a simulator for analyzing the trainee’s performance by capturing video of the insertion of the needle through the anatomy and analyzing them to understand and assess correctness of the insertion procedure and skill acquired by the operator etc.

Object of the Invention
It is an object of the present invention to provide a portable adult intraosseous simulator that simulates the anatomical structure mimicking a selected anatomy of a human body including a bone structure.

It is an object of the present invention to provide a portable adult intraosseous simulator that simulates the right leg knee or the left leg knee and proximal tibia of both knees and any bone structure of the human body.

It is another object of the present invention to provide a simulator that has ability to train multiple trainees without loss of key characteristics of insertion including realistic insertion, haptic feedback, aspiration, infusion and biopsy.

It is a further object of the present invention to provide a simulator with inbuilt AI algorithm to analyze the insertion performance and provide feedback to the trainee about his skills during the procedure.

Summary of the Invention
The following disclosure 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 present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.

According to one aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the anatomy including a bone structure, optionally covered with subcutaneous tissue, and a skin-like material; the simulated anatomical structure comprising:
a cavity configured to house a bone module;
the bone module comprising:
a multilayered construction including a subcutaneous tissue layer, a bone layer, and a marrow cavity;
a valve in fluid communication with the marrow cavity, the valve configured to allow aspiration and infusion of fluid;
an axial scale and a rotational scale configured to provide feedback on the position of the bone module within the cavity;
indicators for visually indicating the movement of the bone module; and
a knob configured to adjust the axial and rotational position of the bone module within the cavity.

According to second aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the anatomy including:
external anatomical features configured to simulate surface landmarks for identifying an insertion site;
a cavity within the simulated anatomical structure configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a valve in fluid communication with the marrow cavity, the valve configured to allow infusion of fluid into the marrow cavity;
a fluid simulation system comprising:
tubing operatively connected to the marrow cavity;
a multi-valve configured to control fluid flow;
and a syringe or reservoir configured to supply artificial blood or colored liquid to the marrow cavity;
wherein the simulated anatomical structure and bone module are configured to provide realistic tactile feedback during needle insertion, including resistance and a sudden give-away feel upon penetration into the marrow cavity.

According to third aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the structure including:
a skin-like material configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure configured to house a bone module;
a camera positioned within the simulated anatomical structure and configured to capture video data of a needle insertion procedure;
a display operatively connected to the camera and configured to visually present the captured video data, including the position and trajectory of the needle during the insertion procedure;
a speaker operatively connected to the camera and configured to provide audio feedback during the needle insertion procedure, the audio feedback indicating whether the needle is correctly positioned within the simulated anatomy;
and an artificial intelligence module operatively connected to the camera, the artificial intelligence module configured to analyze the captured video data to determine the accuracy of needle placement, assess the trainee's performance, and provide feedback through the display and speaker.

According to fourth aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the structure including:
a skin-like material configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a camera positioned within the bone module and configured to capture video data of a needle insertion procedure;
a display operatively connected to the camera and configured to visually present the captured video data, including the position and trajectory of the needle during the insertion procedure;
a speaker operatively connected to the camera and configured to provide audio feedback during the needle insertion procedure, the audio feedback indicating whether the needle is correctly positioned within the simulated anatomy; and
an artificial intelligence module operatively connected to the camera, the artificial intelligence module configured to analyze the captured video data to determine the accuracy of needle placement, assess the trainee's performance, and provide feedback through the display and speaker.

According to fifth aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the structure including:
a skin-like material configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a force analysis system comprising:
a first force sensor positioned within the simulated anatomical structure to measure the insertion force applied by a trainee during the needle insertion procedure;
and a second force sensor positioned within the bone module to measure the torque or rotational force applied during the procedure;
wherein the force analysis system is configured to provide real-time feedback on the insertion force and torque applied by the trainee, enabling assessment of the trainee's technique and accuracy during the procedure.

According to sixth aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the structure including:
a skin-like material configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a force analysis system comprising:
a first force sensor positioned within the simulated anatomical structure to measure the insertion force applied by a trainee during the needle insertion procedure;
and a second force sensor positioned within the bone module to measure the torque or rotational force applied during the procedure;
wherein the force analysis system is configured to provide real-time feedback on the insertion force and torque applied by the trainee, enabling assessment of the trainee's technique and accuracy during the procedure.

According to seventh aspect of the present invention there is provided a portable intraosseous access simulator comprising:
a simulated anatomical structure mimicking a selected anatomy of a human body, the structure including:
a skin-like material configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
an external camera system positioned outside the simulated anatomical structure, the external camera system configured to capture video data of the needle insertion procedure and the trainee’s body posture and technique during the procedure;
wherein the external camera system is operatively connected to a display and an artificial intelligence module, the artificial intelligence module configured to analyze the captured video data to assess the accuracy of needle placement, the trainee’s ergonomics, and overall technique, and provide feedback through the display and audio cues.

According to eighth aspect of the present invention there is provided a method for training intraosseous access using a portable simulator, the method comprising:
identifying anatomical landmarks on a simulated anatomical structure mimicking the proximal tibia region of a human leg, the structure including a skin-like material, a subcutaneous tissue layer, and a bone module;
inserting a needle through the skin-like material, subcutaneous tissue layer, and bone layer of the bone module into a marrow cavity within the bone module;
aspirating simulated marrow or fluid from the marrow cavity through a valve operatively connected to the marrow cavity;
infusing fluid into the marrow cavity through the valve using a syringe connected to tubing and a multi-valve;
capturing video data of the needle insertion procedure using a camera positioned within the simulated anatomical structure;
analyzing the captured video data using an artificial intelligence module operatively connected to the camera to determine the accuracy of needle placement and the skill level of the trainee;
and providing feedback to the trainee through a display and a speaker, the feedback including visual and audio cues indicating the correctness of the insertion procedure.

According to ninth aspect of the present invention there is provided a system for training intraosseous access procedures, the system comprising:
a portable intraosseous access simulator including:
a simulated anatomical structure mimicking the proximal tibia region of a human leg, the structure comprising:
a skin-like material configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure configured to house a bone module;
the bone module comprising:
a multilayered construction including a subcutaneous tissue layer, a bone layer, and a marrow cavity;
a valve in fluid communication with the marrow cavity, the valve configured to allow aspiration and infusion of fluid;
an axial scale and a rotational scale configured to provide feedback on the position of the bone module within the cavity;
indicators for visually indicating the movement of the bone module;
and a knob configured to adjust the axial and rotational position of the bone module within the cavity;
a camera positioned within the simulated anatomical structure and configured to capture video data of a needle insertion procedure;
a display operatively connected to the camera and configured to visually present the captured video data;
a speaker configured to provide audio feedback during the needle insertion procedure;
an artificial intelligence module operatively connected to the camera, the artificial intelligence module configured to analyze the captured video data to determine the accuracy of needle placement and provide feedback to a trainee;
and a fluid simulation system comprising:
tubing operatively connected to the marrow cavity;
a multi-valve configured to control fluid flow;
and a syringe or reservoir configured to supply artificial blood or colored liquid to the marrow cavity.

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

Brief Description of Accompanying Drawings
The accompanying figures illustrate various components of the wearable ultrasound hardware system design. These figures are provided to enhance the understanding of the invention and are not intended to limit its scope.

Figure 1 illustrates Overall configuration of the proximal Tibia Simulator. The overall anatomy with anatomical landmarks along with movable bone module positioned within the simulated body.

Figure 2 illustrates the insertion of the bone module along the axis of the opening in the simulator anatomy.

Figure 3 illustrates cross sectional view of the simulator along with bone module.

Figure 4 illustrates outline of the simulator with insertion site.

Figure 5 illustrates replaceable insertion pad for multiple punctures

Figure 6 illustrates axial and rotational movement and positioning of the bone module with respect to the simulator anatomy for providing fresh insertion site for each new insertion procedure.

Figure 7 illustrates detailed view and features of the bone module.

Figure 8 illustrates camera-based system to capture and analyze the needle insertion procedure where in camera is positioned in the simulator anatomy.

Figure 9 illustrates camera-based system to capture and analyze the needle insertion procedure where in camera is positioned in the bone module.

Figure 10 illustrates Hall effect sensor based system to capture and analyze the needle insertion procedure where in Hall effect sensor is positioned in the simulator anatomy.

Figure 11 illustrates strain gauge/force sensor based system to capture and analyze the needle insertion force and torque etc.

Figure 12 illustrates a mobile phone with camera placed in the simulator to record and analyze the insertion procedure.

Figure 13 illustrates external camera-based system to capture and analyze the needle insertion procedure/user technique.

Figure 14 illustrates the representative intraosseous device positioned on the insertion site.

Figure 15 illustrates the representative intraosseous device positioned on the insertion site.

