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Wednesday, February 28, 2024

IIT-M Provides Free 3D-Printed Face Implants To Poor Sufferers Disfigured by Black Fungus

In a heartening improvement, researchers on the Indian Institute of Know-how, Madras (IIT-M), have developed 3D-printed face implants for sufferers affected by Mucormycosis, a uncommon however lethal an infection also called Black Fungus. 

This an infection has been reported in sufferers affected by uncontrolled diabetes, HIV/AIDS, and different medical circumstances as much as the very latest COVID-19. 

Based on this description within the Journal of Pure and Utilized Microbiology, “In 1885, the German pathologist Paltauf, reported the primary case of Mucormycosis and described it as Mycosis Mucorina. Throughout [the] Eighties and Nineteen Nineties Mucormycosis was more and more seen amongst immunocompromised people.”  The time period Mucormycosis, nonetheless, was first coined by American pathologist RD Baker within the Nineteen Fifties. 

The workforce at IIT-M has joined palms with ZorioX Innovation Labs, a Chennai-based medical tools manufacturing startup, to organise round 65 implants for sufferers from economically-weaker sections. This initiative relies on metallic 3D printing or additive manufacturing.

The Higher India sits down with the minds behind this considerate enterprise to grasp its scope in depth.

Risks of the lethal black fungus

Based on an August 2023 paper printed within the Journal of Medical Mycology by Gregoire Pasquier, “Mucormycosis is a uncommon opportunistic an infection brought on by a filamentous fungus belonging to the Mucorales order…The prognosis is tough and consequently, it’s typically delayed, leading to excessive lethality regardless of acceptable antifungal and surgical remedy.”

In India, the second wave of the COVID-19 pandemic in 2021 led to an upsurge in mucormycosis instances often called Covid-19-associated mucormycosis or CAM. 

“Indian media, based mostly on statements by members of the Indian authorities, reported 11,717 CAM instances on Might 25, 28,252 CAM instances on June 7, 45,274 CAM instances (together with 4332 deaths) on July 20, and 51,775 CAM instances on November 29, 2021,” notes Pasquier. 

“These exact information had been out there as a result of on Might 20, 2021, mucormycosis grew to become a notifiable illness underneath the Epidemic Illnesses Act 1897. Earlier than this epidemic, mucormycosis was thought of a uncommon opportunistic an infection,” he provides.  

A very devastating impact of this illness is the lack of facial options which may have a debilitating impact on a affected person’s psychological well being. The fungus answerable for mucormycosis can invade the tissues of the face, inflicting necrosis and disfigurement. In extreme instances, sufferers can lose their eyes, nostril, and even their total face. The lack of these very important organs can severely impression a affected person’s skill to carry out primary capabilities like respiratory, consuming, and speaking.  

Team behind face implants for black fungus patients
Dr Murugaiyan Amirthalingam (L) of IIT Madras with the workforce that works on 3D-printed face implants

Options present in 3D implants

One viable answer is reconstructive surgical procedure for sufferers who’ve misplaced their facial options as a result of this debilitating illness. As an in depth press launch issued by IIT-M final month states, 

“These procedures contain the reconstruction of the nostril, eyes, and different facial constructions utilizing a wide range of methods, reminiscent of pores and skin grafts, tissue growth, and microvascular surgical procedure.”

“These procedures may also help restore the affected person’s look and performance, permitting them to guide a extra regular life. Nonetheless, patient-specific implants and procedures are costly, rendering them inaccessible for individuals from weaker sections,” the discharge provides.  

Chatting with The Higher India, Dr Karthik Balaji, a maxillofacial surgeon and CEO of ZorioX remembers, “In faculty, I delved into exploring superior methods for changing facial constructions. Witnessing the complexities and limitations of current strategies fueled my dedication to discover a extra environment friendly and patient-friendly method.” 

