Disposable orbit isolation pad for nystagmus video recorder and use method of disposable orbit isolation pad

Abstract

The invention discloses a disposable orbit isolation pad for a nystagmus video recorder and a use method. The isolation pad comprises a binocular hollow part and an eye socket sealing ring integrally formed by a medical elastic material, the hollow part is provided with a left eye opening and a right eye opening to completely expose pupils and part of sclera; the sealing ring is attached to the orbital bone edge to isolate the host from being in contact with the skin; no entity exists in the field angle avoiding cone with the center of any pupil as the original point, the horizontal field angle is larger than or equal to + / -35 degrees, and the vertical field angle is larger than or equal to + / -25 degrees. The pad is tightly attached to the face through an independent structure, or an embedded structure is adopted to be matched with a host installation cavity, so that a host indirectly makes contact with the skin through the pad. The left eye opening and the right eye opening are asymmetric, the size of the left eye opening and the size of the right eye opening are 25-30 mm * 20-25 mm and 26-31 mm * 21-26 mm respectively, and the eye tracker is adaptive to a mainstream asymmetric eye tracker. The thickness of the sealing ring ranges from 1.5 mm to 3.0 mm, and the hardness ranges from 10 A to 40 A. Cross infection can be prevented, unshielded collection of eye movement signals is guaranteed, and the device is suitable for vestibular function examination.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a disposable hygienic protective device for video eye-tracking recording devices (such as VNG, vHIT, Caloric Test) used in vestibular function examinations, and more particularly to a disposable orbital isolation pad that isolates the skin around the eye socket while ensuring that the eyeball is fully exposed to the camera's field of vision, and its method of use. Background Technology

[0002] Currently, widely used video eye trackers in clinical practice (such as Interacoustics I-GBG and EyeSeeCamvHIT+) are all equipped with reusable rigid eye shields. These eye shields come into direct contact with the patient's skin around the eyes, eyelashes, and tears during the examination. In scenarios where multiple people use them continuously, there is a risk of cross-infection, including bacterial conjunctivitis, blepharitis, and the spread of Demodex mites.

[0003] Existing disinfection methods (such as alcohol wiping or ultraviolet irradiation) cannot completely inactivate viruses or spores, and frequent disinfection can easily lead to equipment aging, fogging of optical components, or structural deformation. Some medical institutions have attempted to temporarily cover goggles with transparent plastic films, but this method has the following drawbacks:

[0004] (1) The reflection on the thin film surface interferes with the imaging of the infrared camera and reduces the signal-to-noise ratio of the eye movement signal;

[0005] (2) The full-coverage design encourages patients to close their eyes, significantly increasing blink artifacts and affecting the interpretation of nystagmus waveforms;

[0006] (3) Universal films cannot be adapted to the asymmetrical structure of different brands of equipment (such as the EyeSeeCam vHIT+ right eye camera being positioned too high), resulting in unstable installation or obstruction of the field of vision.

[0007] According to the patent database, CN210783567U discloses a "medical anti-fog goggle", but it is a fully enclosed structure that completely covers the eyeball and is not suitable for eye-tracking scenarios that require continuous exposure of the pupil; US20180014792A1 "System and method for video-based eye tracking" describes the optical and algorithm system of an eye tracker, but does not involve any consumables or hygiene protection solutions.

[0008] In summary, there is currently no existing technology that proposes a dedicated disposable isolation pad that "isolates only the orbital contact area while maintaining full pupil exposure," nor is there a quick-release compatible design for mainstream eye tracker interfaces or a comprehensive protection solution with a dual "independent wear" approach.

[0009] Therefore, there is an urgent need for a one-time isolation solution that does not rely on a specific host interface and focuses solely on functional results (skin isolation + optical unobstructed + full pupil exposure). Summary of the Invention

[0010] The purpose of this invention is to provide a disposable orbital isolation pad with a simple structure, low cost, and compatibility with mainstream eye trackers, as well as its usage method, to solve the problem of cross-infection, while not obstructing the camera's field of vision and maintaining the quality of the original eye movement signal.

[0011] To achieve the above objectives, the present invention provides a disposable orbital isolation pad (10) for an oculomotor video recorder, comprising:

[0012] The eye-opening section has a left eye opening (1) and a right eye opening (2) to fully expose the subject's left and right pupils and part of the sclera;

[0013] An orbital sealing ring (3) is set around the left eye opening (1) and the right eye opening (2), and is integrally formed from medical elastic material. It is used to fit the orbital bone edge of the subject and isolate the eye tracker host (20) from direct contact with the skin.

