Project: SAFE SHUNT FLOW CONTROL TECHNOLOGY

The kidneys are the primary organs responsible for waste removal. Chronic renal failure (kidney failure) results in an inability to filter the blood and remove waste substances. The most common treatment for chronic renal failure is Hemodialysis, using a dialysis machine that replaces the failing kidneys._x000D__x000D_Today over 1.6 million patients globally undergo chronic Hemodialysis each year as treatment for renal failure (350.000 in the United States alone). The total Medicare expenditures for Hemodialysis in the U.S. totaled nearly $17,6 billion in 2007. Worldwide, the kidney dialysis and dialysis equipment market approached $55 billion in 2007._x000D__x000D_Effective Hemodialysis entails the filtering of large volumes of blood and necessitates a connection of the dialysis machine to the subject's circulatory system. The primary method used to gain access to the blood is via an arteriovenous (AV) synthetic or native shunt created in the forearm, that connects an artery to a vein to create an access site to remove blood from the patient and to return it after dialysis._x000D__x000D_This shunt is accompanied by numerous complications, including ischemia, steal syndrome, thrombosis, stenosis, aneurysm formation, intimal hyperplasia, heart failure and others. While some attempts to create access systems have been made, no system is commonly used nor standardized so far, because the use of these systems result in significant flow turbulence, contributing to these complications._x000D__x000D_An ideal hemodynamic access system, which is controllable and reduces flow and pressure without causing blood flow turbulence, has not as yet been identified. As a result Hemodialysis vascular access (fistulas) is the single most important cause of morbidity in Hemodialysis population and is responsible for 20% of all hospitalization of end stage renal patients, as well as 80% of all vascular dysfunctions (Hyperplasia or buildup of fibrin). Moreover, most Hemodialysis fistulas need replacing within thirteen months at an average cost of $25.000 per surgical procedure. There are roughly 300,000 junctions (shunts) made in the US (E.U. 200,000) annually, and this number is growing by 5% each year._x000D__x000D_The consortium aims to develop a ‘Safe Shunt flow Control Technology’ that will significantly decrease the need for repeated surgical procedures to replace failing shunts, because SSCT considerably reduces the complications that are COly related to permanent high blood flow and pressure developing in the draining vein between treatments and leading to intimal hyperplasia._x000D_Besides major cost and medical benefits, as a result SSCT will reduce the amount of pain to suffer by Hemodialysis patients extensively and will truly improve their quality of life._x000D__x000D_The technology to be developed consists of an one-time surgical implanted device positioned around the shunt (only a small additional step when the shunt is surgically being created) and a wireless operating system which together control and regulate blood flow and pressure. This technology aims to eliminate blood flow turbulences, physical stress and stagnation points, using an innovative but reliable control principle._x000D__x000D_The Consortium consists of 2 international orientated, R&D driven SME’s. The Dutch SME is specialized in development, production and sales of flow control systems for medical and industrial applications. The other participant is an Israelian SME with a large experience in the field of research and development of medical devices. This team is completed by a Board of 4 scientific renowned experts. For research and testing purposes, two University Medical Centers and two specialized Research Centers will contribute to the project on a subcontractor basis._x000D__x000D_Parallel to the research and development process the consortium will develop a marketing and distribution strategy which concerns a successively global approach, engaging health insurance companies, medical specialist groups and renal patient organizations._x000D__x000D_A controllable flow regulator activated externally has a hugh potential of many additional clinical applications in Cardiology, blood flow and pressure control systems as well as in Urology and Gynecology (for example: urine flow control & regulator leak prevention, a U.S. market of twenty million Americans who suffer from urinary incontinence).

Acronym	S.S.C.T. (Reference Number: 5660)
Duration	12/08/2010 - 12/08/2013
Project Topic	Development of a technology which provides a more than significant improvement of the current way of Hemodialysis treatment by minimizing the cost, side-effects and pain suffered. The technology creates a new way of blood flow control formed by an implanted device and an easy-to-use operating system
Project Results (after finalisation)	FIRST OF ALL: K.S.T. Dynamics Ltd. did not receive Eurostars subsidy for this project._x000D__x000D_The CO results of the SSCT project can be divided into three categories:_x000D_1. Medical/Physiological_x000D_2. Technological _x000D_3. IPR_x000D__x000D__x000D_1. MEDICAL/PHYSIOLOGICAL_x000D__x000D_A). The project medical background: Over 1.6 million patients globally undergo chronic Hemodialysis treatment each year as treatment for renal failure. Conventional hemodialysis treatment requires extensive and often extended, long-term vascular access. Access to the patient blood supply is generally sought through the shunt, which is usually accomplished by surgically created communications between the native artery and vein. The access that is created (hemodialysis shunt) is routinely used for hemodialysis treatment. The hemodynamic complications that occur in hemodialysis shunts are thrombosis, stenosis, aneurysm formation, ischemia, steal syndrome and heart failure. These complications are related COly to permanent hemodynamic alterations such as high blood flow and flow turbulence leading to endothelial dysfunction and intimal hyperplasia._x000D__x000D_B). The proposed medical solution history – Controlling and regulating the blood flow and pressure in the shunt (synthetic graft or native fistula) will significantly decrease flow-dependent and intimal hyperplasia dependent complications and improve patency rate of porcine arteriovenous grafts. The kinetic structure of the implanted SSCT device and its operating system enable to narrow or widen the shunt cross section in a gradual way, providing to control blood flow and pressure within the shunt without causing blood flow turbulence, physical stress and stagnation points. A shunt could be put into a “passive” mode in times when the shunt is not used for Hemodialysis treatment. _x000D__x000D_C). The medical/physiological outcome of the simulations and pre-clinical studies have partially substantiated the project hypothesis claim, indicating that the SSCT device decreases patency rates; in addition the histological analyses determined that partial occlusion generated within the shunt was due to intimal hyperplasia and not due to acute thrombosis._x000D__x000D_2. TECHNOLOGICAL _x000D__x000D_A). The developed SSCT device is based on an innovative operating principle with a novel geometry kinetic structure of an implanted encapsulated device that is positioned around Hemodialysis fistulas/grafts. The SSCT kinetic structure is to respond to an external induction of electromagnetic stimulation (generated by the developed operating system) through the patient skin, narrowing or enlarging the fistula diameter cross section in a gradual way and therefore enables controllable blood flow and pressure._x000D__x000D_B). The mechanical control mechanism of the implanted device has been volumetrically reduced several times during the course of the project in order to enable effective animal carotids implementation during the pre-clinical studies. The control mechanism adjustment of the partial occlusion was developed in two stages:_x000D__x000D_ - Preset adjustment, prior to final implementation surgical procedure._x000D_ - Online adjustment, following implementation surgical procedure was successfully tested only on simulated shunts, due_x000D_ device implanted depth limitation within tested animal. _x000D__x000D_C). The external operating control system was developed and originally tested successfully on simulated models only using the implanted mechanical device. During the pre-clinical trials it appeared that its functioning was directly dependent upon the depth of implant and that the strength of the electromagnetic signal was unable to reach the implanted device when implanted at greater depths. A significantly increase magnetic source would have been necessary to provide the strength needed, however this is not possible COly due to the electrical interference to other medical appliances._x000D__x000D_3. IPR_x000D_National patent was submitted and granted in The Netherlands._x000D__x000D_
Network	Eurostars
Call	Eurostars Cut-Off 4

Project partner

Number	Name	Role	Country
2	Geva Sol B.V.	Coordinator	Netherlands
2	K.S.T. Dynamics Ltd	Partner	Israel