He continues, “The combination of 3D printing know-how emerged as a promising answer, providing exact and customised implants that streamline the reconstruction course of, cut back surgical time, and alleviate the necessity for a number of procedures.”

Explaining the method, he says, “In typical reconstructive surgical procedure, we take bones from legs, hips, or ribs and reconstruct the face. This needs to be adopted by a microvascular surgical procedure which may take so long as 18 hours. To repair these bones, we use a plate that’s going contained in the physique. As a medical researcher, I used to be engaged on discovering methods to develop a plate within the form of the facial bone, repair the issue, and keep away from microvascular surgical procedure, thus decreasing the time taken for surgical procedure.”

Fortunately, 3D-printing know-how got here to be. With the introduction of 3D-printing know-how, Dr Balaji claims that they’ve decreased surgical time from 18 hours to 2 hours. 

“We don’t use bones from one other a part of the physique now. As an alternative, we are going to use this titanium 3D-printed implant which is biocompatible. Not like typical reconstructive surgical procedure, which permits sufferers to eat solely two years after, adopted by one other surgical procedure; in using 3D-printed implants, we solely want one surgical procedure and the affected person can eat inside a month. In different phrases, these 3D-printed implants enable sufferers to return to regular life quite a bit sooner,” he explains.

Solutions to black fungus in face implants
Dr Murugaiyan Amirthalingam (L) and a workforce member with a 3D-printed face implant

The important thing variations between typical reconstructive surgical procedure and using IIT-M’s 3D-printed customised implants lie in precision, effectivity, and the general affected person expertise. 

Dr Balaji explains, “In typical reconstructive surgical procedure, the method typically begins from surgical removing of facial bones and reconstruction of these defects with using bone grafting methods; this provides complexity to the process and is very technique-sensitive. Over these grafts, conventionally made implants have to be positioned and that incurs further burden to the affected person barring the process.”

Dr Murugaiyan Amirthalingam, affiliate professor on the Division of Metallurgical and Supplies Engineering, IIT-Madras explains, “Quite the opposite, our 3D-printed {custom} implants supply a extra tailor-made and exact answer. The implants are created based mostly on detailed scans of the affected person’s anatomy making certain an actual match, post-removal of facial bones. This stage of customisation not solely enhances the aesthetic consequence but additionally contributes to a extra environment friendly surgical course of. The usage of 3D printing know-how permits for intricate designs that match the affected person’s distinctive facial options, leading to improved performance.” 

As Dr Amirthalingam goes on to clarify, “The motivation behind growing 3D-printed face implants stemmed from the challenges confronted in typical methods of facial reconstruction. We’ve got developed a technique for using 3D printing to design and manufacture distinctive custom-designed elements for numerous biomedical and engineering purposes. When the COVID-19 pandemic arose and the variety of black fungus instances elevated, surgeons approached us with potential options to develop patient-specific implants utilizing 3D printing. We may instantly assist them because the know-how was already developed in our lab.”

When Dr Balaji and his colleagues began these procedures initially, they needed to import the [3D-printed] implants from the Netherlands or the US. “The price of a single implant was round Rs 24 lakh. Working with numerous engineering establishments, we developed the requisite amenities and software program to develop these implants, and IIT-Madras started serving to us manufacture them. After bringing all the mandatory amenities to India, the price of the implant fell from Rs 24 lakh to Rs 8 lakh,” he says.

Black Fungus Innovation for face implants
Dr Karthik Balaji (R) of Zoriox Innovation Lab presenting an MOU with IIT Madras to develop 3D-printed face implants

How does it work?

Dr Amirthalingam says, “Utilizing distinctive in-house algorithms, a affected person’s MRI/CT information is transformed to printable CAD (computer-aided design) format, and {custom} implants are printed from medical-grade titanium utilizing an indigenously-built laser powder mattress facility in IIT-M. Intensive analysis actions are already being carried out in IIT Madras to commercialise this know-how for printing patient-specific implants in stainless-steel, Ti-6Al-4V, and Co-Cr-Mo alloys.”