Figure 16 illustrates representative simulator rendering

Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may not have been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help to improve understanding of various exemplary embodiments of the present disclosure.

Detailed description of the Invention
The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of various embodiments of the present disclosure as defined by the claims and their equivalents. It includes various specific details to assist in that understanding, but these are to be regarded as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the various embodiments described herein can be made without departing from the scope and spirit of the present disclosure. In addition, descriptions of well-known functions and constructions may be omitted for clarity and conciseness.
All terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which various embodiments belong. Further, the meaning of terms or words used in the specification and the claims should not be limited to the literal or commonly employed sense but should be construed in accordance with the spirit of the disclosure to most properly describe the present disclosure.

The terminology used herein is for the purpose of describing particular various embodiments only and is not intended to be limiting of various embodiments. As used herein, the singular forms "a," "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising" used herein specify the presence of stated features, integers, steps, operations, members, components, and/or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, members, components, and/or groups thereof.

The present disclosure will now be described more fully with reference to the accompanying drawings, in which various embodiments of the present disclosure are shown.

In the first embodiment of the invention, the portable intraosseous access simulator is designed to mimic the anatomical features of a selected bone anatomy, such as the proximal tibia region of a human leg. The simulated anatomical structure (1) includes a skin-like material (1a) that replicates the texture and firmness of human skin, allowing trainees to identify external anatomical landmarks, such as the tibial tuberosity and flat plateau, to locate the correct insertion site.

The simulator further includes a cavity (1b) within the simulated anatomical structure (1) that houses a bone module (3). The bone module (3) is constructed with multiple layers, including:
• A bone layer (3c) that simulates the hardness and resistance of human cortical bone.
• An optional subcutaneous tissue layer (3b) that mimics the elasticity and texture of subcutaneous tissue.
• A marrow cavity (3g) that replicates the internal cavity of a bone, filled with spongy material to simulate bone marrow.

The bone module (3) is adjustable within the cavity (1b), allowing axial and rotational movement to present fresh insertion sites for multiple punctures. This feature ensures that the simulator can be used repeatedly by multiple trainees without loss of insertion characteristics.

The simulator is configured to provide realistic tactile feedback during needle insertion, including varying resistance as the needle passes through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c). A sudden give-away feel is provided when the needle penetrates the cortical bone and enters the marrow cavity (3g), simulating the haptic feedback experienced during a real intraosseous procedure.

This embodiment enables trainees to practice identifying anatomical landmarks, performing needle insertion, and experiencing realistic tactile feedback, thereby improving their skills and confidence in performing intraosseous access procedures.

In second embodiment of the invention, the portable intraosseous access simulator includes a fluid simulation system integrated into the simulated anatomical structure (1) and bone module (3) to replicate the circulatory characteristics of the marrow cavity. The fluid simulation system enables trainees to practice realistic marrow aspiration and infusion procedures, enhancing the training experience.

The bone module (3) includes a marrow cavity (3g) filled with spongy material that mimics the texture and absorption properties of human bone marrow. The marrow cavity (3g) is in fluid communication with a valve (3a), which is configured to allow controlled aspiration and infusion of fluid. The valve (3a) can be a one-way or two-way valve, enabling precise control of fluid flow during the procedure.

The fluid simulation system further comprises:
• Tubing (5): Flexible tubing operatively connected to the marrow cavity (3g) to simulate fluid flow.
• Multi-valve (14): A valve system configured to control the direction and pressure of fluid flow.
• Syringe or reservoir (6): A fluid supply system configured to deliver artificial blood or colored liquid into the marrow cavity (3g) and replenish it for repeated use.

During training, the trainee inserts a needle through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c) into the marrow cavity (3g). Once the needle is correctly positioned, the trainee can aspirate simulated marrow or fluid from the cavity (3g) through the valve (3a). The syringe or reservoir (6) can then be used to infuse artificial blood or colored liquid into the marrow cavity (3g), simulating the infusion of fluids or medications in a real intraosseous procedure.

The fluid simulation system is designed to provide realistic tactile feedback during fluid aspiration and infusion, replicating the resistance and flow characteristics of human bone marrow. This embodiment allows trainees to practice both the mechanical aspects of needle insertion and the functional aspects of fluid handling, ensuring comprehensive training in intraosseous access procedures.

In the third embodiment, the portable intraosseous access simulator integrates a camera-based system positioned within the simulated anatomical structure (1) to capture and analyze the needle insertion procedure. This system provides trainees with real-time visual and audio feedback, enhancing their ability to perform accurate intraosseous access procedures.

The simulated anatomical structure (1) includes a skin-like material (1a), a cavity (1b) housing a multilayered bone module (3), and external anatomical features that mimic surface landmarks for identifying the correct insertion site. The bone module (3) comprises a bone layer (3c), an optional subcutaneous tissue layer (3b), and a marrow cavity (3g), replicating the internal anatomy of a bone.

The camera / probe (10) is positioned within the simulated anatomical structure (1) to capture video data of the needle insertion procedure. The camera /probe (10) operates in the visible spectrum, infrared spectrum, or ultrasound spectrum, enabling precise visualization of the needle's position, trajectory, and depth as it passes through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c) into the marrow cavity (3g).

The captured video data is displayed on a display (11) operatively connected to the camera (10). The display (11) provides real-time visual feedback, including the needle's position and trajectory within the simulated anatomy. Additionally, a speaker (12) emits audio cues indicating whether the needle has reached the correct anatomical location within the marrow cavity (3g).

An artificial intelligence module is operatively connected to the camera (10) to analyze the captured video data. The AI module evaluates the accuracy of needle placement, insertion force, and overall technique, providing feedback to the trainee through the display (11) and speaker (12). The AI module can also generate detailed reports analyzing the trainee's performance, which can be stored, replayed, or transmitted to external devices for further review.

This embodiment allows trainees to visually and audibly assess their needle placement during the procedure, ensuring accurate insertion and improving their technique. The integration of the camera-based system and AI analysis provides a comprehensive training experience, enabling trainees to refine their skills and gain confidence in performing intraosseous access procedures.

In the fourth embodiment, the portable intraosseous access simulator incorporates an artificial intelligence (AI) module integrated with a camera system positioned within the bone module (3) to analyze the needle insertion procedure and provide real-time feedback to the trainee. This advanced system enhances the training experience by offering detailed performance analysis and guidance.

The simulated anatomical structure (1) includes a skin-like material (1a), a cavity configured to house a multilayered bone module (3), and external anatomical features to assist in identifying the correct insertion site. The bone module (3) comprises:
• A bone layer (3c) to simulate the hardness and resistance of human bone.
• An optional subcutaneous tissue layer (3b) to replicate the characteristics of subcutaneous tissue.
• A marrow cavity (3g) to simulate the internal cavity of a bone.

A camera / probe (10) is positioned within the bone module (3) to capture video data of the needle insertion procedure. The camera / probe (10) is configured to operate in the visible spectrum, infrared spectrum, or ultrasound spectrum, enabling precise visualization of the needle's interaction with the simulated bone and marrow.

The captured video data is displayed on a display (11) operatively connected to the camera (10). The display (11) provides real-time visual feedback, including the needle's position, trajectory, and depth within the bone module (3). A speaker (12) is also operatively connected to the camera (10) and emits audio cues indicating whether the needle has been correctly positioned within the marrow cavity (3g).

The artificial intelligence module is operatively connected to the camera (10) and is configured to analyze the captured video data. The AI module evaluates the accuracy of needle placement, insertion force, and overall technique. It provides real-time feedback to the trainee through the display (11) and speaker (12), including visual and audio cues to guide the trainee during the procedure.

Additionally, the AI module generates a detailed report analyzing the trainee's performance, including metrics such as accuracy of needle placement, insertion trajectory, and overall skill level. The report can be stored, replayed, or transmitted to external devices via email or mobile applications for further review and record-keeping.

This embodiment allows trainees to practice intraosseous access procedures with immediate feedback and detailed performance analysis. The integration of the AI module with the camera system ensures that trainees can refine their technique, improve accuracy, and gain confidence in performing intraosseous procedures in real-world scenarios.

In the fifth embodiment, the portable intraosseous access simulator integrates a force analysis system to measure the insertion force and torque applied by the trainee during the needle insertion procedure. This system provides real-time feedback on the physical dynamics of the procedure, enabling trainees to refine their technique and improve accuracy.

The simulated anatomical structure (1) includes a skin-like material (1a), a cavity configured to house a multilayered bone module (3), and external anatomical features to assist in identifying the correct insertion site. The bone module (3) comprises:
• A bone layer (3c) to simulate the hardness and resistance of human bone.
• An optional subcutaneous tissue layer (3b) to replicate the characteristics of subcutaneous tissue.
• A marrow cavity (3g) to simulate the internal cavity of a bone.

