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Title:
THREE-DIMENTIONAL PRINTED PROTECTIVE EYE GEAR WITH PRESCRIPTION GLASSES
Document Type and Number:
WIPO Patent Application WO/2023/209689
Kind Code:
A1
Abstract:
A wearer specific eye protection goggles with prescription glasses for use during micro-surgical procedures has been disclosed herein. The eye protection goggles have provision to close-fit the eye -piece lenses of the operating microscope used in neurosurgery and microsurgery has been developed, the goggles have been developed as per the facial anthropometry of the wearer. The 3D model of the wearer's face was developed using photogrammetry.

Inventors:
SINGH RAMANDEEP (IN)
SINGH RAJDEEP (IN)
SURI ASHISH (IN)
Application Number:
PCT/IB2023/054489
Publication Date:
November 02, 2023
Filing Date:
April 29, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
ALL INDIA INST OF MEDICAL SCIENCES AIIMS (IN)
DBT DEPT OF BIOTECHNOLOGY GOVT OF INDIA (IN)
International Classes:
A61F9/02; B29C64/10; B33Y10/00; G02C11/08
Foreign References:
US20050088613A12005-04-28
US20180303190A12018-10-25
CN111452350A2020-07-28
Attorney, Agent or Firm:
MAJUMDAR, Subhatosh et al. (IN)
Download PDF:
Claims:
CLAIMS:

1. A wearer specific eye protection goggles; comprising,

(a) a frame adapted to be seated over the eyes of a wearer and comprising a front support and a spaced pair of rearwardly extending side supports connected thereto;

(b) sealing means defining edges of the frame to provide a sealed environment for protection during aerosol-producing operations;

(c) flexible adjustable straps detachably secured to frame side supports; wherein said goggles comprises prescription glasses, wherein the prescription glasses of said goggles are releasably secured in said front support, wherein said frame is soft and flexible, wherein said front support has provision to close-fit eye-piece lenses of the operating microscope; wherein said frame includes air vents with filters therein to provide free passage of air while eliminating fogging; wherein said frame is prepared based on wearer's facial anthropometry data obtained through 3D modelling of the wearer’s face to ensure a perfect ergonomic fit; wherein the 3D model of wearer’s face is achieved by photogrammetry or capturing multiple images, by a 3D scanner, of their face from different angles, tracing a 3D curve on the nose, temples and forehead regions of the scanned surface and using said 3D curve to fabricate 3D model of the wearer specific eyegear.

2. The protection goggles as claimed in claim 1, wherein the sealing means includes a rubberized strip of 3 mm width along the edges of the goggles to provide a sealed environment inside.

3. The protection goggles as claimed in claim 1, wherein said goggles includes slots in the front support to releasably secure the prescription glasses, wherein the slots are provided with dimension similar to real glasses.

4. The protection goggles as claimed in claim 1, wherein said frame side supports includes two slots designed for fixation of the flexible adjustable straps.

5. The protection goggles as claimed in claim 1, wherein the air vents include HEPA filters on each side supports of the frame. 6. The protection goggles as claimed in claim 1, wherein said goggles are made of ABS plastic and Agilus materials.

7. The protection goggles as claimed in claim 1, comprising provisions for incorporating sensors and miniature cameras for tracking the eye and head movements of the wearer. 8. The protection goggles as claimed in claim 7, wherein said sensor includes

Inertial Measurement Units (IMU), configured to measure acceleration, rotation, and magnetic field orientation of the goggles in three dimensions.

9. The protection goggles as claimed in claim 7, wherein said cameras are placed on the front region of the frame, near the prescription glasses, to capture clear and detailed images of the wearer's eye movements.

10. The protection goggles as claimed in claim 7, wherein the measurements obtained from said sensors and cameras are analyzed using artificial intelligence techniques for providing valuable feedback related to surgical skill levels.

Description:
THREE-DIMENTIONAL PRINTED PROTECTIVE EYE GEAR WITH

PRESCRIPTION GLASSES

TECHNICAL FIELD

The present invention relates to a wearer specific protective eye gear with prescription glasses. The invention allows the wearers to perform delicate neurosurgical procedures without the need of additional protective eye-gear and protects them from exposure to viruses and other contaminants. The disclosure more particularly relates to wearer specific prescription glass based protective goggles for use during micro-surgical procedures.

