Non-surgical percutaneous closure of Atrial Septal Defects by using an occluder device. The device seals the septal defect separating the Left atrium from the right atrium, with a novel hubless left atrial flange.

Atrial septal defect is a congenital heart defect which is closed percutaneously using nitinol based double umbrella devices. Incidence of major congenital heart disease is approximately 8 per 1000 live births. A good number of these defects close spontaneously, but close to half require closure by surgery or non-surgical methods. A large number of patients with ASD undergo device closure using nitinol based double umbrella devices.

The device has two components:

The frame has two lobes of which one expands in left atrium and the other in the right atrium thus occluding the septal defect. The device is introduced/implanted using a catheter. The occluder fabric interacts with blood and forms a clotted layer within the fabric which seals the septum.

The following processes are standardized :

Flow diversion is an endovascular technique whereby the device is placed in the parent blood vessel to divert blood flow away from the aneurysm. It has been designed to disrupt flow into the aneurysm thereby leading to the thrombosis (clotting) of the aneurysm and its healing. It incorporates a novel design with improved kink resistance and radial strength.

Flow diverter stents are used to treat cerebral aneurysms. The goal of aneurysm treatment is reconstruction of the parent artery with exclusion of aneurysm from circulation. The rationale for the development of flow diverter was the need for effective treatment of a portion of complex cerebral aneurysms that are not effectively treatable by the current endovascular techniques or surgery. The flow diverting stent has been designed to disrupt flow into the aneurysm thereby promoting thrombosis of the aneurysm and preserving the luminal patency.

The material used is superelastic Nitinol that allows the device to be crimped to low diameters to aid delivery via microcatheters, and allow deployment to the required size and shape at the site of implantation. Thin strands are braided to form a tightly knit mesh which reduces blood flow into the aneurysm while preserving normal flow in the vessel lumen.

The following processes are standardized :

Blood pump technology for Extracorporeal Cardiopulmonary Bypass for establishing blood circulation during open heart surgeries or surgeries requiring stopping of the heart.

The device is intended to be used for replacing the function of natural heart for 6 to 8 hours, during Cardiopulmonary bypass surgical procedure.

The device has a disposable pump head and a reusable drive unit . It has lower blood damage levels compared to conventional roller pumps. The pump head is magnetically coupled to the motor, which provides mechanical energy to rotate the impeller. The centrifugal pumping system has a detachable motor and drive unit. Thus the pump and motor can be kept very near to the patient, reducing the priming volume. Drive unit monitors the rotational speed and performance of the system.

1.   Disposable Bloodpump Head

2.   Reusable blood pump drive controller

3.   Electromagnetic Blood flow meter – available as a separate technology.

Wound dressing with antioxidant properties for in situ application of antibiotics aimed at chronic non healing wounds.

Healing of chronic wounds is a major problem of concern especially in cases of diabetic and pressure ulcers. Systemic delivery of antibiotics may not be effective in these cases. For delivery of antibiotics at the wound site an ideal dressing is required which can deliver the antibiotics in a controlled but effective manner at the wound site.

The product is an advanced wound care material (primary dressing) meant for managing chronic non-healing wounds with the following features:

The following stages have been completed

The technology is related to local delivery of antibiotics in bone diseases using resorbable bioactive grafts in the shape of beads.

Bone and joint infections (Osteomyelitis) remain the disturbing complications of orthopedic surgery. It is difficult to control the bone infection through systemic antibiotic infusion because of low blood supply in hard tissue. Current method for local antibiotic delivery in bone is to use drug-loaded PMMA cement, which requires surgical removal after the delivery. This technology offers a resorbable matrix that obviates surgical removal.

Ceramic beads with micro to nano graded porosities have been designed for on site loading of antibiotics.

The following stages have been completed

Patent filed

The technology is related to intervertebral fusion devices for spinal fusion surgery.

The degeneration of inter-vertebral discs, especially in the lumbar area, often causes crippling pain. To manage the condition, the vertebral motion segment is immobilized surgically.Pain relief is achieved by fusing the unstable portion of the spine. The inter-vertebral fusion devices like titanium spacers and cages are used as supporting system for bone grafting to achieve better stability. Coated fusion device is an innovation in which the metallic surface is modified with a bioactive coating so that the spacer/ cage will get attached with host bone and adds to the stability.