The force analysis system includes:
• A first force sensor (14a) positioned within the simulated anatomical structure (1) to measure the vertical insertion force applied by the trainee during the needle insertion procedure.
• A second force sensor (14b) embedded within the bone module (3) to measure the torque or rotational force applied during the procedure, simulating the forces required to penetrate the cortical bone layer.

The force analysis system is operatively connected to a display, which visually presents real-time data on the insertion force and torque applied during the procedure. This feedback allows the trainee to monitor their technique and make adjustments as needed to achieve proper needle placement.

The measured force and torque data are stored within the simulator for post-procedure analysis and review by the trainee or instructor. The stored data can be used to evaluate the trainee's performance over time, track skill development, and identify areas for improvement.

In addition, the force analysis system is integrated with an artificial intelligence module, which analyzes the measured force and torque data to provide detailed feedback on the trainee's technique. The AI module generates recommendations for improving insertion accuracy, reducing excessive force, and optimizing rotational movements during the procedure.

This embodiment enables trainees to understand the physical dynamics of intraosseous access procedures, including the forces required to penetrate the skin, subcutaneous tissue, and cortical bone layers. By providing real-time feedback and detailed analysis, the force analysis system ensures that trainees develop the necessary skills to perform intraosseous access procedures with precision and confidence.

In the sixth embodiment, the portable intraosseous access simulator integrates a mobile phone-based system to capture, analyze, and provide feedback on the needle insertion procedure. This system leverages the mobile phone's camera and software application to enhance the portability and accessibility of the simulator while maintaining advanced training capabilities.

The simulated anatomical structure (1) includes a skin-like material (1a), a cavity configured to house a multilayered bone module (3), and external anatomical features to assist in identifying the correct insertion site. The bone module (3) comprises:
• A bone layer (3c) to simulate the hardness and resistance of human bone.
• An optional subcutaneous tissue layer (3b) to replicate the characteristics of subcutaneous tissue.
• A marrow cavity (3g) to simulate the internal cavity of a bone.

A mobile phone (15) is positioned within the simulated anatomical structure (1) and configured to capture video data of the needle insertion procedure using its integrated camera. The mobile phone (15) operates in real-time, recording the needle's position, trajectory, and depth as it passes through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c) into the marrow cavity (3g).

The mobile phone (15) is equipped with a software application that analyzes the captured video data to evaluate the accuracy of needle placement and the trainee's technique. The application provides feedback to the trainee through:
• A display (15a) operatively connected to the mobile phone (15), which visually presents the captured video data, including the needle's position and trajectory within the simulated anatomical structure (1).
• A speaker (15b) operatively connected to the mobile phone (15), which emits audio cues indicating whether the needle has been correctly positioned within the simulated anatomy.

The software application generates a detailed report analyzing the trainee's performance, including metrics such as accuracy of needle placement, insertion force, and overall technique. The report can be stored on the mobile phone (15) or transmitted to external devices via wireless communication protocols, such as Wi-Fi or Bluetooth, for further review and record-keeping.

This embodiment provides a cost-effective and portable solution for training intraosseous access procedures. By utilizing the mobile phone's camera and software application, the simulator enables trainees to practice needle insertion, receive real-time feedback, and analyze their performance without requiring additional hardware. The integration of mobile technology ensures that the simulator is accessible in diverse training environments, including hospitals, field settings, and remote locations.

In the seventh embodiment of the present invention, the portable intraosseous access simulator integrates an external camera system to capture video data of the needle insertion procedure as well as the trainee’s body posture and overall technique. This system provides a comprehensive analysis of both the procedural accuracy and the ergonomics of the trainee, enabling targeted feedback for skill improvement.

The simulated anatomical structure (1) includes a skin-like material (1a), a cavity configured to house a multilayered bone module (3), and external anatomical features to assist in identifying the correct insertion site. The bone module (3) comprises:
• A bone layer (3c) to simulate the hardness and resistance of human bone.
• An optional subcutaneous tissue layer (3b) to replicate the characteristics of subcutaneous tissue.
• A marrow cavity (3g) to simulate the internal cavity of a bone.

An external camera system (16) is positioned outside the simulated anatomical structure (1) to capture a wide-angle view of the needle insertion procedure, including the trainee’s body posture, hand positioning, and needle trajectory. The external camera system (16) records high-resolution video data, ensuring precise visualization of the trainee’s technique during the procedure.

The external camera system (16) is operatively connected to a display, which visually presents the captured video data in real-time. The display provides feedback on the trainee’s body posture, hand movements, and needle trajectory, enabling the trainee to make immediate adjustments to their technique.

An artificial intelligence module is operatively connected to the external camera system (16) to analyze the captured video data. The AI module evaluates the accuracy of needle placement, the trainee’s ergonomics, and overall technique. It provides feedback through the display and audio cues, highlighting areas for improvement in both procedural accuracy and body mechanics.

The AI module generates a detailed performance report, including metrics such as needle trajectory, hand positioning, and adherence to proper ergonomic practices. The report can be stored, replayed, or transmitted to external devices via wireless communication protocols for further review and record-keeping.

This embodiment is particularly beneficial for training scenarios where proper body posture and hand positioning are critical to the success of the procedure. By capturing and analyzing the trainee’s overall technique, the external camera system ensures that trainees not only develop procedural accuracy but also adopt ergonomic practices that reduce fatigue and improve efficiency during real-world intraosseous access procedures.

In the eighth embodiment, the portable intraosseous access simulator is designed for training intraosseous access procedures using a method that replicates the anatomical and procedural characteristics of the proximal tibia region of a human leg. The simulator provides a comprehensive training experience by enabling trainees to practice needle insertion, marrow aspiration, fluid infusion, and performance analysis in a realistic and controlled environment.

The simulated anatomical structure (1) includes a skin-like material (1a), a cavity configured to house a multilayered bone module (3), and external anatomical features such as the tibial tuberosity and flat plateau to assist in identifying the correct insertion site. The bone module (3) comprises:
• A bone layer (3c) to simulate the hardness and resistance of human bone.
• An optional subcutaneous tissue layer (3b) to replicate the characteristics of subcutaneous tissue.
• A marrow cavity (3g) to simulate the internal cavity of a bone, filled with spongy material to mimic bone marrow.

The method begins with the trainee identifying anatomical landmarks on the simulated anatomical structure (1), such as the tibial tuberosity and flat plateau, to locate the correct insertion site. The trainee then inserts a needle through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c) into the marrow cavity (3g).

Once the needle is correctly positioned, the trainee aspirates simulated marrow or fluid from the marrow cavity (3g) through a valve (3a) operatively connected to the cavity. The trainee can then infuse artificial blood or colored liquid into the marrow cavity (3g) using a syringe (6) connected to tubing (5) and a multi-valve (14), simulating the infusion of fluids or medications in a real intraosseous procedure.

The simulator includes a camera (10) positioned within the simulated anatomical structure (1) to capture video data of the needle insertion procedure. The captured video data is displayed on a display (11), providing real-time visual feedback on the needle’s position, trajectory, and depth. A speaker (12) emits audio cues indicating whether the needle has been correctly positioned within the marrow cavity (3g).

An artificial intelligence module analyzes the captured video data to evaluate the trainee’s performance, including accuracy of needle placement, insertion force, and overall technique. The AI module provides feedback through the display (11) and speaker (12), offering visual and audio cues to guide the trainee during the procedure. The AI module also generates a detailed report that can be stored, replayed, or transmitted to external devices for further review and record-keeping.

This embodiment supports field training environments, including military training for paramedics and first responders, as well as hospital-based training for medical staff. The simulator’s portability, realistic anatomical features, and advanced feedback systems ensure that trainees can practice intraosseous access procedures effectively, even in remote or resource-limited settings. By replicating the procedural and anatomical characteristics of intraosseous access, this embodiment provides a cost-effective, ethical, and versatile solution for training medical professionals.

In the ninth embodiment, the portable intraosseous access simulator is implemented as a comprehensive training system for intraosseous access procedures, integrating advanced anatomical simulation, fluid dynamics, performance analysis, and feedback mechanisms. The system is designed to provide trainees with a realistic and interactive training experience, enabling them to develop the skills necessary for accurate and effective intraosseous access.

The simulated anatomical structure (1) mimics the proximal tibia region of a human leg and includes:
• A skin-like material (1a) configured to simulate the external surface of human skin.
• A cavity (1b) within the simulated anatomical structure (1) configured to house a multilayered bone module (3).