BACKGROUND OF THE INVENTION

Coronavirus 2019 (COVID -19) is a virus caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The virus can cause respiratory tract infection which leads to serious health problems or even death. The outbreak was first started in Wuhan, Hubei, China in December 2019 and declared as a pandemic by World Health Organization (WHO) on March 11, 2020. As of May 2022, almost 108 million COVID cases and nearly 2.4 million deaths have been documented worldwide. The pandemic severely impacted the global healthcare system. A healthcare system's top priorities during a pandemic are the prevention of infection and the delivery of high-quality medical care to infected patients. Therefore, medical personnel on the frontlines, notably surgeons and paramedics, face the greatest risk of infection. Surgical specialties such as neurosurgery and ENT surgery require direct access to nasal cavities and paranasal sinuses. These procedures are more likely to produce infectious respiratory aerosols than coughing, sneezing, talking, or breathing. Therefore, the high-risk nature of the surgical operating rooms during such pandemics necessitates the deployment of additional protective measures. Neurosurgical procedures involve direct exposure to direct nasal spaces and paranasal sinuses. This high-risk environment requires additional methods of effective protection. Therefore, wearing personal protective equipment (PPE) is mandatory to prevent spread of infection during neurosurgery.

The routinely used personal protective equipment (PPE) for operating surgeons includes respirator masks, gowns with long sleeves and gloves. The Center for Disease Control and Prevention (CDC) recommended additional eye protection PPE for surgeons during COVID. The use of the eye protection was crucial as the presence of SARS-CoV-19 has been noted in the conjunctival swabs of patients with Covid-19 (Wu P, JAMA Ophthalmol, 2020). Moreover, ACE2 and TMPRSS2 are expressed on the human ocular surface, suggesting susceptibility to SARS-CoV-2 infection via the conjunctival route (Ma D, Eye, 2020). However, the usage of eye protection equipment such as face shields, goggles, or glasses causes ergonomic discomfort and makes operating microscopes difficult to use. Numerous studies have reported the widespread usage of exoscopes as surgical microscope alternatives to resolve the incompatibility of microscopes with eye protection PPE. However, the operating microscope is more suitable for the success of neurosurgical treatments involving deep-seated tumours. Moreover, an operating microscope provides better dexterity and performance and a greater operational comfort level to the surgeons as compared to an exoscope. Consequently, an eye protection method that does not impede microneurosurgical workflow is required.

However, wearing protective goggles causes ergonomic discomfort especially during micro-neurosurgical procedures. This is due to the fact that the protective goggles increase the distance of eyes from the operating microscope eye -piece lenses. The protective goggles do not allow the wearer to adjust the distance of the lens from the microscope eye-piece. Also, the eye -protection goggles are available in a standard size and thus cannot readily accommodate wearers with different face configurations, preferences and needs. Most of the surgeons today suffer from refraction errors of the eye and wear prescription eye glasses. For them the ergonomic discomfort of wearing protective goggles is even more escalated due to prescription glasses. This creates three layers of optics including the eye-piece lenses of microscope, personal prescription glasses and protection goggles. It can result in strain of the eye muscles, blurred vision, trouble focusing, dry or watery eyes, soreness of eyes. All these parameters can significantly affect the ability of a surgeon to focus and perform the surgery. Also, it puts the surgeon at risk of becoming a carrier; and patient’s life at risk as it may lead to iatrogenic injuries. Performing the surgeries with non-ergonomic optics for longer hours may result in serious vision distortion.

However, there is no protective eye gear that is designed as per surgeons’s facial anthropometry and includes prescription glasses to correct refractive error. Some of the related patents are described below:

