Project: Irrigation-aspiration catheter for local drug delivery without volume restrictions

Background_x000D_Cancerous and infectious diseases are highly prevalent in thoracic and abdominal surgeries, of which 18 million people undergo annually in Europe alone. Cancer is often treated through chemotherapy, but it has serious side effects; one study (BBC News Report, 2008-11-09) found that 27% of chemotherapy patients died from or had their deaths hastened by chemotherapy due to the toxicity. This mortality is often a consequence of organ and tissue damage caused by the chemotherapeutic drug. Treatment of tumors or diseases is often done systemically, where a patient’s entire body is exposed, hence the toxicity. _x000D__x000D_Drug resistance and side effects are two major problems concerning chemotherapy treatments and infections of body and brain. Both problems can be addressed successfully by local drug administration but there are actually no drug delivery systems able to deliver therapeutic concentrations locally to non-dermatological pathologies. _x000D__x000D_During treatment of infections, catheters are often used to aspirate bodily fluids. These are however insufficient as existing catheters clog due to the high viscosity of the fluids. To date, there are no catheters for the evacuation of bodily fluids that do not clog, putting patients’ lives at risk._x000D__x000D_Local administration of medications without volume restrictions and anti-blocking mechanism_x000D_Chemotherapy administered intravenously (systematically) can cause serious side effects. A direct delivery of the drugs through a tube or catheter able to deliver therapeutic volumes will conquer systemic toxicity and is less toxic to surrounding organs. A commonly used chemotherapy pump can administer drugs at a rate of at a rate of 2.5 to 3 ml/day, whereas the IRRAS’ technology platform enables an infusion rate of several liters/day. _x000D__x000D_In addition to delivering medications, IRRAS’ catheter system will effectively aspirate fluids and debris from the treatment site which is a breakthrough in disease treatment and management. Thereby it does not allow neoplastic reactive tissue formation that blocks the catheter, causing clogging._x000D__x000D_Market Applications_x000D_The catheter will be used for drug delivery and aspiration treating infections and cancers. The targeted areas will be abdominal and thoracic infections and cancers as these are most prevalent. Addressing critical patients with high mortality and morbidity rates is the aim for IRRAS novel catheter._x000D__x000D_Competitive technologies_x000D_Existing technologies for drug delivery include systemically administered medications, either orally or by injection, and locally administered medications in small amounts either by injection or local pump. However, these have restrictions in terms of volume as no direct aspiration function is present._x000D__x000D_Several types of infusion pumps and administration catheter sets exist on the market. Nevertheless, so far no system exists that can continuously irrigate and aspirate fluids in a pressure and volume controlled way. _x000D__x000D_Prior technologies_x000D_A previous drainage catheter was developed by IRRAS for use in the central nervous system. It has been successful in multi-center clinical research trials including 70 patients. The results have been presented in a case report accepted at the 14th European Congress for Neurosurgery and in the Asian Journal of Neurosurgery. These publications testify for IRRAS’ superiority to existing treatment methods in 8 major neurosurgical pathologies._x000D__x000D_Participating parties_x000D_The consortium within this project involves expertise in product development, engineering, medical technology, regulatory proceedings and clinical trials:_x000D__x000D_1. IRRAS AB – A Swedish medical technology SME that developed the previous catheter and owns the IPR, hereinafter referred to as IRRAS. The company provides expertise in surgery and disease treatment. _x000D__x000D_2. HotSwap AB – An R&D performing SME, specialized in engineering of medical devices from design to working prototype, hereinafter referred to as HotSwap._x000D__x000D_3. Medicoplast International GmbH – A German SME focusing on the developing, producing and sterilizing medical disposables of plastic, hereinafter referred to as Medicoplast._x000D__x000D_4. Oslo University Hospital – One of the largest hospitals in Scandinavia, with expertise within surgery, end-user trials, and clinical studies, hereinafter referred to as Oslo University Hospital. _x000D__x000D_Expected aims of the project:_x000D_1. Validation of the prototype’s technical applicability_x000D_2. Finalization of the catheter to be used in clinical trials_x000D_3. Completion of clinical study_x000D_4. Protection of IPR_x000D_5. Acquisition of the CE-mark_x000D_6. Formation of strategic alliances _x000D_

Acronym DDC (Reference Number: 8000)
Duration 01/06/2013 - 30/09/2016
Project Topic This project proposal concerns the development of a novel drug delivery catheter with the ability to simultaneously aspirate and irrigate fluids from and into body cavities. It provides an alternative to systemic treatments of cancerous and infectious diseases, thus removing severe adverse effects.
Network Eurostars
Call Eurostars Cut-Off 9

Project partner

Number Name Role Country
4 Oslo University Hospital Partner Norway
4 Medicoplast International GmbH Partner Germany
4 HotSwap Jönköping Aktiebolag Partner Sweden
4 IRRAS AB Coordinator Sweden