[0014] The field of view avoidance cone constructed with the center of any pupil as the origin has no solid structure, and the horizontal opening angle of the field of view avoidance cone is not less than ±35° and the vertical opening angle is not less than ±25°.

[0015] Furthermore, the isolation pad adopts any of the following structural forms:

[0016] Universal independent structure: It does not rely on the main unit mounting cavity. Its overall area is larger than the contact area between the eye tracker main unit (20) and the face. It can be equipped with fixing parts (such as elastic ear loops, headbands or Velcro) to first fix the isolation pad to the subject's face, and then wear the eye tracker main unit (20) on it, so that the contact surface of the main unit is indirectly in contact with the skin through the isolation pad.

[0017] Or embedded structure: The overall shape is adapted to the eye mask mounting cavity of the eye tracker host (20) (typical gap ≤1mm), and can be detached and installed through the mounting fit structure (5) (such as positioning post, edge boss) set on the eye socket sealing ring (3);

[0018] The isolation pad adopts a structure that is independent of the eye mask installation of the eye tracker main unit (20). The isolation pad includes at least one hole that allows the eyes to be fully exposed. The film or pad where the hole is located is made of medical soft material, with an area larger than the area of ​​the eye mask in contact with the subject. It is tightly attached to the subject's face or fixed to the subject's face by elastic material / ear loops / fasteners. Then, by fixing the eye tracker main unit (20), the contact surface of the eye tracker main unit (20) with the patient is fixed through the film or pad so that it does not directly contact the subject.

[0019] Alternatively, the overall shape of the isolation pad is adapted to the eye mask mounting cavity of the eye tracker host (20), so that the eye tracker host (20) does not directly contact the subject's facial skin.

[0020] Furthermore, in the disposable orbital isolation pad (10), the left eye opening (1) of the binocular hollow part is an ellipse with a diameter of not less than 25mm×20mm and not more than 30mm×25mm, and the right eye opening (2) is an ellipse with a diameter of not less than 26mm×21mm and not more than 31mm×26mm. The two are arranged asymmetrically to adapt to the optical channel offset structure of the eye tracker.

[0021] Furthermore, the disposable orbital isolation pad (10) and the orbital sealing ring (3) have a thickness of not less than 1.5 mm and not more than 3.0 mm, a Shore hardness of not less than 10 A and not more than 40 A, and the material is selected from medical silicone foam or thermoplastic elastomer TPE.

[0022] Furthermore, the disposable orbital isolation pad (10) also includes an installation and fitting structure (5) disposed on the orbital sealing ring (3) for detachably installing the isolation pad into the eye mask mounting cavity of the eye tracker host (20) without obstructing the optical acquisition path after installation; wherein, the installation and fitting structure (5) includes at least one positioning post for aligning and fitting with the corresponding mating hole or groove on the eye tracker host (20).

[0023] Furthermore, the disposable orbital isolation pad (10) is characterized in that the number of positioning posts is not less than two, wherein at least one positioning post is disposed in the nasal bridge connection part (6) area of ​​the orbital sealing ring (3).

[0024] Furthermore, the disposable orbital isolation pad (10) is characterized in that the positioning post is cylindrical with a diameter of not less than 2.0 mm and not more than 3.0 mm, and a height of not less than 2.5 mm and not more than 5.0 mm.

[0025] Furthermore, the disposable orbital isolation pad (10) is characterized in that the outer surface of the orbital sealing ring (3) is provided with a matte black light-shielding layer for absorbing ambient stray light and reducing its entry into the eye tracker optical system.

[0026] The present invention also provides a method of using the isolation pad, comprising at least:

[0027] Remove the disposable orbital isolation pad (10) from its sterile, individually packaged form;

[0028] For the general type: First, attach the isolation pad tightly to the subject's face or fix it with elastic bands / ear loops / fasteners, and then put the main unit goggles on it.

[0029] For embedded installation: First, align the isolation pad with the eye mask mounting cavity of the eye tracker host (20) so that the mounting mating structure (5) is aligned with the corresponding mating part on the host; press along the direction perpendicular to the eye mask plane until the isolation pad is fully embedded in the mounting cavity to achieve a stable installation;

[0030] Subjects wore an eye tracker with an attached isolation pad to perform vestibular function tests, during which pupil images were captured without obstruction;

[0031] After the inspection, the isolation pad was removed and disposed of as medical waste.

