Projects

Completed Projects

 

Medical devices developed at BETiC and licensed to start-up companies, manufacturers or NGO; given to hospitals for clinical studies; and being taken forward for production and supply are described in this chapter. This includes 16 products in three categories:

  • Diagnosis,screening& monitoring (low-risk devices): smart stethoscope, Clubfoot brace monitor, diabetic foot screener, Endotracheal tube obstruction monitor glaucoma screener, biopsy gun.
  • Surgical instruments & software (low-medium risk): surgery planner, laparoscopy instrument, aortic valve template, nasal osteotomy forceps, surgery guides, skin gun.
  • Prostheses, orthoses &implants (medium-high risk): prosthetic leg, fracture splint, silicone implants, bone scaffold implant, compression screw, cleft palate impression tray.

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Medical products developed at BETiC IITB, VNIT and COEP

 

Endotracheal Tube Monitor

 

Endotracheal tube obstruction monitor device is a non-invasive device, which can be easily connected in between the endotracheal tube, and mechanical ventilator by using specially designed ‘junction connector’. Endotracheal tube gets obstruct due to internal secretion of human body and resulting into the serious injury to human or leads to death. This proposed device will help to detect the obstruction occurs/present in the tube at early stage. Presently clinicians observe the behaviour of mechanical ventilator to detect the obstruction and most of the time obstruct detection occurs when it reaches to last level.

Clinical Need Definition: Intubation is a regular practice in the intensive care unit, it is not new that patient has lost their lives due to obstruction occurs in endotracheal tube. Clinicians are always try to detect the obstruction in the endotracheal tube using few traditional methods as discuss above. However, none of them is producing accurate results so it is very difficult to detect obstruction in endotracheal tube. To put the new endotracheal tube inside the human body through mouth is also one of the challenging task in intensive care unit and needs very skilled hand to perform intubation. It is very important to make a device which will detect the endotracheal tube obstruction at early level. This will saves the many lives.

 

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L-R: CAD Model of device, Testing with AMBU bag

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L-R: Discussion with Dr. Kadam and Dr. Sonali Salvi, Device Prototype

 

Device Development: Dr. Sonali Salvi from B.j Medical and Sassoon General Hospital Pune and Dr. Sandeep Anasane BETiC-COEPmentored this project. Aimimg to make a device which will monitor and detect the obstruction present in the endotracheal tube of any size.

Values and Benefits

  1. Continuous Feedback: This device continuously provides information related to endotracheal tube obstruction.Real-Time MonitoringInformation is in real-time to assist clinicians in better monitoring their patients.
  2. Actionable Information:This device provides detailed information regarding endotracheal obstruction to clinicians to improve the care of intubated patients.
  3. Easy to Use and low cost:This device will have, easy-to-use interface displays, graphics, alarm configurations, wireless communication with other system and user instructions help clinicians easily learns how to use proposed device.
  4. Compact and Complete:This device is a small handheld, portable device which will work with all major mechanical ventilation systems and any brand of endotracheal tube.
  5. Potential Improvement in Quality of Care: Preliminaryexperiments demonstrates efficacy in providing direct, precise, real-time monitoring of endotracheal tube obstructions, which may also result in improved patient safety and quality of care.

Mr. Abhijeet Bhagat, who is involved in this project right from inception of this device, the device has won Biotechnology Ignition grant (BIG) of Rs.50.00 Lakh for startup. Recently he has registered Atmen Technovention Pvt. Ltd., health care device domain startup.

 

 Skin Gun

 

In India, over one million peopleget burnt every year. The most common treatment for severe burns is by grafting of skin tissue taken from another area of patient’s body. The procedure is painful, prone to complications and slow-to-heal. There is a need for better utilization of tissue taken from donor site and reduce hospitalization time of patients.

Clinical Need Definition: For patients with major burns, who have limited donor site area, an epidermal spray or skin gun is used. A small strip of skin is harvested, minced, added to saline fluid and sprayed over the burn area. The skin pieces act as seeds for new skin to grow and cover the wound area. In consultation with Dr. Nikhil Panse and Dr.RohitPhulwar, B.J. Medical College, BETiC-COEP researchers SaiprasadPoyarekar and ChetanMahale guided by Dr. Sandeep Anasane and Prof.B.B. Ahuja defined the need as “hand-driven spray gun for controlled uniform distribution of skin tissue pieces”.

 

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Left- Skin graft and spraying. Right- Proposed concept of device

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Left- Prototype device with electronics. Right- Dr. Nikhil Panse with BETiC-COEP team

 

Device Development: The proof-of-concept used controlled flow of compressed air mixed with a solution containing skin minced graft cells and released on burn areas. The proof-of-concept was tested with pieces of paper, glitter plastic and chicken skin and achieved 1:15 expansion ratio. Therewere difficulties in spraying skin over large burn area due to its stickiness and own weight. An easily detachable and auto-clavable stirrer mechanism was designedto maintain uniform solution of skin pieces and saline. The flow of skin is controlled by electronics systems. The team is working on a light-weight functional prototype with electronically controlled valves to provide the desired specificity and sensitivity. Pre-clinical trials and clinical trials are planned at B.J. Medical College, Pune.