Titanium inter-vertebral spacer-cages coatedwith bioactive material on the surface.

The following stages have been completed

Indian Patent filed –Application No. 201841042752, filed on 14/11/2018
Title:“An Inter Vertebral Spacer with Protracting Pin Mechanism”.

Fibrin as sealants during surgical procedures.
Albumin and immunoglobulin for therapy in cases where blood volume loss happens, liver diseases and cancer.

Fibrin Sealants is a two component system for use as hemostats, tissue sealants, and tissue adhesives.
Albumin is used as a replacement therapy in cases where blood volume loss happens, liver diseases and cancer.Two main uses for IVIG are as replacement therapy in primary or acquired antibody deficiency disorders and as immuno-modulatory agents in patients with autoimmune or inflammatory conditions.

All three products are listed in Indian/European/US pharmacopoeia and has similar specifications.

Patent: Indian patent applied:

For wound healing application. Alginate scaffold incorporated with growth factor allows excellent healing of exudating wounds.

The wound healing process is highly complex because of the intricate interactions between highly regulated factors to restore injured skin. In superficial wounds these events occur normally; however, if patients are suffering from conditions such as diabetes or severe burn, there will be considerable delay in the healing process resulting in chronic or non-healing wounds.

Scaffold: Alginate has been modified to form the shape of the wound to allow proper contact of growth factors to the surface. The scaffold can be easily removed without disturbing the wound.
Growth factors: Two human recombinant growth factors – VEGF and TGF-alpha have been developed and tested for cytotoxicity, sterility, and wound healing property in animal models

Indian patent application filed for both TGF and VEGF.

Biodegradable skin substitute with biomimetic human extracellular matrix (ECM) components for wound regeneration. The product is made from polymer of L-lactic acid, L-glycolic acid & ξ-caprolactone combined with modified composition of pharmacopoeia grade Fibrin Sealant enriched with highly pure human hyaluronic acid.

Suture-less one-time application on fresh wounds or surgically debrided wounds for promoting regeneration of dermal tissue and epithelialization is indented. The lyophilized PLGCFIBHA adheres to debrided wound through the hemostatic mechanism and subsequently breaks down during the healing process.

SCTPLGCFIBHA2016 is an innovative skin substitute indicated for the treatment of dermal and epidermal wounds. This product is a combination of: (i) synthetic polymer and (ii) human extracellular matrix (ECM) components. The synthetic compartment of the product is biodegradable polymer, developed using FDA approved monomers such as L-lactide, L-glycolide and ε-caprolactone. The synthesized polymer is electrospun to mats of required size and is embedded in modified composition of pharmacopoeia grade Fibrin Sealant enriched with highly pure human hyaluronic acid. Synthetic polymer and biopolymers are proven to degrade by physiological mechanisms upon implantation and the resultant molecules are cleared through natural processes and are non-toxic to body Safety and efficacy of the product has been demonstrated in experimental animals for use as soft tissue substitute.

Indian patent filed
Development of a biodegradable and biomimetic hybrid scaffold using synthetic PLGC teripolymer and biopolymer for tissue engineering

To improve venous circulation in the limbs of patients suffering from Deep Vein Thrombosis (DVT)

DVT occurs when blood clots (thrombus) form in one or more of the deep veins in the body, usually in legs. Deep vein thrombosis (DVT) is a serious disorder with an estimated annual incidence of 1 per 1,000 persons per year and a lifetime incidence of 2% to 5%.The major outcomes include mortality, thromboembolism and bleeding.

This equipment has an array of air pockets , placed inside a cuff, which are provided with closed loop monitoring of pressure levels in each air pocket and controlled by employing pneumatic valves driven by a microcontroller. The operation of the air pump is made efficient and its longevity is ensured by controlling the timing chains of air pocket inflation and deflation. Also the device has its pressure level programmable at every point time over the cuffs so that a physician can change pressure levels of cuffs to adjust the patient needs .Device is also equipped with 2 user selectable programs to work so that a patient can operate it from home. Device can also be provided with a power supply back up to serve in case of power failure for longer runs. The cuff used along with is meant to be of disposable single patient user type. The device can be made in compatible to different cuff available in market or with a specified cuff with the instrument.