[0032] Beneficial effects

[0033] Infection control: Implement "one person, one pad", the eye tracker main unit (20) only comes into contact with the disposable isolation pad, completely blocking the path of cross-infection;

[0034] Optical fidelity: The eyeball is fully exposed and the field of view is clear, so the signal-to-noise ratio of eye movement signals is consistent with that of the naked eye.

[0035] Universal compatibility: With its asymmetrical openings and flexible mounting structure, it is compatible with mainstream devices such as Interacoustics I-GBG and EyeSeeCamvHIT+. Attached Figure Description

[0036] Figure 1 : A three-dimensional structural schematic diagram of the universal disposable orbital isolation pad (10) of the present invention;

[0037] Figure 2 : A three-dimensional structural schematic diagram of the embedded disposable orbital isolation pad (10) of the present invention;

[0038] Figure 3 : A schematic diagram of the wearing state of the universal disposable orbital isolation pad (10) of the present invention.

[0039] Explanation of reference numerals in the attached figures:

[0040] 1- The left eye is open;

[0041] 2- Right eye opening;

[0042] 3-Orbital sealing ring;

[0043] 4-Elastic ear loops;

[0044] 5- Installation and assembly structure;

[0045] 6- Nose bridge connection;

[0046] 10 - Disposable orbital isolation pads;

[0047] 20 - Eye tracker main unit. Detailed Implementation

[0048] To enable those skilled in the art to clearly and completely implement the present invention, the following description is provided in conjunction with the appendix. Figure 1 To be continued Figure 3 The embodiments are described in detail below. All embodiments are within the scope of protection of the claims of this invention.

[0049] Example 1: Universal disposable orbital isolation pad (10)

[0050] Structural features

[0051] Structure: The orbital sealing ring (3) extends to form a large area of ​​flexible pad, with an overall size of about 150mm×60mm, which is much larger than the contact surface of the host (about 132×45mm);

[0052] Fixing method: The two sides are equipped with one-piece molded elastic ear loops made of TPE, which can be stretched and hung on the auricle;

[0053] Usage procedure: First wear the isolation pad → then wear the eye tracker main unit (20) → the main unit is pressed on the isolation pad, with zero skin contact;

[0054] Material: Medical-grade TPE, 2.0mm thick, 30A hardness;

[0055] Advantages: No modification required to the main unit; compatible with all brands of eye trackers.

[0056] Specific use cases

[0057] Case 1: Rapid Application in the Emergency Room Environment

[0058] In the emergency department, doctors need to quickly assess a patient's vestibular function to determine if acute vertigo symptoms are present. In such situations, time is of the essence and the number of patients varies greatly, making the universal, freestanding isolation mat of this invention particularly convenient.

[0059] First, medical staff remove the isolation pad from the sterile packaging and easily put it on the patient's face using the ear loops.

[0060] Next, gently press the eye mask portion of the video eye tracker onto the fixed isolation pad to ensure indirect contact between the device and the skin while keeping the pupil fully exposed.

[0061] During the inspection, the matte black light-blocking layer of the isolation pad effectively prevented external light from affecting the test results, thus improving diagnostic accuracy.

[0062] Case 2: Routine examinations at a community clinic

[0063] When conducting routine health checkups at community clinics, patients may be from diverse age groups, including children and the elderly. Universal, freestanding isolation mats are particularly suitable due to their ease of wear.

[0064] For pediatric patients, parents can help their children put on the isolation pad under the guidance of medical staff, and then have professionals complete the subsequent examination steps. This not only reduces the child's fear, but also ensures hygiene and safety.

[0065] Elderly patients may have skin sensitivity issues. Using the isolation pad of the present invention can effectively prevent the eye tracker host (20) from directly contacting the skin and reduce the risk of allergic reactions.

[0066] Example 2: Embedded disposable orbital isolation pad (10)

[0067] Structural features

[0068] The overall shape is precisely matched to the eyecup mounting cavity of the EyeSeeCam vHIT+ eye tracker, with a maximum outer contour of 132mm×45mm;

[0069] The hollowed-out part of the binoculars adopts an asymmetrical elliptical design: the left eye opening (1) is 27mm×22mm, the right eye opening (2) is 28mm×23mm, and the center is vertically offset by 2.5mm to fit the high-position layout of its right eye camera.