Curiously, the IIT-Madras workforce can print the implant precisely to match the affected person’s face. 

“What units our method aside is the flexibility to custom-design and print implants that exactly match a affected person’s distinctive facial anatomy. Historically, reconstructive surgeons depend on pre-fabricated implants, that are akin to off-the-rack clothes. They may match considerably, however hardly ever completely, and in addition require further alterations to sufferers’ bone constructions. 3D printing permits us to turn out to be bespoke craftsmen, crafting implants which are the precise measurement and form of the lacking facial bone. We use CT scans or MRIs of the affected person on to create an in depth 3D digital mannequin of the affected person’s face. Consider it as a high-resolution image, however as a substitute of simply depth, it captures the intricate contours and inner constructions of the lacking bone,” he says. 

Subsequent comes the magic of CAD. “Our expert analysis students and Zoriox workforce take the medical picture information and, utilizing specialised algorithms, remodel it right into a digital blueprint for the implant. This blueprint, known as a CAD STL (stereolithography) file, basically tells the 3D printer precisely learn how to construct the implant, layer by layer, mimicking the affected person’s distinctive facial options,” he says. 

“As soon as the CAD STL file is prepared, the 3D printer takes centre stage. Think about a high-tech sculpting machine that makes use of medical-grade titanium powder to meticulously construct the implant, following the exact directions within the CAD STL file. Layer by layer, the lacking bone construction involves life, completely customised for the affected person,” he provides.

A big hurdle was the preliminary capital expenditure price related to buying and implementing 3D printing know-how. One other problem concerned making certain a dependable provide of titanium, the chosen materials for the implants. Most medical grade 3D-printable titanium powders had been imported which elevated the price of the implants manyfold. 

“We had then collaborated with an Indian provider to assist produce medical-grade titanium powders. Intensive testing was carried out in our lab to qualify the uncooked materials produced by the Indian vendor for medical implant manufacturing,” explains Dr Amirthalingam.

“Subsequently, cautious useful resource planning helped safe a constant procurement of high-quality, biocompatible titanium appropriate for facial implants. Establishing correct parameters for 3D printing was a vital step in attaining the specified precision. Our workforce of consultants in additive manufacturing fine-tuned the printing parameters, making certain that the implants met stringent high quality requirements and conformed exactly to the affected person’s anatomy,” he provides.

However as Dr Balaji explains, “No undertaking like that is full with out the invaluable enter of the surgeons. Their in depth expertise and meticulous suggestions guided each step of the method, from preliminary design to post-operative care. This synergistic collaboration between engineers, designers, and surgeons was the cornerstone of our success.”

Black Fungus patients need 3D-printed face implants
Dr. Murugaiyan Amirthalingam with the 3D Printer used for printing Face Implants

#Right2Face Initiative 

Dr Amirthalingam, says, “Our collaboration with Zoriox started in 2021, pushed by a shared imaginative and prescient to revolutionise maxillofacial [relating to jaws and face] implants by way of 3D printing know-how.” 

As he explains, “Initially, our efforts centered on addressing key technical challenges related to these novel implants specifically:

  • Floor end: Optimising the implant floor to advertise tissue integration and minimise bacterial adhesion. 
  • Machinability: Streamlining the manufacturing course of for improved effectivity and price discount.
  • Osseointegration: Enhancing bone ingrowth and long-term implant stability.”

Via collaborative analysis and improvement, they’ve made vital progress in these areas, paving the way in which for extra dependable and useful 3D-printed implants.

As their technical developments matured, the main target shifted to broader societal impression. In 2023, the trouble blossomed into the Right2Face motion, pushed by the next aims:

  • Elevating consciousness: Educating the general public and medical group in regards to the transformative potential of 3D-printed maxillofacial implants.
  • Requirements improvement: Contributing to the institution of sturdy high quality and security requirements for these progressive implants.
  • Materials exploration: Researching and growing new biocompatible supplies that additional improve implant efficiency and affordability.
  • Improved surgical outcomes: Collaborating with surgeons to refine surgical methods and optimise affected person outcomes with 3D-printed implants.