Indian patent filed

For measurement of flow of blood and other priming fluids in an extracorporeal circuit during cardiac bypass surgeries.

The measurement and analysis of any conductive fluid, more particularly the measurement of flow of blood and other priming fluids in an extracorporeal circuit during cardiac bypass surgeries is essential. A compact device that would have high immunity to external noises, drift and eliminate the DC offset due to polarization would prove advantageous with respect to safety and performance.

Aminiature novel magnetic flow meter with biocompatibledisposable sensor to measure flow rate of blood and other conductive fluids used in bypass surgeries and other similar applications is developed.The specification is given below:

Patents Applied

An infrared based infant warmer bassinet with over the head and under the bed warming.

Premature babies born with low birth weight are subjected to high temperature loss and may even die if the ambient temperature is not maintained at the core body temperature requirement of 370C. Hence such new-born babies are kept in an incubator or radiant warmer, which warms the environment to compensate for temperature loss and improve weight gain. However, these warmers consume very high power and liberates intense heat energy to regulate the baby bed temperature. The warming units are kept very high for safety concerns and lacks under the bed warming. The baby needs to be shifted in position to attain all around warming. These radiant warmers are exorbitantly costly and are devised to be work in super specialty centres which could only be afforded by a small group of people in our country.

Annovel infant warming bassinet is developed which consumes less electrical power and provides over the head and under the bed warming.

Patent Filed: An improved Portable bassinet with controlled infrared warming facility for thermo regulation of low birth weight infants to achieve faster weight recovery and a method for the same.
Patent application No 5557/CHE/2015

A battery operated portable Infant Warming Wrapper to maintain physiological temperature for preterm born babies with low birth weight to prevent onset of hypothermia. The device is transportable and warms while carried by the caretaker.

Premature babies born with low birth weight are subjected to high temperature loss and may even die if the ambient temperature is not maintained at the core body temperature requirement of 370C. Hence such new-born babies are kept in a warm environment to compensate for temperature loss and improve weight gain. Present technologies for warming infants can be used only on a specialty care centre in a hospital under the strict supervision of a technician. These radiant warmers require few hundreds of watts of electrical power and uses intense radiation, which may damage skin and eyes of baby. They are bulky, designed primarily for hospital NICUs and have limited portability. The accessibility of common man to a warmer is limited due to its high cost and unavailability in small hospitals especially in developing countries and underdeveloped countries. Also, these warmers are not transportable and cannot operate in home conditions.

A portable and disposable baby warming wrapper is developed which provides non-contact warming of premature born babies with low birth weight using infrared energy while at hospital/home or during transportation.


Other features include:

Patent filed - An improved portable infant warming device having radiant non-contact warming infrared light emitting diodes for providing a uniform warm environment around a premature born baby.
Patent application No 2918/CHE/2015

Non-contact bulk warming of blood and intravenous fluids using distributed low power infrared light with inline temperature drop compensation.

Even though Hypothermia is most common in patients who are exposed to a cold environment, it can develop secondary toxin exposure, metabolic derangements, infections, and dysfunction of the central nervous and endocrine systems. Fluid warming is a method of raising the temperature of fluids administered to a patient to maintain normal body temperature and prevent hypothermia.

A blood and IV fluid warming system suitable for slow as well as massive transfusion of blood and IV fluids using infrared radiations emitted from distributed low power IR LEDs. The system consists of a blood bag warming chamber and an inline IV tube warming cartridge connected to a power controller. For massive transfusion, blood bag can be placed inside the bag warming chamber and the IV tube is passed through the small cartridge before connecting to the patient. A standard intravenous administrationset is used without any additional disposable components.
Specification:

As dura substitute for neurosurgical application.

Dura substitute is used for providing safe and effective fluid-tight barrier against CSF leakage following dural repair in cranial and spinal procedure. This product is derived form glutaraldehyde processed porcine pericardium which is rendered non-toxic and biocompatible. It has required suppleness and mechanical strength for this application

Glutaraldehyde treated porcine pericardium for dura substitute application.