[0070] The orbital sealing ring (3) is 2.5 mm thick, with a Shore hardness of 30A, and is made of medical-grade silicone foam (density 0.3 g / cm³). 3 One-piece molding;

[0071] The mounting and fitting structure (5) is an edge boss that is continuously set along the outer edge of the sealing ring, with a height of 0.8mm and a width of 2.0mm, forming a 0.3mm interference fit with the main unit cavity;

[0072] Technical effectiveness verification: Installation force <15N, no residue after disassembly, achieving both skin isolation and unobstructed optics.

[0073] The outer surface has a matte black light-blocking layer to reduce infrared reflection interference.

[0074] Specific use cases

[0075] Case 1: Standardized Procedures of Vestibular Function Testing Center

[0076] A top-tier hospital's vestibular function room sees 30-50 patients with vertigo daily and uses the EyeSeeCam vHIT+ device for caloric testing. To ensure hygiene and efficiency, the embedded isolation pad of this invention is used.

[0077] The nurse removed the isolation pad from the sterile, individually packaged packaging and aligned it with the goggle cavity of the main unit;

[0078] Press gently along the vertical direction, and the edge protrusion will automatically snap into the cavity, making a slight "click" sound to indicate that it is installed in place;

[0079] After the patient puts on the device, because the isolation pad is pre-integrated with the main unit, no additional position adjustment is required, and the pupil is always located in the center of the camera's field of view;

[0080] Each examination takes about 15 minutes. After the examination, the isolation pad is removed and discarded, and the main unit can be used for the next patient without disinfection.

[0081] Based on 200 clinical trials, there was no statistically significant difference in the signal-to-noise ratio of eye movement signals compared to when no isolation pad was used (p>0.05), and the number of cross-infection events was zero.

[0082] Case Study 2: High-Precision Requirements in Scientific Research Experiments

[0083] In a multicenter study on vestibular compensation mechanisms, high consistency of eye movement data was required across all participants. The research team uniformly used the embedded isolation pad of this invention.

[0084] Because of its rigid connection with the host, it avoids the slight displacement that may occur with universal ear pads;

[0085] Asymmetrical openings ensure consistent viewing angles for both eyes, eliminating device compatibility issues.

[0086] The black light-blocking layer effectively suppresses specular reflection from laboratory LED light sources, improving the accuracy of high-speed eye movement capture;

[0087] All research centers use the same size isolation pads, ensuring data comparability across sites.

[0088] Both embodiments satisfy the following requirements: full pupil exposure, clear field of view, and skin isolation.

[0089] Comparative Example 1:

[0090] If only ordinary perforated films available on the market are used (without orbital sealing ring (3) and without fixing strap), then:

[0091] Easy displacement can lead to obstruction of the field of vision;

[0092] It cannot fit the orbital bone rim, resulting in poor comfort;

[0093] Without a light-shielding layer, stray light interferes with the signal.

[0094] Comparative Example 2: (Illustrate the necessity of parameter boundaries)

[0095] To verify the functional necessity of the parameter range of the present invention, the following comparative experiment was conducted:

[0096] When the sealing ring thickness is less than 1.5mm, it is prone to tearing during installation, resulting in a yield rate of less than 60%.

[0097] When the Shore hardness is >40A, the patient's subjective pressure score increases by 47% and blinking frequency increases by 37%.

[0098] When the left eye opening (1) < 25×20mm, 15% of Asian users with small faces experience upper eyelid occlusion;

[0099] The positioning post with a diameter of less than 2.0 mm breaks after being inserted and removed three times, making it unreliable for fixing.

[0100] Therefore, the parameter range defined in this invention (such as thickness 1.5-3.0mm, hardness 10-40A, opening 25-30mm, etc.) is a functionally necessary range that has been verified by a large number of experiments, and is not arbitrarily expanded. All technical solutions falling within this range can achieve the core purpose of "anti-infection + optical protection".

[0101] Usage instructions and procedures:

[0102] Tear open the sterile individual packaging and remove the isolation pad;

[0103] For general-purpose independent isolation pads: first fix the isolation pad to the subject's face, then wear the eye tracker main unit (20) on it, so that the contact surface of the main unit is in close contact with the skin indirectly through the isolation pad; for embedded isolation pads: align the isolation pad with the inner cavity of the eye tracker eye mask, press lightly in the vertical direction, press until the edge protrusion automatically snaps into the cavity, and emit a slight "click" sound to indicate that the installation is in place;

[0104] The patient wears a device to undergo vestibular function testing;

[0105] After the examination, first remove the goggles, then remove or take out the isolation pad and discard it into the medical waste bin.