The bone module (3) comprises:
• A subcutaneous tissue layer (3b) to replicate the characteristics of subcutaneous tissue.
• A bone layer (3c) to simulate the hardness and resistance of human bone.
• A marrow cavity (3g) to simulate the internal cavity of a bone, filled with spongy material to mimic bone marrow.
• A valve (3a) in fluid communication with the marrow cavity (3g), configured to allow aspiration and infusion of fluid.
• An axial scale (3d) and a rotational scale (3f) to provide feedback on the position of the bone module (3) within the cavity (1b).
• Indicators (3e) for visually indicating the movement of the bone module (3).
• A knob (3h) configured to adjust the axial and rotational position of the bone module (3) within the cavity (1b), allowing fresh insertion sites for multiple punctures.

The system includes a fluid simulation system comprising:
• Tubing (5) operatively connected to the marrow cavity (3g).
• A multi-valve (14) configured to control fluid flow.
• A syringe or reservoir (6) configured to supply artificial blood or colored liquid to the marrow cavity (3g), enabling realistic simulation of marrow aspiration and infusion procedures.

The system further integrates a camera (10) positioned within the simulated anatomical structure (1) to capture video data of the needle insertion procedure. The captured video data is displayed on a display (11), providing real-time visual feedback, including the needle’s position, trajectory, and depth. A speaker (12) emits audio cues indicating whether the needle has been correctly positioned within the marrow cavity (3g).

An artificial intelligence module is operatively connected to the camera (10) to analyze the captured video data. The AI module evaluates the accuracy of needle placement, insertion force, and overall technique, providing real-time feedback through the display (11) and speaker (12). The AI module also generates a detailed report analyzing the trainee’s performance, which can be stored, replayed, or transmitted to external devices for further review and record-keeping.

Additional features of the system include:
• Hall effect sensors (13): Positioned within the simulated anatomical structure (1) to detect the position and orientation of the needle during insertion.
• Strain gauge sensors (14a, 14b): Configured to measure the insertion force and torque applied by the trainee during the procedure.
• A replaceable insertion pad: Positioned within the cavity (1b) to allow multiple punctures without loss of insertion characteristics.

This embodiment is designed for use in diverse training environments, including hospitals, military training for paramedics and first responders, and remote field settings. The system’s portability, durability, and advanced feedback mechanisms ensure that trainees can practice intraosseous access procedures effectively and repeatedly. By integrating anatomical realism, fluid simulation, and AI-driven performance analysis, this embodiment provides a comprehensive and versatile solution for training medical professionals in intraosseous access techniques.

The simulator as described in the present invention is a portable adult intraosseous simulator. This simulates the anatomical characteristics of the region surrounding the right leg knee and proximal tibia. With the touch, one is able to identify the anatomical location - tibial tuberosity. With the reference of tibial tuberosity one is able to identify the flat plateau of the proximal tibia for intraosseous insertion.

The simulator as disclosed in FIGURE1, consists of a whole or partial anatomy 1, base board 7, bone module 3, tubing 5, multi-valve 14, syringe or reservoir 6.

The anatomy 1 has an Insertion site 2 and anatomical surface feature – Tibial Tuberosity 8. It also mimics the flat plateau above the proximal tibia and has an insertion site 2. Conduit 4 passes through the anatomy 1. Through conduit 4, bone module 3 can be inserted into the anatomy 1.

Anatomy 1 is made up of thick skinny material 1a to mimic the skin. It can be made up of rubber, silicon or any spongy material mimicking the skin surface. The cavity 1b within the anatomy 1 can be filled with foam or resin/plastic material or granules to give firmness to the skin.

Figure 2 illustrates the insertion of the bone module 3 along the axis of the opening 4 in the simulator anatomy.

Figure 3 illustrates cross sectional view of the simulator along with bone module 3, insertion pad 2, conduit 4 and tuning 5.

Figure 4 illustrates outline of the simulator with insertion site. It illustrates the anatomical landmark 8(tibial tuberosity) on the anatomy 1.

Figure 5 illustrates replaceable insertion pad 2 in the insertion cavity 9 of the anatomy 1 for multiple punctures

Bone module 3 is positioned inside the anatomy 1. The bone module 3 is can slide and rotate inside the hollow conduit 4. It can have axial motion or rotational motion with reference to anatomy 1 as shown in Figure 6. Hence for each new insertion, the fresh insertion site can be provided by adjusting the bone module.

The bone module is attached to tubing 5, multi valve (one way or two way) 14, and syringe or reservoir 6. Along with the cavity 3g in connection with tubing 5, multivalve 14 and syringe or reservoir 6 forms a circulatory system which mimics the marrow region and blood flow through the marrow. This complete system can be filled with colored liquid or artificial blood and realistically mimics the marrow within the marrow cavity.

The cavity 3g can be filled with spongy material which mimics the marrow and also soak the blood or liquid marrow.

The bone module 3, consists of multilayered construction with hard thickness 3c. It(3c) mimics the bone and is made up of either plastic, resin, polypropylene, styrene, PC ABS combination. The layer 3b mimics the subcutaneous tissue and is made up of rubber, silicon or foam. The combination of 1a, 3b and 3c together mimics the structural anatomy of insertion at proximal tibia of human leg with bone and hollow bone marrow cavity.

This configuration helps in providing the realistic feel of insertion resistance and sudden give-away feel or haptic feedback during the insertion procedure of intraosseous access. Once the external device is inserted, one is able to aspire the marrow through the cavity 3g. The biopsy procedure can be performed and spongy material in the cavity mimics as a solid marrow sample.

The marrow cavity 3g can be replenished with artificial blood or colored liquid with the help of syringe or reservoir 6 through the multi valve 14 and valve 3a. One can also do the infusion through external device into the marrow region wherein the fluid is stored in syringe or reservoir 6.

The bone module 3 (Figure 7) has a valve 3a, multilayer thickness of 3b and 3c which forms the cavity 3g. It has a stem with axial scale 3d and rotational scale 3f which is used for giving feedback of the insertion location of the bone module with respect to anatomy1. It has indicators 3e to indicate the visual indication for movement of bone module within the conduit 4. The knob 3h is used for adjusting the position of bone module 3.

The simulator (Figure 8) has a camera/probe based system which captures the audio and visual recording during the insertion procedure. It realistically displays the actual needle position of the intraosseous device on a display. With audio signal it indicates if the needle is placed in correct location or not. Camera based system to determine needle position and orientation.

Camera/probe can be in Visible spectrum, IR, ultrasound or any other source. A particular wavelength of light and its detector system can be used to identify the needle position and orientation

The integrated Artificial intelligence algorithm analyses the needle position of the external device and indicates whether the insertion is correct or not. Also, it analyses the individual care provider skill during the procedure. It gives output whether he needs more practice, correctness of insertion etc. The output can be downloaded, printed, stored or forwarded by email etc.

In another implemention, a mobile with camera can be positioned in the simulator and it can capture the insertion procedure.

The camera can be positioned within the simulator anatomy 1 (Figure 8) or within the bone module 3 (Figure 9). The array of hall effect sensors are positioned either axial array or cylindrical array to capture the exact position of the needle and can be displayed on to the screen. Array of Hall effect sensors for detection of the position and orientation of needle.

The needle is to be magnetised prior to the insertion or a probe can be inserted in the hole of already inserted site to capture the needle orientation. (Figure 10)

The camera can also be placed outside in a way to capture the complete procedure of insertion. This helps in analysing the trainees body posture, external feature of insertion and provide feedback to improve the performance.

Force sensors 14a, 14b positioned as shown in Figure 11 helps in analyzing the force extended during insertion. The force gauge sensors can be on the base or paced inside 1.

A mobile phone15 with camera when placed in the given provision can be used to analyze the insertion technique (Figure 12).

A standalone camera system (16) can be used to assist, record and analyze the insertions by the trainee. A report and feedback are generated for the trainee. Special markings can be used for tracking and positioning purposes (Figure 13).

The simulator helps in practicing the complete procedure of intraosseous access in adult human access.

It provides ability to identify the insertion site with the help of anatomical features of the leg (eg. Tibial tuberosity) and ability to gain access through the subcutaneous tissue, cortical layer of the bone into marrow region. It simulates the subcutaneous tissue and bone with its unique bone module which realistically mimics the needle insertion characteristics through bone and provides a haptic feedback (that the needle is in correct vascular location in the marrow) to care provider while practicing the insertion procedure which is realistic to actual procedure being performed in live anatomy. The simulator provides ability to realistically imitate the marrow aspiration procedure and to infuse fluids and medications into the marrow. With the camera positioned within the simulator, one can record and analyze its performance during the procedure. Multiple users can use the simulator with every user having fresh insertion point.

The software enabled interface can help in analysing the quality of the procedure for effective training. The inbuilt AI module helps in analyzing the procedure performance and helps trainee to give feedback. The information can be shared through email, mobile phone or downloaded and shared for analysis and records. The inbuilt strain gauge/ force sensor helps in recording and analyzing the insertion force by care provider. This can be recorded and analyzed further with software or AI analyzer. The inbuilt microphone captures/amplifies the sound within the simulator during the insertion procedure. This gives feedback to the trainee and helps in analyzing correct positioning/orientation and insertion characteristics.