Reference is made to US4785481. The document discloses a device in the form of a pair of specially designed glasses, goggles or an eye mask sealingly engaging the wearer's head. In each case, a frame includes a front support bearing one or more transparent, preferably prescription-ground lenses or eye shields, and a pair of side supports connected thereto. Components are connected to or built into the frame to allow free passage of air to the eyes while blocking contaminant-bearing liquids and solids. Thus, in one embodiment, eyeglasses are fitted with two sets of triangular preferably air permeable flexible sheets. One set of sheets depends from the side supports and is connected to the sides of the front support, with the other pair is connected to the side and front supports above the latter, being connected at its rear end to slides in the top of side support channels to permit easy folding of the glasses. In two other embodiments, goggles and eye masks bear air vents fitted with liquid and solid-blocking filters. Such filters may be replaced and may be sandwiched between screens within outer vented boxes. Yet again reference is made to US5424787. This patent literature discloses a pair of eyeglasses comprising attachment pieces formed on the temple pieces anterior of the eyeglasses ear pieces for the attachment of the non- rigid support ties of a non- rigid face mask thereto to support the face mask from the eye-glasses temple pieces rather than the ears of the wearer. The combination of the pair of eyeglasses and the thusly supported mask is also provided. The pair of eyeglasses may take the form of safety glasses, and the mask the form of a conventional surgical mask.

Further reference is made to WO1998003893A1. This invention discloses an eye wear that is structured to give a customized fit to each individual wearer. The eyewear comprises a lens-supporting frame, a surface engaging member and a retractable device inter-connecting the lens supporting frame to the surface engaging member. Various embodiments are disclosed, but one exemplary embodiment comprises a frame structured with the retractable device.

Yet another reference is made to US11096827B1. This invention provides protective eyewear comprising at least one removable filter assembly allowing ambient air to circulate to the eye while filtering out pathogens and other particles, he protective eyewear is adapted to removably receive and secure multiple PPE accessories, including for example face shields and face masks. Together with the protective eyewear, the PPE accessories are fastened to the user through a single head strap. The eyewear can accommodate normal or prescription lenses and is configured with a rigid frame and flexible seal to provide a snug, airtight fit.

Further, 3D printed lenses such as provided in the link https://www.luxexcel.com/ relates to fabrication of the prescription lenses with embedded sensors for Augmented Reality & Virtual Reality applications. However, there is no disclosure of development of a sealed environment for the eyes during surgical procedures by providing slots as per the surgeon’s exiting prescription glasses in the eye gear. Therefore, there remain a need for a wearer specific protective eye gear with prescription glasses for protection of eyes from contaminants and viruses during surgery, specifically for use during micro-surgical procedures by providing a sealed environment for the eyes during surgical procedures by providing slots as per the wearer’s exiting prescription glasses in the eye gear.

SUMMARY OF THE INVENTION

The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the 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.

One object of present invention is to provide a wearer specific protective eye gear with prescription glasses for protection of eyes from contaminants and viruses during surgery.

Another object of present invention is to develop wearer specific protective eye gear for microscopic surgeons based on wearer's facial anthropometry data to ensure a perfect ergonomic fit.

Another object of present invention is to develop a wearer specific fully protected person specific protective goggles with inbuilt prescription glasses.

Yet another object of present invention is to omit the risk of becoming a carrier by a wearer and putting patient’s life at risk.

Yet another object is to protect the wearer's eyes during aerosol-producing operations and to offer the largest field of view (FOV) range of vision feasible when utilising an operating microscope.

One aspect of present invention relates to a wearer specific eye protection goggles with prescription glasses for use during micro-surgical procedures. The eye protection goggles have provision to close-fit the eye-piece lenses of the operating microscope used in neurosurgery and microsurgery has been developed. The goggles have been developed as per the facial anthropometry of the wearer. The 3D model of the wearer’s face was developed using photogrammetry or 3D scanning.

The goggles further include a rubberized strip of 3 mm width along the edges of the goggles to provide a sealed environment inside. For fixation of the glasses, slots were provided with dimension similar to real glasses. On the sides of the eye-gear two slots were designed for fixation of the elastic strap. Bottom and top vents on each side were made to prevent fogging of the goggles.

Another aspect of present invention is to provide a method of developing a wearer specific eye protection goggles with prescription glasses by 3D printing technology using 2D images or by 3D scanning. For photogrammetry, a set of images from various orientations was captured by the wearer himself using a photo capturing device. A mesh head model was matched with the contours in the images using various points. For 3D scanning, a portable hand-held scanner was used to capture the facial data. The face model developed using photogrammetry or 3D scanning was equivalent to the facial features of the wearer. Computer aided designing was used to develop the 3D model of the goggles as per the 3D model of wearer’s face. To match the model with actual dimensions the prescription glasses of the wearer were taken as reference. The prescription glasses of the wearer were scanned and used for scaling the face model. The printed prototype was then fitted with the prescription glasses of the wearer and elastic strap.