To avoid wasting the lives of a affected person, loads of facial bones needed to be eliminated. These sufferers are largely breadwinners of the household and at the moment are confined inside 4 partitions due to their facial deformity. The #Right2face motion is aimed to assist these needy sufferers in affiliation with oral and maxillofacial surgeons to revive their faces and “give them again their smile”.  

Dr Karthik Balaji (R) presenting the #Right2Face initiative in entrance of stalwarts of facial reconstruction surgical procedure

Based on the press launch, “IIT Madras researchers are additionally figuring out sufferers who can not afford pricey imported implants and giving these implants freed from price underneath the marketing campaign known as #Right2Face.”

This marketing campaign was began by a bunch of maxillofacial surgeons together with Dr Balaji final yr. This group started by working with dental schools the place maxillofacial surgical procedures had been performed. They began working with state-funded dental schools in Chennai, Cuddalore, and different such schools in Tamil Nadu and Telangana the place they’d discover sufferers from economically weaker sections who wanted these implants. 

“IIT-Madras additionally got here to assist us with this initiative. We additionally labored with native nonprofits to boost some funds for these instances. It started with two or three instances after which IIT-Madras got here in to assist us with the implants. Earlier than these procedures, we conduct one-on-one interviews with these sufferers, following which we receive a letter from their medical doctors saying that they can’t afford these procedures and need assistance. After this letter, we verify the ration card of the affected person (if it’s out there) to verify their credibility after which we proceed with the implants,” says Dr Balaji. 

“As a industrial entity, now we have accomplished virtually 450 implants. Underneath #Right2Face the place sufferers couldn’t afford these procedures, now we have performed 47 instances and in about 18 instances or so sufferers had been in a position to shell out some cash however not sufficient to cowl the process. Medical schools are additionally serving to us in waiving prices for sufferers,” he provides.  

One such beneficiary of this initiative is a 63-year-old vegetable vendor from Coimbatore who needs to stay nameless. Residing with a spouse and 4 daughters, issues had been okay until the primary lockdown. Making issues worse, he examined constructive for COVID-19 and was contaminated by black fungus.

“After the lockdown, I used to be affected by black fungus due to which medical doctors needed to take away my higher jaw. Eager to resume work after the lockdown, I heard about facial reconstruction surgical procedure and a physician in Madurai who may carry out it. Once I reached Madurai, I approached Dr S Suraj (a maxillofacial surgeon) for assist,” he remembers.

Dr Suraj then referred his case to the Zoriox workforce, and either side agreed on growing 3D-printed patient-specific face implants.

“It [the procedure] was costly, and I couldn’t afford it. However underneath this [#Right2Face] initiative, they equipped the implant to me [free of cost]. Dr Suraj did the surgical procedure, positioned the implant inside, and reconstructed my higher jaw, and I received my denture inside one month. Now, I can eat correctly and keep on with my on a regular basis routine. I’d wish to sincerely thank Dr Suraj, Zoriox, and IIT-Madras for serving to me, ” he provides.

Wanting forward, they’re planning to assist as many as sufferers who require these face implants. 

“Official information exhibits not less than 60,000 persons are affected by post-black fungus facial deformities. We’re approaching numerous companies for CSR (Company Social Accountability) funding and reaching out to different funding our bodies. To date, we may handle utilizing the prevailing funding from IIT Madras and CSR in-kind contributions from the hospitals. Nonetheless, by way of The Higher India, we’re reaching out to your readers to assist us,” says Dr Balaji. 

(Edited by Padmashree Pande; Photos courtesy IIT-Madras and Dr Karthik Balaji/LinkedIn)

(If you wish to contribute to this initiative, please click on right here.)

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