[0106] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

[0107] Feasibility description

[0108] The materials used in this invention (medical TPE, silicone foam) are all commercially available mature medical polymers with a stable supply chain; the manufacturing processes (hot pressing, liquid silicone injection) are conventional technologies in the medical device industry.

[0109] The only difference between "general-purpose" and "embedded" is the installation method; their core functions are the same.

[0110] The “installation and mating structure (5)” can be a positioning post, a boss, a hook, a magnetic component or a friction surface, etc., all of which are well-known technical means in this field.

[0111] Field-of-view avoidance design can be verified using optical simulation software (such as Zemax).

Claims

1. A disposable orbital isolation pad for an oculomotor video recorder, characterized in that, include: The eye-opening section has openings for the left and right eyes to fully expose the subject's left and right pupils and part of the sclera. An orbital sealing ring, which surrounds the left and right eye openings, is integrally molded from a medical elastic material and is used to fit the orbital bone edge of the subject and isolate the eye tracker main unit from direct contact with the skin; The field of view avoidance cone constructed with the center of any pupil as the origin has no solid structure, and the horizontal opening angle of the field of view avoidance cone is not less than ±35° and the vertical opening angle is not less than ±25°. The isolation pad adopts a structure that is independent of the eye mask installation of the eye tracker main unit. The isolation pad includes at least one hole that allows the eyes to be fully exposed. The film or pad containing the hole is made of medical soft material, with an area larger than the area of ​​the eye mask in contact with the subject, and is closely attached to the subject's face or fixed to the subject's face by elastic material / ear loops / fasteners. By fixing the eye tracker main unit, the contact surface of the eye tracker main unit with the patient is fixed through the film or pad so that it does not directly contact the subject. Alternatively, the overall shape of the isolation pad is adapted to the eye mask mounting cavity of the eye tracker host (typical gap ≤ 1mm), so that the eye tracker host does not directly contact the subject's facial skin.

2. The disposable orbital isolation pad according to claim 1, characterized in that, The left eye opening of the binocular hollow section is an ellipse with a size of not less than 25mm×20mm and not more than 30mm×25mm, and the right eye opening is an ellipse with a size of not less than 26mm×21mm and not more than 31mm×26mm. The two are arranged asymmetrically to adapt to the optical channel offset structure of the eye tracker.

3. The disposable orbital isolation pad according to claim 1, characterized in that, The thickness of the orbital sealing ring is not less than 1.5 mm and not more than 3.0 mm, and the Shore hardness is not less than 10 A and not more than 40 A. The material is selected from medical silicone foam or thermoplastic elastomer (TPE).

4. The disposable orbital isolation pad according to claim 1, characterized in that, It also includes an installation and fitting structure disposed on the orbital sealing ring, for removably installing the isolation pad into the eye mask mounting cavity of the eye tracker host, and without obstructing the optical acquisition path after installation; wherein, the installation and fitting structure includes at least one positioning post for aligning and fitting with a corresponding mating hole or groove on the eye tracker host.

5. The disposable orbital isolation pad according to claim 4, characterized in that, The number of positioning posts is not less than two, and at least one positioning post is located in the nasal bridge connection area of ​​the orbital sealing ring.

6. The disposable orbital isolation pad according to claim 4, characterized in that, The positioning post is cylindrical, with a diameter of not less than 2.0 mm and not more than 3.0 mm, and a height of not less than 2.5 mm and not more than 5.0 mm.

7. The disposable orbital isolation pad according to claim 1, characterized in that, The outer surface of the orbital sealing ring is provided with a matte black light-shielding layer to absorb ambient stray light and reduce its entry into the eye tracker's optical system.

8. A method of using the disposable orbital isolation pad as described in any one of claims 1-7, characterized in that, Includes the following steps: Remove the disposable orbital isolation pad from its sterile, individually packaged form; First, attach the isolation pad tightly to the subject's face or fix it with elastic bands / ear loops / fasteners, and then put the main unit's goggles on it; Alternatively, first align the isolation pad with the eye mask mounting cavity of the eye tracker main unit, so that the mounting and mating structure is aligned with the corresponding mating part on the main unit; Press along a direction perpendicular to the plane of the goggles until the isolation pad is fully embedded in the mounting cavity to achieve a secure installation; Subjects wore an eye tracker with an attached isolation pad to perform vestibular function tests, during which pupil images were captured without obstruction; After the inspection, the isolation pad was removed and disposed of as medical waste.

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