The proximal tibia simulator can be used to train the intraosseous insertion, aspiration and infusion procedure through the simulator. The simulator can be used in the field including inside hospital, out of hospital, military training for paramedics, first responders, nursing or medical staff to learn and practice the procedure. It offsets the need to have elaborate training setup including either cadavers or actual use cases.

During the training, it is difficult to assess the skill learnt or the real condition of the insertion within anatomy. The simulator provides visual aid through recording of needle travel and position during the insertion. This can be played again and analyzed to see the insertion accuracy and skill of the practicing careprovider.

Advantages of the Invention
1. Realistic Anatomical Simulation
o The simulator mimics the anatomical features of the proximal tibia region, including the skin, subcutaneous tissue, cortical bone, and marrow cavity, providing a highly realistic training experience.
o Trainees can identify anatomical landmarks such as the tibial tuberosity and flat plateau, enhancing their ability to locate the correct insertion site.
2. Haptic Feedback
o The simulator provides realistic tactile feedback during needle insertion, including the sudden give-away feel when penetrating the cortical bone into the marrow cavity.
o This feature helps trainees develop the necessary skills to perform intraosseous access procedures with confidence and precision.
3. Multiple Puncture Capability
o The replaceable insertion pads and adjustable bone module allow multiple trainees to use the simulator without loss of insertion characteristics.
o Fresh insertion sites can be presented by rotating or sliding the bone module, ensuring consistent training quality.
4. Fluid Simulation System
o The integrated fluid simulation system mimics marrow aspiration and infusion procedures, allowing trainees to practice realistic fluid handling techniques.
o The marrow cavity can be replenished with artificial blood or colored liquid, ensuring repeated use without compromising functionality.
5. Integrated Camera System
o The camera system captures video data of the needle insertion procedure, providing real-time visual feedback to the trainee.
o The camera / probe can operate in various spectrums (visible, infrared, ultrasound), enhancing the accuracy of needle position and orientation analysis.
6. Artificial Intelligence Analysis
o The AI module analyzes the trainee's performance, including needle placement accuracy, insertion force, and overall technique.
o Feedback is provided in the form of visual and audio cues, as well as detailed reports that can be stored, shared, or transmitted for further analysis.
7. Force and Position Analysis
o Strain gauge sensors measure the insertion force and torque applied by the trainee, while Hall effect sensors detect the needle's position and orientation.
o These features help trainees understand the physical dynamics of the procedure and refine their technique.

8. Portable and Field-Ready Design
o The simulator is lightweight, compact, and durable, making it suitable for use in hospitals, military training environments, and remote locations.
o Its portability allows for easy setup and operation, enabling training in diverse scenarios.
9. Enhanced Training Feedback
o The simulator provides comprehensive feedback through integrated systems, including visual, audio, and data-driven analysis.
o Trainees can review their performance, identify areas for improvement, and track their skill development over time.
10. Data Storage and Communication
• The simulator's software interface allows performance data to be recorded, stored, and shared via email or mobile devices.
• This feature facilitates long-term tracking of trainee progress and enables remote feedback from instructors or supervisors.
11. Cost-Effective Training Solution
• The simulator offsets the need for cadavers or live cases, providing a cost-effective and ethical alternative for training intraosseous access procedures.
• Its reusable components, such as replaceable insertion pads and refillable marrow cavity, ensure long-term usability and reduced operational costs.
12. Versatility in Training Applications
• The simulator can be used for various training purposes, including intraosseous insertion, marrow aspiration, fluid infusion, and biopsy procedures.
• It is suitable for paramedics, first responders, nursing staff, and medical professionals, making it a versatile tool for skill development.
13. Improved Trainee Assessment
• The simulator's integrated systems, including AI analysis and camera feedback, enable detailed assessment of trainee performance.
• Instructors can use the data to evaluate skill acquisition, provide targeted feedback, and ensure trainees meet competency standards.
14. Ethical and Safe Training Environment
• The simulator eliminates the need for invasive procedures on live subjects or cadavers, providing a safe and ethical training environment.
• Trainees can practice repeatedly without risk to patients, ensuring they are well-prepared for real-world scenarios.
15. Adaptability to Technological Advancements
• The simulator's modular design and software interface allow for future upgrades, such as enhanced AI algorithms, additional sensors, or improved fluid simulation systems.
• This adaptability ensures the simulator remains relevant and effective as training needs evolve.
16. Support for Remote and Collaborative Training
• The simulator's ability to transmit data and feedback via email or mobile devices supports remote training and collaboration among trainees and instructors.
• This feature is particularly beneficial for distributed training programs or scenarios where in-person instruction is not feasible.

By combining anatomical realism, advanced feedback systems, and portability, the invention provides a comprehensive and effective solution for training intraosseous access procedures, addressing the limitations of existing simulators and enhancing the overall training experience.

The descriptions and illustrations provided in this document are intended to explain the principles of the invention and its best mode of working. They are not intended to limit the scope of the invention, which is defined by the claims. Variations and modifications to the described embodiments may be made without departing from the scope of the invention. The specific embodiments described in this document are examples of the invention and are not intended to limit the scope of the claims. The claims should be interpreted broadly to cover all equivalent structures and methods that fall within the scope of the invention. The technical specifications and details provided in this document are for illustrative purposes only. Actual implementations of the invention may vary based on specific design requirements, manufacturing processes, and application needs.

It is to be noted that the embodiments described herein relate to any bone structure in human body while some embodiments have dealt with right leg, the invention can also be adapted to simulate the anatomical features of the left leg, specifically the proximal tibia region, to provide versatility in training scenarios. The simulated anatomical structure for the left leg includes the same components as the right leg configuration, such as the skin-like material, cavity, and multilayered bone module with a subcutaneous tissue layer, bone layer, and marrow cavity. The bone module for the left leg is similarly adjustable via a knob to allow axial and rotational movement, presenting fresh insertion sites for multiple punctures. The fluid simulation system, including tubing, multi-valve, and syringe, enables realistic marrow aspiration and infusion for the left leg. Integrated systems such as the camera, display, speaker, and artificial intelligence module are equally applicable, ensuring comprehensive training for both legs and enhancing anatomical familiarity for trainees.

Any references to prior art documents, patents, or publications are provided for informational purposes only. The inclusion of such references does not imply that the present invention is limited by or dependent on the prior art.
,CLAIMS:
1. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the anatomy including a bone structure, optionally covered with subcutaneous tissue, and a skin-like material (1a); the simulated anatomical structure (1) comprising:
a cavity (1b) configured to house a bone module (3);
the bone module (3) comprising:
a multilayered construction including a subcutaneous tissue layer (3b) optionally, a bone layer (3c), and a marrow cavity (3g);
a valve (3a) in fluid communication with the marrow cavity (3g), the valve (3a) configured to allow aspiration and infusion of fluid;
an axial scale (3d) and a rotational scale (3f) configured to provide feedback on the position of the bone module (3) within the cavity (1b);
indicators (3e) for visually indicating the movement of the bone module (3);
and
a knob (3h) configured to adjust the axial and rotational position of the bone module (3) within the cavity (1b).

2. The simulator of claim 1, wherein the skin-like material (1a) is made of rubber, silicone, or a spongy material configured to mimic the texture and firmness of human skin.

3. The simulator of claim 1, wherein the cavity (1b) within the simulated anatomical structure (1) is filled with foam, resin, plastic material, or granules to provide firmness and realistic anatomical resistance during needle insertion.

4. The simulator of claim 1, wherein the bone module (3) is configured to slide and rotate within the cavity (1b) to present fresh insertion sites for multiple punctures.
5. The simulator of claim 1, wherein the marrow cavity (3g) is optionally filled with spongy material configured to mimic bone marrow and filled with artificial blood or colored liquid.

6. The simulator of claim 1, wherein the valve (3a) is a one-way or two-way valve configured to allow controlled aspiration and infusion of fluid into the marrow cavity (3g).

7. The simulator of claim 1, wherein the axial scale (3d) and rotational scale (3f) are marked with numerical indicators to provide precise feedback on the position of the bone module (3) within the cavity (1b).

8. The simulator of claim 1, wherein the bone module (3) is made of a combination of plastic, resin, polypropylene, styrene, or PC-ABS to mimic the hardness and resistance of human bone.

9. The simulator of claim 1, further comprising a replaceable insertion pad positioned within the cavity (1b) to allow multiple punctures without loss of insertion characteristics.

10. The simulator of claim 1, wherein the marrow cavity (3g) is replenished with artificial blood or colored liquid using a syringe (6) connected to the valve (3a) and tubing (5).

11. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the anatomy including:
external anatomical features configured to simulate surface landmarks for identifying an insertion site;
a cavity (1b) within the simulated anatomical structure (1) configured to house a bone module (3);
the bone module (3) comprising:
a multilayered construction including:
a bone layer (3c) configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer (3b) configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity (3g) configured to simulate the internal cavity of a bone;
a valve (3a) in fluid communication with the marrow cavity (3g), the valve (3a) configured to allow infusion of fluid into the marrow cavity;
a fluid simulation system comprising:
tubing (5) operatively connected to the marrow cavity (3g);
a multi-valve (14) configured to control fluid flow;
and a syringe or reservoir (6) configured to supply artificial blood or colored liquid to the marrow cavity (3g);
wherein the simulated anatomical structure (1) and bone module (3) are configured to provide realistic tactile feedback during needle insertion, including resistance and a sudden give-away feel upon penetration into the marrow cavity (3g).

12. The simulator of claim 11, wherein the external anatomical features include surface landmarks such as the tibial tuberosity, flat plateau, or other identifiable features to assist in locating the correct insertion site.

13. The simulator of claim 11, wherein the bone layer (3c) is made of a material selected from plastic, resin, polypropylene, styrene, or PC-ABS to mimic the hardness and resistance of human bone.

14. The simulator of claim 11, wherein the subcutaneous tissue layer (3b) is made of rubber, silicone, or foam to simulate the texture and elasticity of human subcutaneous tissue.

15. The simulator of claim 11, wherein the marrow cavity (3g) is filled with spongy material configured to mimic bone marrow and absorb artificial blood or colored liquid.

16. The simulator of claim 11, wherein the valve (3a) is a one-way or two-way valve configured to allow controlled infusion of fluid into the marrow cavity (3g).

17. The simulator of claim 11, wherein the tubing (5) is flexible and operatively connected to the multi-valve (14) to simulate fluid flow through the marrow cavity (3g).

18. The simulator of claim 11, wherein the syringe or reservoir (6) is configured to supply artificial blood or colored liquid to the marrow cavity (3g) and replenish the cavity for repeated use.

19. The simulator of claim 11, wherein the simulated anatomical structure (1) is configured to provide realistic tactile feedback during needle insertion, including varying resistance through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c).

20. The simulator of claim 11, wherein the bone module (3) is adjustable within the cavity (1b) to present fresh insertion sites for multiple punctures.

21. The simulator of claim 11, wherein the external anatomical features are designed to visually and tactilely mimic the surface characteristics of human anatomy, enabling trainees to practice identifying insertion sites.

22. The simulator of claim 11, wherein the marrow cavity (3g) is configured to allow both infusion and aspiration of fluid, simulating realistic intraosseous procedures.

23. The simulator of claim 11, wherein the simulated anatomical structure (1) is configured to provide haptic feedback simulating the sudden give-away feel upon penetration into the marrow cavity (3g).

24. The simulator of claim 11, wherein the multi-valve (14) is configured to control fluid flow direction and pressure during infusion into the marrow cavity (3g).

25. The simulator of claim 11, wherein the syringe or reservoir (6) is detachable and refillable, allowing repeated use of the simulator for multiple trainees.

26. The simulator of claim 11, wherein the external anatomical features are designed to simulate anatomical variations, enabling trainees to practice identifying insertion sites in diverse anatomical conditions.

27. The simulator of claim 11, wherein the simulated anatomical structure (1) is configured for use in field training environments, including military training for paramedics and first responders.

28. The simulator of claim 11, wherein the bone module (3) is configured to rotate and slide within the cavity (1b) to provide fresh insertion sites for multiple punctures.

29. The simulator of claim 11, wherein the simulated anatomical structure (1) is made of durable materials to withstand repeated use and provide consistent tactile feedback.

30. The simulator of claim 11, wherein the syringe or reservoir (6) is operatively connected to the tubing (5) and multi-valve (14) to simulate fluid infusion into the marrow cavity (3g) with controlled pressure.

31. The simulator of claim 11, wherein the simulated anatomical structure (1) is configured to simulate anatomical features of various bones, including the tibia, humerus, femur, or other long bones.

32. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the structure including:
a skin-like material (1a) configured to simulate the external surface of human skin;
a cavity (1b) within the simulated anatomical structure (1) configured to house a bone module;
a camera (10) positioned within the simulated anatomical structure (1) and configured to capture video data of a needle insertion procedure;
a display (11) operatively connected to the camera (10) and configured to visually present the captured video data, including the position and trajectory of the needle during the insertion procedure;
a speaker (12) operatively connected to the camera (10) and configured to provide audio feedback during the needle insertion procedure, the audio feedback indicating whether the needle is correctly positioned within the simulated anatomy;
and an artificial intelligence module operatively connected to the camera (10), the artificial intelligence module configured to analyze the captured video data to determine the accuracy of needle placement, assess the trainee's performance, and provide feedback through the display (11) and speaker (12).

33. The simulator of claim 32, wherein the camera or ultrasound probe (10) is configured to operate in the visible spectrum, infrared spectrum, or ultrasound spectrum to capture the position and orientation of the needle during the insertion procedure.

34. The simulator of claim 32, wherein the display (11) is configured to provide real-time visual feedback, including the needle's position, trajectory, and depth within the simulated anatomical structure (1).

35. The simulator of claim 32, wherein the speaker (12) is configured to emit audio cues indicating whether the needle has reached the correct anatomical location within the simulated anatomy.

36. The simulator of claim 32, wherein the artificial intelligence module is configured to generate a detailed report analyzing the trainee's performance, including accuracy of needle placement, insertion force, and overall technique.

37. The simulator of claim 32, wherein the artificial intelligence module is further configured to provide recommendations for improving the trainee's technique based on the analysis of the captured video data.

38. The simulator of claim 32, wherein the camera (10) is positioned to capture a cross-sectional view of the simulated anatomical structure (1) during the needle insertion procedure.

39. The simulator of claim 32, wherein the display (11) is configured to replay the captured video data for post-procedure analysis and review by the trainee or instructor.

40. The simulator of claim 32, wherein the artificial intelligence module is configured to provide real-time feedback during the procedure, including visual and audio cues indicating the correctness of the needle's position and trajectory.

41. The simulator of claim 32, wherein the speaker (12) is configured to amplify sounds generated during the needle insertion procedure, such as the penetration of the needle through simulated tissue and bone layers.

42. The simulator of claim 32, wherein the camera (10) is positioned within the cavity (1b) to capture the internal view of the needle's interaction with the bone module.

43. The simulator of claim 32, wherein the artificial intelligence module is configured to store the captured video data and analysis results for record-keeping and further review.

44. The simulator of claim 32, wherein the display (11) is a touchscreen interface configured to allow the trainee or instructor to interact with the captured video data and analysis results.

45. The simulator of claim 32, wherein the speaker (12) is configured to provide step-by-step audio guidance to the trainee during the needle insertion procedure.

46. The simulator of claim 32, wherein the camera (10) is detachable and can be repositioned within the simulated anatomical structure (1) to capture different angles of the needle insertion procedure.

47. The simulator of claim 32, wherein the artificial intelligence module is configured to transmit the captured video data and analysis results to external devices via email or mobile applications.

48. The simulator of claim 32, wherein the display (11) is configured to overlay visual indicators, such as color-coded markers, to guide the trainee during the needle insertion procedure.

49. The simulator of claim 32, wherein the artificial intelligence module is further configured to compare the trainee's performance against predefined benchmarks or expert-level procedures.

50. The simulator of claim 32, wherein the camera (10) is configured to capture high-resolution video data to enhance the accuracy of the analysis performed by the artificial intelligence module.

51. The simulator of claim 32, wherein the speaker (12) is configured to provide feedback in multiple languages to accommodate trainees from diverse backgrounds.

52. The simulator of claim 32, wherein the artificial intelligence module is configured to integrate with external training systems or databases for collaborative analysis and feedback.

53. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the structure including:
a skin-like material (1a) configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure (1) configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a camera (10) positioned within the bone module and configured to capture video data of a needle insertion procedure;
a display (11) operatively connected to the camera (10) and configured to visually present the captured video data, including the position and trajectory of the needle during the insertion procedure;
a speaker (12) operatively connected to the camera (10) and configured to provide audio feedback during the needle insertion procedure, the audio feedback indicating whether the needle is correctly positioned within the simulated anatomy; and
an artificial intelligence module operatively connected to the camera (10), the artificial intelligence module configured to analyze the captured video data to determine the accuracy of needle placement, assess the trainee's performance, and provide feedback through the display (11) and speaker (12).

54. The simulator of claim 53, wherein the camera (10) is positioned within the marrow cavity of the bone module to capture the internal view of the needle's interaction with the simulated bone and marrow.