Mr. Saiprasad Poyarekar, who is involved in this project right from inception of this device, the device has won Biotechnology Ignition grant (BIG) of Rs.50.00 Lakh for startup. Recently he started Pacify Medical Technologies Pvt. Ltd., health care device domain startup.

 

On-going Projects

 

In the last four years, BETiC team members have identified nearly 400 unmet clinical needs during visits to hospitals and discucssions with clinicians. These were short-listd based on the size of local market, innovation potential, manufacturability and availability of clinical guidance. Some of the short-listed problems were given to students and participants of innovation training workshops and are described in the next chapter. The projects taken forward in BETiC IITB, COEP and VNIT by full-time researchers, and are still under development or put on hold for any reason are briefly described here.

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The devices are grouped in three categories as follows:

  • Diagnosis, screening & monitoring: Stroke Detection, Wireless ECG Patch, Pulse-Based Diagnostics, Pulmonary OAD Screener, Trachea Blockage Detector, Haemoglobin Quantifier.
  • Surgical instruments& tools: Modular Laparoscopy Heads, Endo Retractor, Surgery Forceps, Skin Gun.
  • Prostheses, orthoses &implants: Smart Acupressure Glove, Dialysis Cuff and Suture Anchor.

 

Endoscope Insertion and Fixation

 

Back pain is the 2nd most common complaint in the country. Every person suffers from back pain at least once in his lifetime. Medicines have limited or no roles in treating back pain and medicines have a lot of side effects on the heart, Kidney and entire body.

Spine surgery is one of the solutions. However, Open spine surgery is risky and complications are high. Hence endoscopic spine surgery is one of the best options. It is very safe and can be done under local anesthesia. Patient can be discharged on the same day. However endoscopic spine surgery has a high learning curve. Hence many orthopaedic surgeons, spine surgeons, neurosurgeons and pain physicians tend to avoid this procedure.

Clinical Need Definition: Insertion of guide wire is the first and most important step in performing this surgery. If the guide wire is inserted properly the surgery can be performed easily and it need to hit the target in first iteration only to avoid any trauma.

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Demo of sergery

Device Development: Dr. Dinesh Kabre shared an initial design concept with BETiC-COEP team to meet the clinical need. Dr. Sandeep Anasane, Swapnil Bukshete, Hemant Pawar, Dipak Chaudhary and Abhijeet Bhagat had attended live surgery to understand the need and requirements. The developed instrument helps in proper insertion of guide wire in standardized manner. Fixation of endoscope by this instrument helps the surgeon to use both his hands freely; surgical precision increases. The same instrument can be used for giving root blocks and pain management in the lumbar region.

 

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ProPrototype Discussion with Dr. Dinesh Kabre and BETiC-COEP Team

This instrument will enable all Orthopaedic, Spine and Neurosurgeons to perform lumbar endoscopic spine surgery in a faster, precise and safer way. It will enable all Pain Physicians to give lumbar root blocks in an easy and safe way on Out Patient Basis.

The functional prototype of the device has been developed under Biomedical Engineering technology incubation centre at Department of Production engineering and Industrial management, College of engineering Pune.

Monopolar Hook

The principle of electrosurgery revolve around the fact that human tissue introduced into an incomplete circuit will conduct current, there-fore closing the circuit and resulting heating of the tissue. There are two types of electrosurgeries monopolar and biopolar. Here we are targeting the device which will helpful in performing monopolar electrocautery surgery. Due to the traditional monopolar hook there are chances of mechanical and thermal injuries during operation, also efforts (Mechanical forces) required by surgeon to perform monopolar electrocautery are more.

Clinical need definition: these days clinician faces many problem In performing laproscopic surgery due unavailability of smart and effective instruments. After interacting and interviewing with Dr. Dasmit Singh, Pediatric laproscopic Surgen, he provides his clinical inputs to improve current instruments used in monopolar electrocautery. Device needs are listed below

  • The device should minimise mechanical and thermal injuries during surgery.
  • Mechanical forces required during operation should be reduced.
  • Current should stop flowing through circuit at the instant, instrument leaves the tissue.
  • Flexibility in shape and size of consumables.
  • Instrument should be low cost as compared to current available methods.

Device development: Mr. Sandesh Patil is involved in device from inception of the problem statement, which is given by the Dr. Dasmit Singh. During MEDIC2018 which is held at IIT Bombay he has developed working proof of concept of the above described problem. After discussing with BETiC-COEP team some initial design sketches are made.

Currently he is working on designing and CAD model of the proposed solution after that will fabricate new prototype. After fabricating the prototype, we will validate the same with Dr. Dasmit Singh for any further modifications if needed. This solution will surely solve the clinical need.