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 above and other aspects, features and advantages of the embodiments of the present disclosure will be more apparent in the following description taken in conjunction with the accompanying drawings, in which:

FIG. 1 illustrates a block diagram of the process of surgeon specific eye gear development.

FIG. 2 illustrates a schematic diagram depicting the front view of the surgeon specific eye gear 1, wherein, 2 represents the main frame of protective eye-gear, 3 and 4 represent an operating microscope eye -piece lens insertion grooves, and 5 and 6 depict hooks for the adjustable strap.

FIG. 3 illustrates a schematic diagram depicting the bottom view of the surgeon specific eye gear 1, wherein, 7b represents rubber sealing for the nose and 9a and 9b depicts bottom vents with HEP A filters.

FIG. 4 illustrates a schematic diagram depicting the top view of the surgeon specific eye gear 1, wherein, 8a and 8b represents top vents with HEPA filters and 7a portrays rubber sealing for the forehead.

FIG. 5 illustrates a schematic diagram depicting the side view of the surgeon specific eye gear 1, wherein 7 represents rubber sealing (to ensure proper fitting), 8a and 9a depicts top and bottom vents (to prevent fogging) and 5 represents hooks for the adjustable strap.

FIG. 6 illustrates a schematic diagram depicting the isometric view of the surgeon specific eye gear 1, wherein, 7 represents the rubber seal (to ensure proper fitting), and 10 depicts press-fitted vison glasses space.

Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may have not 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. Throughout the drawings, it should be noted that like reference numbers are used to depict the same or similar elements, features, and structures.

DETAILED DESCRIPTION OF THE INVENTION

The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of exemplary implementations of the invention. It includes various specific details to assist in that understanding but these are to be regarded as merely exemplary.

Features that are described and/or illustrated with respect to one implementation may be used in the same way or in a similar way in one or more other implementations and/or in combination with or instead of the features of the other implementations .

The various embodiments of the present invention describe a wearer specific eye protection goggle with prescription glasses. The various embodiments herein may include one or more of the components to provide wearer specific protective eye gear or goggles for use during micro -surgical procedures. In the following description, for purpose of explanation, specific details are set forth in order to provide an understanding of the present disclosure.

In an embodiment of present invention, a wearer specific eye protection goggles; comprising,

(a) a frame adapted to be seated over the eyes of a wearer and comprising a front support and a spaced pair of rearwardly extending side supports connected thereto;

(b) sealing means defining edges of the frame to provide a sealed environment for protection during aerosol-producing operations

(c) flexible adjustable straps detachably secured to frame side supports; wherein said goggles comprises prescription glasses, wherein the prescription glasses of said goggles are releasably secured in said front support, wherein said frame hass soft and flexible material at the area that comes into contact with the user's face, wherein said front support has provision to close-fit eye-piece lenses of the operating microscope; wherein said frame includes air vents with filters therein to provide free passage of air while eliminating fogging; wherein said frame is prepared based on wearer's facial anthropometry data obtained through 3D modelling of the wearer’s face to ensure a perfect ergonomic fit; wherein the 3D model of wearer’s face can be achieved by capturing multiple images, by a 3D scanner, of their face from different angles, tracing a 3D curve on the nose, temples and forehead regions of the scanned surface and using said 3D curve to fabricate 3D model of the wearer’s face.

In an embodiment, the 3D model of the wearer’s face can also be developed using photogrammetry. This method involves development of 3D rendering using 2D images. A set of 7 images from various orientation that were captured by the wearer himself using his mobile phone. A mesh head model is matched with the contours in the images using various points.

In one of the embodiments, the present invention is related to eye-protection goggles that have provision to close-fit the eye-piece lenses of the operating microscope used in neurosurgery and microsurgery. This allows wearers to maintain optimal distance between the eye-piece lenses of operating microscope and wearer’s eyes and hence provides required focus.