55. The simulator of claim 53, wherein the camera or ultrasound probe (10) operates in the visible spectrum, infrared spectrum, or ultrasound spectrum to enhance the accuracy of needle position and trajectory analysis.

56. The simulator of claim 53, wherein the display (11) is configured to provide real-time visual feedback, including the depth and angle of the needle within the bone module.

57. The simulator of claim 53, wherein the speaker (12) emits audio cues indicating whether the needle has successfully penetrated the simulated bone layer and reached the marrow cavity.

58. The simulator of claim 53, wherein the artificial intelligence module generates a detailed report analyzing the trainee's performance, including accuracy of needle placement, insertion force, and overall technique.

59. The simulator of claim 53, wherein the artificial intelligence module provides real-time feedback during the procedure, including visual and audio cues to guide the trainee in achieving correct needle placement.

60. The simulator of claim 53, wherein the camera (10) is configured to capture high-resolution video data to enhance the precision of the analysis performed by the artificial intelligence module.

61. The simulator of claim 53, wherein the display (11) is configured to replay the captured video data for post-procedure analysis and review by the trainee or instructor.

62. The simulator of claim 53, wherein the speaker (12) is configured to amplify sounds generated during the needle insertion procedure, such as the penetration of the needle through simulated tissue and bone layers.

63. The simulator of claim 53, wherein the artificial intelligence module is configured to store the captured video data and analysis results for record-keeping and further review.

64. The simulator of claim 53, wherein the display (11) is a touchscreen interface configured to allow the trainee or instructor to interact with the captured video data and analysis results.

65. The simulator of claim 53, wherein the speaker (12) provides step-by-step audio guidance to the trainee during the needle insertion procedure.

66. The simulator of claim 53, wherein the camera (10) is detachable and can be repositioned within the bone module to capture different angles of the needle insertion procedure.

67. The simulator of claim 53, wherein the artificial intelligence module transmits the captured video data and analysis results to external devices via email or mobile applications.

68. The simulator of claim 53, wherein the display (11) overlays visual indicators, such as color-coded markers, to guide the trainee during the needle insertion procedure.

69. The simulator of claim 53, wherein the artificial intelligence module compares the trainee's performance against predefined benchmarks or expert-level procedures.

70. The simulator of claim 53, wherein the camera (10) is configured to capture video data of the needle's interaction with simulated fluids within the marrow cavity.

71. The simulator of claim 53, wherein the speaker (12) provides feedback in multiple languages to accommodate trainees from diverse backgrounds.

72. The simulator of claim 53, wherein the artificial intelligence module integrates with external training systems or databases for collaborative analysis and feedback.

73. The simulator of claim 53, wherein the camera or ultrasould probe (10) is configured to detect the needle's orientation and depth using specialized imaging techniques, such as infrared or ultrasound.

74. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the structure including:
a skin-like material (1a) configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure (1) configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a force analysis system comprising:
a first force sensor (14a) positioned within the simulated anatomical structure (1) to measure the insertion force applied by a trainee during the needle insertion procedure;
and a second force sensor (14b) positioned within the bone module to measure the torque or rotational force applied during the procedure;
wherein the force analysis system is configured to provide real-time feedback on the insertion force and torque applied by the trainee, enabling assessment of the trainee's technique and accuracy during the procedure.

75. The simulator of claim 74, wherein the first force sensor (14a) is positioned at the base of the simulated anatomical structure (1) to measure the vertical insertion force applied by the trainee during the needle insertion procedure.

76. The simulator of claim 74, wherein the second force sensor (14b) is embedded within the bone module to measure rotational torque applied by the trainee, simulating the forces required to penetrate the cortical bone layer.

77. The simulator of claim 74, wherein the force analysis system is operatively connected to a display, the display configured to visually present real-time data on the insertion force and torque applied during the procedure.

78. The simulator of claim 74, wherein the force analysis system is configured to store the measured force and torque data for post-procedure analysis and review by the trainee or instructor.

79. The simulator of claim 74, wherein the force analysis system is integrated with an artificial intelligence module, the module configured to analyze the measured force and torque data to provide feedback on the trainee's technique and recommend improvements.

80. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the structure including:
a skin-like material (1a) configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure (1) configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
a mobile phone (15) positioned within the simulated anatomical structure (1), the mobile phone (15) configured to capture video data of a needle insertion procedure using its integrated camera;
wherein the mobile phone (15) is further configured to analyze the captured video data using a software application, the application providing feedback on the accuracy of needle placement and the trainee's technique;
and wherein the mobile phone (15) is operatively connected to a display (15a) and a speaker (15b) to provide visual and audio feedback to the trainee during the procedure.

81. The simulator of claim 80, wherein the mobile phone (15) is configured to operate in real-time, capturing and analyzing video data during the needle insertion procedure and providing immediate feedback to the trainee.

82. The simulator of claim 80, wherein the software application on the mobile phone (15) is configured to generate a detailed report analyzing the trainee's performance, including accuracy of needle placement, insertion force, and overall technique.

83. The simulator of claim 80, wherein the mobile phone (15) is configured to transmit the captured video data and analysis results to external devices via wireless communication protocols, including Wi-Fi or Bluetooth.

84. The simulator of claim 80, wherein the display (15a) is configured to visually present the captured video data, including the position and trajectory of the needle within the simulated anatomical structure (1).

85. The simulator of claim 80, wherein the speaker (15b) is configured to emit audio cues indicating whether the needle has been correctly positioned within the simulated anatomy, providing step-by-step guidance to the trainee during the procedure.

86. A portable intraosseous access simulator comprising:
a simulated anatomical structure (1) mimicking a selected anatomy of a human body, the structure including:
a skin-like material (1a) configured to simulate the external surface of human skin;
a cavity within the simulated anatomical structure (1) configured to house a bone module;
the bone module comprising:
a multilayered construction including:
a bone layer configured to simulate the hardness and resistance of human bone;
an optional subcutaneous tissue layer configured to simulate the characteristics of subcutaneous tissue;
and a marrow cavity configured to simulate the internal cavity of a bone;
an external camera system (16) positioned outside the simulated anatomical structure (1), the external camera system (16) configured to capture video data of the needle insertion procedure and the trainee’s body posture and technique during the procedure;
wherein the external camera system (16) is operatively connected to a display and an artificial intelligence module, the artificial intelligence module configured to analyze the captured video data to assess the accuracy of needle placement, the trainee’s ergonomics, and overall technique, and provide feedback through the display and audio cues.

87. The simulator of claim 86, wherein the external camera system (16) is configured to capture a wide-angle view of the trainee’s body posture, hand positioning, and needle trajectory during the insertion procedure.

88. The simulator of claim 86, wherein the artificial intelligence module is configured to analyze the trainee’s body posture and hand movements to provide recommendations for improving ergonomics and technique.

89. The simulator of claim 86, wherein the external camera system (16) is configured to record high-resolution video data for post-procedure analysis and review by the trainee or instructor.

90. The simulator of claim 86, wherein the artificial intelligence module is further configured to compare the trainee’s performance against predefined benchmarks or expert-level procedures and generate a detailed performance report.

91. The simulator of claim 86, wherein the external camera system (16) is operatively connected to a wireless communication module, enabling the captured video data and analysis results to be transmitted to external devices for remote feedback and collaboration.

92. A method for training intraosseous access using a portable simulator, the method comprising:
identifying anatomical landmarks on a simulated anatomical structure (1) mimicking the proximal tibia region of a human leg, the structure including a skin-like material (1a), a subcutaneous tissue layer (3b), and a bone module (3);
inserting a needle through the skin-like material (1a), subcutaneous tissue layer (3b), and bone layer (3c) of the bone module (3) into a marrow cavity (3g) within the bone module (3);
aspirating simulated marrow or fluid from the marrow cavity (3g) through a valve (3a) operatively connected to the marrow cavity (3g);
infusing fluid into the marrow cavity (3g) through the valve (3a) using a syringe (6) connected to tubing (5) and a multi-valve (14);
capturing video data of the needle insertion procedure using a camera (10) positioned within the simulated anatomical structure (1);
analyzing the captured video data using an artificial intelligence module operatively connected to the camera (10) to determine the accuracy of needle placement and the skill level of the trainee;
and providing feedback to the trainee through a display (11) and a speaker (12), the feedback including visual and audio cues indicating the correctness of the insertion procedure.

93. The method of claim 92, wherein the anatomical landmarks identified include the tibial tuberosity and the flat plateau of the proximal tibia.

94. The method of claim 92, wherein the skin-like material (1a) is configured to provide realistic tactile feedback simulating the texture and firmness of human skin during needle insertion.

