Gerresheimer item optimizes a TAVI delivery system for minimally invasive implantation
Düsseldorf/ Münster/ Regensburg, July 7, 2015. When heart valves get constricted or don’t close properly, putting a person’s life at risk, artificial heart valves can help. A minimally invasive approach is often taken with elderly patients who aren’t fit enough for open-heart surgery. Gerresheimer item GmbH optimized the delivery device so that the insertion of the heart valve via catheter is a simple and safe as possible for its customer JenaValve.
An artificial heart valve that can be compressed small enough to fit into a catheter is necessary for minimally invasive aortic valve implantation. JenaValve GmbH uses a self-expanding Nitinol stent with a tissue prosthesis for this purpose. This material has an excellent shape memory. It is very elastic at low temperatures and does not revert to its original shape until it warms up. The surgeon inserts the refrigerated artificial valve into the beating heart via the defective aortic valve. When it warms to body temperature it expands and immediately starts to perform its function.
For the launch of a second, optimized generation of aortic valves, JenaValve needed an optimized delivery system that considerably simplified the surgical procedure. Gerresheimer item GmbH was requested to optimize the design of the operating handle in terms of its ergonomics.
The customer naturally had high requirements of product design for several reasons. Firstly, it wanted a system that underlined its status as innovation leader in its market. Above all, bearing in mind the time pressure during heart surgery, the product had to have a simple and intuitive operating concept. So the most elementary product requirement was easy handling without the assistance of a second person at all times. Another requirements was a design that facilitated ergonomic operation. All controls had to be reliably operable, even with a slippery surface or if the user wears surgical gloves. The number of operating elements also had to be reduced to the minimum to make processes as simple and plausible as possible, thereby preventing mistakes in time-critical situations.
Gerresheimer item GmbH's optimized product comprised a handle with just one single control element plus a lock button. During the process of positioning the artificial heart valve, the lock button is released by rotating it one position to the right so that the operating ring can be used. This rules out any uncertainty about operating sequences or incorrect use.
Gerresheimer AG is one of the world’s leading partners to the pharma and healthcare industry with a comprehensive range of primary packaging and drug delivery products. As a full-service provider, it covers all stages of the value chain. The company in the Gerresheimer Group that is responsible for the earliest phase of the value chain, when a concept is developed into series production readiness, is Gerresheimer item GmbH. This Münster-based service company has over 10 years of experience in the fields of product design and development. In projects it collaborates closely with Gerresheimer’s Technical Competence Centers in Germany, the USA and China.
This allows Gerresheimer to contribute its extensive industrialization competence to the development of the product even in the design phase. Customers profit as a result because lead times, development costs and project risks are reduced due to the fact that optimization for polymer processing after product development is no longer necessary. Another advantage is that Gerresheimer item GmbH is an independent company. When the product development phase concludes, the customer can decide whether to have its product manufactured in series at one of Gerresheimer’s facilities, or whether to go to another manufacturer. For example, JenaValve has its TAVI delivery system manufactured by another company.
Gerresheimer item GmbH optimized an ergonomic handle for a new catheter delivery system called Cathlete on behalf of JenaValve Technology, a leading, highly specialized medical technology supplier.
Gerresheimer is a leading global partner to the pharma and healthcare industries. The company’s special glass and plastic products contribute to health and well-being. Gerresheimer is a global organization with 11,000 employees and manufacturing operations in the local markets, close to customers. It has over 40 production facilities in Europe, North and South America and Asia generating revenue in excess of EUR 1.3 billion. The comprehensive product portfolio includes pharmaceutical packaging products as well as convenient and safe drug delivery systems such as insulin pens, inhalers, pre-fillable syringes, vials, ampoules, bottles and containers for liquid and solid pharmaceuticals with closure and safety systems, plus cosmetic packaging products.