In yet another embodiment, Computer aided designing was used to develop the 3D model of the goggles as per the 3D model of wearer’s face. However, the scaling of the model was not as per actual dimensions of wearers face in case of photogrammetry based face model. To match the model with actual dimensions the prescription glasses of the wearer were taken as reference. The prescription glasses of the wearer were scanned and used for scaling the face model.

In yet another embodiment, the sealing means includes a rubberized strip of 3 mm width along the edges of the goggles to provide a sealed environment inside.

In an embodiment, said goggles includes slots in the front support to releasably secure the prescription glasses. The slots are provided with dimension similar to real glasses.

In another embodiment, said frame side supports includes two slots designed for fixation of the flexible adjustable straps.

In further embodiment, the air vents include HEPA filters on each side supports of the frame.

In yet another embodiment of the present invention, the goggles were developed using multi-material 3D printing technology. This allows fabrication of different materials in a single print and provides the final assembled prototype. The goggles were developed using two materials, which include ABS plastic for the eye-gear and agilus for the rubber seal. The printed prototype was then fitted with the prescription glasses of the wearer and elastic strap.

In another embodiment of the present invention, the eye protection goggles have provisions to integrate sensors and cameras for tracking the eye and head movements of the surgeon. The sensors may include Inertial Measurement Units (IMU), which measure the acceleration, rotation, and magnetic field orientation of the goggles in three dimensions, providing data related to the movement and orientation of the wearer's head. In addition, miniature cameras can be integrated into the goggles, allowing for the tracking of the surgeon's eye movements. These cameras can be placed on the front region of the frame, near the prescription glasses, to capture clear and detailed images of the wearer's eye movements. The data from sensors and cameras is analyzed using artificial intelligence techniques for providing valuable feedback related to surgical skill levels.

According to Fig. 1, a process of developing a surgeon specific eye gear has been disclosed. Said process comprises the steps of capturing multiple images, by a 3D scanner or photogrammetry, of the face of the user from different angles, tracing a 3D curve on the nose, temples and forehead regions of the scanned surface and using said 3D curve to fabricate 3D model of the wearer specific eye-gear.

FIG. 2 depicts the front view of the surgeon specific eye gear 1, wherein, 2 represents the main frame of protective eye-gear, 3 and 4 represent an operating microscope eye -piece lens insertion grooves, and 5 and 6 depict hooks for the adjustable strap.

FIG. 3 depicts the bottom view of the surgeon specific eye gear 1, wherein, 7b represents rubber sealing for the nose and 9a and 9b depicts bottom vents with HEPA filters.

FIG. 4 depicts the top view of the surgeon specific eye gear 1, wherein, 8a and 8b represents top vents with HEPA filters and 7a portrays rubber sealing for the forehead.

FIG. 5 illustrates the side view of the surgeon specific eye gear 1, wherein 7 represents rubber sealing (to ensure proper fitting), 8a and 9a depicts top and bottom vents (to prevent fogging) and 5 represents hooks for the adjustable strap.

FIG. 6 illustrates a schematic diagram depicting the isometric view of the surgeon specific eye gear 1, wherein, 7 represents the rubber seal (to ensure proper fitting), and 10 depicts press-fitted vison glasses space. Validation

The effectiveness of surgeon-specific protective eye gear was assessed using participant feedback and evaluating the field of view. The neurosurgeon feedback was generally positive, with the eye gear being comfortable and providing improved visibility and surgical performance. The neurosurgeons provided positive feedback about the fit, visibility improvement, likelihood of continued use, comparison to other eye gear, and improvement in overall surgical performance. Moreover, the eye gear had only a minimal impact on the surgeon's field of view, with a minimal decrease across all magnifications tested. These results suggest that the personalized eye gear is effective in providing adequate protection while minimizing the reduction in the surgeon's field of view caused by the use of other PPE.

The design and fabrication of customized prescription glasses using 3D scanning and 3D printing technologies allows for the creation of glasses that provide the highest field of view possible and a comfortable and secure fit. The ability to use a variety of materials also allows for customization of the glasses to suit the needs of the wearer. This technology can be used to make glasses for people with special needs or for people working in extreme environments. This research highlights the potential of 3D scanning and 3D printing technology in the design and fabrication of customized prescription glasses.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from scope and spirit of the invention. It is intended that present invention covers such modifications and variations disclosed in the description.