95. The method of claim 92, wherein the bone module (3) is adjusted axially and rotationally within the simulated anatomical structure (1) to present a fresh insertion site for each trainee.

96. The method of claim 92, wherein the marrow cavity (3g) is filled with spongy material configured to mimic bone marrow and soak artificial blood or colored liquid.

97. The method of claim 92, wherein the fluid infused into the marrow cavity (3g) is artificial blood or a colored liquid simulating the characteristics of human marrow.

98. The method of claim 92, wherein the camera or ultrasound probe (10) operates in the visible spectrum, infrared spectrum, or ultrasound spectrum to capture the position and orientation of the needle during insertion.

99. The method of claim 92, wherein the artificial intelligence module generates a report analyzing the trainee's performance, including accuracy of needle placement, insertion force, and overall skill level.

100. The method of claim 92, further comprising detecting the position and orientation of the needle using Hall effect sensors (13) positioned within the simulated anatomical structure (1).

101. The method of claim 92, further comprising measuring the insertion force and torque applied by the trainee using strain gauge sensors (14a, 14b) positioned within the simulator.

102. The method of claim 92, wherein the feedback provided to the trainee includes real-time visual cues displayed on the display (11) and audio cues emitted by the speaker (12) indicating whether the needle is correctly positioned within the marrow cavity (3g).

103. The method of claim 92, further comprising replacing an insertion pad within the simulated anatomical structure (1) to allow multiple punctures without loss of insertion characteristics.

104. The method of claim 92, wherein the artificial intelligence module transmits feedback reports via email or mobile devices for record-keeping and further analysis.

105. The method of claim 92, further comprising capturing the needle insertion procedure using a mobile phone (15) positioned within the simulated anatomical structure (1).

106. The method of claim 92, further comprising capturing the trainee's body posture and overall technique during the insertion procedure using an external camera system (16).

107. The method of claim 92, wherein the artificial intelligence module provides real-time feedback during the procedure, including visual and audio cues indicating the accuracy of needle placement.

108. The method of claim 92, wherein the simulated anatomical structure (1) is configured for use in field training environments, including military training for paramedics and first responders.

109. The method of claim 92, further comprising replenishing the marrow cavity (3g) with artificial blood or colored liquid using a syringe (6) connected to the valve (3a) and tubing (5).

110. The method of claim 92, wherein the trainee's performance is analyzed based on the insertion force, needle trajectory, and anatomical accuracy of the procedure.

111. The method of claim 92, further comprising amplifying sounds generated during the needle insertion procedure using a microphone integrated within the simulator to provide additional feedback to the trainee.

112. The method of claim 92, wherein the feedback provided includes recommendations for improving the trainee's technique based on the analysis performed by the artificial intelligence module.

113. A system for training intraosseous access procedures, the system comprising:
a portable intraosseous access simulator including:

a simulated anatomical structure (1) mimicking the proximal tibia region of a human leg, the structure comprising:
a skin-like material (1a) configured to simulate the external surface of human skin;
a cavity (1b) within the simulated anatomical structure (1) configured to house a bone module (3);
the bone module (3) comprising:
a multilayered construction including a subcutaneous tissue layer (3b), a bone layer (3c), and a marrow cavity (3g);
a valve (3a) in fluid communication with the marrow cavity (3g), the valve (3a) configured to allow aspiration and infusion of fluid;
an axial scale (3d) and a rotational scale (3f) configured to provide feedback on the position of the bone module (3) within the cavity (1b);
indicators (3e) for visually indicating the movement of the bone module (3);
and a knob (3h) configured to adjust the axial and rotational position of the bone module (3) within the cavity (1b);
a camera (10) positioned within the simulated anatomical structure (1) and configured to capture video data of a needle insertion procedure;
a display (11) operatively connected to the camera (10) and configured to visually present the captured video data;
a speaker (12) configured to provide audio feedback during the needle insertion procedure;
an artificial intelligence module operatively connected to the camera (10), the artificial intelligence module configured to analyze the captured video data to determine the accuracy of needle placement and provide feedback to a trainee;
and a fluid simulation system comprising:
tubing (5) operatively connected to the marrow cavity (3g);
a multi-valve (14) configured to control fluid flow;
and a syringe or reservoir (6) configured to supply artificial blood or colored liquid to the marrow cavity (3g).

114. The system of claim 113, wherein the skin-like material (1a) is made of rubber, silicone, or a spongy material configured to mimic the texture and firmness of human skin.

115. The system of claim 113, wherein the cavity (1b) within the simulated anatomical structure (1) is filled with foam, resin, plastic material, or granules to provide firmness and realistic anatomical resistance during needle insertion.

116. The system of claim 113, wherein the bone module (3) is configured to slide and rotate within the cavity (1b) to present fresh insertion sites for multiple punctures.

117. The system of claim 113, wherein the marrow cavity (3g) is filled with spongy material configured to mimic bone marrow and soak artificial blood or colored liquid.

118. The system of claim 113, wherein the valve (3a) is a one-way or two-way valve configured to allow controlled aspiration and infusion of fluid into the marrow cavity (3g).

119. The system of claim 113, wherein the axial scale (3d) and rotational scale (3f) are marked with numerical indicators to provide precise feedback on the position of the bone module (3) within the cavity (1b).

120. The system of claim 113, wherein the camera or ultrasound probe (10) operates in the visible spectrum, infrared spectrum, or ultrasound spectrum to capture the position and orientation of the needle during insertion.

121. The system of claim 113, wherein the artificial intelligence module generates a report analyzing the trainee's performance, including accuracy of needle placement, insertion force, and overall skill level.

122. The system of claim 113, further comprising Hall effect sensors (13) positioned within the simulated anatomical structure (1) to detect the position and orientation of the needle during insertion.

123. The system of claim 113, further comprising strain gauge sensors (14a, 14b) configured to measure the insertion force and torque applied by the trainee during the procedure.

124. The system of claim 113, wherein the display (11) is configured to provide real-time visual feedback, including the needle's position and trajectory within the simulated anatomical structure (1).

125. The system of claim 113, wherein the speaker (12) is configured to emit audio cues indicating whether the needle has been correctly positioned within the marrow cavity (3g).

126. The system of claim 113, further comprising a replaceable insertion pad positioned within the cavity (1b) to allow multiple punctures without loss of insertion characteristics.

127. The system of claim 113, wherein the artificial intelligence module transmits feedback reports via email or mobile devices for record-keeping and further analysis.

128. The system of claim 113, further comprising a mobile phone (15) positioned within the simulated anatomical structure (1) to capture and analyze the needle insertion procedure.

129. The system of claim 113, further comprising an external camera system (16) configured to capture the trainee's body posture and overall technique during the insertion procedure.

130. The system of claim 113, wherein the bone module (3) is made of a combination of plastic, resin, polypropylene, styrene, or PC-ABS to mimic the hardness and resistance of human bone.

131. The system of claim 113, wherein the artificial intelligence module provides real-time feedback during the procedure, including visual and audio cues indicating the accuracy of needle placement.

132. The system of claim 113, wherein the fluid simulation system is configured to replenish the marrow cavity (3g) with artificial blood or colored liquid using the syringe (6) connected to the valve (3a) and tubing (5).

133. The system of claim 113, wherein the simulated anatomical structure (1) is configured for use in field training environments, including military training for paramedics and first responders.

Documents

Application Documents

# Name Date
1 202441034202-STATEMENT OF UNDERTAKING (FORM 3) [30-04-2024(online)].pdf 2024-04-30
2 202441034202-PROVISIONAL SPECIFICATION [30-04-2024(online)].pdf 2024-04-30
3 202441034202-FORM FOR STARTUP [30-04-2024(online)].pdf 2024-04-30
4 202441034202-FORM FOR SMALL ENTITY(FORM-28) [30-04-2024(online)].pdf 2024-04-30
5 202441034202-FORM 1 [30-04-2024(online)].pdf 2024-04-30
6 202441034202-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [30-04-2024(online)].pdf 2024-04-30
7 202441034202-EVIDENCE FOR REGISTRATION UNDER SSI [30-04-2024(online)].pdf 2024-04-30
8 202441034202-DRAWINGS [30-04-2024(online)].pdf 2024-04-30
9 202441034202-FORM-26 [04-05-2024(online)].pdf 2024-05-04
10 202441034202-Proof of Right [28-10-2024(online)].pdf 2024-10-28
11 202441034202-FORM-5 [30-04-2025(online)].pdf 2025-04-30
12 202441034202-DRAWING [30-04-2025(online)].pdf 2025-04-30
13 202441034202-COMPLETE SPECIFICATION [30-04-2025(online)].pdf 2025-04-30
14 202441034202-Covering Letter [17-05-2025(online)].pdf 2025-05-17
15 202441034202-Response to office action [30-10-2025(online)].pdf 2025-10-30